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Short-term acceptability of the PATH Woman's Condom among couples at three sites
Contraception 73 (2006) 588 – 593
Original research article
Short-term acceptability of the PATH Woman’s Condom among couples at three sites Patricia S. Coffey4, Maggie Kilbourne-Brook, Glenn Austin, Yancy Seamans, Jessica Cohen Program for Appropriate Technology in Health (PATH), Seattle, WA 98107-5136, USA Received 20 June 2005; revised 31 August 2005; accepted 21 October 2005
Abstract Purpose: The objective of this study is to evaluate acceptability of the PATH Woman’s Condom among user populations in Mexico, South Africa and Thailand. Methods: A nonrandomized, nonblinded, nonsignificant risk study was conducted among 20 couples per site. Data were collected via structured questionnaires after the first, second and third condom uses and through in-depth interviews after all condoms were used. Results: Women from all sites reported that the PATH Woman’s Condom was easy and comfortable to insert, and the pouch and ring were very stable during use. Both women and men reported that the comfort and sensation of sex while using the condom was acceptable. Conclusions: The PATH Woman’s Condom is easy to use, stable during use, comfortable and satisfactory during sex among users from diverse populations and cultures. The iterative user-driven product development process helped ensure that this new product addresses a wide range of user preferences. D 2006 Elsevier Inc. All rights reserved. Keywords: Female condom; Acceptability; Mexico; South Africa; Thailand
1. Introduction A female condom that is highly acceptable to women and their partners could make a significant public health impact on the prevention of unwanted pregnancy and sexually transmitted infections (STIs). Research with the FC Female CondomR (manufactured by the Female Health Company) has shown substantial interest in the concept of a female condom but mixed acceptability due to design and user related issues [1]. PATH, a nonprofit, nongovernmental, international health organization dedicated to improving health in lowresource settings has worked for 6 years with couples from four regions to develop a woman’s condom that would be: ! ! ! ! ! !
easy to handle and insert, easy to use (especially for new users), stable during use, comfortable for both partners, easy to remove, and less expensive than current options, with a target price of 25 cents per device.
4 Corresponding author. Tel.: +1 206 285 3500; fax: +1 206 285 6619. E-mail address: [email protected] (P.S. Coffey). 0010-7824/$ – see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2005.10.017
After 3 years of iterative prototype development where the condom design was modified to address user needs in each region, PATH selected the most promising condom design and used it to conduct a nonrandomized, nonblinded, nonsignificant risk, multisite study to determine user acceptability among couples in Mexico, South Africa and Thailand.
2. Materials and methods The PATH Woman’s Condom (Fig. 1) evaluated in this study is a single-size, nonlubricated, single-use device consisting of a plastic pouch that is inserted in the vagina prior to intercourse and stays in the vagina during intercourse, providing a physical barrier between partners’ genitalia. It is packaged with water-based lubricant that is applied before intercourse. The condom is composed of a pouch made of 0.003-mmthick urethane film, a urethane ring and four small elliptical pieces of hydrophilic urethane foam approximately 2 mm thick. The distal end of the pouch and the foam pieces are packaged into a dissolving insertion capsule made of polyvinyl alcohol. The capsule aids in handling and insertion,
P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
589
Fig. 1. PATH woman’s condom.
and dissolves once placed in the vagina; the foam shapes stabilize the pouch inside the vagina by lightly clinging to the vaginal walls. Condoms were supplied with Astroglide lubricant (Biofilm, Vista, CA) provided in 5-mL tubes. The study was conducted with collaborators in three sites: the National Institute of Public Health in Cuernavaca, Mexico; the Reproductive Health Research Unit in Durban, South Africa; and the Khon Kaen University School of Nursing in Khon Kaen, Thailand. This study was reviewed and approved by the PATH Human Subjects Protection Committee and the relevant ethical review committees at the three international sites. Women and their partners participated in multiple visits. At the screening visit, both participants provided written informed consent and underwent medical screenings to ensure that they met the eligibility criteria for good general and genital health. All couples were monogamous for the duration of the study, at low risk of STIs by selfreport and protected from pregnancy by use of a nonbarrier method. At a second visit, women practiced condom insertion and removal at the clinic to gain experience handling the device before using it at home with their partners. At the third visit, each couple received three PATH Woman’s Condoms, three individually packaged lubricant tubes, study questionnaires and user instructions. Couples were instructed to complete a questionnaire after each condom use and to return to the clinic after all three condoms were used. In South Africa and Thailand, couples returned to the clinic and completed the questionnaire after each product use. At the final visit — about 2 weeks later — researchers collected the study questionnaires and any unused condoms, and conducted an open-ended debriefing interview with each couple. In the analysis, univariate statistics and frequency distributions were employed for descriptive purposes. Aggregate percentages for comfort and sensation included user responses of b very comfortable Q, bcomfortable Q, or bOK Q except for ease of condom insertion which did not
include the bOK Q response category. The statistical tests employed included v 2 to detect differences among experienced vs. new users and ANOVA to determine any effect across the three condom uses or among users from the three sites. Due to the relatively small sample size, the alpha level for all statistical tests was set at p b .01. Only significant associations are reported in the text. 3. Results 3.1. User characteristics Each site enrolled 20 couples. Most women in Mexico and Thailand were married, and most women in all sites were parous (Table 1). Of the 60 couples enrolled, 34 had prior experience with PATH female condom prototypes and 26 had no prior experience. As a result, 57% (102/180) of the product uses were completed by experienced users, and 43% (78/180) of product uses were completed by new users. 3.2. Stability during use As per the couples’ reporting, the condom pouch remained stable during use in 97% (175/180) of product Table 1 Female participant characteristics (n = 60) Mexico (n = 20), n (%)
South Africa (n = 20), n (%)
Thailand (n = 20), n (%)
Marital status Married 16 (80) Single 4 (20)
0 20 (100)
20 (100) 0
Parity 0 1+
2 (10) 18 (90)
2 (10) 18 (90)
5 (25) 15 (75)
Previous experience with vaginal methods or male condom Yes 12 (75)a 20 (100) 10 (50) No 4 (25) 0 10 (50) a
Data were not available for four respondents.
590
P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
Table 2 Comfort during insertion (female), by timing of use, user experience and site (n = 180)
Total users (n = 180) First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
Very comfortable, number of uses (%)
Comfortable, number of uses (%)
OK, number of uses (%)
Uncomfortable, number of uses (%)
60 13 22 25 33 27 23 16 21
84 30 28 26 45 39 31 35 18
24 12 8 4 17 7 3 8 13
12 5 2 5 7 5 3 1 8
(33) (22) (37) (42) (32) (35) (38) (27) (35)
(47) (50) (47) (43) (44) (50) (52) (58) (30)
(13) (20) (13) (7) (17) (9) (5) (13) (22)
(7) (8) (3) (8) (7) (6) (5) (2) (13)
reported that the condom adhered to the penis (like a male condom) and was inadvertently removed from the vagina during sex. This pullout occurred during the first and second product uses and only occurred with experienced users in Mexico. Pullout occurred when the device was used for 6 to 10 min in one instance and when the device was used from 11 to 20 min in two instances. None of the three condoms associated with these events were reported to have rips, tears, or holes in the device. The specifics of the other two instances are unknown.
uses. Couples reported good stability of the condom pouch in the vagina during intercourse regardless of whether the device was used the first, second or third time. The majority of experienced users and all new users reported that the condom pouch was stable during sex. Likewise, little variation was noted across study sites. Couples reported that the outer ring remained stable on the women’s external genitalia during sex in almost all product uses. No differences were noted between experienced and new users in terms of ring stability during sex. In three uses, the outer ring went partially inside the woman’s vagina, but two couples (one experienced and one new) were able to readjust the condom and continue sex, and the remaining couple (new users) continued having sex without readjusting the condom. All three instances of poor stability of the outer ring occurred in South Africa. Penile misrouting was reported in only 1% (2/180) of product uses, confirming that the external portion of the condom maintained its stability against the external genitalia during sexual intercourse.
3.4. Comfort Female users reported that the PATH Woman’s Condom was comfortable during insertion in 168 (93%) product uses (Table 2). Some users indicated a feeling of irritation caused by the cap during insertion, but these feelings diminished shortly after insertion and at the beginning of intercourse. As experience with the devices increased between the first and third use, women responded increasingly positively to the question about comfort during insertion. More users in Thailand reported insertion as being buncomfortableQ than users in the other two sites. Male users thought that initial insertion of their penis into the PATH Woman’s Condom was comfortable in 173 (96%) product uses (Table 3). As men gained experience over three uses of the PATH Woman’s Condom, their reported level of comfort while inserting their penis improved. Men in South Africa and Thailand reported slightly more positive experiences regarding comfort during penile insertion than did men in Mexico. Mexican men reported that penile insertion was
3.3. Condom failures during use Couples were asked to report any instances of eversion (condom coming completely out of the vagina by sticking to the penis and then turning inside out), complete slippage (condom slipping completely out of the vagina without turning inside out or acting like a male condom) or pullout (condom coming completely out of the vagina by adhering to the penis like a male condom). Couples reported five instances of condom failure. During three uses, couples
Table 3 Comfort during penile insertion (male) by timing of use, user experience and site (n = 180)
Total users (n = 180) First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
Very comfortable, number of uses (%)
Comfortable, number of uses (%)
OK, number of uses (%)
Uncomfortable, number of uses (%)
51 14 15 22 24 27 17 12 22
107 35 39 33 64 43 34 42 31
15 6 5 4 9 6 3 6 6
7 5 1 1 5 2 6 0 1
(28) (23) (25) (37) (24) (35) (28) (20) (37)
(59) (58) (65) (55) (63) (55) (57) (70) (52)
(8) (10) (8) (7) (9) (8) (5) (10) (10)
(4) (8) (2) (2) (5) (3) (10) (2)
P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
591
Table 4 Comfort during sex by timing of use, user experience and site Female (n = 180)
Male (n = 180)
Very comfortable, Comfortable, OK, number Uncomfortable or Very comfortable, Comfortable, OK, number Uncomfortable or number of number of of uses (%) very uncomfortable, number number of of uses (%) very uncomfortable, uses (%) uses (%) number of uses (%) of uses (%) uses (%) number of uses (%) Total users First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
60 20 18 22 29
(33) (33) (30) (37) (28)
99 29 37 33 58
(55) (48) (62) (55) (57)
131 9 0 4 9
(8) (15) (7) (9)
8 2 5 1 6
(5) (3) (9) (2) (6)
54 15 15 24 24
(30) (25) (25) (40) (24)
92 30 34 28 54
(51) (50) (58) (47) (53)
30 13 9 8 22
(17) (22) (15) (13) (22)
3 2 1 0 2
31 26 12 22
(40) (43) (20) (37)
41 26 45 28
(53) (43) (75) (47)
4 3 3 7
(2) (3) (2)
(5) (5) (5) (12)
2 (3) 5 (8) 0 3 (5)
30 20 9 25
(39) (33) (15) (42)
38 33 37 22
(49) (55) (62) (37)
8 6 14 10
(10) (10) (23) (17)
1 (1) 1 (2) 0 2 (3)
(2)
(Table 5). Women reported a high level of satisfaction with the sensation of the device during sex regardless of whether they used the device during the first, second or third time. Male partners reported increased levels of satisfaction in the feeling of sex while their partner used the PATH Woman’s Condom from the first to third product use. One product use was reported as having unsatisfactory sensation, and one product use was reported as having very unsatisfactory sensation; both occurred during the time of first use. None of the men reported that they were bunsatisfiedQ or bvery unsatisfiedQ in their sensation during the sex during second or third product uses. Similar to the results from the female users, male users in South Africa reported relatively more bsatisfactory Q sensation, and male users in Mexico and Thailand reported relatively more bunsatisfactory Q sensation during use.
uncomfortable in six product uses compared to zero product uses in South Africa and one product use in Thailand. During intercourse, female participants reported that the condom was comfortable during 172 (96%) product uses and male participants reported that the condom was comfortable during 176 (98%) product uses (Table 4). Women’s levels of reported comfort increased over the three product uses. Men also reported an increased level of comfort from the first to the third use. There were three reports of the device being buncomfortableQ during the first and second use, and no reports of discomfort during the third product use. New users reported the device as being bvery comfortableQ during use more often than experienced users. Women reported the PATH Woman’s Condom was comfortable to remove in 96% (173/180) of product uses. Reports of buncomfortableQ removal decreased from the first use (5%) to the third product use (2%). There was little difference in the comfort level during removal between experienced and new users or across sites.
3.6. Ease of condom insertion Women reported that the condom was easy to insert in 158 (88%) uses (Table 6). Across the three product uses, women reported that the ease of insertion increased [ F(2,177) =5.67, pb .004]. The number of women who reported it was bvery easy Q increased from 27% (16) during the first product use to 53% (31) during the third use. Both experienced and new
3.5. Sensation During use, women reported that sensation was satisfactory in 98% (176/180) of product uses and men reported satisfactory sensation in 99% (178/180) of product uses
Table 5 Sensation of sex while condom in place by timing of use, user experience and site Female (n = 180)
Total users First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
Male (n = 180)
Very satisfactory, number of uses (%)
Satisfactory, number of uses (%)
OK, number of uses (%)
Unsatisfactory, number of uses (%)
Very satisfactory, number of uses (%)
Satisfactory, number of uses (%)
OK, number of uses (%)
Unsatisfactory, number of uses (%)
61 17 23 21 32
(34) (28) (38) (35) (31)
99 33 32 34 57
(55) (55) (53) (57) (56)
16 (9) 9 (15) 4 (7) 3 (5) 11 (11)
4 1 1 2 2
(2) (2) (2) (3) (2)
59 20 18 21 31
(33) (33) (30) (35) (30)
97 30 35 32 55
(54) (50) (58) (53) (54)
22 8 7 7 15
(12) (13) (12) (12) (15)
2 (2) 2 (4) 0 0 1 (1)
29 26 15 20
(37) (43) (25) (33)
42 28 39 32
(54) (47) (65) (53)
2 (3) 2 (3) 0 2 (3)
28 20 12 27
(36) (33) (20) (45)
42 34 36 27
(54) (57) (60) (45)
7 5 12 5
(9) (8) (20) (8)
1 (1) 1 (2) 0 1 (2)
5 4 6 6
(6) (7) (10) (10)
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P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
Table 6 Ease of insertion of condom (female) by timing of use, user experience and site (n = 179)
Total users (n = 179) 1st use (n = 60) 2nd use (n = 60) 3rd use (n = 59) Experienced users (n = 101) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 59)
Very easy, number of uses (%)
Easy, number of uses (%)
OK, number of uses (%)
Difficult, number of uses (%)
71 16 24 31 37 34 18 26 27
87 33 28 26 53 34 30 32 25
17 (9) 10 (17) 6 (10) 1 (2) 7 (7) 10 (13) 11 (18) 2 (3) 4 (7)
4 1 2 1 4 0 1 0 3
(40) (27) (40) (53) (37) (44) (30) (43) (46)
users found insertion of the condom to be relatively easy. New users reported no difficulties with inserting the device as compared with a small number of experienced users that reported the insertion of the condom as being bdifficult.Q 3.7. Ease of condom removal Women reported that the condom was easy to remove during 99% (176/180) of product uses. Most women reported that the condom was beasyQ to bvery easyQ to remove even on the first use. New users reported slightly greater ease in removing the condom than did experienced users. One product use in Thailand was reported to be bdifficultQ during removal.
4. Discussion Results of this user evaluation suggest that the PATH Woman’s Condom is easy to use, stable during use, comfortable and satisfactory during sex among users from diverse populations and cultures. This is not surprising given that this study is the culmination of a 6-year research and development process aimed toward developing such a device. This device met or exceeded all but one of the primary product specification requirements used to establish success criteria by the product development team. Product performance objectives were achieved primarily through a userdriven design process. By listening carefully to user input through every step of the development process, a number of design features were changed substantially, in some cases, in direct opposition to the development team’s initial assumptions. Interactions with users and field investigators assisted in the prioritization process when balancing the trade-offs among various user needs and inputs. We hypothesized that users would experience a learning curve with this product, and that results from the first product use would be less favorable than results from subsequent product uses. This was not, however, the case. In general, participants reported similar experiences during first, second and third uses. In some cases, such as with ease and comfort of insertion, comfort of removal for women and comfort of penis insertion by men, a modest upward trend over time seemed to indicate that a learning curve was
(49) (55) (47) (44) (52) (44) (50) (53) (42)
(2) (2) (3) (2) (4) (2) (5)
present. A statistically significant difference was only visible in ease of condom insertion for women, however. These results indicate that a woman’s familiarity with the insertion process may lead to an easier insertion experience. Ease of removal remained high over the three product uses, suggesting that the removal process did not appear to be difficult to learn. Difficulty with condom insertion has been noted in studies with the currently marketed female condom product in other settings [1– 4]. Results from this study also indicated some difficulties with insertion. We hypothesize that this difficulty in insertion was partially due to the presence of side seams on the dissolving insertion cap — a prototype design that was necessitated by the need to fabricate the cap from flat film. A seamless cap with a smooth spherical tip subsequently superseded this design. Ease as well as comfort of insertion is expected to improve significantly using this new cap configuration. We also hypothesized that more experienced users would have relatively more positive experiences with the condom than new users. No significant differences were noted, however, suggesting that this product may meet users’ demands for a barrier method that is both acceptable and easy to use for new and experienced users. Although user input during the product development process varied significantly by region, acceptability remained consistently high across all groups. We believe that the iterative user-driven product development process helped ensure that a wide range of user and cultural preferences was addressed by this new product design. The uniformly high levels of acceptability demonstrated by men as well as women in this study indicate that the PATH Woman’s Condom may inspire the level of partner cooperation needed for successful use of female condom products [5]. Data were collected about user experience from both female and male partners after each of three consecutive condom uses, adding to the strength of the study. Quantitative data were collected through standardized questionnaires, and qualitative experiences were collected in a debriefing session after all condoms were used. Although no standard definition of bacceptability Q is used in contraceptive research [6], we believe that the elements
P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
used to assess acceptability in this study are consistent with recent literature [7,8]. Additionally, we assessed the failure of our device during use by applying slippage and breakage criteria (e.g., eversion, pullout and complete slippage) commonly used in condom breakage and slippage trials [9]. Participants in this study were self-selected, and study design demanded that they be at low-risk for STIs. In addition, almost 60% of participants had prior experience with PATH Woman’s Condom prototypes. Due to this selection bias, it is not clear if similar study results could be replicated among the general population. A Phase I clinical trial to evaluate the safety and acceptability of the PATH Woman’s Condom compared to the FCR Female Condom is underway. Further research should be undertaken to directly compare the effectiveness of the PATH Woman’s Condom to the FCR, male condoms and other woman-initiated barriers such as the V-Amour, Lea’s Shield contraceptive or Femcap. Comparative studies with a wide range of products among a richly varied mix of users from various regions, cultures and social backgrounds would determine the selection of prevention options that can best meet users’ needs and ultimately result in more protected sex acts and fewer cases of STIs and unwanted pregnancy. Acknowledgment PATH would like to acknowledge the effort and commitment of our research partners, Dilys Walker of the National Institute of Public Health in Cuernavaca, Mexico; Mags Beksinska of the Reproductive Health Research Unit, University of Witwaterstand in Durban, South Africa; and
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Earmporn Thongkrajai of the Department of Community Nursing, Khon Kaen University in Khon, Kaen, Thailand; and the women and men who have willingly shared their experience and ideas. This study was supported by the CONRAD Program, Eastern Virginia Medical School, under USAID Cooperative Agreement #HRN-A-00-9800020-00. We also appreciate the support of the Bill and Melinda Gates Foundation.
References [1] World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). The female condom: an information pack. Monograph. Geneva7 WHO; 1997. [2] Cecil H, Perry MJ, Seal DW, et al. The female condom: what we have learned thus far. AIDS Behav 1998;2:241 – 56. [3] Hoffman S, Exner TM, Cheng-Shium L, Ehrhardt AA, Stein Z. Female-condom use in a gender-specific family planning clinic trial. Am J Public Health 2003;93:1897 – 903. [4] Artz L, Demand M, Pulley L, Posner SF, Macaluso M. Predictors of difficulty inserting the female condom. Contraception 2002;65:151 – 7. [5] Hoffman S, Mantell J, Exner T, Stein Z. The future of the female condom. Perspect Sex Reprod Health 2004;36:120 – 6. [6] Mantell JE, Myer L, Carballo-Dieguez A, et al. Microbicide acceptability research: current approaches and future directions. Soc Sci Med 2005;60:319 – 30. [7] Kukczycki A, Dhong-Jin KM, Duerr A, Jamieson DJ, Macaluso M. The acceptability of the female and male condom: a randomized crossover trial. Perspect Sex Reprod Health 2004;36:114 – 6. [8] Latka M, Joanis C, Glover L. Acceptability of the reality female condom and a latex prototype. J Urban Health 2001;78:614 – 26. [9] Steiner M, Trussell J, Glover L, Joanis C, Spruyt A, Dorflinger L. Standardized protocols for condom breakage and slippage trials: a proposal. Am J Public Health 1994;84:1897 – 900.
Original research article
Short-term acceptability of the PATH Woman’s Condom among couples at three sites Patricia S. Coffey4, Maggie Kilbourne-Brook, Glenn Austin, Yancy Seamans, Jessica Cohen Program for Appropriate Technology in Health (PATH), Seattle, WA 98107-5136, USA Received 20 June 2005; revised 31 August 2005; accepted 21 October 2005
Abstract Purpose: The objective of this study is to evaluate acceptability of the PATH Woman’s Condom among user populations in Mexico, South Africa and Thailand. Methods: A nonrandomized, nonblinded, nonsignificant risk study was conducted among 20 couples per site. Data were collected via structured questionnaires after the first, second and third condom uses and through in-depth interviews after all condoms were used. Results: Women from all sites reported that the PATH Woman’s Condom was easy and comfortable to insert, and the pouch and ring were very stable during use. Both women and men reported that the comfort and sensation of sex while using the condom was acceptable. Conclusions: The PATH Woman’s Condom is easy to use, stable during use, comfortable and satisfactory during sex among users from diverse populations and cultures. The iterative user-driven product development process helped ensure that this new product addresses a wide range of user preferences. D 2006 Elsevier Inc. All rights reserved. Keywords: Female condom; Acceptability; Mexico; South Africa; Thailand
1. Introduction A female condom that is highly acceptable to women and their partners could make a significant public health impact on the prevention of unwanted pregnancy and sexually transmitted infections (STIs). Research with the FC Female CondomR (manufactured by the Female Health Company) has shown substantial interest in the concept of a female condom but mixed acceptability due to design and user related issues [1]. PATH, a nonprofit, nongovernmental, international health organization dedicated to improving health in lowresource settings has worked for 6 years with couples from four regions to develop a woman’s condom that would be: ! ! ! ! ! !
easy to handle and insert, easy to use (especially for new users), stable during use, comfortable for both partners, easy to remove, and less expensive than current options, with a target price of 25 cents per device.
4 Corresponding author. Tel.: +1 206 285 3500; fax: +1 206 285 6619. E-mail address: [email protected] (P.S. Coffey). 0010-7824/$ – see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2005.10.017
After 3 years of iterative prototype development where the condom design was modified to address user needs in each region, PATH selected the most promising condom design and used it to conduct a nonrandomized, nonblinded, nonsignificant risk, multisite study to determine user acceptability among couples in Mexico, South Africa and Thailand.
2. Materials and methods The PATH Woman’s Condom (Fig. 1) evaluated in this study is a single-size, nonlubricated, single-use device consisting of a plastic pouch that is inserted in the vagina prior to intercourse and stays in the vagina during intercourse, providing a physical barrier between partners’ genitalia. It is packaged with water-based lubricant that is applied before intercourse. The condom is composed of a pouch made of 0.003-mmthick urethane film, a urethane ring and four small elliptical pieces of hydrophilic urethane foam approximately 2 mm thick. The distal end of the pouch and the foam pieces are packaged into a dissolving insertion capsule made of polyvinyl alcohol. The capsule aids in handling and insertion,
P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
589
Fig. 1. PATH woman’s condom.
and dissolves once placed in the vagina; the foam shapes stabilize the pouch inside the vagina by lightly clinging to the vaginal walls. Condoms were supplied with Astroglide lubricant (Biofilm, Vista, CA) provided in 5-mL tubes. The study was conducted with collaborators in three sites: the National Institute of Public Health in Cuernavaca, Mexico; the Reproductive Health Research Unit in Durban, South Africa; and the Khon Kaen University School of Nursing in Khon Kaen, Thailand. This study was reviewed and approved by the PATH Human Subjects Protection Committee and the relevant ethical review committees at the three international sites. Women and their partners participated in multiple visits. At the screening visit, both participants provided written informed consent and underwent medical screenings to ensure that they met the eligibility criteria for good general and genital health. All couples were monogamous for the duration of the study, at low risk of STIs by selfreport and protected from pregnancy by use of a nonbarrier method. At a second visit, women practiced condom insertion and removal at the clinic to gain experience handling the device before using it at home with their partners. At the third visit, each couple received three PATH Woman’s Condoms, three individually packaged lubricant tubes, study questionnaires and user instructions. Couples were instructed to complete a questionnaire after each condom use and to return to the clinic after all three condoms were used. In South Africa and Thailand, couples returned to the clinic and completed the questionnaire after each product use. At the final visit — about 2 weeks later — researchers collected the study questionnaires and any unused condoms, and conducted an open-ended debriefing interview with each couple. In the analysis, univariate statistics and frequency distributions were employed for descriptive purposes. Aggregate percentages for comfort and sensation included user responses of b very comfortable Q, bcomfortable Q, or bOK Q except for ease of condom insertion which did not
include the bOK Q response category. The statistical tests employed included v 2 to detect differences among experienced vs. new users and ANOVA to determine any effect across the three condom uses or among users from the three sites. Due to the relatively small sample size, the alpha level for all statistical tests was set at p b .01. Only significant associations are reported in the text. 3. Results 3.1. User characteristics Each site enrolled 20 couples. Most women in Mexico and Thailand were married, and most women in all sites were parous (Table 1). Of the 60 couples enrolled, 34 had prior experience with PATH female condom prototypes and 26 had no prior experience. As a result, 57% (102/180) of the product uses were completed by experienced users, and 43% (78/180) of product uses were completed by new users. 3.2. Stability during use As per the couples’ reporting, the condom pouch remained stable during use in 97% (175/180) of product Table 1 Female participant characteristics (n = 60) Mexico (n = 20), n (%)
South Africa (n = 20), n (%)
Thailand (n = 20), n (%)
Marital status Married 16 (80) Single 4 (20)
0 20 (100)
20 (100) 0
Parity 0 1+
2 (10) 18 (90)
2 (10) 18 (90)
5 (25) 15 (75)
Previous experience with vaginal methods or male condom Yes 12 (75)a 20 (100) 10 (50) No 4 (25) 0 10 (50) a
Data were not available for four respondents.
590
P.S. Coffey et al. / Contraception 73 (2006) 588 – 593
Table 2 Comfort during insertion (female), by timing of use, user experience and site (n = 180)
Total users (n = 180) First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
Very comfortable, number of uses (%)
Comfortable, number of uses (%)
OK, number of uses (%)
Uncomfortable, number of uses (%)
60 13 22 25 33 27 23 16 21
84 30 28 26 45 39 31 35 18
24 12 8 4 17 7 3 8 13
12 5 2 5 7 5 3 1 8
(33) (22) (37) (42) (32) (35) (38) (27) (35)
(47) (50) (47) (43) (44) (50) (52) (58) (30)
(13) (20) (13) (7) (17) (9) (5) (13) (22)
(7) (8) (3) (8) (7) (6) (5) (2) (13)
reported that the condom adhered to the penis (like a male condom) and was inadvertently removed from the vagina during sex. This pullout occurred during the first and second product uses and only occurred with experienced users in Mexico. Pullout occurred when the device was used for 6 to 10 min in one instance and when the device was used from 11 to 20 min in two instances. None of the three condoms associated with these events were reported to have rips, tears, or holes in the device. The specifics of the other two instances are unknown.
uses. Couples reported good stability of the condom pouch in the vagina during intercourse regardless of whether the device was used the first, second or third time. The majority of experienced users and all new users reported that the condom pouch was stable during sex. Likewise, little variation was noted across study sites. Couples reported that the outer ring remained stable on the women’s external genitalia during sex in almost all product uses. No differences were noted between experienced and new users in terms of ring stability during sex. In three uses, the outer ring went partially inside the woman’s vagina, but two couples (one experienced and one new) were able to readjust the condom and continue sex, and the remaining couple (new users) continued having sex without readjusting the condom. All three instances of poor stability of the outer ring occurred in South Africa. Penile misrouting was reported in only 1% (2/180) of product uses, confirming that the external portion of the condom maintained its stability against the external genitalia during sexual intercourse.
3.4. Comfort Female users reported that the PATH Woman’s Condom was comfortable during insertion in 168 (93%) product uses (Table 2). Some users indicated a feeling of irritation caused by the cap during insertion, but these feelings diminished shortly after insertion and at the beginning of intercourse. As experience with the devices increased between the first and third use, women responded increasingly positively to the question about comfort during insertion. More users in Thailand reported insertion as being buncomfortableQ than users in the other two sites. Male users thought that initial insertion of their penis into the PATH Woman’s Condom was comfortable in 173 (96%) product uses (Table 3). As men gained experience over three uses of the PATH Woman’s Condom, their reported level of comfort while inserting their penis improved. Men in South Africa and Thailand reported slightly more positive experiences regarding comfort during penile insertion than did men in Mexico. Mexican men reported that penile insertion was
3.3. Condom failures during use Couples were asked to report any instances of eversion (condom coming completely out of the vagina by sticking to the penis and then turning inside out), complete slippage (condom slipping completely out of the vagina without turning inside out or acting like a male condom) or pullout (condom coming completely out of the vagina by adhering to the penis like a male condom). Couples reported five instances of condom failure. During three uses, couples
Table 3 Comfort during penile insertion (male) by timing of use, user experience and site (n = 180)
Total users (n = 180) First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
Very comfortable, number of uses (%)
Comfortable, number of uses (%)
OK, number of uses (%)
Uncomfortable, number of uses (%)
51 14 15 22 24 27 17 12 22
107 35 39 33 64 43 34 42 31
15 6 5 4 9 6 3 6 6
7 5 1 1 5 2 6 0 1
(28) (23) (25) (37) (24) (35) (28) (20) (37)
(59) (58) (65) (55) (63) (55) (57) (70) (52)
(8) (10) (8) (7) (9) (8) (5) (10) (10)
(4) (8) (2) (2) (5) (3) (10) (2)
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Table 4 Comfort during sex by timing of use, user experience and site Female (n = 180)
Male (n = 180)
Very comfortable, Comfortable, OK, number Uncomfortable or Very comfortable, Comfortable, OK, number Uncomfortable or number of number of of uses (%) very uncomfortable, number number of of uses (%) very uncomfortable, uses (%) uses (%) number of uses (%) of uses (%) uses (%) number of uses (%) Total users First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
60 20 18 22 29
(33) (33) (30) (37) (28)
99 29 37 33 58
(55) (48) (62) (55) (57)
131 9 0 4 9
(8) (15) (7) (9)
8 2 5 1 6
(5) (3) (9) (2) (6)
54 15 15 24 24
(30) (25) (25) (40) (24)
92 30 34 28 54
(51) (50) (58) (47) (53)
30 13 9 8 22
(17) (22) (15) (13) (22)
3 2 1 0 2
31 26 12 22
(40) (43) (20) (37)
41 26 45 28
(53) (43) (75) (47)
4 3 3 7
(2) (3) (2)
(5) (5) (5) (12)
2 (3) 5 (8) 0 3 (5)
30 20 9 25
(39) (33) (15) (42)
38 33 37 22
(49) (55) (62) (37)
8 6 14 10
(10) (10) (23) (17)
1 (1) 1 (2) 0 2 (3)
(2)
(Table 5). Women reported a high level of satisfaction with the sensation of the device during sex regardless of whether they used the device during the first, second or third time. Male partners reported increased levels of satisfaction in the feeling of sex while their partner used the PATH Woman’s Condom from the first to third product use. One product use was reported as having unsatisfactory sensation, and one product use was reported as having very unsatisfactory sensation; both occurred during the time of first use. None of the men reported that they were bunsatisfiedQ or bvery unsatisfiedQ in their sensation during the sex during second or third product uses. Similar to the results from the female users, male users in South Africa reported relatively more bsatisfactory Q sensation, and male users in Mexico and Thailand reported relatively more bunsatisfactory Q sensation during use.
uncomfortable in six product uses compared to zero product uses in South Africa and one product use in Thailand. During intercourse, female participants reported that the condom was comfortable during 172 (96%) product uses and male participants reported that the condom was comfortable during 176 (98%) product uses (Table 4). Women’s levels of reported comfort increased over the three product uses. Men also reported an increased level of comfort from the first to the third use. There were three reports of the device being buncomfortableQ during the first and second use, and no reports of discomfort during the third product use. New users reported the device as being bvery comfortableQ during use more often than experienced users. Women reported the PATH Woman’s Condom was comfortable to remove in 96% (173/180) of product uses. Reports of buncomfortableQ removal decreased from the first use (5%) to the third product use (2%). There was little difference in the comfort level during removal between experienced and new users or across sites.
3.6. Ease of condom insertion Women reported that the condom was easy to insert in 158 (88%) uses (Table 6). Across the three product uses, women reported that the ease of insertion increased [ F(2,177) =5.67, pb .004]. The number of women who reported it was bvery easy Q increased from 27% (16) during the first product use to 53% (31) during the third use. Both experienced and new
3.5. Sensation During use, women reported that sensation was satisfactory in 98% (176/180) of product uses and men reported satisfactory sensation in 99% (178/180) of product uses
Table 5 Sensation of sex while condom in place by timing of use, user experience and site Female (n = 180)
Total users First use (n = 60) Second use (n = 60) Third use (n = 60) Experienced users (n = 102) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 60)
Male (n = 180)
Very satisfactory, number of uses (%)
Satisfactory, number of uses (%)
OK, number of uses (%)
Unsatisfactory, number of uses (%)
Very satisfactory, number of uses (%)
Satisfactory, number of uses (%)
OK, number of uses (%)
Unsatisfactory, number of uses (%)
61 17 23 21 32
(34) (28) (38) (35) (31)
99 33 32 34 57
(55) (55) (53) (57) (56)
16 (9) 9 (15) 4 (7) 3 (5) 11 (11)
4 1 1 2 2
(2) (2) (2) (3) (2)
59 20 18 21 31
(33) (33) (30) (35) (30)
97 30 35 32 55
(54) (50) (58) (53) (54)
22 8 7 7 15
(12) (13) (12) (12) (15)
2 (2) 2 (4) 0 0 1 (1)
29 26 15 20
(37) (43) (25) (33)
42 28 39 32
(54) (47) (65) (53)
2 (3) 2 (3) 0 2 (3)
28 20 12 27
(36) (33) (20) (45)
42 34 36 27
(54) (57) (60) (45)
7 5 12 5
(9) (8) (20) (8)
1 (1) 1 (2) 0 1 (2)
5 4 6 6
(6) (7) (10) (10)
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Table 6 Ease of insertion of condom (female) by timing of use, user experience and site (n = 179)
Total users (n = 179) 1st use (n = 60) 2nd use (n = 60) 3rd use (n = 59) Experienced users (n = 101) New users (n = 78) Mexico (n = 60) South Africa (n = 60) Thailand (n = 59)
Very easy, number of uses (%)
Easy, number of uses (%)
OK, number of uses (%)
Difficult, number of uses (%)
71 16 24 31 37 34 18 26 27
87 33 28 26 53 34 30 32 25
17 (9) 10 (17) 6 (10) 1 (2) 7 (7) 10 (13) 11 (18) 2 (3) 4 (7)
4 1 2 1 4 0 1 0 3
(40) (27) (40) (53) (37) (44) (30) (43) (46)
users found insertion of the condom to be relatively easy. New users reported no difficulties with inserting the device as compared with a small number of experienced users that reported the insertion of the condom as being bdifficult.Q 3.7. Ease of condom removal Women reported that the condom was easy to remove during 99% (176/180) of product uses. Most women reported that the condom was beasyQ to bvery easyQ to remove even on the first use. New users reported slightly greater ease in removing the condom than did experienced users. One product use in Thailand was reported to be bdifficultQ during removal.
4. Discussion Results of this user evaluation suggest that the PATH Woman’s Condom is easy to use, stable during use, comfortable and satisfactory during sex among users from diverse populations and cultures. This is not surprising given that this study is the culmination of a 6-year research and development process aimed toward developing such a device. This device met or exceeded all but one of the primary product specification requirements used to establish success criteria by the product development team. Product performance objectives were achieved primarily through a userdriven design process. By listening carefully to user input through every step of the development process, a number of design features were changed substantially, in some cases, in direct opposition to the development team’s initial assumptions. Interactions with users and field investigators assisted in the prioritization process when balancing the trade-offs among various user needs and inputs. We hypothesized that users would experience a learning curve with this product, and that results from the first product use would be less favorable than results from subsequent product uses. This was not, however, the case. In general, participants reported similar experiences during first, second and third uses. In some cases, such as with ease and comfort of insertion, comfort of removal for women and comfort of penis insertion by men, a modest upward trend over time seemed to indicate that a learning curve was
(49) (55) (47) (44) (52) (44) (50) (53) (42)
(2) (2) (3) (2) (4) (2) (5)
present. A statistically significant difference was only visible in ease of condom insertion for women, however. These results indicate that a woman’s familiarity with the insertion process may lead to an easier insertion experience. Ease of removal remained high over the three product uses, suggesting that the removal process did not appear to be difficult to learn. Difficulty with condom insertion has been noted in studies with the currently marketed female condom product in other settings [1– 4]. Results from this study also indicated some difficulties with insertion. We hypothesize that this difficulty in insertion was partially due to the presence of side seams on the dissolving insertion cap — a prototype design that was necessitated by the need to fabricate the cap from flat film. A seamless cap with a smooth spherical tip subsequently superseded this design. Ease as well as comfort of insertion is expected to improve significantly using this new cap configuration. We also hypothesized that more experienced users would have relatively more positive experiences with the condom than new users. No significant differences were noted, however, suggesting that this product may meet users’ demands for a barrier method that is both acceptable and easy to use for new and experienced users. Although user input during the product development process varied significantly by region, acceptability remained consistently high across all groups. We believe that the iterative user-driven product development process helped ensure that a wide range of user and cultural preferences was addressed by this new product design. The uniformly high levels of acceptability demonstrated by men as well as women in this study indicate that the PATH Woman’s Condom may inspire the level of partner cooperation needed for successful use of female condom products [5]. Data were collected about user experience from both female and male partners after each of three consecutive condom uses, adding to the strength of the study. Quantitative data were collected through standardized questionnaires, and qualitative experiences were collected in a debriefing session after all condoms were used. Although no standard definition of bacceptability Q is used in contraceptive research [6], we believe that the elements
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used to assess acceptability in this study are consistent with recent literature [7,8]. Additionally, we assessed the failure of our device during use by applying slippage and breakage criteria (e.g., eversion, pullout and complete slippage) commonly used in condom breakage and slippage trials [9]. Participants in this study were self-selected, and study design demanded that they be at low-risk for STIs. In addition, almost 60% of participants had prior experience with PATH Woman’s Condom prototypes. Due to this selection bias, it is not clear if similar study results could be replicated among the general population. A Phase I clinical trial to evaluate the safety and acceptability of the PATH Woman’s Condom compared to the FCR Female Condom is underway. Further research should be undertaken to directly compare the effectiveness of the PATH Woman’s Condom to the FCR, male condoms and other woman-initiated barriers such as the V-Amour, Lea’s Shield contraceptive or Femcap. Comparative studies with a wide range of products among a richly varied mix of users from various regions, cultures and social backgrounds would determine the selection of prevention options that can best meet users’ needs and ultimately result in more protected sex acts and fewer cases of STIs and unwanted pregnancy. Acknowledgment PATH would like to acknowledge the effort and commitment of our research partners, Dilys Walker of the National Institute of Public Health in Cuernavaca, Mexico; Mags Beksinska of the Reproductive Health Research Unit, University of Witwaterstand in Durban, South Africa; and
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Earmporn Thongkrajai of the Department of Community Nursing, Khon Kaen University in Khon, Kaen, Thailand; and the women and men who have willingly shared their experience and ideas. This study was supported by the CONRAD Program, Eastern Virginia Medical School, under USAID Cooperative Agreement #HRN-A-00-9800020-00. We also appreciate the support of the Bill and Melinda Gates Foundation.
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