Acceptability of the Woman’s Condom in a Phase III multicenter open-label study

Abstract

Objective:

To evaluate the acceptability of the Woman’s Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a U.S.-based multicenter open-label Phase III contraceptive efficacy trial.

Study Design:

We assessed acceptability via written questionnaire at Visit 2 (after the 3^rd cycle) and Visit 3 (after the 6^th cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction, and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions.

Results:

Most women (327/405 (81%) had limited or no previous experience with female condoms. Of 405 evaluable women, 346 and 303 women completed questionnaires at Visits 2 and 3, respectively; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at Visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at Visit 3 (P=.03). Many women (166/281 (59%)) either preferred the WC (105/281 (37%)) or were neutral (61/281 (22%)) while 115/281 (41%) preferred male condoms. Women attending Visit 3 felt confident that the WC could prevent pregnancy (246/303 (81%)) and STIs (217/303 (72%)). Many women expressed empowerment with having control over their contraception; some disliked the WC’s design, aesthetics, and insertion process. Most women (254/299 (85%)) would recommend the WC to a friend.

Conclusion:

The WC’s acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs.

Implications:

The Woman’s Condom’s overall acceptability and ease of use is promising for a new female-controlled method that can protect against both pregnancy and sexually transmitted infections.

TRIAL REGISTRATION:

Clinicaltrials.gov, www.clinicaltrials.gov, NCT01223313

1. Introduction

The U.S. Food and Drug Administration (FDA) approved the FC1, or Reality, female condom in 1993. The FC2, manufactured from a synthetic polymer (nitrile) allowing for lower cost manufacturing, has similar design, effectiveness, and acceptability [1, 2]. The FC2 replaced the FC1 in the U.S. after its 2009 FDA approval [3]. U.S. female condom consumer experience has been limited to the FC1 and FC2 products (manufactured by Female Health Company).

Female condoms are not widely used. In the 2006–2010 National Survey of Family Growth, only 1.7% of U.S. women aged 15–44 reported ever using female condoms, while 93.4% ever used male condoms [4]. Female condom distribution doubled globally between 2007 and 2010 [3], but in 2015 accounted for only 1.6% of worldwide condom distribution [5]. Female condoms provide multipurpose protection against human immunodeficiency virus (HIV), sexually transmitted infections (STI) and pregnancy [3, 6], and offer an important protection option for women. Reasons for low uptake include low demand, negative media attention, and inaccurate information [6–8]. Female condoms cost more than male condoms, in part because regulatory barriers and low production limit economies of scale [6].

Consumer concerns with FC1 about difficulty with insertion or the inner ring being painful or poorly fitting reduce acceptability [9]. Recent female condom designs may improve ease of use and acceptability [10, 11]. PATH, an international nonprofit health organization with funding from the United States Agency for International Development (USAID) through CONRAD, developed The Woman’s Condom (WC). An iterative user-centered design process aimed to improve the WC’s functionality, acceptability, and ease of insertion compared to prior designs [12]. The WC has shown non-inferior efficacy and safety compared to other female condoms [10, 12, 13], and studies demonstrate short-term acceptability [14, 15]. In this planned analysis, we evaluated WC acceptability in a contraceptive efficacy trial among U.S. women.

2. Materials and methods

This Phase III, multicenter, open-label study (NCT01223313) was designed to assess contraceptive efficacy and safety of the WC over 6 months (183 days) and at least 6 menstrual cycles. WC acceptability was a secondary outcome. Eligible women were 18–40 years old, reported cyclic menses (21–35 days), at risk for pregnancy, willing to engage in at least 4 acts of heterosexual vaginal intercourse per month, and willing to use the WC as their primary method of contraception. All site Institutional Review Boards approved the study.

The WC (Shanghai Dahua Medical Apparatus Corp., Ltd., Figure 1) is a 0.03 mm thick pliable polyurethane pouch that conforms to the vagina. It is 22.9±0.3 cm (9±0.1 inches) long, with a flexible soft outer ring designed to hug the external genitalia. The WC has a dissolving polyvinyl alcohol capsule to facilitate insertion. Four foam shapes on its external surface cling to vaginal walls to ensure stability. The WC is not pre-lubricated; thus, participants were instructed to apply study-provided lubricant to the inside of the condom and the penis after the WC was inserted, and to wait 30–60 seconds for the capsule to dissolve. Women used a new WC with each act of intercourse. At least 30 WC were dispensed at each visit; more were provided between visits if needed.

Figure 1.

Woman’s Condom, pre-insertion (pouch packaged inside a dissolvable capsule)

We evaluated women at baseline (Visit 1), Visit 2 (after the 3^rd menstrual cycle, visit window 45–137 days), and Visit 3 (after the 6^th menstrual cycle or 183 days, whichever was later (visit window 138 days and higher)). If a participant attended Visit 2 outside of the visit window but also attended Visit 3, out-of-window Visit 2 data were analyzed with Visit 2. If a participant discontinued before day 137, the discontinuation visit was assigned to the Visit 2 analysis window. If a woman discontinued early, but after day 137, she completed Visit 3, including the acceptability questionnaire, as a discontinuation visit.

Written questionnaires assessed acceptability at Visits 2 and 3 (see supplemental material). Thirteen questions used a 5-point Likert-type scale, with the center (value of 3) being “neutral”, the left anchor (1) indicating negative experience (e.g., “very difficult”, “painful”) and the right anchor (5) indicating positive experience (e.g., “very easy”, “very comfortable”). The five response options were grouped into three categories: negative (responses 1 or 2), neutral (3), and positive (4 or 5). Key domains included ease of use, comfort/lubrication, preferences, sexual satisfaction, male partner satisfaction, and confidence in the WC to prevent pregnancy and STIs. Four questions were open-ended, and one question addressed willingness to pay for the WC at multiple proposed price points.

Sample size was based on the FDA requirement to demonstrate contraceptive efficacy in 200 women over 6 months of use. With expected dropout of 50–60% [16], we planned to enroll 500 participants. We analyzed a modified intent-to-treat population (MITT) that included all enrolled participants whose diaries indicated at least one coital episode using the WC, and for whom there was at least one report of pregnancy status. We also analyzed data from the subset of women reporting at least one WC failure, defined as clinical breakage, misdirection (penis inserted between the WC and the vaginal wall), slippage (WC completely slipped out of vagina during intercourse), and invagination (entire external component of WC pushed into vagina during intercourse) [17]. Clinical failure rates were defined as the percentage of all female condoms used during intercourse with each type of failure (e.g. breakage, misdirection, slippage, or invagination), and was calculated per participant.

We used descriptive statistics for participant characteristics. We compared categorical responses using Cochran-Mantel-Haenszel statistics. Comparisons over time are based on women who completed the questionnaire at both follow-up visits. We conducted a sensitivity analysis where women who only attended Visit 2 had their last response carried forward to Visit 3. We also analyzed acceptability stratified by body mass index (BMI) <30 kg/m² (non-obese) and ≥30 kg/m² (obese).

For content analysis of four open-ended questions, two authors (BAC, AAL) reviewed responses and used an iterative process to identify themes and develop a codebook. Codes were then applied to the data using Dedoose Version 7.5.16 (Los Angeles, CA). We assessed the frequencies of each code for an indication of the most common themes. A code could be applied multiple times per participant if her response mentioned a theme more than once.

3. Results

3.1. Quantitative Findings

Figure 2 describes study flow. Of 676 women screened, 511 enrolled and 276 (54.0%) completed 6 months use. The MITT population included 405 evaluable women. Table 1 shows participant characteristics. Women used the WC for a median of 38.0 days (range 1–127). Fifteen of 405 women (3.7%) reported a pregnancy during the study. Three hundred forty-six women completed Visit 2 acceptability questionnaires, 303 women completed Visit 3 questionnaires, and 282 women completed both. Some women completed only Visit 2 or Visit 3 questionnaires due to missing study visits or discontinuing early.

Figure 2.

Flowchart of participants*

* One enrollment protocol deviation occurred for a 41-year-old participant whose date of birth was incorrectly reported at screening. Missing questionnaires were due to participants not attending study visits or discontinuing early. Participants who discontinued early may have completed a questionnaire at time of discontinuation.

Table 1.

Demographics and participant characteristics

Characteristic	Total (N=405)
Age in years (n, range)	29.0 (18, 41)
Race (n, %)*
White	162 (40.0%)
Black or African American	204 (50.4%)
Asian or Pacific Islander	22 (5.4%)
American Indian or Native Alaskan	14 (3.5%)
Other	24 (5.9%)
Hispanic or Latina (n, %)	88 (21.7%)
BMI at baseline (mean, SD)	29.2 (7.6)
Marital status (n, %)
Never married	258 (63.7%)
Married	101 (24.9%)
Divorced	33 (8.1%)
Separated or widowed	13 (3.2%)
Highest level of education (n, %)
Has not completed high school	25 (6.2%)
High school or equivalent	78 (19.3%)
Some college	169 (41.7%)
College degree or higher	133 (32.8%)
Prior experience with female condoms	78 (19.3%)
Contraceptive methods used in past 6 months (n, %)*
Male condom	335 (82.7%)
Female condom	9 (2.2%)
Diaphragm	6 (1.5%)
Spermicides	25 (6.2%)
Natural family planning/rhythm method	46 (11.4%)
Withdrawal	163 (40.2%)
Abstinence	22 (5.4%)
Emergency contraception	13 (3.2%)
Oral contraceptive pill	36 (8.9%)
Vaginal ring	14 (3.5%)
Contraceptive patch	7 (1.7%)
Intrauterine device	5 (1.2%)
Implant	1 (0.2%)
Injectables	1 (0.2%)

^*Participants could select more than one response

Seventy-eight of 405 (19.3%) had prior female condom experience, although only nine (2.2%) had used female condoms more than 10 times. Table 2 describes changes in WC acceptability from Visit 2 to Visit 3 for women who attended both visits. Of these, 165/282 (58.5%) reported at Visit 2 that WC insertion was easy/very easy; this increased significantly to 195/282 (69.1%) at Visit 3 (P=.03). Findings were similar for women who had never used female condoms (Visit 2: 126/225 (56.0%) vs. Visit 3: 155/225 (68.9%), P=.02). In the sensitivity analysis (n=346, including 282 who attended both visits and 64 who only attended Visit 2, but whose responses were carried forward to Visit 3), this difference was not statistically significant (P=.07). When these 282 women were asked at Visit 3 whether they preferred the WC or a male condom, 166/281 (59.1%) either preferred the WC (105/281 (37.4%)) or were neutral (61/281 (21.7%)) while 115/281 (40.9%) preferred male condoms (Table 2).

Table 2.

Changes in acceptability of the Woman’s Condom from Visit 2 to Visit 3 (%, n/N)

Response	Visit 2 N=282	Visit 3 N=282	P value
Ease of WC insertion  Easy  Neutral  Difficult	165/282 (58.5%) 92/282 (32.6%) 25/282 (8.9%)	195/282 (69.1%) 70/282 (24.8%) 17/282 (6.0%)	.03
Ease of WC removal  Easy  Neutral  Difficult	244/282 (86.5%) 32/282 (11.3%) 6/282 (2.1%)	232/282 (82.3%) 36/282 (12.8%) 14/282 (5.0%)	.15
Did the WC get easier to use over time?  Easier  Neutral  Harder	236/281 (84.0%) 41/281 (14.6%) 4/281 (1.4%)	242/281 (86.1%) 37/281 (13.2%) 2/281 (0.7%)	.62
Comfort of WC during sex  Comfortable  Neutral  Painful	143/282 (50.7%) 121/282 (42.9%) 18/282 (6.4%)	153/282 (54.3%) 109/282 (38.7%) 20/282 (7.1%)	.59
Movement of the WC during sex  Not bothersome  Neutral  Bothersome	123/281 (43.8%) 92/281 (32.7%) 66/281 (23.5%)	115/281 (40.9%) 100/281 (35.6%) 66/281 (23.5%)	.74
Comparison of sexual satisfaction between male condom and WC			.93
Prefer WC  Neutral  Prefer male condom	81/278 (29.1%) 89/278 (32.0%) 108/278 (38.8%)	84/278 (30.2%) 85/278 (30.6%) 109/278 (39.2%)
Do you prefer the WC or male condom?  Prefer WC  Neutral  Prefer male condom	89/281 (31.7%) 81/281 (28.8%) 111/281 (39.5%)	105/281 (37.4%) 61/281 (21.7%) 115/281 (40.9%)	.12
How satisfied was your partner with this product?			.96
Satisfied  Neutral  Not satisfied	103/282 (36.5%) 83/282 (29.4%) 96/282 (34.0%)	105/282 (37.2%) 80/282 (28.4%) 97/282 (34.4%)

WC = Woman’s Condom

N may not equal 282 due to missing responses. Questions used a 5-point Likert-type scale, with the center (value of 3) being “neutral”, the left anchor (1) indicating negative experience (e.g., “very difficult”, “painful”) and the right anchor (5) indicating positive experience (e.g., “very easy”, “very comfortable”). For analysis, the five response options were grouped into three categories: negative (responses 1 or 2), neutral (3), and positive (4 or 5).

Many participants (197/405 (48.6%)) reported at least one WC failure during the study. Women who experienced a WC failure and attended both follow-up visits nonetheless reported the WC was easy to insert (81/155 (52.3%) at Visit 2, 105/155 (67.7%) at Visit 3, P=.02). More of these 155 women preferred the male condom at Visit 3 (75/155 (48.4%) over the WC (54/155 (34.8%), P=.014); the remainder (26/155 (16.8%)) were neutral.

Of all women attending Visit 3, 246/303 (81.2%) felt confident that the WC could prevent pregnancy and 217/303 (71.6%) felt confident that it could prevent transmission of STIs. Even women who experienced at least one WC failure remained confident in its ability to prevent pregnancy (115/139 (82.7%)) and STIs (109/139 (78.4%)). Women were divided as to whether their partner was satisfied (113/303 (37.3%)) or dissatisfied (104/303 (34.3%)) with the WC. At end of study, most women (254/299 (84.9%)) would recommend the WC to a friend. When asked the most they would be willing to pay for a WC, with a range of $3 to $8, 235/302 (77.8%) were willing to pay $4 or less.

We found no difference in ease of insertion, comfort during sex, or movement during sex by BMI category. At Visit 3 only, non-obese women felt more confident than obese women in the WC’s ability to prevent pregnancy (145/171 (84.8%) vs. 85/111 (76.6%), P=.003) or STIs (126/170 (74.1%) vs. 76/111 (68.5%), P=.01). However, obese women reported fewer WC failures compared to non-obese women (median 0.0 [interquartile range (IQR) 0.0, 5.0] vs. 2.0 [IQR 0.0, 10.0], P=.03).

3.2. Qualitative Findings

Table 3 lists the frequency of code applications at Visits 2 and 3. The most frequent themes focused on the WC design, including concerns about fit, material, capsules, and lubrication. Many women stated that the WC “would be better if [it] came pre-lubricated.” Women also stated the WC was inconvenient and that it took longer than expected for the capsule to dissolve. One woman noted “Maybe the capsule should dissolve quicker. The 15 min [sic] wait time stresses the act.” Others noted the WC was “not good for a ‘quickie’” or interfered with intimacy.

Table 3.

Thematic analysis code application frequency at Visits 2 and 3 for women who attended each visit^*

Frequency of code application	Visit 2 (n=346)	Visit 3 (n=303)
Negative themes
Negative attributes of WC design	340	267
Condom failures	75	56
Difficulty of use	71	52
Inconvenience of the WC	69	61
Personal sexual dissatisfaction when using the WC	61	35
Concerns about aesthetic aspects of the WC	58	45
Partner sexual dissatisfaction when using the WC	27	10
Negative comparisons to male condom	18	17
Feeling unprotected from pregnancy and/or STIs	18	6
Side effects	17	8
Awkward or embarrassing nature of the WC	13	6
Positive themes
Ease of use	171	164
Feeling protected from pregnancy and/or STIs	145	123
Feeling that WC gives women control over birth control	136	107
Positive attributes of WC design	112	75
Personal sexual satisfaction when using the WC	75	47
Positive comparisons to male condom	51	26
Specific situations in which the WC may be useful	22	8
Partner sexual satisfaction when using the WC	13	9
Cleanliness of the WC	12	15

WC = Woman’s Condom, STI = sexually transmitted infection

^*Codes could be applied more than once per participant if the theme was addressed more than once within the four open-ended questions.

Some women stated the WC should be smaller, or that the outside ring should be smaller or stiffer. Others found the WC awkward or unattractive. A few commented on the noise, with one participant reporting that it “felt like having sex w/a sandwich bag.” Participants also described condom failures, with slippage being the most frequent complaint (Visit 2: n=56; Visit 3: n=47). One participant noted “it either slipped out or it went inside me.”

The WC design also received many positive comments; women found it “very comfortable” and more natural than the male condom. One woman stated, “I liked that it felt like not having a condom on and I could ‘feel’ my partner more.” Some women liked the non-hormonal aspect; one woman would recommend it because she “didn’t have to take a pill or get a shot.” Many noted it was easy to use and insert, and that it “become[s] easier to use over time.”

Women commonly reported that the WC helped them feel protected from STIs and pregnancy. Some felt more protected than with male condoms, because the WC “covers the vagina to protect more than a male condom would.” Another woman stated, “I felt (once in) completely covered/safe.”

Female empowerment and control over contraception was a frequent theme; one woman liked the WC because she “was in control of making sure there was birth control.” Another woman stated, “It is nice to know I can protect myself – its [sic] female empowerment.” Several women noted that they liked not having to “rely on a man to have condoms.”

4. Discussion

Most women in this study found the WC easy to insert and remove, and felt confident in its ability to prevent pregnancy and STIs. Ease of use and women’s preference for the WC increased over time. This is reassuring, since the failure rate of female condoms decreases as women become more experienced [18]. Increased familiarity may also correlate with increasing acceptability.

Over half of women preferred the WC or were neutral when compared to the male condom, and only a third felt their partner was dissatisfied with the WC. Content analysis suggested that for some women, WC acceptability related to a sense of control over their contraceptive options. Others specifically noted the multipurpose protection aspect of the WC. Given overall WC acceptability together with women’s confidence in its ability to protect against both pregnancy and STIs, WC could fill an important need for individuals seeking multipurpose protection.

Some women were dissatisfied with specific aspects of the WC related to design or inconvenience, in particular the need for the capsule to dissolve and lack of pre-lubrication. These specific concerns can inform design improvements for female condoms. Notwithstanding these caveats, most women still would recommend the WC to others, reflecting the overall acceptability of this product.

Translating WC acceptability into use may be challenging. Obstacles include limited availability, cost and lack of familiarity. Without advocacy, knowledge may not translate to use: a South African study found that while over 75% of women knew about female condoms, only 7% had ever used them [19]. Small as this is, this is higher than the usage reported among women in the U.S. Multi-pronged approaches may be needed to increase use outside of study settings [9]. These could include market development, product promotion, and tailored educational interventions for selected groups such as women residing in areas of high STI or HIV prevalence. Health departments, communities and providers can assume meaningful roles in diffusing knowledge and training about female condoms [19–24]. The regulatory climate may also be improving. The FDA is considering changing the classification of female condoms from Class III (the most highly regulated or ‘risky’ devices), to Class II, the less onerous classification that applies to male condoms [25]. Easing regulations could increase female condom availability.

Study strengths included using a multi-item questionnaire that explored several domains of acceptability over 6 months, in contrast to short-term analyses [14, 15]. Limitations included the anticipated high discontinuation rate, although completion was higher than initially predicted (54% of all enrolled; 68% of the MITT population). Women who had difficulty using the WC or were unhappy with it may have discontinued earlier, their absence thus biasing the analyses presented here. The “neutral” option in the Likert scales may have allowed women to avoid taking a stance on a question [26]. Limiting the question about cost to $3 and above did not allow participants to say what lower price they were willing to pay.

Programmatic focus on long-acting reversible contraceptives (LARC) has shifted attention away from barrier contraception. However, not every woman wants a LARC or a hormonal contraceptive; the potential for STI and HIV protection makes female condoms one of few methods that can offer dual protection. In addition, the WC holds promise for vaginal delivery of HIV and STI prevention medications [27]. Female-controlled methods that can protect against STI, HIV, and pregnancy would be a boon. The WC may also have additional uses with the now preferred term ‘internal condom’ communicating potential for STI protection not restricted to heterosexual vaginal intercourse. Our results demonstrate that the WC is an acceptable method for most women, which is promising for wider dissemination.