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Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only
Contraception 74 (2006) 110 – 117
Original research article
Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only Terri L. Walsh4, Ron G. Frezieres Research Division, California Family Health Council, Los Angeles, CA 90010, USA Received 16 November 2005; revised 16 February 2006; accepted 17 February 2006
Abstract Purpose: This study measures the impact of the advance provision of emergency contraception (EC) among family planning clients at 31 clinics in California. Methods: We randomized over 9000 clients to receive a packet containing either two 0.75-mg levonorgestrel pills (Plan Bk) or an identical packet containing EC information only. We conducted follow-up interviews on a subset of 1130 clients selected to optimize the age and ethnicity distribution. The interviews collected information on EC use, contraception, risk-taking behaviors and EC attitudes. Results: Clients who received EC in advance were significantly more likely to have used EC (19%) than women who received information only (12%) (p = .0009). There were no significant differences between the contraceptive and risk-taking behavior of the two treatment groups. Study respondents of all ages and ethnicities expressed positive attitudes about EC. Nevertheless, even with EC on-hand, many respondents who reported unprotected intercourse decided not to take EC. Conclusion: More research should be done on the reasons women decide not to use EC even when readily available. D 2006 Elsevier Inc. All rights reserved. Keywords: Emergency contraception; Morning-after-pill; Advance provision; Clinical trial
1. Introduction Every year millions of American women experience unintended pregnancy. The public health community has had high hopes that emergency contraception (EC; also known as the morning-after-pill) would substantially reduce these events [1]. Optimism increased when EC became available as an FDA-approved prescription drug in 1998 [2]. While EC has proved to be safe and effective [3–5], utilization has lagged behind expectations. Numerous policy statements and surveys have addressed possible reasons for this phenomenon: inadequate public education [6], logistical barriers to EC access [7,8], provider attitudinal barriers [9–12] and consumer attitudinal barriers [13,14]. A number of randomized clinical trials conducted in the United States and United Kingdom have compared the frequency of EC use when provided in advance of need with on-demand provision [15–20]. These studies have reassured providers that ready access to EC does not increase risk-taking behavior or 4 Corresponding author. Tel.: +1 213 368 5614; fax: +1 213 368 4410. E-mail address: [email protected] (T.L. Walsh). 0010-7824/$ – see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2006.02.005
decrease contraceptive compliance. These studies have also demonstrated that women who have EC on-hand use EC more frequently than women who do not. However, the additional EC taken by women who had EC on-hand did not significantly reduce their risk of pregnancy. The common thread among all these studies was that most acts of unprotected intercourse and method failures were NOT followed by EC use, even when EC was readily available. The EC clinical trials described above tended to be small studies or confined to a particular clinic setting or ethnic background. The goal of our trial was to test the impact of providing EC in advance of need within a large study population of ethnically diverse family planning clients of community clinics throughout California. Half of the participating clients were randomly assigned to receive a take-home packet containing EC, while the other half received an identical-appearing packet containing only EC information. We developed simple study procedures which fit easily within the work flow of the community clinics. A subgroup of approximately 1000 clients was interviewed approximately 6 months after receiving the study packet. Follow-up selection criteria were primarily age and ethnicity.
T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
The study measured contraceptive compliance, EC use, pregnancy and EC attitudes. Of particular interest was information about why women chose not to use EC after unprotected intercourse or method failure.
2. Materials and methods 2.1. Participants Over 9,000 family planning clients at 31 community clinics located throughout California enrolled in the study between October 2003 and October 2004. Clients between the ages of 15 and 45 years and not pregnant or seeking pregnancy were offered enrollment during their clinic visit irrespective of any expressed interest in EC and preferred method of birth control. All participants were fluent in either English or Spanish. The study protocol, study procedures, data collection instruments and informed consent were reviewed and approved by the Institutional Review Board of the California Family Health Council (CFHC). 2.2. Study procedures and data collection Participants signed an informed consent, provided contact information and completed a short demographic questionnaire before they received a study packet from a clinician. Half of the study packets contained two 0.75-mg levonorgestrel pills commercially packaged as Plan Bk (Duramed Pharmaceuticals, Cincinnati, OH) with English and Spanish instructions consistent with the package insert. The other half of the study packets contained only information about EC and how to obtain EC if needed. All participants were entered into a raffle of 10 gift certificates worth $500 each. A subset of participants was interviewed over the phone approximately 3 to 9 months after they received the study packet. Study staff conducted the structured phone interviews in the participant’s preferred language (Spanish or English). At least three phone attempts were made to reach participants selected for follow-up. 2.3. Randomization and analysis We used a computer-generated randomization sequence to assign participants to treatment groups. The sequence was blocked in sets of 48 assignments to facilitate shipment of study packets to participating clinics. Participants, clinic staff and interviewers were masked from study assignment. The two types of study packets were identical in appearance, having been labeled and assembled at the CFHC central office. Each study packet had an extra peel-off identification label which clinic staff transferred to the participant’s demographic questionnaire at the time the participant received the study packet. We considered women available for follow-up if we received their signed consent, randomization label, phone number, and if they were between the ages of 15 and 45 years. Since it was not feasible to try to contact everyone
111
who received a study packet, we devised a selection strategy to maximize diversity among women chosen for follow-up. We tried to achieve a follow-up group composed of equal numbers from four ethnic groups (Hispanic, White, Asian and African American) and equal numbers from three age groups (under age 19, age 19–24, over age 24). We used a SAS randomization program to randomly select for phone interview participants who were over age 18 or identified themselves as either Hispanic or White since women in these groups were heavily represented in the study population. Since far fewer participants were under age 19 or identified themselves as Asian or African American, we attempted to contact all participants in these age/ethnic groups. Outcome measures recorded on the phone interview included pregnancy status, birth control method use, incidents of method failure, frequency of use of EC and frequency of unprotected intercourse. All measures were based on the participant’s self-report. We also administered a series of true/false statements about reasons for not using EC and a series of EC attitude statements using a four-point scale. We collected only EC attitudinal data from women who told the interviewer that they did not remember having received a study packet. We constructed the following binary outcome variables: use of EC one or more times since study visit; positive pregnancy test since study visit; and one or more risk events (unprotected sex, incorrect method use, use of withdrawal or method failure) since study visit. We used chi-square tests to determine significant differences between assignment groups for the binary variables. We analyzed all outcome measures within the group to which the participant had been assigned. We also analyzed responses to true/false statements concerning reasons for not using EC by age and ethnic groups. We employed a four-point scale (strongly agree, somewhat agree, somewhat disagree, strongly disagree) to measure response to a series of attitudes about EC. We also analyzed attitudinal data collapsed into two categories (strongly/somewhat agree, strongly/somewhat disagree) by age and ethnic group. We used chi-square tests to identify statistically significant differences between the treatment groups and the age and ethnicity subgroups for the true/false statements and the EC attitudes.
3. Results 3.1. Characteristics of the study population Participating clinics collected 9216 demographic questionnaires. Approximately 5% (462/9216) are not reported because they were missing a signature, randomization label, or were completed by a woman who did not meet the study age criteria. Of the 2868 participants selected for follow-up interviews, we reached 1130. Approximately 53% of the follow-up population had received EC in advance, while
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47% had received EC information only. About 3% of participants in both treatment groups did not remember having received a study packet. The age and ethnicity distribution of the participants who completed follow-up interviews is presented in Table 1. The composition of the follow-up population is segmented into 12 subgroup ethnicity/age combinations. The largest segments were Hispanic and White participants over age 24, which constituted 14% and 13% of the follow-up population, respectively. The smallest segments, each representing less than 5% of the follow-up population, were Hispanic, Asian and African American women under age 19. 3.2. Advance provision of EC and contraceptive behavior We obtained post-assignment EC and contraceptive use information for 96% of the 1130 participants in the followup population. There were no statistically significant differences between the contraceptive practices of the two treatment groups following study enrollment (Table 2). The majority of participants had relied on hormonal contraception since their study visit; only a quarter had depended primarily on a barrier method. Slightly more than 50% of participants in both treatment groups reported one or more risk events. About a third of respondents reported having used withdrawal, 10% reported a condom failure, 16% had used a hormonal method incorrectly and 21% reported unprotected intercourse. Overall, women who had received EC in advance were significantly more likely to have used EC (19%) since their study visit than women who had received information only (12%) (p= .0009). Among participants who had reported one or more risk events, 29% in the advance EC group used EC at least once and 20% in the information-only group used EC (p =.01). Few women in either group took EC more than once (2%). A higher proportion of women in the advance EC group took their first EC pill within 12 h of Table 1 Age/ethnicity of participants who completed a follow-up interview Ethnicity
Age
Advance EC (n)
Information only (n)
Total n
%
Hispanic
15 –18 19 –24 25 – 45 15 – 18 19 – 24 25 – 45 15 – 18 19 – 24 25 – 45 15 – 18 19 – 24 25 – 45
28 49 84 44 62 78 27 68 35 24 37 54 594
25 62 75 32 51 67 20 58 34 19 54 37 536
53 111 159 76 113 145 47 126 69 43 91 91 1130
4.7 9.8 14.1 6.7 10.0 12.8 4.2 11.2 6.1 3.8 8.1 8.1 100.0
White
Asian
African American
Total
Drawn from study population consisting of 4388 women who received EC in advance and 4366 women who received information only. Thirty-nine percent (1130/2968) of participants selected for follow-up completed an interview.
Table 2 Contraceptive activity and EC use following receipt of study packet Advance ECa (N = 573)
Information Totala onlya (N = 1090) (N = 517)
n
n
%
Contraceptive practice since receiving study packet Used hormonal method at least 372 65 356 part of the time Used barrier method(s) only 153 27 120 One or more risk events 306 53 271 One or more condom failures 56 10 51 One or more acts of 188 33 163 withdrawal One or more incorrect uses of 92 16 86 hormonal method One or more acts of 111 19 113 unprotected intercourse EC use since receiving study packet Used EC at least once 108 Used EC at least once 89 (if one or more risk events) Used EC more than once 15 Took first EC dose b 12 h 46 after intercourseb Why EC was takenb Method failure 27 Did not use method 28 Incorrect method use 19 Used withdrawal 18 Extra protection 15 Other 1 Reported side effectsb 21
%
n
%
69
728
67
23 52 10 32
273 577 107 351
25 53 10 32
17
178
16
22
224
21
194 294
60 54
124 204
168 143
15 25
3 43
10 16
2 28
25 62
2 37
25 26 18 17 14 1 19
19 16 9 8 6 0 15
33 28 16 14 10 0 26
46 44 28 26 21 1 36
28 27 17 16 13 1 22
Pregnancy since receiving study packet Took pregnancy test 169 30 Pregnant 31 5 (positive pregnancy test)
172 21
34 4
341 52
32 5
a Does not include respondents who did not remember having received a study packet or whose EC use was unknown. b First EC use after clinic visit. 4 Statistically significant difference, p V .05.
intercourse compared to women who received information only (43 vs. 28%; pV .06). There were no statistically significant differences between the two treatment groups concerning the reasons given for taking EC, side effects or pregnancy. A nearly equal percentage of participants took EC after unprotected intercourse (27%) or after a method failure (28%). Sixteen percent of participants reported EC use following withdrawal and 17% following incorrect method use. Less than a quarter of participants reported side effects (22%). Approximately one third of participants in both groups had taken at least one pregnancy test since their study visit and approximately 5% became pregnant. Table 3 presents post-assignment EC and contraceptive use by age and ethnicity. Women under age 19 reported greater reliance on hormonal methods (74%) than women in the older age groups (19–24: 70%; over 24: 60%) (p = .0003). The proportion of women reporting one or more risk events declined with age (under 19: 63%; 19–24:
T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
113
There were pronounced differences among the ethnic subgroups regarding contraceptive practice. Although Hispanic participants reported the highest percentage of barrier method use (30%; p =.02), they were less likely to report having had one or more risk events (43%; p b .0001), having used withdrawal (22%; p b.0001), having used a hormonal method incorrectly (12%; p= .02) or having had an act of unprotected intercourse (16%; p= .03), than the other ethnic groups. White participants differed from other ethnic groups only in that they were less likely to have reported a condom failure (11%; p =.03) and more likely to have used withdrawal (37%; p= .02). Participants who identified themselves as Asian reported the highest reliance on hormonal methods (77%; p =.0003), the lowest reliance on barrier methods (19%; p = .02) and the highest use of withdrawal (40%; p= .003). A higher proportion of African American participants reported one or more risk events (64%; p =.0004) compared to other ethnic groups. The risk events were more frequently attributed to incorrect use of a hormonal method (25%; p= .0001) or unprotected intercourse (29%; p =.001) than was the case for the other ethnicities.
56%; over 24: 44%) (p b .0001). Nearly half of the participants under age 19 reported having used withdrawal (45%), compared to 32% of women age 19–24 and 26% of women over 24 years of age (p b .0001). Participants under age 19 were also more likely to report unprotected intercourse (28%) than participants in the older age groups (p =.002). Women under 19 were over twice as likely to have used EC at least once since their study visit (22%) compared to women over age 24 (9%) (pb .0001). A similar age-related pattern occurred among women who had experienced one or more risk events where 32% of participants under 19 had used EC at least once, as had 27% of participants between the ages of 19 and 24, and 17% of the participants over age 24 (p=.007). There were no statistically significant differences among the age subgroups concerning reasons for taking EC or side effects. The youngest participants, however, were more likely to have taken a pregnancy test since their study visit than older participants (under 19: 42%; 19–24: 33%; over 24: 25%) (p= .0001), although they did not have a higher rate of pregnancy.
Table 3 Contraceptive activity and EC use following receipt of study packet, by age and ethnic groupa By age group
By ethnic group Total 15–18 19–24 25–45 Hispanic White Asian African American (N = 1090) (%) (n = 210) (%) (n = 431) (%) (n = 443) (%) (n = 316) (%) (n = 325) (%) (n = 232) (%) (n = 217) (%)
Contraceptive practice since receiving study packet Relied on hormonal method 74 70 Relied on barrier contraception 21 23 One or more risk events 63 56 One or more condom failures 17 18 One or more acts of withdrawal 45 32 One or more incorrect uses 19 18 of hormonal method One or more acts of 28 22 unprotected intercourse EC use since receiving study packet Used EC at least once 22 Used EC at least once 32 (if one or more risk events) Used EC more than once 2 Took first EC dose b 12 h 30 after intercourseb Why EC was takenb Method failure 28 Did not use method 30 Incorrect method use 9 Used withdrawal 21 Extra protection 11 Other 2 Reported side effectsb 21 Pregnancy since receiving study packet Took pregnancy test 42 Pregnant (positive pregnancy test) 5 a
604 29 444 13 264 14
63 3044 4344 18 2244 1244
66 25 51 1144 3744 14
7744 1944 58 14 4044 17
63 25 6444 21 31 2544
67 25 53 16 32 16
164
1644
18
22
2944
21
18 27
94 174
12 26
14 21
2144 3144
17 22
15 25
2 44
2 31
2 39
1 30
3 42
3 39
2 37
27 27 21 12 13 0 26
31 18 21 15 15 0 15
4744 34 11 544 344 0 26
23 23 9 2544 20 0 27
19 21 23 23 13 2 17
25 31 25 6 14 0 17
28 26 17 16 13 1 22
33 5
254 4
35 6
26 3
27 3
4144 8
32 5
Does not include respondents who did not remember having received study packet or whose EC use was unknown. First EC use after clinic visit. 4 Age distribution statistically significant (chi-square; p V .05). 44 Ethnic subgroup statistically different from the rest of follow-up participants (chi-square; p V .05).
b
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Of the four ethnic groups, EC use was more frequent among Asian participants (21%) than among African American participants (17%), White participants (14%) and Hispanic participants (12%) (p= .01). This was also true for Asian women who reported one or more risk events (31%), compared to the other ethnic groups (Hispanic, 26%; White, 21%; African American, 22%; p =.05). There were several significant differences among the ethnic groups concerning reasons for taking EC. A higher proportion of Hispanic participants reported taking EC following a method failure (47%; p =.002), while a lower proportion reported taking EC after withdrawal (5%; p =.04) or for extra protection (3%; p =.03) compared to the other ethnic groups. On the other hand, White participants were more likely to take EC following withdrawal (25%; p =.05) than non-White participants. A higher proportion of African American respondents had taken a pregnancy test (41%; p =.001) compared to the other ethnic groups. 3.3. Attitudes about EC In general, participants indicated highly positive attitudes toward EC (Table 4). At least 90% somewhat agreed/
strongly agreed that they would recommend EC to a friend (95%), that they would take EC if their method did not work (94%), that they thought having EC on-hand was a good idea (93%), that EC is safe (93%) and that they would take EC if they had not used a method (90%). Nevertheless, 86% agreed that they would feel safer if they talked to a nurse before taking EC and over a third (38%) agreed that they would get their partner’s permission before using EC. Less than a quarter of respondents agreed that EC would make it harder to get pregnant in the future (24%) or that EC encourages people not to use a method (22%). Participants in the information-only group were slightly less likely to agree that it was a good idea to have EC onhand (91% vs. 95%, p = .03) and that they would take EC if they had not used a method (87% vs. 92%, p= .01) than participants who received advance EC. Respondents who received information only were also more likely to agree that they would feel safer if they spoke to a nurse before taking EC (89% vs. 83%, p= .003). The attitudes of the 429 participants who had experienced a risk event but decided not to use EC were nearly identical to those of the main study population (not shown). The largest difference
Table 4 Attitudes toward EC, by treatment group, age and ethnic groupa % Strongly agree or somewhat agree
By treatment group
By age group
Plan B (n = 573) (%)
Information only (n = 517) (%)
15–18 (n = 219) (%)
19–24 (n = 438) (%)
25–45 (n = 462) (%)
Hispanic (n = 316) (%)
White (n = 325) (%)
Asian (n = 232) (%)
African American (n = 217) (%)
I would recommend EC to a friend I would take EC if my method didn’t work I think it is a good idea to have EC on-hand, before it is needed EC is safe I would take EC if I forgot to use birth control I would feel safer talking to a nurse before taking EC I would get my partner’s permission before taking EC Using EC might make it harder for me to get pregnant in the future EC is dangerous because it encourages people to not use a method
96
95
98
97
9344
94
97
96
95
95
94
93
98
93
9144
95
96444
93
88
94
95
914
92
94
92
94
93
93
91
93
94 92
93 874
93 92
93 90
94 88
93 92
96444 91
91 88
91 85444
93 90
83
894
86
88
84
84
83
90444
88
86
38
38
30
38
4244
47444
34444
38
31444
38
23
26
28
27
21
23
21
29
26
24
23
22
17
22
2644
26
20
24
19
22
a
By ethnic group
Does not include respondents who did not remember having received study packet or whose EC use was unknown. 4 Treatment groups statistically different (chi-square; p V .05). 44 Age distribution statistically significant (chi-square; p V .05). 444 Ethnic subgroup statistically different from the rest of follow-up participants (chi-square; p V .05).
Total (N = 1090) (%)
T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
115
Table 5 Reasons for not using EC, by treatment group, age and ethnic groupa
I didn’t think I was at risk of getting pregnant EC might make me sick I was trying or didn’t mind getting pregnant It was too much trouble to go get EC Didn’t know where to get EC Didn’t know how to take EC My religious beliefs prevent me from taking EC EC probably wouldn’t work EC cost too much
By treatment group
By age group
Plan B (n = 137) (%)
Information only (n = 151) (%)
15–18 (n = 64) (%)
19–24 (n = 113) (%)
25–45 (n = 110) (%)
By ethnic group Hispanic (n = 67) (%)
White (n = 78) (%)
Asian (n = 60) (%)
African American (n = 83) (%)
47
36
48
37
42
33
45
5344
37
42
27 19
29 16
22 11
33 17
27 23
19 21
26 16
34 12
33 22
28 18
12
16
11
13
18
17
18
15
8
14
10 10 10
13 10 8
0 3 10
10 8 7
204 164 10
16 2544 1844
14 8 4
12 344 5
544 5 8
11 10 7
4 4
6 6
3 2
6 5
6 7
1144 9
4 3
2 5
5 4
Total (N = 288) (%)
5 5
a
Includes only respondents who reported a method failure, incorrect method use or unprotected intercourse; does not include respondents who did not remember having received a study packet or whose EC use was unknown. 4 Age distribution statistically significant (chi-square; p V .05). 44 Ethnic subgroup statistically different from the rest of follow-up participants (chi-square; p V .05).
between the groups was in response to whether they would take EC if they forgot to use birth control (85% vs. 90%). Younger respondents tended to have slightly more positive EC attitudes than women in the older age groups (Table 4). Furthermore, younger participants were less likely to agree that they would get their partner’s permission before taking EC (under 19: 30%; 19–24: 38%; over 24: 42%) (p = .01) and that EC is dangerous because it encourages people to not use a method (under 19: 17%; 19–24: 22%; over 24: 26%) (p =.008). There were a number of significant differences in EC attitudes among women from different ethnic groups. Hispanic participants were more likely to agree that they would get their partner’s permission to use EC than participants in other ethnic groups (47% vs. 34%; pb .0001). Conversely, White participants were less likely to agree that they would get their partner’s permission (34% vs. 40%; p = .04) and more likely to agree that they would take EC if their method did not work (96% vs. 92%; p =.02) and that EC is safe (96% vs. 92%; p = .04). Asian participants were the group that expressed the most agreement with feeling safer about talking to a nurse before taking EC (90% vs. 85%; p = .04). African American respondents were less likely to agree that they would take EC if they forgot to use a method (85% vs. 91%; p = .02) and that they would ask their partner’s permission before taking EC (31% vs. 40%; p =.02). A series of true/false reasons for not taking EC were read to participants who had chosen not to use EC following one or more method failures, incorrect method uses or acts of unprotected intercourse (Table 5). The reason that received the most true responses was thinking that they were not at risk of pregnancy (42%). However, participants who had received information only were less likely to agree (36%) than
participants who received EC in advance (47%) (p =.06). Fewer women thought EC would make them sick (28%) or did not mind getting pregnant (18%). Only 7% of participants who decided not to use EC indicated a religious reason. Cost and efficacy were rarely selected as reasons (5%). The respondents over the age of 24 were more likely to cite not knowing where to get EC (20%; p= .0003) or not knowing how to use EC (16%; p =.01) as impediments to taking EC than the younger age groups. Hispanic participants were most likely than other ethnic groups to concur that not knowing how to take EC (25% vs. 5%; p b.0001), their religious beliefs (18% vs. 6%; p= .002) or thinking that EC probably would not work (11% vs. 4%; p =.03) were factors in their decision not to take EC. Not thinking that they were at risk of pregnancy was more common among Asian participants than members of other ethnic groups (53% vs. 39%; p= .04). However, very few Asian participants claimed that they did not know how to take EC (3% vs. 12%; p= .05). African American respondents were the least likely to agree that not knowing where to get EC was an obstacle (5% vs. 14%; p = .02).
4. Discussion 4.1. Strengths and weaknesses One of the strongest features of this large communitybased clinical trial was how it reflected typical clinical conditions much more closely than a trial conducted at a research center. Every effort was made to develop simple study procedures that fit seamlessly into the clinics’ routine practice. Approximately 95% of clinic patients who received a study packet met eligibility criteria and provided written consent. Since over 9,000 women participated, we were able
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to select a follow-up subgroup of women who represented a wide range of age, ethnicity and birth control preference. Some of the advantages of conducting the trial in community clinic settings were offset by common protocol deviations. We estimate that clinicians may have handed out extra EC pills in conjunction with approximately 15% of the study packets, thus providing advance EC to participants who had been assigned to the information-only group. The effect of this deviation was to potentially reduce the difference between the two treatment groups and thus diminish the potential benefit of advance provision. It was also unfortunate that we were able to reach only 50% of the participants selected for follow-up. Since we had a large pool of participants to draw from, we were able to replace many of the participants we could not reach and thus achieve our goal of interviewing at least 1000 participants. Replacements were not available, however, for women age 18 or younger, who made up a relatively small portion of the study population. In the end, we reached over 200 women age 18 or under, compared to over 400 women in the 19–24 and 25–45 age groups. Finally, while much of the difficulty of contacting women selected for follow-up was due to changed or disconnected phone numbers, some women may have been reluctant to talk with us about EC. It is possible that the participants who agreed to speak with us may have been more favorably inclined toward EC than those who would not. Study staff were masked from the treatment assignment when conducting follow-up interviewers. Nonetheless, there were fewer respondents in the informationonly group than in the advance EC group. We suspect that women who had not received EC were less receptive to participating in the phone interviews. 4.2. Confirmation of previous studies Findings from this trial were consistent with previous studies which have shown that advance provision increases EC use but does not increase risk-taking behavior [15–21]. However, these studies as well as ours failed to demonstrate a significant reduction in unintended pregnancy among women who received EC in advance. This disappointing result may be explained by the relatively low frequency of EC use compared to the high incidence of risk events such as unprotected intercourse and incorrect method use. Although 224 participants reported having unprotected intercourse, only 28% elected to use EC, and of the 96 participants who reported the most unprotected sex ( N5 times), only 14.5% used EC. On the other hand, 34% of the participants who had used withdrawal incorrectly used EC and 41% of the 107 participants who reported a condom failure used EC. This pattern suggests that EC is used more readily by participants who have already attempted to protect themselves than by participants who made no contraceptive effort at all. General attitudes toward EC were positive, even among women who had experienced a risk event but decided not to use EC. Among these participants, the most common reason
for not taking EC was the perception that they were not at risk of getting pregnant (42%), while the second most common reason was thinking that EC might make them sick (28%). This suggests that health educators and clinicians might be more effective in increasing EC use if patients understood that the risks associated with pregnancy are far greater than the risks associated with taking EC. That patients may overestimate EC side effects is further suggested by the fact that 86% of participants agreed that they would feel safer if they talked to a nurse before taking EC. The current prescription status of EC may serve to amplify these misplaced concerns. Several interesting trends arose from the subgroup analyses. Regardless of whether they had received EC or information only, respondents under age 19 were more likely to have reported one or more risk events (condom failure, act of withdrawal or unprotected sex, incorrect use of hormonal method — 63%) than women in the older age groups (19–24: 56%; over 25: 44%). Fortunately, younger participants were also far more likely to use EC following one of these risk events (32%) than older participants (19–24: 27%; over 24: 17%). Hispanic respondents were significantly more likely to express attitudes that might impede EC use such as getting their partner’s permission (47%) and belief that EC might encourage unprotected intercourse (26%) than members of other ethnic groups. In particular, Hispanic participants who decided not to use EC following a risk event were more likely to concur that they did not know how to take EC (25%), that their religious beliefs prevented them from taking EC (18%) and that EC probably would not work (11%). Nevertheless, Hispanic women who reported at least one risk event were no less likely to have actually taken EC than women in other ethnic groups. Only Asian participants reported a higher frequency of EC use. 5. Conclusion This study, as well as a number of other studies, has shown that access to EC does not increase risk-taking behavior and does encourage EC use. Nevertheless, even women who have EC on-hand report many more risk events than EC uses. Nearly 50% of the women who reported one or more risk events decided not to take EC even though they had it on-hand because they thought they were not at risk of pregnancy. Although this is undoubtedly true in some cases, many women are taking unwise chances. Future studies might explore whether women might make better choices about when to use EC as an adjunct to the consistent use of reliable birth control if they had a better understanding of the reproductive cycle and its associated fertility risk. It is also imperative that women understand that EC presents fewer health hazards than unintended pregnancy. Finally, it is clear that our public health efforts should be directed at increasing EC use rather than deliberating over theoretical but unsubstantiated concerns about overutilization, particularly among young sexually active women.
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Acknowledgments This trial was supported by the California Family Health Council, a nonprofit organization. We wish to thank Dawn Ginzl, MPH; Elizabeth Suden; Christy Holloway; and other staff of the Research Division for their efforts in managing the study and conducting follow-up interviews. We also extend our sincere appreciation to the clinicians and staff at the participating clinics whose collaboration made this study possible. References [1] Trussell J, Stewart F, Guest F, Hatcher RA. Emergency contraceptive pills: a simple proposal to reduce unintended pregnancies. Fam Plann Perspect 1992;24:269 – 73. [2] Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect 1998;30:24 – 9. [3] Conard LA, Gold MA. Emergency contraceptive pills: a review of the recent literature. Curr Opin Obstet Gynecol 2004;16:389 – 95. [4] Weismiller DG. Emergency contraception. Am Fam Physician 2004;70:707 – 14. [5] Trussell J, Ellertson C, Stewart F, Raymond EG, Shochet T. The role of emergency contraception. Am J Obstet Gynecol 2004;190 (4 Suppl):S30 - 8. [6] Foster DG, Harper CC, Bley JJ, et al. Knowledge of emergency contraception among women aged 18 to 44 in California. Am J Obstet Gynecol 2004;191:150 – 6. [7] Gardner JS, Hutchings J, Fuller TS, Downing D. Increasing access to emergency contraception through community pharmacies: lessons from Washington State. Fam Plann Perspect 2001;33:172 – 5. [8] Blanchard K, Bungay H, Furedi A, Sanders L. Evaluation of an emergency contraception advance provision service. Contraception 2003;67:343 – 8. [9] Gold MA, Schein A, Coupey SM. Emergency contraception: a national survey of adolescent health experts. Fam Plann Perspect 1997;29:15 – 9.
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[10] Brown JW, Boulton ML. Provider attitudes toward dispensing emergency contraception in Michigan’s Title X programs. Fam Plann Perspect 1999;31:39 – 43. [11] Bissell P, Anderson C. Supplying emergency contraception via community pharmacies in the UK: reflections on the experiences of users and providers. Soc Sci Med 2003;57:2367 – 78. [12] Karasz A, Kirchen NT, Gold M. The visit before the morning after: barriers to preprescribing emergency contraception. Ann Fam Med 2004;2:345 – 50. [13] Romo LF, Berenson AB, Wu ZH. The role of misconceptions on Latino women’s acceptance of emergency contraceptive pills. Contraception 2004;69:227 – 35. [14] Fairhurst K, Ziebland S, Wyke S, Seaman P, Glasier A. Emergency contraception: why can’t you give it away? Qualitative findings from an evaluation of advance provision of emergency contraception. Contraception 2004;70:25 – 9. [15] Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med 1998;339:1 – 4. [16] Raine T, Harper C, Leon K, Darney P. Emergency contraception: advance provision in a young, high-risk clinic population. Obstet Gynecol 2000;96:1 – 7. [17] Jackson RA, Schwarz EB, Freedman L, Darney P. Advance supply of emergency contraception: effect on use and usual contraception — a randomized trial. Obstet Gynecol 2003;102:8 – 16. [18] Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17: 87 – 96. [19] Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005; 293:54 – 62. [20] Ellertson C, Ambardekar S, Hedley A, Coyaji K, Trussell J, Blanchard K. Emergency contraception: randomized comparison of advance provision and information only. Obstet Gynecol 2001;98: 570 – 5. [21] Glasier A, Fairhurst K, Wyke S, et al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004;69:361 – 6.
Original research article
Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only Terri L. Walsh4, Ron G. Frezieres Research Division, California Family Health Council, Los Angeles, CA 90010, USA Received 16 November 2005; revised 16 February 2006; accepted 17 February 2006
Abstract Purpose: This study measures the impact of the advance provision of emergency contraception (EC) among family planning clients at 31 clinics in California. Methods: We randomized over 9000 clients to receive a packet containing either two 0.75-mg levonorgestrel pills (Plan Bk) or an identical packet containing EC information only. We conducted follow-up interviews on a subset of 1130 clients selected to optimize the age and ethnicity distribution. The interviews collected information on EC use, contraception, risk-taking behaviors and EC attitudes. Results: Clients who received EC in advance were significantly more likely to have used EC (19%) than women who received information only (12%) (p = .0009). There were no significant differences between the contraceptive and risk-taking behavior of the two treatment groups. Study respondents of all ages and ethnicities expressed positive attitudes about EC. Nevertheless, even with EC on-hand, many respondents who reported unprotected intercourse decided not to take EC. Conclusion: More research should be done on the reasons women decide not to use EC even when readily available. D 2006 Elsevier Inc. All rights reserved. Keywords: Emergency contraception; Morning-after-pill; Advance provision; Clinical trial
1. Introduction Every year millions of American women experience unintended pregnancy. The public health community has had high hopes that emergency contraception (EC; also known as the morning-after-pill) would substantially reduce these events [1]. Optimism increased when EC became available as an FDA-approved prescription drug in 1998 [2]. While EC has proved to be safe and effective [3–5], utilization has lagged behind expectations. Numerous policy statements and surveys have addressed possible reasons for this phenomenon: inadequate public education [6], logistical barriers to EC access [7,8], provider attitudinal barriers [9–12] and consumer attitudinal barriers [13,14]. A number of randomized clinical trials conducted in the United States and United Kingdom have compared the frequency of EC use when provided in advance of need with on-demand provision [15–20]. These studies have reassured providers that ready access to EC does not increase risk-taking behavior or 4 Corresponding author. Tel.: +1 213 368 5614; fax: +1 213 368 4410. E-mail address: [email protected] (T.L. Walsh). 0010-7824/$ – see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2006.02.005
decrease contraceptive compliance. These studies have also demonstrated that women who have EC on-hand use EC more frequently than women who do not. However, the additional EC taken by women who had EC on-hand did not significantly reduce their risk of pregnancy. The common thread among all these studies was that most acts of unprotected intercourse and method failures were NOT followed by EC use, even when EC was readily available. The EC clinical trials described above tended to be small studies or confined to a particular clinic setting or ethnic background. The goal of our trial was to test the impact of providing EC in advance of need within a large study population of ethnically diverse family planning clients of community clinics throughout California. Half of the participating clients were randomly assigned to receive a take-home packet containing EC, while the other half received an identical-appearing packet containing only EC information. We developed simple study procedures which fit easily within the work flow of the community clinics. A subgroup of approximately 1000 clients was interviewed approximately 6 months after receiving the study packet. Follow-up selection criteria were primarily age and ethnicity.
T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
The study measured contraceptive compliance, EC use, pregnancy and EC attitudes. Of particular interest was information about why women chose not to use EC after unprotected intercourse or method failure.
2. Materials and methods 2.1. Participants Over 9,000 family planning clients at 31 community clinics located throughout California enrolled in the study between October 2003 and October 2004. Clients between the ages of 15 and 45 years and not pregnant or seeking pregnancy were offered enrollment during their clinic visit irrespective of any expressed interest in EC and preferred method of birth control. All participants were fluent in either English or Spanish. The study protocol, study procedures, data collection instruments and informed consent were reviewed and approved by the Institutional Review Board of the California Family Health Council (CFHC). 2.2. Study procedures and data collection Participants signed an informed consent, provided contact information and completed a short demographic questionnaire before they received a study packet from a clinician. Half of the study packets contained two 0.75-mg levonorgestrel pills commercially packaged as Plan Bk (Duramed Pharmaceuticals, Cincinnati, OH) with English and Spanish instructions consistent with the package insert. The other half of the study packets contained only information about EC and how to obtain EC if needed. All participants were entered into a raffle of 10 gift certificates worth $500 each. A subset of participants was interviewed over the phone approximately 3 to 9 months after they received the study packet. Study staff conducted the structured phone interviews in the participant’s preferred language (Spanish or English). At least three phone attempts were made to reach participants selected for follow-up. 2.3. Randomization and analysis We used a computer-generated randomization sequence to assign participants to treatment groups. The sequence was blocked in sets of 48 assignments to facilitate shipment of study packets to participating clinics. Participants, clinic staff and interviewers were masked from study assignment. The two types of study packets were identical in appearance, having been labeled and assembled at the CFHC central office. Each study packet had an extra peel-off identification label which clinic staff transferred to the participant’s demographic questionnaire at the time the participant received the study packet. We considered women available for follow-up if we received their signed consent, randomization label, phone number, and if they were between the ages of 15 and 45 years. Since it was not feasible to try to contact everyone
111
who received a study packet, we devised a selection strategy to maximize diversity among women chosen for follow-up. We tried to achieve a follow-up group composed of equal numbers from four ethnic groups (Hispanic, White, Asian and African American) and equal numbers from three age groups (under age 19, age 19–24, over age 24). We used a SAS randomization program to randomly select for phone interview participants who were over age 18 or identified themselves as either Hispanic or White since women in these groups were heavily represented in the study population. Since far fewer participants were under age 19 or identified themselves as Asian or African American, we attempted to contact all participants in these age/ethnic groups. Outcome measures recorded on the phone interview included pregnancy status, birth control method use, incidents of method failure, frequency of use of EC and frequency of unprotected intercourse. All measures were based on the participant’s self-report. We also administered a series of true/false statements about reasons for not using EC and a series of EC attitude statements using a four-point scale. We collected only EC attitudinal data from women who told the interviewer that they did not remember having received a study packet. We constructed the following binary outcome variables: use of EC one or more times since study visit; positive pregnancy test since study visit; and one or more risk events (unprotected sex, incorrect method use, use of withdrawal or method failure) since study visit. We used chi-square tests to determine significant differences between assignment groups for the binary variables. We analyzed all outcome measures within the group to which the participant had been assigned. We also analyzed responses to true/false statements concerning reasons for not using EC by age and ethnic groups. We employed a four-point scale (strongly agree, somewhat agree, somewhat disagree, strongly disagree) to measure response to a series of attitudes about EC. We also analyzed attitudinal data collapsed into two categories (strongly/somewhat agree, strongly/somewhat disagree) by age and ethnic group. We used chi-square tests to identify statistically significant differences between the treatment groups and the age and ethnicity subgroups for the true/false statements and the EC attitudes.
3. Results 3.1. Characteristics of the study population Participating clinics collected 9216 demographic questionnaires. Approximately 5% (462/9216) are not reported because they were missing a signature, randomization label, or were completed by a woman who did not meet the study age criteria. Of the 2868 participants selected for follow-up interviews, we reached 1130. Approximately 53% of the follow-up population had received EC in advance, while
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47% had received EC information only. About 3% of participants in both treatment groups did not remember having received a study packet. The age and ethnicity distribution of the participants who completed follow-up interviews is presented in Table 1. The composition of the follow-up population is segmented into 12 subgroup ethnicity/age combinations. The largest segments were Hispanic and White participants over age 24, which constituted 14% and 13% of the follow-up population, respectively. The smallest segments, each representing less than 5% of the follow-up population, were Hispanic, Asian and African American women under age 19. 3.2. Advance provision of EC and contraceptive behavior We obtained post-assignment EC and contraceptive use information for 96% of the 1130 participants in the followup population. There were no statistically significant differences between the contraceptive practices of the two treatment groups following study enrollment (Table 2). The majority of participants had relied on hormonal contraception since their study visit; only a quarter had depended primarily on a barrier method. Slightly more than 50% of participants in both treatment groups reported one or more risk events. About a third of respondents reported having used withdrawal, 10% reported a condom failure, 16% had used a hormonal method incorrectly and 21% reported unprotected intercourse. Overall, women who had received EC in advance were significantly more likely to have used EC (19%) since their study visit than women who had received information only (12%) (p= .0009). Among participants who had reported one or more risk events, 29% in the advance EC group used EC at least once and 20% in the information-only group used EC (p =.01). Few women in either group took EC more than once (2%). A higher proportion of women in the advance EC group took their first EC pill within 12 h of Table 1 Age/ethnicity of participants who completed a follow-up interview Ethnicity
Age
Advance EC (n)
Information only (n)
Total n
%
Hispanic
15 –18 19 –24 25 – 45 15 – 18 19 – 24 25 – 45 15 – 18 19 – 24 25 – 45 15 – 18 19 – 24 25 – 45
28 49 84 44 62 78 27 68 35 24 37 54 594
25 62 75 32 51 67 20 58 34 19 54 37 536
53 111 159 76 113 145 47 126 69 43 91 91 1130
4.7 9.8 14.1 6.7 10.0 12.8 4.2 11.2 6.1 3.8 8.1 8.1 100.0
White
Asian
African American
Total
Drawn from study population consisting of 4388 women who received EC in advance and 4366 women who received information only. Thirty-nine percent (1130/2968) of participants selected for follow-up completed an interview.
Table 2 Contraceptive activity and EC use following receipt of study packet Advance ECa (N = 573)
Information Totala onlya (N = 1090) (N = 517)
n
n
%
Contraceptive practice since receiving study packet Used hormonal method at least 372 65 356 part of the time Used barrier method(s) only 153 27 120 One or more risk events 306 53 271 One or more condom failures 56 10 51 One or more acts of 188 33 163 withdrawal One or more incorrect uses of 92 16 86 hormonal method One or more acts of 111 19 113 unprotected intercourse EC use since receiving study packet Used EC at least once 108 Used EC at least once 89 (if one or more risk events) Used EC more than once 15 Took first EC dose b 12 h 46 after intercourseb Why EC was takenb Method failure 27 Did not use method 28 Incorrect method use 19 Used withdrawal 18 Extra protection 15 Other 1 Reported side effectsb 21
%
n
%
69
728
67
23 52 10 32
273 577 107 351
25 53 10 32
17
178
16
22
224
21
194 294
60 54
124 204
168 143
15 25
3 43
10 16
2 28
25 62
2 37
25 26 18 17 14 1 19
19 16 9 8 6 0 15
33 28 16 14 10 0 26
46 44 28 26 21 1 36
28 27 17 16 13 1 22
Pregnancy since receiving study packet Took pregnancy test 169 30 Pregnant 31 5 (positive pregnancy test)
172 21
34 4
341 52
32 5
a Does not include respondents who did not remember having received a study packet or whose EC use was unknown. b First EC use after clinic visit. 4 Statistically significant difference, p V .05.
intercourse compared to women who received information only (43 vs. 28%; pV .06). There were no statistically significant differences between the two treatment groups concerning the reasons given for taking EC, side effects or pregnancy. A nearly equal percentage of participants took EC after unprotected intercourse (27%) or after a method failure (28%). Sixteen percent of participants reported EC use following withdrawal and 17% following incorrect method use. Less than a quarter of participants reported side effects (22%). Approximately one third of participants in both groups had taken at least one pregnancy test since their study visit and approximately 5% became pregnant. Table 3 presents post-assignment EC and contraceptive use by age and ethnicity. Women under age 19 reported greater reliance on hormonal methods (74%) than women in the older age groups (19–24: 70%; over 24: 60%) (p = .0003). The proportion of women reporting one or more risk events declined with age (under 19: 63%; 19–24:
T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
113
There were pronounced differences among the ethnic subgroups regarding contraceptive practice. Although Hispanic participants reported the highest percentage of barrier method use (30%; p =.02), they were less likely to report having had one or more risk events (43%; p b .0001), having used withdrawal (22%; p b.0001), having used a hormonal method incorrectly (12%; p= .02) or having had an act of unprotected intercourse (16%; p= .03), than the other ethnic groups. White participants differed from other ethnic groups only in that they were less likely to have reported a condom failure (11%; p =.03) and more likely to have used withdrawal (37%; p= .02). Participants who identified themselves as Asian reported the highest reliance on hormonal methods (77%; p =.0003), the lowest reliance on barrier methods (19%; p = .02) and the highest use of withdrawal (40%; p= .003). A higher proportion of African American participants reported one or more risk events (64%; p =.0004) compared to other ethnic groups. The risk events were more frequently attributed to incorrect use of a hormonal method (25%; p= .0001) or unprotected intercourse (29%; p =.001) than was the case for the other ethnicities.
56%; over 24: 44%) (p b .0001). Nearly half of the participants under age 19 reported having used withdrawal (45%), compared to 32% of women age 19–24 and 26% of women over 24 years of age (p b .0001). Participants under age 19 were also more likely to report unprotected intercourse (28%) than participants in the older age groups (p =.002). Women under 19 were over twice as likely to have used EC at least once since their study visit (22%) compared to women over age 24 (9%) (pb .0001). A similar age-related pattern occurred among women who had experienced one or more risk events where 32% of participants under 19 had used EC at least once, as had 27% of participants between the ages of 19 and 24, and 17% of the participants over age 24 (p=.007). There were no statistically significant differences among the age subgroups concerning reasons for taking EC or side effects. The youngest participants, however, were more likely to have taken a pregnancy test since their study visit than older participants (under 19: 42%; 19–24: 33%; over 24: 25%) (p= .0001), although they did not have a higher rate of pregnancy.
Table 3 Contraceptive activity and EC use following receipt of study packet, by age and ethnic groupa By age group
By ethnic group Total 15–18 19–24 25–45 Hispanic White Asian African American (N = 1090) (%) (n = 210) (%) (n = 431) (%) (n = 443) (%) (n = 316) (%) (n = 325) (%) (n = 232) (%) (n = 217) (%)
Contraceptive practice since receiving study packet Relied on hormonal method 74 70 Relied on barrier contraception 21 23 One or more risk events 63 56 One or more condom failures 17 18 One or more acts of withdrawal 45 32 One or more incorrect uses 19 18 of hormonal method One or more acts of 28 22 unprotected intercourse EC use since receiving study packet Used EC at least once 22 Used EC at least once 32 (if one or more risk events) Used EC more than once 2 Took first EC dose b 12 h 30 after intercourseb Why EC was takenb Method failure 28 Did not use method 30 Incorrect method use 9 Used withdrawal 21 Extra protection 11 Other 2 Reported side effectsb 21 Pregnancy since receiving study packet Took pregnancy test 42 Pregnant (positive pregnancy test) 5 a
604 29 444 13 264 14
63 3044 4344 18 2244 1244
66 25 51 1144 3744 14
7744 1944 58 14 4044 17
63 25 6444 21 31 2544
67 25 53 16 32 16
164
1644
18
22
2944
21
18 27
94 174
12 26
14 21
2144 3144
17 22
15 25
2 44
2 31
2 39
1 30
3 42
3 39
2 37
27 27 21 12 13 0 26
31 18 21 15 15 0 15
4744 34 11 544 344 0 26
23 23 9 2544 20 0 27
19 21 23 23 13 2 17
25 31 25 6 14 0 17
28 26 17 16 13 1 22
33 5
254 4
35 6
26 3
27 3
4144 8
32 5
Does not include respondents who did not remember having received study packet or whose EC use was unknown. First EC use after clinic visit. 4 Age distribution statistically significant (chi-square; p V .05). 44 Ethnic subgroup statistically different from the rest of follow-up participants (chi-square; p V .05).
b
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T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
Of the four ethnic groups, EC use was more frequent among Asian participants (21%) than among African American participants (17%), White participants (14%) and Hispanic participants (12%) (p= .01). This was also true for Asian women who reported one or more risk events (31%), compared to the other ethnic groups (Hispanic, 26%; White, 21%; African American, 22%; p =.05). There were several significant differences among the ethnic groups concerning reasons for taking EC. A higher proportion of Hispanic participants reported taking EC following a method failure (47%; p =.002), while a lower proportion reported taking EC after withdrawal (5%; p =.04) or for extra protection (3%; p =.03) compared to the other ethnic groups. On the other hand, White participants were more likely to take EC following withdrawal (25%; p =.05) than non-White participants. A higher proportion of African American respondents had taken a pregnancy test (41%; p =.001) compared to the other ethnic groups. 3.3. Attitudes about EC In general, participants indicated highly positive attitudes toward EC (Table 4). At least 90% somewhat agreed/
strongly agreed that they would recommend EC to a friend (95%), that they would take EC if their method did not work (94%), that they thought having EC on-hand was a good idea (93%), that EC is safe (93%) and that they would take EC if they had not used a method (90%). Nevertheless, 86% agreed that they would feel safer if they talked to a nurse before taking EC and over a third (38%) agreed that they would get their partner’s permission before using EC. Less than a quarter of respondents agreed that EC would make it harder to get pregnant in the future (24%) or that EC encourages people not to use a method (22%). Participants in the information-only group were slightly less likely to agree that it was a good idea to have EC onhand (91% vs. 95%, p = .03) and that they would take EC if they had not used a method (87% vs. 92%, p= .01) than participants who received advance EC. Respondents who received information only were also more likely to agree that they would feel safer if they spoke to a nurse before taking EC (89% vs. 83%, p= .003). The attitudes of the 429 participants who had experienced a risk event but decided not to use EC were nearly identical to those of the main study population (not shown). The largest difference
Table 4 Attitudes toward EC, by treatment group, age and ethnic groupa % Strongly agree or somewhat agree
By treatment group
By age group
Plan B (n = 573) (%)
Information only (n = 517) (%)
15–18 (n = 219) (%)
19–24 (n = 438) (%)
25–45 (n = 462) (%)
Hispanic (n = 316) (%)
White (n = 325) (%)
Asian (n = 232) (%)
African American (n = 217) (%)
I would recommend EC to a friend I would take EC if my method didn’t work I think it is a good idea to have EC on-hand, before it is needed EC is safe I would take EC if I forgot to use birth control I would feel safer talking to a nurse before taking EC I would get my partner’s permission before taking EC Using EC might make it harder for me to get pregnant in the future EC is dangerous because it encourages people to not use a method
96
95
98
97
9344
94
97
96
95
95
94
93
98
93
9144
95
96444
93
88
94
95
914
92
94
92
94
93
93
91
93
94 92
93 874
93 92
93 90
94 88
93 92
96444 91
91 88
91 85444
93 90
83
894
86
88
84
84
83
90444
88
86
38
38
30
38
4244
47444
34444
38
31444
38
23
26
28
27
21
23
21
29
26
24
23
22
17
22
2644
26
20
24
19
22
a
By ethnic group
Does not include respondents who did not remember having received study packet or whose EC use was unknown. 4 Treatment groups statistically different (chi-square; p V .05). 44 Age distribution statistically significant (chi-square; p V .05). 444 Ethnic subgroup statistically different from the rest of follow-up participants (chi-square; p V .05).
Total (N = 1090) (%)
T.L. Walsh, R.G. Frezieres / Contraception 74 (2006) 110 – 117
115
Table 5 Reasons for not using EC, by treatment group, age and ethnic groupa
I didn’t think I was at risk of getting pregnant EC might make me sick I was trying or didn’t mind getting pregnant It was too much trouble to go get EC Didn’t know where to get EC Didn’t know how to take EC My religious beliefs prevent me from taking EC EC probably wouldn’t work EC cost too much
By treatment group
By age group
Plan B (n = 137) (%)
Information only (n = 151) (%)
15–18 (n = 64) (%)
19–24 (n = 113) (%)
25–45 (n = 110) (%)
By ethnic group Hispanic (n = 67) (%)
White (n = 78) (%)
Asian (n = 60) (%)
African American (n = 83) (%)
47
36
48
37
42
33
45
5344
37
42
27 19
29 16
22 11
33 17
27 23
19 21
26 16
34 12
33 22
28 18
12
16
11
13
18
17
18
15
8
14
10 10 10
13 10 8
0 3 10
10 8 7
204 164 10
16 2544 1844
14 8 4
12 344 5
544 5 8
11 10 7
4 4
6 6
3 2
6 5
6 7
1144 9
4 3
2 5
5 4
Total (N = 288) (%)
5 5
a
Includes only respondents who reported a method failure, incorrect method use or unprotected intercourse; does not include respondents who did not remember having received a study packet or whose EC use was unknown. 4 Age distribution statistically significant (chi-square; p V .05). 44 Ethnic subgroup statistically different from the rest of follow-up participants (chi-square; p V .05).
between the groups was in response to whether they would take EC if they forgot to use birth control (85% vs. 90%). Younger respondents tended to have slightly more positive EC attitudes than women in the older age groups (Table 4). Furthermore, younger participants were less likely to agree that they would get their partner’s permission before taking EC (under 19: 30%; 19–24: 38%; over 24: 42%) (p = .01) and that EC is dangerous because it encourages people to not use a method (under 19: 17%; 19–24: 22%; over 24: 26%) (p =.008). There were a number of significant differences in EC attitudes among women from different ethnic groups. Hispanic participants were more likely to agree that they would get their partner’s permission to use EC than participants in other ethnic groups (47% vs. 34%; pb .0001). Conversely, White participants were less likely to agree that they would get their partner’s permission (34% vs. 40%; p = .04) and more likely to agree that they would take EC if their method did not work (96% vs. 92%; p =.02) and that EC is safe (96% vs. 92%; p = .04). Asian participants were the group that expressed the most agreement with feeling safer about talking to a nurse before taking EC (90% vs. 85%; p = .04). African American respondents were less likely to agree that they would take EC if they forgot to use a method (85% vs. 91%; p = .02) and that they would ask their partner’s permission before taking EC (31% vs. 40%; p =.02). A series of true/false reasons for not taking EC were read to participants who had chosen not to use EC following one or more method failures, incorrect method uses or acts of unprotected intercourse (Table 5). The reason that received the most true responses was thinking that they were not at risk of pregnancy (42%). However, participants who had received information only were less likely to agree (36%) than
participants who received EC in advance (47%) (p =.06). Fewer women thought EC would make them sick (28%) or did not mind getting pregnant (18%). Only 7% of participants who decided not to use EC indicated a religious reason. Cost and efficacy were rarely selected as reasons (5%). The respondents over the age of 24 were more likely to cite not knowing where to get EC (20%; p= .0003) or not knowing how to use EC (16%; p =.01) as impediments to taking EC than the younger age groups. Hispanic participants were most likely than other ethnic groups to concur that not knowing how to take EC (25% vs. 5%; p b.0001), their religious beliefs (18% vs. 6%; p= .002) or thinking that EC probably would not work (11% vs. 4%; p =.03) were factors in their decision not to take EC. Not thinking that they were at risk of pregnancy was more common among Asian participants than members of other ethnic groups (53% vs. 39%; p= .04). However, very few Asian participants claimed that they did not know how to take EC (3% vs. 12%; p= .05). African American respondents were the least likely to agree that not knowing where to get EC was an obstacle (5% vs. 14%; p = .02).
4. Discussion 4.1. Strengths and weaknesses One of the strongest features of this large communitybased clinical trial was how it reflected typical clinical conditions much more closely than a trial conducted at a research center. Every effort was made to develop simple study procedures that fit seamlessly into the clinics’ routine practice. Approximately 95% of clinic patients who received a study packet met eligibility criteria and provided written consent. Since over 9,000 women participated, we were able
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to select a follow-up subgroup of women who represented a wide range of age, ethnicity and birth control preference. Some of the advantages of conducting the trial in community clinic settings were offset by common protocol deviations. We estimate that clinicians may have handed out extra EC pills in conjunction with approximately 15% of the study packets, thus providing advance EC to participants who had been assigned to the information-only group. The effect of this deviation was to potentially reduce the difference between the two treatment groups and thus diminish the potential benefit of advance provision. It was also unfortunate that we were able to reach only 50% of the participants selected for follow-up. Since we had a large pool of participants to draw from, we were able to replace many of the participants we could not reach and thus achieve our goal of interviewing at least 1000 participants. Replacements were not available, however, for women age 18 or younger, who made up a relatively small portion of the study population. In the end, we reached over 200 women age 18 or under, compared to over 400 women in the 19–24 and 25–45 age groups. Finally, while much of the difficulty of contacting women selected for follow-up was due to changed or disconnected phone numbers, some women may have been reluctant to talk with us about EC. It is possible that the participants who agreed to speak with us may have been more favorably inclined toward EC than those who would not. Study staff were masked from the treatment assignment when conducting follow-up interviewers. Nonetheless, there were fewer respondents in the informationonly group than in the advance EC group. We suspect that women who had not received EC were less receptive to participating in the phone interviews. 4.2. Confirmation of previous studies Findings from this trial were consistent with previous studies which have shown that advance provision increases EC use but does not increase risk-taking behavior [15–21]. However, these studies as well as ours failed to demonstrate a significant reduction in unintended pregnancy among women who received EC in advance. This disappointing result may be explained by the relatively low frequency of EC use compared to the high incidence of risk events such as unprotected intercourse and incorrect method use. Although 224 participants reported having unprotected intercourse, only 28% elected to use EC, and of the 96 participants who reported the most unprotected sex ( N5 times), only 14.5% used EC. On the other hand, 34% of the participants who had used withdrawal incorrectly used EC and 41% of the 107 participants who reported a condom failure used EC. This pattern suggests that EC is used more readily by participants who have already attempted to protect themselves than by participants who made no contraceptive effort at all. General attitudes toward EC were positive, even among women who had experienced a risk event but decided not to use EC. Among these participants, the most common reason
for not taking EC was the perception that they were not at risk of getting pregnant (42%), while the second most common reason was thinking that EC might make them sick (28%). This suggests that health educators and clinicians might be more effective in increasing EC use if patients understood that the risks associated with pregnancy are far greater than the risks associated with taking EC. That patients may overestimate EC side effects is further suggested by the fact that 86% of participants agreed that they would feel safer if they talked to a nurse before taking EC. The current prescription status of EC may serve to amplify these misplaced concerns. Several interesting trends arose from the subgroup analyses. Regardless of whether they had received EC or information only, respondents under age 19 were more likely to have reported one or more risk events (condom failure, act of withdrawal or unprotected sex, incorrect use of hormonal method — 63%) than women in the older age groups (19–24: 56%; over 25: 44%). Fortunately, younger participants were also far more likely to use EC following one of these risk events (32%) than older participants (19–24: 27%; over 24: 17%). Hispanic respondents were significantly more likely to express attitudes that might impede EC use such as getting their partner’s permission (47%) and belief that EC might encourage unprotected intercourse (26%) than members of other ethnic groups. In particular, Hispanic participants who decided not to use EC following a risk event were more likely to concur that they did not know how to take EC (25%), that their religious beliefs prevented them from taking EC (18%) and that EC probably would not work (11%). Nevertheless, Hispanic women who reported at least one risk event were no less likely to have actually taken EC than women in other ethnic groups. Only Asian participants reported a higher frequency of EC use. 5. Conclusion This study, as well as a number of other studies, has shown that access to EC does not increase risk-taking behavior and does encourage EC use. Nevertheless, even women who have EC on-hand report many more risk events than EC uses. Nearly 50% of the women who reported one or more risk events decided not to take EC even though they had it on-hand because they thought they were not at risk of pregnancy. Although this is undoubtedly true in some cases, many women are taking unwise chances. Future studies might explore whether women might make better choices about when to use EC as an adjunct to the consistent use of reliable birth control if they had a better understanding of the reproductive cycle and its associated fertility risk. It is also imperative that women understand that EC presents fewer health hazards than unintended pregnancy. Finally, it is clear that our public health efforts should be directed at increasing EC use rather than deliberating over theoretical but unsubstantiated concerns about overutilization, particularly among young sexually active women.
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