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Two-Year Prospective Cohort Study on Quality of Life Outcomes Among People Living With HIV After Initiation of Antiretroviral Therapy in Guangxi, China
Accepted Manuscript Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China Ming Zhongqiang, PhD Dimitri Prybylski, PhD, MPH Cheng Feng, PhD Rangsima Airawanwat, PhD Zhu Qiuying, MPH Liu Wei, MD Huang Shaobiao, MD PII:
S1055-3290(14)00094-6
DOI:
10.1016/j.jana.2014.04.003
Reference:
JANA 652
To appear in:
Journal of the Association of Nurses in AIDS Care
Received Date: 9 December 2013 Accepted Date: 14 April 2014
Please cite this article as: ZhongqiangM., PrybylskiD., FengC., AirawanwatR., QiuyingZ., WeiL. & ShaobiaoH., Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China, Journal of the Association of Nurses in AIDS Care (2014), doi: 10.1016/j.jana.2014.04.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China Ming Zhongqiang, PhD Dimitri Prybylski, PhD, MPH
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Cheng Feng, PhD Rangsima Airawanwat, PhD Zhu Qiuying, MPH Liu Wei, MD
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Huang Shaobiao, MD
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Ming Zhongqiang, PhD, is Adjunct Faculty, Research Center for Public Health, Tsinghua University and Program Manager of FHI 360 China Office, Beijing, China. Dimitri Prybylski, PhD, MPH, is an epidemiologist of the FHI 360 Asia Pacific Regional Office, Bangkok, Thailand. Cheng Feng, PhD, is a Professor, Research Center for Public Health, Tsinghua University and former Country Director of FHI 360 China Office, Beijing, China. Rangsima Airawanwat, PhD, is an Associate Country Director of FHI 360 China Office, Kunming City, Yunnan Province, China. Zhu Qiuying, MPH, is an Associate Professor, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi Autonomous Region, China. Liu Wei, MD, is Professor, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi Autonomous Region, China. Huang Shaobiao, MD, is Clinical Director, 4th Nanning Hospital ART Clinic, Nanning, Guangxi Autonomous Region, China.
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Corresponding Author: Cheng Feng: [email protected]
Conflict of Interest Statement
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The authors report no real or perceived vested interests that relate to this article that could be construed as a conflict of interest. Acknowledgements
The study was supported by USAID under the TASCIII TASC Order 2 – Technical Support for HIV/AIDS Prevention, Care and Treatment – RDMA, Contract Number: GHS-I-00-07-0007-00. We would like to thank Mr. Tang Zhi Rong, Ms. Luo Hui Ping, Mr. Huang Shao Biao, Ms. Mei Qin Ying, Ms. Nong Ying Xing, Mr. Hua He Hai, Ms. Huang Yi Feng, Mr. Shuang Wei Fa, Mr. Li Kai Hua, Mr. Wen Xiao Qing, and Ms. Zhou Yun for their great contributions to the implementation of this study. We are most grateful to all study respondents for their valuable participation.
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ABSTRACT The long-term impact of antiretroviral therapy (ART) on quality of life (QOL) is not well
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understood in China. From 2007-2008, 332 treatment-naïve, HIV-infected adults from 5
hospitals in Guangxi were enrolled in a 2-year prospective cohort study. Information was collected at the time of ART initiation and during 6-, 12-, and 24-month follow-up visits.
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Significant improvements were observed across all QOL domains during the first 6 months on ART as measured using the WHOQOL-HIV BREF instrument. These were closely tracked by
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increases in CD4+ T cell counts, total lymphocyte counts, and the Karnofsky performance scores (p < .05). After 6 months, improvements were smaller and uneven across QOL domains; social relationships was the only domain to not significantly improve at 24 months compared to baseline. Poorer and socially isolated participants had lower QOL outcomes. Strengthening ART
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program interventions to increase social support for patients may increase QOL outcomes.
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Key words: antiretroviral therapy; cohort; Guangxi, China; HIV infection; quality of life
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Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China Guangxi has a total population of 48.6 million people (Chinese Statistic Bureau, 2011)
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and is located in southern China bordering Northern Vietnam and four other Chinese provinces. Although Guangxi has historically been one of the less developed provinces in China, it has experienced rapid economic growth and urbanization (Population Division of the Department of
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Economic and Social Affairs of the United Nations Secretariat, 2009). It is also one of the
provinces most seriously affected by the HIV epidemic in China (Ministry of Health of the
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People's Republic of China, 2010; State Council AIDS Working Committee Office & United Nations Theme Group on AIDS in China, 2007). By 2008, it was estimated that there were 50,000-80,000 people living with HIV (PLWH) in Guangxi (State Council AIDS Working Committee Office & United Nations Theme Group on AIDS in China, 2007). Guangxi has the
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second highest cumulative number of reported HIV and AIDS cases in all of China (Ministry of Health of the People's Republic of China, 2010; State Council AIDS Working Committee Office & United Nations Theme Group on AIDS in China, 2007).
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As the HIV epidemic continues to mature in Guangxi, it puts increasing pressure on the ability to provide care, treatment, and support services (Zhang et al., 2009). Antiretroviral
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therapy (ART) can dramatically reduce HIV-related morbidity and mortality by interfering with the life cycle of the virus, reducing the viral load, and ultimately preserving immune function (Mayor, Gomez, Rios-Oliveras, & Hunter-Mellado, 2005). Within the framework of a comprehensive program that responds to the needs of PLWH across a continuum of care, the introduction of ART has transformed HIV into a manageable chronic illness in diverse settings. The resulting benefits are twofold: PLWH have reduced morbidity and mortality and better
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quality of life (QOL) and, for society, individuals are restored to productive participation in social and economic activities in their communities. PLWH typically face many new physical, psychological, and social challenges, often
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resulting from stigma and discrimination. The World Health Organization (WHO) developed a broad definition of QOL to facilitate cross-cultural comparisons for research purposes. QOL is defined as “individuals’ perception of their position in life in the context of the culture and value
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systems in which they live and in relation to their goals, expectations, standards and concerns” (The World Health Organization Quality of Life [WHOQOL] Group, 1995, p. 1403). The
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WHOQOL Group developed two validated and reliable generic QOL instruments that were created for international research across different cultures and settings; these are the QOL long form (The WHOQOL Group, 1998b) and its condensed brief version, the WHOQOL-BREF (The WHOQOL Group, 1998a). The WHOQOL-HIV Group (2004) further developed new
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instruments to address specific aspects of QOL for PLWH: the WHOQOL-HIV (O'Connell, Skevington, & Saxena, 2003) and the WHOQOL-HIV BREF, a shorter version of the WHOQOL-HIV, with a total of 31 items (O'Connell & Skevington, 2010). The WHOQOL-HIV
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BREF has been used and validated in diverse international settings (Chandra et al., 2006; Marcellin et al., 2007; O'Connell & Skevington, 2010; Saddki et al., 2009), including China
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(Hsiung, Fang, Chang, Chen, & Wang, 2005; Shan et al., 2011), and it is especially appropriate to use in resource-poor settings to maximize efficiency of staff-patient interactions for research purposes.
Delivery of ART began in Guangxi in 2004. The international non-governmental organization, FHI 360, collaborated with the Guangxi Centers for Disease Control and Prevention to provide HIV-related prevention, care, treatment, and support programs in select
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hot-spot sites in Guangxi. By December 2007, about 5,000 HIV-infected patients in Guangxi had received ART, but the impact of ART on quality of life (QOL) has not yet been evaluated. To complement existing routine clinical and laboratory monitoring activities, this multi-center
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prospective 2-year cohort study was conducted to further understand the impact of ART on QOL outcomes over time. Specifically, our study had two objectives: (a) to explore whether treatmentnaïve adults in Guangxi initiating ART experience improvements in QOL during the first 24
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months of therapy, and (b) to identify sociodemographic and clinical factors associated with
patient care and ART programs.
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QOL status over time. It was anticipated that the results would provide evidence to improve
Method Study Design
Our study was a prospective observational cohort study of HIV-infected patients
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initiating ART, conducted across five participating government health facilities in Guangxi, China. Study participants were enrolled from May 2007 to May 2008 and followed longitudinally for up to 2 years. Standardized forms were administered at baseline (initiation of
Study Subjects
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ART) and during follow-up visits at 6, 12, and 24 months.
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All adult patients who met study inclusion criteria were invited to participate in our observational study. The inclusion criteria were: (a) confirmed diagnosis of HIV infection; (b) medical eligibility according to the National Free Antiretroviral Treatment Program (CD4+ T cell count < 200 cells/mm3, total lymphocyte count < 1,200 cells/mm3, or WHO stage 3 or 4 disease; Hsiung et al., 2005); (c) patient readiness (including clinical readiness, adherence, education, family/peer support); (d) 18 years of age or older; (e) ART naïve; (f) aware that
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participation was voluntary and signed the informed consent form; and (g) capable of verbally completing the interviews. Study Sites
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Participants were recruited from five government health facilities. These were: (a)
Guangxi CDC ART clinic, (b) Nanning Number 4 Hospital ART clinic, (c) Pingxiang ART clinic, (d) Giguang City People’s Hospital, and (e) Guilin Third People’s Hospital.
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Ethical Review
We obtained written informed consent from all participants involved in our study who
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signed their own names on the informed consent form. The confidentiality of individuals was protected in the managing of individual patient files and the processing of personal data. Our study protocol and consent procedures were approved by the FHI 360 Protection of Human Subjects Committee and the local Guangxi Institutional Review Board, the Office of
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International Ethics. Data Collection Method and Instruments
Eligible patients who expressed an interest in participating in our study to their attending
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physicians were referred to an interviewer; the standardized informed consent form was read to the patient by the interviewer in the ART clinic. Patients were asked to sign the consent form if
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they agreed to participate. After completing the informed consent procedure, study participants were administered the detailed baseline and follow-up questionnaires during face-to-face interviews in a private setting. Patients were followed regularly and appointments were made to complete the 6-month, 12-month, and 24-month surveys. No incentives for study participation were provided. Structured questionnaires were developed specifically for our study and included data on
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sociodemographics, key clinical indicators such as the Karnofsky performance scale (Hsiung et al., 2005), CD4+ T cell counts (cells/mm3), total lymphocyte counts (cells/mL), and QOL information. QOL data were obtained using the standardized and validated WHOQOL-HIV
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BREF instrument, consisting of 31 items using Likert-type 5-point scales (Schag, Heinrich, & Ganz, 1984). The WHOQOL-HIV BREF provides 9 QOL scores including 6 domain scores (physical, psychological, level of independence, social relationships, environment, and
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spirituality), 2 health perception scores, and an overall QOL score constructed from the 8 previous sub-scales. All original scores were transformed to a 4-20 scale continuum for
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comparison purposes. Data Analysis
Statistical analysis was performed using the SAS statistical software package (version 9.1, SAS Institute Inc., Cary, North Carolina, USA). Internal consistency reliability of the
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WHOQOL-HIV BREF was assessed using Cronbach’s α coefficient at each of the assessment time points. Chi-square tests or Fisher’s Exact tests were used to compare categorical variables within each assessment round. McNemar’s test was used to compare categorical variables
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between different assessment rounds. For continuous variables, Student’s t-tests were used to compare QOL scores between groups within one assessment round, and paired t-tests were used
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to compare differences in QOL scores between different assessment rounds. All statistical tests were two-sided and a p-value less than 0.05 was considered statistically significant. Results
Recruitment and Follow-up Information A total of 332 baseline study participants were recruited between May 2007 and May 2008, and all 24-month follow-up surveys were completed by May 2010. Most participants
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(38.3%, n = 127) were recruited from the Guangxi CDC ART clinic, while 29.8% (n = 99), came from the Nanning Number 4 Hospital ART Clinic, and 19.6% (n = 65) from the Pingxiang ART clinic. The Guigang City Peoples’ Hospital ART department and Guilin 3rd People’s Hospital
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recruited 9.0% (n = 30) and 3.3% (n = 11) of participants, respectively. Of the 332 participants enrolled at baseline, 80.4%, 78.3%, and 74% successfully completed the 6-, 12-, and 24-month follow-up assessments, respectively (Table 1).
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Baseline Sociodemographic Characteristics of Study Participants
Of the baseline participants, approximately two thirds (68.1%) were male and the average
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age at baseline was 39.6 years (range = 20.2 - 76.5 years; Table 1). Participants had diverse education backgrounds; 33.2% had a primary school education or less; 21.5% had a middle school education; and 45.3% had a high school education. Almost two thirds (65.7%) of participants were married or cohabitating and only 14.8% of participants were living alone.
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Sixty-two percent of participants were rural farmers or unemployed. Most participants (59.4%) had an average monthly household income of less than 1,000 RMB (Table 2). Clinical Measures of Study Participants at Baseline and Follow-up
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The general wellbeing and activities of daily life of participants, as measured by the Karnofsky performance scale, showed steady and statistically significant improvements over
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time. Overall, average performance increased from 84.7 at baseline to 94.6 at 24 months (Table 3). Moreover, there were concomitant statistically significant improvements at each of the follow-up time points in both mean CD4+ T cell counts (from 107.1 cells/mm3 at baseline to 350.2 cells/mm3 at 24 months) and mean total lymphocyte counts (from 1,400 cells/mm3 at baseline to 2,500 cells/mm3 at 24 months). Quality of Life at Baseline and Follow-up Visits
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Cronbach’s α coefficients for the overall score of the WHOQOL-BREF at each of the assessment time points were high (0.88, 0.92, 0.91, and 0.93 at baseline, 6, 12, and 24 months, respectively). This demonstrated a high overall degree of internal consistency or reliability
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across the five study sites.
Consistent, statistically significant improvements in the overall QOL scale, overall
perception on QOL, and overall perception on health scale scores were observed as time on ART
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increased. Improvements of the greatest magnitude occurred during the first 6 months after initiating ART but statistically significant increases were also observed between 12 and 24
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months as well (Table 4). The mean physical and spirituality domain scores increased significantly between baseline and 6 months and plateaued between 6 and 12 months, before increasing significantly again between 12 and 24 months. The mean psychological domain scores showed a similar trend but actually decreased significantly between 6 and 12 months
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before increasing significantly between 12 and 24 months (Table 4). The average level of independence and environment domain scores increased significantly during the first 6 months on ART but then stabilized with no further significant changes over time. The social
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relationships domain scores improved significantly between baseline and 6 months but then decreased significantly between 6 and 12 months and showed no overall increase at 24 months
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compared to baseline.
Relationships Between Sociodemographic Characteristics and Overall QOL Scores Over Time
The average overall QOL summary scale scores were similar between male and female participants at baseline (Table 5). Similar increases in overall QOL were observed for both males and females between baseline and 6 months. However, the average overall QOL score stabilized
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after 6 months for males and females and were not significantly improved at 24 months. Married or cohabitating participants generally had higher overall QOL scores than unmarried, divorced, or widowed participants and this difference was statistically significant at
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the 6-month follow-up visit (Table 5). For both groups, statistically significant increases in overall QOL were observed after initiation on ART and follow-up for 6 months. However, these gains did not significantly improve between 6 and 24 months of follow-up for either group.
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Employed participants had higher QOL scores at baseline and 6 months compared to
unemployed participants or rural farmers. Statistically significant improvements in overall QOL
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were observed between baseline and 6 months of follow-up regardless of employment status (Table 5). For both groups, overall QOL scores stabilized after 6 months and did not show further significant improvement at 24 months of follow-up.
Participants who were living with others had higher overall QOL scores than those living
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alone at the 6-month time period (Table 5). However, participants in both groups showed statistically significant improvements in overall QOL scores after initiation and follow-up on ART. Among participants living alone, further significant improvements were found between 6
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and 24 months. On the other hand, among those living with others no further statistically significant improvements in overall QOL were observed between 6 and 24 months of follow-up.
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There were no significant differences across age categories in overall QOL at baseline or at any of the follow-up time points (Table 5). Participants in all four age categories showed statistically significant improvements in overall QOL scores between baseline and 6 months. However, no statistically significant improvements were noted for any of the age groups between the 6- and 24-month time intervals on ART despite significant fluctuations between these two time points.
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Participants with higher education status tended to have higher overall QOL scores but these differences were not statistically significant at any of the assessment periods (Table 5). Statistically significant improvements in overall QOL scores were observed in all three strata of
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education status between baseline and 6 months (Table 5). However, these positive trends
leveled off after 6 months and there were no further significant increases in overall QOL scores noted at 24 months despite some temporary significant changes during the intermediate
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assessment time points.
Participants in the highest strata of monthly household income (i.e., ≥ 1,000 RMB) had
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significantly higher overall QOL scores at baseline than participants with lower income (Table 5). Participants in all income categories showed statistically significant increases on overall QOL scores between the baseline and 6-month follow-up visits. However, no statistically significant increases were seen between the 6-month and 24-month follow-up visits across any of the
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income categories despite significant changes during intermediate follow-up intervals. Discussion
This prospective observational cohort study of QOL among treatment-naïve individuals
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initiating ART is one of few such studies conducted in China and to our knowledge has the longest period of follow-up (24 months). As a result, our study gives a clearer picture of the
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long-term relationship between ART and QOL than the cross-sectional or short-duration followup studies commonly reported in the literature. Additionally, this observational multi-site study used a standardized inclusion criteria based on national treatment guidelines. This allowed data to be pooled over five major hospitals in Guangxi and increased the statistical power of the study. The observational design of our study kept costs low and allowed for the recruitment of individuals from diverse sociodemographic backgrounds. Hence, the results are more broadly
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representative of persons initiating ART than clinical trials of short duration that enroll selected study populations (Liu, Weber et al., 2006). The WHOQOL-HIV BREF instrument used in our study showed high internal
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consistency and validity across the four assessment time points. This corroborated experiences with the use of this instrument in other settings in China (Hsiung et al., 2005; Shan et al., 2011). Our study showed improvements in QOL among a cohort of treatment naïve patients
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initiating ART. However, the speed and magnitude of improvement was consistently greatest during the first 6 months after ART initiation. After 6 months, improvements were smaller and
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uneven across QOL domains. Nevertheless, all QOL domain scores increased significantly between 6 and 24 months of follow-up with the exception of social relationships. The rapid improvement in QOL observed shortly after ART initiation was consistent with the results of other studies reported in the literature (Jelsma, Maclean, Hughes, Tinise, & Darder, 2005;
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Mannheimer et al., 2005; Stangl, Wamai, Mermin, Awor, & Bunnell, 2007). A U.S.-based cohort study also demonstrated significant short-term ART effects on most QOL domains between 6 and 12 months after ART initiation. However, additional use of ART did not modify long-term
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trends (Liu, Weber, et al., 2006). In our study, the most plausible reasons for the initial shortterm increase in QOL related to ART initiation were the rapid improvements in physical health
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due to increased immune function and reduced physical symptoms. This hypothesis was supported by the rapid concomitant increases we observed in CD4+ T cell counts, total lymphocyte counts, and general wellbeing and activities of daily life. Other longitudinal studies have shown significant associations between CD4+ T cell counts, viral loads, and QOL (Call et al., 2000; Jia, Uphold, Wu, Chen, & Duncan, 2005; Murri et al., 2003; Stangl et al., 2007). However, after initial short-term improvement, studies that followed patients for longer than 12
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months found less consistent associations (Mannheimer et al., 2005; Mrus, Williams, Tsevat, Cohn, & Wu, 2005; Stangl et al., 2007). In our study, the only QOL domain not to show significant improvement between
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baseline and 24-month follow-up was social relationships. The level of independence and
environment domains showed significant improvements only between baseline and 6 months and
amenable to QOL improvement simply by starting ART.
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stabilized thereafter. These domains are influenced by broader factors that may not be as
A national 5-year analysis of immunological treatment outcomes in China showed that
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short-term gains in CD4+ T cell counts stabilized over time and treatment failure rates increased over time when second-line treatment options were not available (Zhang et al., 2009). This is likely to have negative repercussions for long-term QOL outcomes and indicates the need for longer-term studies of the interactions of clinical markers and QOL. Zhang et al. (2009) reported
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that 81% of patients had symptoms when they initiated ART in China. Nieuwkerk et al. (2000) showed that the QOL of patients with symptoms was significantly better compared to patients without symptoms after initiation of ART.
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In our study, no significant differences in QOL were observed by gender, age, or education status. Studies in the literature have demonstrated relationships between gender and
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QOL, usually favoring males (Mannheimer et al., 2005; Molassiotis, Callaghan, Twinn, & Lam, 2001; Mrus et al., 2005; Shan et al., 2011); other studies also found no gender differences (Bastardo & Kimberlin, 2000; Shan et al., 2011). Many studies showed that age played important roles on QOL (Xiang, Wang, & Fu, 2005; Xie et al., 2006; Zhang & Sheng, 2008; Zhao et al., 2008) and elderly persons had lower QOL (Kuang, Li, Ma, & Liao, 2005; Xiang, Fu, & Wang, 2004; Zhang & Sheng, 2008). Some studies found a positive association between age and QOL,
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with elderly individuals having higher QOL (Xie et al., 2006). Stangl et al. (2007) also found no significant differences by age group. Our study showed that unemployed participants and rural farmers had lower overall QOL than their employed counterparts at baseline and this difference
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persisted at 6 months despite significant increases in QOL in both groups. Rural farmers also had lower QOL scores in a recent study in Henan province (Shan et al., 2011). Other studies also found that persons with higher household income had higher overall QOL scores than lower
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income groups (Eriksson, Nordstrom, Berglund, & Sandstrom, 2000; Ma, He, Ye, & Wang, 2006; Sheng, He, Zhang, & Qiu, 2008).
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In summary, our study shows that poorer participants, with less access to social support, tended to have lower overall QOL. The importance of social support in improving QOL outcomes have been identified in diverse settings worldwide (Bastardo & Kimberlin, 2000; Friedland, Renwick, & McColl, 1996; Jia et al., 2004; Jia et al., 2005; Liu, Johnson et al., 2006;
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Molassiotis et al., 2001; Stangl et al., 2007). More recently, Rao et al. (2012) showed that social support mediated the relationship of HIV stigma, depression, and QOL in PLWH in Beijing, China. More in-depth study is required to elucidate the reasons for these associations, but our
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study results suggest that strengthening social support mechanisms in clinical and/or communitybased settings could further improve QOL outcomes in Guangxi.
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Our study had several limitations. First, some participants interviewed at baseline were lost to follow-up over time. However, the high retention rate of participants in our study minimized this bias. Moreover, improvements in QOL paralleled increases in CD4+ T cell counts supporting a positive influence of ART. Second, the face-to-face interviews may have led to social desirability biases and inflated QOL scores. However, nurses and counselors were trained to conduct the interviews in a non-judgmental way and changes over time were consistent
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across study sites. Third, all the patients in the study were outpatients. Hence, our study results may not be generalizable to inpatients or patients with more severe conditions. Lastly, we could not examine important variables such as adherence to ART, social support, stigma, and
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discrimination.
In conclusion, our study showed large improvements in QOL among HIV-infected
treatment-naïve adults in Guangxi, with inconsistent and smaller improvements thereafter.
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Poorer, unemployed, and unmarried persons who were living alone had poorer QOL outcomes and it will be important that future research is conducted to gain a more detailed understanding
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clinical and programmatic interventions.
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of the mechanisms that influence QOL to more clearly tailor the development of appropriate
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AIDS patients during terminal stage in Weishi county, Henan province. Chinese Journal of Nursing, 43(07), 655-658. Stangl, A. L., Wamai, N., Mermin, J., Awor, A. C., & Bunnell, R. E. (2007). Trends and
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The World Health Organization Quality of Life Group. (1998b). The World Health Organization Quality of Life Assessment (WHOQOL): Development and general psychometric
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World Health Organization Quality of Life HIV Group. (2004). WHOQOL-HIV for quality of life assessment among people living with HIV and AIDS: Results from the field test. AIDS Care, 16, 882-889. doi:10.1080/09540120412331290194 Xiang, F., Fu, L., & Wang, Y. (2004). Assessing health-related quality of life in AIDS patients.
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Foreign Medical Sciences Epidemiology Lemology, 31(2), 74-75. Xiang, F., Wang, Y., & Fu, L. (2005). Assessing health-related quality of life in AIDS patients. Foreign Medical Sciences Epidemiology Lemology, 32(3), 138-139.
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Xie, J., Shi, X., Wang, F., Gong, C., Chang, L., & Le, M. (2006). Multiple linear regression analysis on influencing factors of quality of life in AIDS patients. Chinese Journal of Clinical Rehabilitation, 10(38), 14-16.
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outcomes of the China National free antiretroviral treatment program. Annals of Internal
Zhang, Y., & Sheng, Y. (2008). Current situation of the suties on quality of life and influencing factor of peopel living with HIV/AIDS. Chinese Journal of Nursing, 43(1), 69-71. Zhao, Y., Zhang, F., Chen, C., Gao, B., Gao, G., Xu, Q., ... Yu, L. (2008). Study on quality of
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life in AIDS patients receiving short-term highly active antiretroviral therapy (HAART).
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Chinese Journal of AIDS STD, 14(3), 217-219.
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Table 1
Completed survey Died Transferred out of facility Lost to follow-up Did not complete survey*
6 months N % 267 80.4 20 6.0 13 3.9 7 2.1 25 7.5
12 months N % 260 78.3 22 6.6 25 7.5 20 6.0 5 1.5
24 months N % 246 74.0 28 8.0 27 8.1 19 5.7 12 3.6
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Follow-up results
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Status of Baseline Participants (N = 332) in the Prospective Cohort Study at Follow-up Assessment Time Points
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Note. * = These patients were known to still be on antiretroviral therapy at the health facility they enrolled in but did not complete interviews at the scheduled assessment visit.
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Table 2
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Baseline Sociodemographic Characteristics of Study Participants (N = 332)
Male Female
Age group
20-29 years 30-39 years ≥ 40 years
95 28.7 105 31.7 131 39.6
Education
Primary school or less Middle school High middle school or above
Marriage status
Married or cohabitating Unmarried/divorced/widowed
218 65.7 114 34.3
Occupation
Unemployed/farmer Employed
204 62.0 125 38.0
Live alone
110 33.2 150 45.3 71 21.5
Yes No
43 14.8 247 85.2
< 500 RMB 500 - 999 RMB ≥ 1000 RMB
95 30.8 88 28.6 125 40.6
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Household monthly average income
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Gender
Baseline N % 226 68.1 106 31.9
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Note. Not all variables add up to 332 because of missing values. RMB =
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Table 3 Clinical Measures Among Study Participants at Baseline and Follow-up Assessment Visits Baseline 6 months 12 months 24 months N Mean N Mean N Mean N Mean 332 84.7 a 262 91.5 b 257 93.5 c 241 94.6 d
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Clinical measures
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Karnofsky Performance Scale scores Total Lymphocyte Count 330 1.4 a 254 1.8 b 254 2.0 c 240 2.5 d (cells/mL) CD4+ T Count (cells/mm3) 330 107.1 a 254 223.5 b 248 269.1 c 237 350.2 d Note. Column values that do not share a common letter for each measure across assessment periods (i.e., table rows) are significantly different from each other (p < .05). For example “d” = significantly different from “a,” “b,” and “c.”
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Table 4 Quality of Life Scores at Baseline and Follow-up Assessment Visit Time Points 6 months N Mean 266 12.6 266 12.9 264 14.4 264 13.1 264 13.6 263 12.0 264 12.4 263 13.1 267 13.0
12 months N Mean 260 12.6 259 13.0 258 14.2 258 12.8 258 13.7 257 11.6 257 12.0 258 12.9 260 12.8
24 months N Mean 243 13.4 c 243 13.7 c 241 14.8 c 241 13.6 d 241 13.8 b 241 11.8 a 240 12.2 bc 241 13.8 c 243 13.4 c
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Baseline N Mean 332 11.3 332 10.3 322 12.5 322 11.3 321 11.6 321 11.4 321 11.4 313 12.0 332 11.5
QOL domains
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Overall perception on quality of life a b b Overall perception on health a b b Physical a b b Psychological a b c Level of independence a b b Social relationships a b a Environment a b c Spirituality a b b Overall QOL score a b b Note. QOL = quality of life; Column values that do not share a common letter for each QOL domain across assessment
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periods (i.e., table rows) are significantly different from each other (p < 0.05). For example “d” = significantly different from “a,” “b,” and “c.”
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Table 5 Overall Quality of Life Scores by Sociodemographic Characteristics at Baseline and Follow-up Assessment Visit Time Points
a a
6 months N Mean 177 13.0 90 13.0
bc bc
12 months N Mean 179 12.9 81 12.7
b b
24 months N Mean 166 13.5 77 13.2
c c
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Baseline N Mean 226 11.5 106 11.5
Male Female
Marriage status
Married or cohabitating Unmarried/ divorced/widowed
218
11.6
a
181
13.2
b*
174
12.9
c
160
13.5
b
114
11.3
a
86
12.7
b
86
12.8
b
83
13.2
b
Unemployed/ farmer Employed
204
11.3
a*
158
12.8
bc*
152
12.7
b
144
13.2
c
125
11.7
a
106
13.4
bc
105
13.1
b
96
13.7
c
Live alone
Yes No
43 247
11.4 11.5
a a
Age group
20 - < 30 years 30 - < 40 years 40+ years
95 105 131
11.6 11.3 11.6
a a a
Education
Primary school or less Middle school High middle school or above
110
11.3
a
< 500 RMB 500 - 999 RMB
≥ 1000 RMB
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b* bc
31 200
12.7 12.9
bc b
30 181
13.2 13.4
c c
84 86 97
13.3 12.8 13.0
bc b bc
78 88 94
12.9 12.9 12.7
b b b
71 77 95
13.6 13.3 13.3
c b c
77
12.8
b
76
12.9
b
75
13.0
b
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Household monthly average income&
32 205
150 71
11.5 11.7
a a
125 64
13.0 13.4
bc bc
123 61
12.8 12.9
b b
110 58
13.4 13.7
c c
95 88
11.1 11.3
a1 a1
75 69
12.8 13.0
bc b
74 68
12.4 13.0
b b
70 65
13.0 13.3
c b
11.8
a2
101
13.2
bc
100
13.0
b
95
13.7
c
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Occupation
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Gender
125
Note. RMB =. Column values that do not share a common letter in each column are significantly different
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from each other across assessment periods (p < .05). * = Statistically significant differences within levels of the sociodemographic characteristic during the same assessment period (p < .05). & = Row values that do not share a common number in each row are significantly different from each other (p < .05).
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Key Considerations
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•
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Quality of life (QOL) is an important holistic measure of patient success in adhering to antiretroviral therapy (ART) and should be assessed in routine settings in addition to conventional clinical and laboratory measures. There were substantial improvements in all domains of QOL during the first 6 months of ART and these were closely tracked by concomitant increases in patient CD4+ T cell counts, total lymphocyte counts, and the Karnofsky performance scale. After 6 months on ART, improvements in QOL scale scores were smaller and uneven across domains, but social relationships was the only QOL domain not to significantly improve at 24 months on treatment. Patients with very low socioeconomic status and with less access to social support, tended to have lower QOL; strengthening of social support mechanisms in clinical and/or communitybased settings could further improve QOL outcomes.
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•
S1055-3290(14)00094-6
DOI:
10.1016/j.jana.2014.04.003
Reference:
JANA 652
To appear in:
Journal of the Association of Nurses in AIDS Care
Received Date: 9 December 2013 Accepted Date: 14 April 2014
Please cite this article as: ZhongqiangM., PrybylskiD., FengC., AirawanwatR., QiuyingZ., WeiL. & ShaobiaoH., Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China, Journal of the Association of Nurses in AIDS Care (2014), doi: 10.1016/j.jana.2014.04.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China Ming Zhongqiang, PhD Dimitri Prybylski, PhD, MPH
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Cheng Feng, PhD Rangsima Airawanwat, PhD Zhu Qiuying, MPH Liu Wei, MD
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Huang Shaobiao, MD
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Ming Zhongqiang, PhD, is Adjunct Faculty, Research Center for Public Health, Tsinghua University and Program Manager of FHI 360 China Office, Beijing, China. Dimitri Prybylski, PhD, MPH, is an epidemiologist of the FHI 360 Asia Pacific Regional Office, Bangkok, Thailand. Cheng Feng, PhD, is a Professor, Research Center for Public Health, Tsinghua University and former Country Director of FHI 360 China Office, Beijing, China. Rangsima Airawanwat, PhD, is an Associate Country Director of FHI 360 China Office, Kunming City, Yunnan Province, China. Zhu Qiuying, MPH, is an Associate Professor, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi Autonomous Region, China. Liu Wei, MD, is Professor, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi Autonomous Region, China. Huang Shaobiao, MD, is Clinical Director, 4th Nanning Hospital ART Clinic, Nanning, Guangxi Autonomous Region, China.
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Corresponding Author: Cheng Feng: [email protected]
Conflict of Interest Statement
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The authors report no real or perceived vested interests that relate to this article that could be construed as a conflict of interest. Acknowledgements
The study was supported by USAID under the TASCIII TASC Order 2 – Technical Support for HIV/AIDS Prevention, Care and Treatment – RDMA, Contract Number: GHS-I-00-07-0007-00. We would like to thank Mr. Tang Zhi Rong, Ms. Luo Hui Ping, Mr. Huang Shao Biao, Ms. Mei Qin Ying, Ms. Nong Ying Xing, Mr. Hua He Hai, Ms. Huang Yi Feng, Mr. Shuang Wei Fa, Mr. Li Kai Hua, Mr. Wen Xiao Qing, and Ms. Zhou Yun for their great contributions to the implementation of this study. We are most grateful to all study respondents for their valuable participation.
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ABSTRACT The long-term impact of antiretroviral therapy (ART) on quality of life (QOL) is not well
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understood in China. From 2007-2008, 332 treatment-naïve, HIV-infected adults from 5
hospitals in Guangxi were enrolled in a 2-year prospective cohort study. Information was collected at the time of ART initiation and during 6-, 12-, and 24-month follow-up visits.
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Significant improvements were observed across all QOL domains during the first 6 months on ART as measured using the WHOQOL-HIV BREF instrument. These were closely tracked by
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increases in CD4+ T cell counts, total lymphocyte counts, and the Karnofsky performance scores (p < .05). After 6 months, improvements were smaller and uneven across QOL domains; social relationships was the only domain to not significantly improve at 24 months compared to baseline. Poorer and socially isolated participants had lower QOL outcomes. Strengthening ART
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program interventions to increase social support for patients may increase QOL outcomes.
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Key words: antiretroviral therapy; cohort; Guangxi, China; HIV infection; quality of life
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Two-year prospective cohort study on quality of life outcomes among people living with HIV after initiation of antiretroviral therapy in Guangxi, China Guangxi has a total population of 48.6 million people (Chinese Statistic Bureau, 2011)
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and is located in southern China bordering Northern Vietnam and four other Chinese provinces. Although Guangxi has historically been one of the less developed provinces in China, it has experienced rapid economic growth and urbanization (Population Division of the Department of
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Economic and Social Affairs of the United Nations Secretariat, 2009). It is also one of the
provinces most seriously affected by the HIV epidemic in China (Ministry of Health of the
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People's Republic of China, 2010; State Council AIDS Working Committee Office & United Nations Theme Group on AIDS in China, 2007). By 2008, it was estimated that there were 50,000-80,000 people living with HIV (PLWH) in Guangxi (State Council AIDS Working Committee Office & United Nations Theme Group on AIDS in China, 2007). Guangxi has the
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second highest cumulative number of reported HIV and AIDS cases in all of China (Ministry of Health of the People's Republic of China, 2010; State Council AIDS Working Committee Office & United Nations Theme Group on AIDS in China, 2007).
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As the HIV epidemic continues to mature in Guangxi, it puts increasing pressure on the ability to provide care, treatment, and support services (Zhang et al., 2009). Antiretroviral
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therapy (ART) can dramatically reduce HIV-related morbidity and mortality by interfering with the life cycle of the virus, reducing the viral load, and ultimately preserving immune function (Mayor, Gomez, Rios-Oliveras, & Hunter-Mellado, 2005). Within the framework of a comprehensive program that responds to the needs of PLWH across a continuum of care, the introduction of ART has transformed HIV into a manageable chronic illness in diverse settings. The resulting benefits are twofold: PLWH have reduced morbidity and mortality and better
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quality of life (QOL) and, for society, individuals are restored to productive participation in social and economic activities in their communities. PLWH typically face many new physical, psychological, and social challenges, often
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resulting from stigma and discrimination. The World Health Organization (WHO) developed a broad definition of QOL to facilitate cross-cultural comparisons for research purposes. QOL is defined as “individuals’ perception of their position in life in the context of the culture and value
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systems in which they live and in relation to their goals, expectations, standards and concerns” (The World Health Organization Quality of Life [WHOQOL] Group, 1995, p. 1403). The
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WHOQOL Group developed two validated and reliable generic QOL instruments that were created for international research across different cultures and settings; these are the QOL long form (The WHOQOL Group, 1998b) and its condensed brief version, the WHOQOL-BREF (The WHOQOL Group, 1998a). The WHOQOL-HIV Group (2004) further developed new
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instruments to address specific aspects of QOL for PLWH: the WHOQOL-HIV (O'Connell, Skevington, & Saxena, 2003) and the WHOQOL-HIV BREF, a shorter version of the WHOQOL-HIV, with a total of 31 items (O'Connell & Skevington, 2010). The WHOQOL-HIV
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BREF has been used and validated in diverse international settings (Chandra et al., 2006; Marcellin et al., 2007; O'Connell & Skevington, 2010; Saddki et al., 2009), including China
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(Hsiung, Fang, Chang, Chen, & Wang, 2005; Shan et al., 2011), and it is especially appropriate to use in resource-poor settings to maximize efficiency of staff-patient interactions for research purposes.
Delivery of ART began in Guangxi in 2004. The international non-governmental organization, FHI 360, collaborated with the Guangxi Centers for Disease Control and Prevention to provide HIV-related prevention, care, treatment, and support programs in select
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hot-spot sites in Guangxi. By December 2007, about 5,000 HIV-infected patients in Guangxi had received ART, but the impact of ART on quality of life (QOL) has not yet been evaluated. To complement existing routine clinical and laboratory monitoring activities, this multi-center
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prospective 2-year cohort study was conducted to further understand the impact of ART on QOL outcomes over time. Specifically, our study had two objectives: (a) to explore whether treatmentnaïve adults in Guangxi initiating ART experience improvements in QOL during the first 24
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months of therapy, and (b) to identify sociodemographic and clinical factors associated with
patient care and ART programs.
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QOL status over time. It was anticipated that the results would provide evidence to improve
Method Study Design
Our study was a prospective observational cohort study of HIV-infected patients
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initiating ART, conducted across five participating government health facilities in Guangxi, China. Study participants were enrolled from May 2007 to May 2008 and followed longitudinally for up to 2 years. Standardized forms were administered at baseline (initiation of
Study Subjects
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ART) and during follow-up visits at 6, 12, and 24 months.
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All adult patients who met study inclusion criteria were invited to participate in our observational study. The inclusion criteria were: (a) confirmed diagnosis of HIV infection; (b) medical eligibility according to the National Free Antiretroviral Treatment Program (CD4+ T cell count < 200 cells/mm3, total lymphocyte count < 1,200 cells/mm3, or WHO stage 3 or 4 disease; Hsiung et al., 2005); (c) patient readiness (including clinical readiness, adherence, education, family/peer support); (d) 18 years of age or older; (e) ART naïve; (f) aware that
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participation was voluntary and signed the informed consent form; and (g) capable of verbally completing the interviews. Study Sites
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Participants were recruited from five government health facilities. These were: (a)
Guangxi CDC ART clinic, (b) Nanning Number 4 Hospital ART clinic, (c) Pingxiang ART clinic, (d) Giguang City People’s Hospital, and (e) Guilin Third People’s Hospital.
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Ethical Review
We obtained written informed consent from all participants involved in our study who
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signed their own names on the informed consent form. The confidentiality of individuals was protected in the managing of individual patient files and the processing of personal data. Our study protocol and consent procedures were approved by the FHI 360 Protection of Human Subjects Committee and the local Guangxi Institutional Review Board, the Office of
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International Ethics. Data Collection Method and Instruments
Eligible patients who expressed an interest in participating in our study to their attending
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physicians were referred to an interviewer; the standardized informed consent form was read to the patient by the interviewer in the ART clinic. Patients were asked to sign the consent form if
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they agreed to participate. After completing the informed consent procedure, study participants were administered the detailed baseline and follow-up questionnaires during face-to-face interviews in a private setting. Patients were followed regularly and appointments were made to complete the 6-month, 12-month, and 24-month surveys. No incentives for study participation were provided. Structured questionnaires were developed specifically for our study and included data on
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sociodemographics, key clinical indicators such as the Karnofsky performance scale (Hsiung et al., 2005), CD4+ T cell counts (cells/mm3), total lymphocyte counts (cells/mL), and QOL information. QOL data were obtained using the standardized and validated WHOQOL-HIV
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BREF instrument, consisting of 31 items using Likert-type 5-point scales (Schag, Heinrich, & Ganz, 1984). The WHOQOL-HIV BREF provides 9 QOL scores including 6 domain scores (physical, psychological, level of independence, social relationships, environment, and
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spirituality), 2 health perception scores, and an overall QOL score constructed from the 8 previous sub-scales. All original scores were transformed to a 4-20 scale continuum for
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comparison purposes. Data Analysis
Statistical analysis was performed using the SAS statistical software package (version 9.1, SAS Institute Inc., Cary, North Carolina, USA). Internal consistency reliability of the
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WHOQOL-HIV BREF was assessed using Cronbach’s α coefficient at each of the assessment time points. Chi-square tests or Fisher’s Exact tests were used to compare categorical variables within each assessment round. McNemar’s test was used to compare categorical variables
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between different assessment rounds. For continuous variables, Student’s t-tests were used to compare QOL scores between groups within one assessment round, and paired t-tests were used
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to compare differences in QOL scores between different assessment rounds. All statistical tests were two-sided and a p-value less than 0.05 was considered statistically significant. Results
Recruitment and Follow-up Information A total of 332 baseline study participants were recruited between May 2007 and May 2008, and all 24-month follow-up surveys were completed by May 2010. Most participants
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(38.3%, n = 127) were recruited from the Guangxi CDC ART clinic, while 29.8% (n = 99), came from the Nanning Number 4 Hospital ART Clinic, and 19.6% (n = 65) from the Pingxiang ART clinic. The Guigang City Peoples’ Hospital ART department and Guilin 3rd People’s Hospital
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recruited 9.0% (n = 30) and 3.3% (n = 11) of participants, respectively. Of the 332 participants enrolled at baseline, 80.4%, 78.3%, and 74% successfully completed the 6-, 12-, and 24-month follow-up assessments, respectively (Table 1).
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Baseline Sociodemographic Characteristics of Study Participants
Of the baseline participants, approximately two thirds (68.1%) were male and the average
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age at baseline was 39.6 years (range = 20.2 - 76.5 years; Table 1). Participants had diverse education backgrounds; 33.2% had a primary school education or less; 21.5% had a middle school education; and 45.3% had a high school education. Almost two thirds (65.7%) of participants were married or cohabitating and only 14.8% of participants were living alone.
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Sixty-two percent of participants were rural farmers or unemployed. Most participants (59.4%) had an average monthly household income of less than 1,000 RMB (Table 2). Clinical Measures of Study Participants at Baseline and Follow-up
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The general wellbeing and activities of daily life of participants, as measured by the Karnofsky performance scale, showed steady and statistically significant improvements over
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time. Overall, average performance increased from 84.7 at baseline to 94.6 at 24 months (Table 3). Moreover, there were concomitant statistically significant improvements at each of the follow-up time points in both mean CD4+ T cell counts (from 107.1 cells/mm3 at baseline to 350.2 cells/mm3 at 24 months) and mean total lymphocyte counts (from 1,400 cells/mm3 at baseline to 2,500 cells/mm3 at 24 months). Quality of Life at Baseline and Follow-up Visits
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Cronbach’s α coefficients for the overall score of the WHOQOL-BREF at each of the assessment time points were high (0.88, 0.92, 0.91, and 0.93 at baseline, 6, 12, and 24 months, respectively). This demonstrated a high overall degree of internal consistency or reliability
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across the five study sites.
Consistent, statistically significant improvements in the overall QOL scale, overall
perception on QOL, and overall perception on health scale scores were observed as time on ART
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increased. Improvements of the greatest magnitude occurred during the first 6 months after initiating ART but statistically significant increases were also observed between 12 and 24
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months as well (Table 4). The mean physical and spirituality domain scores increased significantly between baseline and 6 months and plateaued between 6 and 12 months, before increasing significantly again between 12 and 24 months. The mean psychological domain scores showed a similar trend but actually decreased significantly between 6 and 12 months
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before increasing significantly between 12 and 24 months (Table 4). The average level of independence and environment domain scores increased significantly during the first 6 months on ART but then stabilized with no further significant changes over time. The social
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relationships domain scores improved significantly between baseline and 6 months but then decreased significantly between 6 and 12 months and showed no overall increase at 24 months
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compared to baseline.
Relationships Between Sociodemographic Characteristics and Overall QOL Scores Over Time
The average overall QOL summary scale scores were similar between male and female participants at baseline (Table 5). Similar increases in overall QOL were observed for both males and females between baseline and 6 months. However, the average overall QOL score stabilized
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after 6 months for males and females and were not significantly improved at 24 months. Married or cohabitating participants generally had higher overall QOL scores than unmarried, divorced, or widowed participants and this difference was statistically significant at
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the 6-month follow-up visit (Table 5). For both groups, statistically significant increases in overall QOL were observed after initiation on ART and follow-up for 6 months. However, these gains did not significantly improve between 6 and 24 months of follow-up for either group.
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Employed participants had higher QOL scores at baseline and 6 months compared to
unemployed participants or rural farmers. Statistically significant improvements in overall QOL
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were observed between baseline and 6 months of follow-up regardless of employment status (Table 5). For both groups, overall QOL scores stabilized after 6 months and did not show further significant improvement at 24 months of follow-up.
Participants who were living with others had higher overall QOL scores than those living
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alone at the 6-month time period (Table 5). However, participants in both groups showed statistically significant improvements in overall QOL scores after initiation and follow-up on ART. Among participants living alone, further significant improvements were found between 6
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and 24 months. On the other hand, among those living with others no further statistically significant improvements in overall QOL were observed between 6 and 24 months of follow-up.
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There were no significant differences across age categories in overall QOL at baseline or at any of the follow-up time points (Table 5). Participants in all four age categories showed statistically significant improvements in overall QOL scores between baseline and 6 months. However, no statistically significant improvements were noted for any of the age groups between the 6- and 24-month time intervals on ART despite significant fluctuations between these two time points.
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Participants with higher education status tended to have higher overall QOL scores but these differences were not statistically significant at any of the assessment periods (Table 5). Statistically significant improvements in overall QOL scores were observed in all three strata of
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education status between baseline and 6 months (Table 5). However, these positive trends
leveled off after 6 months and there were no further significant increases in overall QOL scores noted at 24 months despite some temporary significant changes during the intermediate
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assessment time points.
Participants in the highest strata of monthly household income (i.e., ≥ 1,000 RMB) had
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significantly higher overall QOL scores at baseline than participants with lower income (Table 5). Participants in all income categories showed statistically significant increases on overall QOL scores between the baseline and 6-month follow-up visits. However, no statistically significant increases were seen between the 6-month and 24-month follow-up visits across any of the
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income categories despite significant changes during intermediate follow-up intervals. Discussion
This prospective observational cohort study of QOL among treatment-naïve individuals
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initiating ART is one of few such studies conducted in China and to our knowledge has the longest period of follow-up (24 months). As a result, our study gives a clearer picture of the
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long-term relationship between ART and QOL than the cross-sectional or short-duration followup studies commonly reported in the literature. Additionally, this observational multi-site study used a standardized inclusion criteria based on national treatment guidelines. This allowed data to be pooled over five major hospitals in Guangxi and increased the statistical power of the study. The observational design of our study kept costs low and allowed for the recruitment of individuals from diverse sociodemographic backgrounds. Hence, the results are more broadly
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representative of persons initiating ART than clinical trials of short duration that enroll selected study populations (Liu, Weber et al., 2006). The WHOQOL-HIV BREF instrument used in our study showed high internal
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consistency and validity across the four assessment time points. This corroborated experiences with the use of this instrument in other settings in China (Hsiung et al., 2005; Shan et al., 2011). Our study showed improvements in QOL among a cohort of treatment naïve patients
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initiating ART. However, the speed and magnitude of improvement was consistently greatest during the first 6 months after ART initiation. After 6 months, improvements were smaller and
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uneven across QOL domains. Nevertheless, all QOL domain scores increased significantly between 6 and 24 months of follow-up with the exception of social relationships. The rapid improvement in QOL observed shortly after ART initiation was consistent with the results of other studies reported in the literature (Jelsma, Maclean, Hughes, Tinise, & Darder, 2005;
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Mannheimer et al., 2005; Stangl, Wamai, Mermin, Awor, & Bunnell, 2007). A U.S.-based cohort study also demonstrated significant short-term ART effects on most QOL domains between 6 and 12 months after ART initiation. However, additional use of ART did not modify long-term
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trends (Liu, Weber, et al., 2006). In our study, the most plausible reasons for the initial shortterm increase in QOL related to ART initiation were the rapid improvements in physical health
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due to increased immune function and reduced physical symptoms. This hypothesis was supported by the rapid concomitant increases we observed in CD4+ T cell counts, total lymphocyte counts, and general wellbeing and activities of daily life. Other longitudinal studies have shown significant associations between CD4+ T cell counts, viral loads, and QOL (Call et al., 2000; Jia, Uphold, Wu, Chen, & Duncan, 2005; Murri et al., 2003; Stangl et al., 2007). However, after initial short-term improvement, studies that followed patients for longer than 12
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months found less consistent associations (Mannheimer et al., 2005; Mrus, Williams, Tsevat, Cohn, & Wu, 2005; Stangl et al., 2007). In our study, the only QOL domain not to show significant improvement between
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baseline and 24-month follow-up was social relationships. The level of independence and
environment domains showed significant improvements only between baseline and 6 months and
amenable to QOL improvement simply by starting ART.
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stabilized thereafter. These domains are influenced by broader factors that may not be as
A national 5-year analysis of immunological treatment outcomes in China showed that
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short-term gains in CD4+ T cell counts stabilized over time and treatment failure rates increased over time when second-line treatment options were not available (Zhang et al., 2009). This is likely to have negative repercussions for long-term QOL outcomes and indicates the need for longer-term studies of the interactions of clinical markers and QOL. Zhang et al. (2009) reported
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that 81% of patients had symptoms when they initiated ART in China. Nieuwkerk et al. (2000) showed that the QOL of patients with symptoms was significantly better compared to patients without symptoms after initiation of ART.
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In our study, no significant differences in QOL were observed by gender, age, or education status. Studies in the literature have demonstrated relationships between gender and
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QOL, usually favoring males (Mannheimer et al., 2005; Molassiotis, Callaghan, Twinn, & Lam, 2001; Mrus et al., 2005; Shan et al., 2011); other studies also found no gender differences (Bastardo & Kimberlin, 2000; Shan et al., 2011). Many studies showed that age played important roles on QOL (Xiang, Wang, & Fu, 2005; Xie et al., 2006; Zhang & Sheng, 2008; Zhao et al., 2008) and elderly persons had lower QOL (Kuang, Li, Ma, & Liao, 2005; Xiang, Fu, & Wang, 2004; Zhang & Sheng, 2008). Some studies found a positive association between age and QOL,
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with elderly individuals having higher QOL (Xie et al., 2006). Stangl et al. (2007) also found no significant differences by age group. Our study showed that unemployed participants and rural farmers had lower overall QOL than their employed counterparts at baseline and this difference
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persisted at 6 months despite significant increases in QOL in both groups. Rural farmers also had lower QOL scores in a recent study in Henan province (Shan et al., 2011). Other studies also found that persons with higher household income had higher overall QOL scores than lower
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income groups (Eriksson, Nordstrom, Berglund, & Sandstrom, 2000; Ma, He, Ye, & Wang, 2006; Sheng, He, Zhang, & Qiu, 2008).
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In summary, our study shows that poorer participants, with less access to social support, tended to have lower overall QOL. The importance of social support in improving QOL outcomes have been identified in diverse settings worldwide (Bastardo & Kimberlin, 2000; Friedland, Renwick, & McColl, 1996; Jia et al., 2004; Jia et al., 2005; Liu, Johnson et al., 2006;
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Molassiotis et al., 2001; Stangl et al., 2007). More recently, Rao et al. (2012) showed that social support mediated the relationship of HIV stigma, depression, and QOL in PLWH in Beijing, China. More in-depth study is required to elucidate the reasons for these associations, but our
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study results suggest that strengthening social support mechanisms in clinical and/or communitybased settings could further improve QOL outcomes in Guangxi.
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Our study had several limitations. First, some participants interviewed at baseline were lost to follow-up over time. However, the high retention rate of participants in our study minimized this bias. Moreover, improvements in QOL paralleled increases in CD4+ T cell counts supporting a positive influence of ART. Second, the face-to-face interviews may have led to social desirability biases and inflated QOL scores. However, nurses and counselors were trained to conduct the interviews in a non-judgmental way and changes over time were consistent
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across study sites. Third, all the patients in the study were outpatients. Hence, our study results may not be generalizable to inpatients or patients with more severe conditions. Lastly, we could not examine important variables such as adherence to ART, social support, stigma, and
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discrimination.
In conclusion, our study showed large improvements in QOL among HIV-infected
treatment-naïve adults in Guangxi, with inconsistent and smaller improvements thereafter.
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Poorer, unemployed, and unmarried persons who were living alone had poorer QOL outcomes and it will be important that future research is conducted to gain a more detailed understanding
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clinical and programmatic interventions.
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of the mechanisms that influence QOL to more clearly tailor the development of appropriate
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Journal of STD & AIDS, 23, 481-484. doi:10.1258/ijsa.2009.009428 Saddki, N., Noor, M. M., Norbanee, T. H., Rusli, M. A., Norzila, Z., Zaharah, S., ... Zarina, Z. A. (2009). Validity and reliability of the Malay version of WHOQOL-HIV BREF in patients
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AIDS patients during terminal stage in Weishi county, Henan province. Chinese Journal of Nursing, 43(07), 655-658. Stangl, A. L., Wamai, N., Mermin, J., Awor, A. C., & Bunnell, R. E. (2007). Trends and
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China. (2007). A joint assessment of HIV/AIDS prevention, treatment and care in China (2007). Retrieved from http://www.unaids.org.cn/uploadfiles/20080725151739.pdf
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Foreign Medical Sciences Epidemiology Lemology, 31(2), 74-75. Xiang, F., Wang, Y., & Fu, L. (2005). Assessing health-related quality of life in AIDS patients. Foreign Medical Sciences Epidemiology Lemology, 32(3), 138-139.
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Xie, J., Shi, X., Wang, F., Gong, C., Chang, L., & Le, M. (2006). Multiple linear regression analysis on influencing factors of quality of life in AIDS patients. Chinese Journal of Clinical Rehabilitation, 10(38), 14-16.
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outcomes of the China National free antiretroviral treatment program. Annals of Internal
Zhang, Y., & Sheng, Y. (2008). Current situation of the suties on quality of life and influencing factor of peopel living with HIV/AIDS. Chinese Journal of Nursing, 43(1), 69-71. Zhao, Y., Zhang, F., Chen, C., Gao, B., Gao, G., Xu, Q., ... Yu, L. (2008). Study on quality of
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Chinese Journal of AIDS STD, 14(3), 217-219.
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Table 1
Completed survey Died Transferred out of facility Lost to follow-up Did not complete survey*
6 months N % 267 80.4 20 6.0 13 3.9 7 2.1 25 7.5
12 months N % 260 78.3 22 6.6 25 7.5 20 6.0 5 1.5
24 months N % 246 74.0 28 8.0 27 8.1 19 5.7 12 3.6
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Follow-up results
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Status of Baseline Participants (N = 332) in the Prospective Cohort Study at Follow-up Assessment Time Points
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Note. * = These patients were known to still be on antiretroviral therapy at the health facility they enrolled in but did not complete interviews at the scheduled assessment visit.
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Table 2
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Baseline Sociodemographic Characteristics of Study Participants (N = 332)
Male Female
Age group
20-29 years 30-39 years ≥ 40 years
95 28.7 105 31.7 131 39.6
Education
Primary school or less Middle school High middle school or above
Marriage status
Married or cohabitating Unmarried/divorced/widowed
218 65.7 114 34.3
Occupation
Unemployed/farmer Employed
204 62.0 125 38.0
Live alone
110 33.2 150 45.3 71 21.5
Yes No
43 14.8 247 85.2
< 500 RMB 500 - 999 RMB ≥ 1000 RMB
95 30.8 88 28.6 125 40.6
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Household monthly average income
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Gender
Baseline N % 226 68.1 106 31.9
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Note. Not all variables add up to 332 because of missing values. RMB =
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Table 3 Clinical Measures Among Study Participants at Baseline and Follow-up Assessment Visits Baseline 6 months 12 months 24 months N Mean N Mean N Mean N Mean 332 84.7 a 262 91.5 b 257 93.5 c 241 94.6 d
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Clinical measures
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Karnofsky Performance Scale scores Total Lymphocyte Count 330 1.4 a 254 1.8 b 254 2.0 c 240 2.5 d (cells/mL) CD4+ T Count (cells/mm3) 330 107.1 a 254 223.5 b 248 269.1 c 237 350.2 d Note. Column values that do not share a common letter for each measure across assessment periods (i.e., table rows) are significantly different from each other (p < .05). For example “d” = significantly different from “a,” “b,” and “c.”
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Table 4 Quality of Life Scores at Baseline and Follow-up Assessment Visit Time Points 6 months N Mean 266 12.6 266 12.9 264 14.4 264 13.1 264 13.6 263 12.0 264 12.4 263 13.1 267 13.0
12 months N Mean 260 12.6 259 13.0 258 14.2 258 12.8 258 13.7 257 11.6 257 12.0 258 12.9 260 12.8
24 months N Mean 243 13.4 c 243 13.7 c 241 14.8 c 241 13.6 d 241 13.8 b 241 11.8 a 240 12.2 bc 241 13.8 c 243 13.4 c
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Baseline N Mean 332 11.3 332 10.3 322 12.5 322 11.3 321 11.6 321 11.4 321 11.4 313 12.0 332 11.5
QOL domains
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Overall perception on quality of life a b b Overall perception on health a b b Physical a b b Psychological a b c Level of independence a b b Social relationships a b a Environment a b c Spirituality a b b Overall QOL score a b b Note. QOL = quality of life; Column values that do not share a common letter for each QOL domain across assessment
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periods (i.e., table rows) are significantly different from each other (p < 0.05). For example “d” = significantly different from “a,” “b,” and “c.”
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Table 5 Overall Quality of Life Scores by Sociodemographic Characteristics at Baseline and Follow-up Assessment Visit Time Points
a a
6 months N Mean 177 13.0 90 13.0
bc bc
12 months N Mean 179 12.9 81 12.7
b b
24 months N Mean 166 13.5 77 13.2
c c
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Baseline N Mean 226 11.5 106 11.5
Male Female
Marriage status
Married or cohabitating Unmarried/ divorced/widowed
218
11.6
a
181
13.2
b*
174
12.9
c
160
13.5
b
114
11.3
a
86
12.7
b
86
12.8
b
83
13.2
b
Unemployed/ farmer Employed
204
11.3
a*
158
12.8
bc*
152
12.7
b
144
13.2
c
125
11.7
a
106
13.4
bc
105
13.1
b
96
13.7
c
Live alone
Yes No
43 247
11.4 11.5
a a
Age group
20 - < 30 years 30 - < 40 years 40+ years
95 105 131
11.6 11.3 11.6
a a a
Education
Primary school or less Middle school High middle school or above
110
11.3
a
< 500 RMB 500 - 999 RMB
≥ 1000 RMB
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b* bc
31 200
12.7 12.9
bc b
30 181
13.2 13.4
c c
84 86 97
13.3 12.8 13.0
bc b bc
78 88 94
12.9 12.9 12.7
b b b
71 77 95
13.6 13.3 13.3
c b c
77
12.8
b
76
12.9
b
75
13.0
b
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Household monthly average income&
32 205
150 71
11.5 11.7
a a
125 64
13.0 13.4
bc bc
123 61
12.8 12.9
b b
110 58
13.4 13.7
c c
95 88
11.1 11.3
a1 a1
75 69
12.8 13.0
bc b
74 68
12.4 13.0
b b
70 65
13.0 13.3
c b
11.8
a2
101
13.2
bc
100
13.0
b
95
13.7
c
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Occupation
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Gender
125
Note. RMB =. Column values that do not share a common letter in each column are significantly different
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from each other across assessment periods (p < .05). * = Statistically significant differences within levels of the sociodemographic characteristic during the same assessment period (p < .05). & = Row values that do not share a common number in each row are significantly different from each other (p < .05).
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Key Considerations
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Quality of life (QOL) is an important holistic measure of patient success in adhering to antiretroviral therapy (ART) and should be assessed in routine settings in addition to conventional clinical and laboratory measures. There were substantial improvements in all domains of QOL during the first 6 months of ART and these were closely tracked by concomitant increases in patient CD4+ T cell counts, total lymphocyte counts, and the Karnofsky performance scale. After 6 months on ART, improvements in QOL scale scores were smaller and uneven across domains, but social relationships was the only QOL domain not to significantly improve at 24 months on treatment. Patients with very low socioeconomic status and with less access to social support, tended to have lower QOL; strengthening of social support mechanisms in clinical and/or communitybased settings could further improve QOL outcomes.
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•