Couples' acceptability of the SILCS diaphragm for microbicide delivery

Article Outline

• Abstract
• 1. Introduction
• 2. Material and methods
  • 2.1. Study products
• 3. Results
  • 3.1. Sociodemographic and reproductive health characteristics
  • 3.2. Acceptability of gel delivery systems
  • 3.3. Preference of gel delivery systems
• 4. Discussion
• Acknowledgments
• References
• Copyright

Abstract 

Background

Disposable plastic applicators used in microbicide gel studies are expensive and have a negative environmental impact. The SILCS diaphragm is a barrier contraceptive that could offer a reusable delivery system.

Study Design

Thirty-six couples in this randomized, cross-over study evaluated single- and double-sided gel delivery from a SILCS diaphragm compared with gel from an applicator. Couples used each gel scenario during two acts of intercourse and completed acceptability questionnaires after each.

Results

All three scenarios received favorable ratings for ease of application, acceptability and perceived effectiveness. Both female and male participants tended to rate the gel applicator significantly more favorably than either SILCS gel delivery scenarios for all attributes except messiness/leakage and effectiveness. Additionally, about 60% of female participants and about half of male participants preferred the gel applicator to either of the gel delivery systems using SILCS. The preference for the SILCS scenario for pregnancy protection was statistically significant for both sexes. Male participants were also significantly more likely to prefer the SILCS single-sided delivery system to the gel applicator for protection from sexually transmitted infection.

Conclusions

In this study population, participants found the gel applicator to be more acceptable than either single- or double-sided gel delivery from a SILCS diaphragm. Further research of the SILCS as a microbicide delivery system should be implemented to assess its acceptability among study populations that reflect diverse potential user groups such as women and men from both low and high HIV prevalence settings including HIV-positive populations and with and without experience using female barrier methods.

Keywords: Contraception, Diaphragm, SILCS, Acceptability, Microbicide delivery

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1. Introduction 

Microbicide gels are being evaluated in clinical studies as protection from HIV and other sexually transmitted infections (STIs) [1]. In these clinical studies, the gels are delivered using plastic, prefilled applicators. Outside of the research setting, however, prefilled applicators may not be optimal due to cost and environmental considerations [2]. Having access to an easy-to-use, reusable diaphragm to deliver microbicide gel could offer advantages over use of a prefilled applicator, especially for women who are interested in dual protection from pregnancy and STIs [3]. The diaphragm could position the gel high in the vagina near the cervix thereby reducing messiness associated with current microbicide acceptability and offering additional protection to the cervix, considered a “hot spot” for infection [4]. First-generation microbicide gels in development are only partly effective at preventing STIs [5], [6]. Combining the chemical protection for STI of the microbicide with the contraceptive barrier protection of a diaphragm may offer greater protection than either method used alone. The SILCS diaphragm is a new cervical barrier that could fit this role.

The SILCS diaphragm is designed to improve protection options for women especially in low-resource settings, such as sub-Saharan Africa, where women have significant unmet need for birth spacing and where access to additional barrier protection options could improve women's reproductive health. The acceptability and ease of use of SILCS in the United States and other countries has been reported previously [7], [8], [9]. Previous studies reported the fit of the SILCS device in women representing a range of body mass and parity [10]. Current clinical guidelines recommend diaphragms be used with contraceptive gel to increase effectiveness [11]. Combining a microbicide gel with a diaphragm would improve women's health by offering protection from both STIs and unwanted pregnancy.

This study is one in a series of evaluations designed to evaluate the feasibility and acceptability of using the SILCS diaphragm as a microbicide delivery system. As background, the Program for Appropriate Technology in Health (PATH) conducted bench tests to evaluate the carrying capacity of the SILCS diaphragm with various microbicide gel candidates (unpublished data, 2008). Subsequently, 19 women in Seattle evaluated the ease of handling, messiness and overall acceptability when the SILCS device was used with different gel volumes (5–10 mL) and different loading techniques (unpublished data, 2009). A recently completed exploratory study assessed the SILCS microbicide delivery system using magnetic resonance imaging to illustrate gel dispersion and retention over time and after simulated intercourse when compared with gel delivered with a vaginal applicator (K. Barnhart, unpublished data, 2010).

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2. Material and methods 

An open-label, randomized, cross-over assessment of SILCS as a microbicide delivery system was conducted among 36 couples who used each of three gel delivery systems during two acts of intercourse. Eligible women and men were between 18 and 45 years old, sexually active and in a self-reported monogamous heterosexual relationship for the past 6 months, willing to engage in six acts of intercourse with the study products within 1 month and willing to comply with all study procedures. In addition, female participants were using a nonbarrier method of contraception (hormonal methods excluding the vaginal ring), intrauterine device or were protected by sterilization (tubal ligation or partner had a vasectomy). Eligible women tested negative for pregnancy test at screening; had normal Pap smear within the previous 12 months, by self-report; and were judged by the clinician to have a satisfactory fitting of the SILCS diaphragm.

Couples were recruited from print media advertisements placed in a variety of community newspapers in the Los Angeles area and Internet classifieds to ensure a diverse, representative study population. Both male and female partners attended a pre-enrollment visit where informed consent and reproductive and contraceptive history was obtained and the couple received an introduction to the use of the SILCS diaphragm and gel. Only the female participants attended the subsequent enrollment visit, at which a urine pregnancy test, height and weight were taken. Women also participated in a fitting with a latex Ortho® diaphragm (Ortho-McNeil Pharmaceuticals, Raritan, NJ) to determine their baseline diaphragm size. In the clinical fitting session, the clinician provided written and verbal instructions on handling and inserting the SILCS diaphragm. The woman practiced insertion and removal with additional assistance as needed from the clinician until the woman felt confident the SILCS diaphragm was inserted correctly. The clinician confirmed the correct placement of the SILCS diaphragm by manual palpation and provided written and verbal instructions demonstrating the procedure for applying gel in this study. If the woman met eligibility criteria, could be fit with a SILCS diaphragm and was able to insert and remove the device, she was enrolled in the study.

Participants evaluated three different gel delivery systems (gel in diaphragm cup, gel split between cervical and vaginal side of diaphragm cup, gel via vaginal applicator). They engaged in a total of six acts of intercourse; two acts with each of the three gel delivery systems. They received a SILCS diaphragm and three separate, color-coded and numbered gel scenario packets. Participants used the three gel scenario packets in numerical order. Each scenario packet contained two prefilled 5-mL applicators or two 8-mL sachets of gel (one for each act of intercourse), appropriate instructions for gel application and use and an acceptability survey. See Fig. 1 for illustrations of the gel application methods used in this study. In Scenario A, the prefilled 5-mL applicator was used to fill the cervical cup of the SILCS diaphragm. In Scenario B, the 8-mL sachet of gel was split equally between the cervical and vaginal sides of the SILCS diaphragm. In Scenario C, the 5-mL gel applicators were used to apply the gel. In Scenario A, prefilled gel applicators were used because they were existing stock. A gel applicator is not necessarily the manner in which gel used with the single-side SILCS diaphragm scenario would be provided to consumers.

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• Fig. 1. 

  Gel application method for each study scenario.

Both male and female participants completed an acceptability survey after they completed both acts of intercourse in the gel scenario set. Participants were instructed to wait at least 3 days between acts of sex with the study products to minimize gel run over from the last episode. Both male and female partners returned to the clinic for an exit visit after they had completed evaluating the three gel scenarios during six acts of intercourse. They returned the SILCS, any unused gel and the six acceptability surveys (three male and three female). Research staff reviewed the surveys for completeness and clarified any missing or unclear responses. Male and female participants completed a comparison survey that collected information on preference for the three gel scenarios as well as open-ended questions designed to solicit more detailed acceptability and product preference information. If a couple did not keep their scheduled exit visit, research personnel initiated a reminder telephone call and rescheduled the visit. A subset of 11 women also participated in a focus group discussion at the end of the study to further explore their perceptions of product acceptability and use. The focus group discussion was facilitated by a reproductive health specialist with extensive experience in group facilitation, reproductive health, contraception, sexuality and partner dynamics/relationships. The focus group discussion lasted approximately 1.5 h.

2.1. Study products 

The SILCS diaphragm is a reusable, single-sized (67×75 mm) cervical barrier designed to fit most women who could successfully wear a traditional diaphragm between the 65- and 80-mm sizes [12], [13]. Design features such as its contoured spring and softer bending force allow it to fit a wider range of women and improve ease of use, acceptability and comfort (see Fig. 2). The SILCS diaphragm is made of silicone molded over a nylon spring. It is manufactured by Molded Rubber and Plastics Corporation at their facility in Butler, WI. Program for Appropriate Technology in Health coordinated cleaning, packaging and labeling in Seattle. The SILCS diaphragm is an investigational device, not currently approved for use by the U.S. Food and Drug Administration (USFDA) or any other regulatory agency.

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• Fig. 2. 

  SILCS diaphragm side view (left) and top view (right). Image not to scale.

Studies from four countries confirm that the SILCS diaphragm is easy to insert and remove and comfortable for both partners (CONRAD and PATH, unpublished data, 1998) [7], [8], [9]. A Phase II/III pivotal contraceptive effectiveness study recently was completed in the United States. Data from that study are forthcoming and will be used as part of the regulatory submission to the USFDA.

BufferGel® is an investigational compound developed by ReProtect (Baltimore, MD) and studied as a microbicide and as a contraceptive. It produces a mildly acidic buffering action in the vagina that inactivates sperm. BufferGel contains Carbopol 974P, a compound commonly used in pharmaceuticals with a long history of safety in humans. BufferGel is odorless, tasteless and colorless and is compatible with diaphragm and condom use. A contraceptive effectiveness study evaluated BufferGel with diaphragms in the United States with good results [14]. However, in a multicenter Phase 2B study of BufferGel for HIV protection, results did not find it protective [15]. BufferGel was provided by ReProtect in prepackaged applicators or sachets. Participants were informed that the study packaging of the gel was not necessarily the final brand packaging of the gel product.

There was no formal sample size calculation for this study since this is not a hypothesis-driven study. Thirty-six couples having two acts of intercourse with each of the three gel application scenarios yields a potential sample size of 72 uses of each gel scenario. Investigators determined that this sample size should provide sufficient results concerning measures of user preference, ease of insertion and removal, feel, fit, sensation and comfort to evaluate the feasibility and acceptability of using the SILCS diaphragm for microbicide delivery.

Feasibility and acceptability were evaluated by comparing the physical attributes of the three gel application scenarios as well as couples' perceptions about using the three different gel application techniques. Acceptability measures were rated on a five-point Likert scale. Ordinal acceptability data were summarized by sex with a mean score for each scenario. Paired t tests (α=.05) were performed to determine whether the acceptability measures were statistically different. Chi-square tests were performed for categorical acceptability data.

Data coding, editing, entry, verification and analysis were performed at the California Family Health Council using Entrypoint Plus™ (Phoenix Software International, El Segundo, CA) and SAS (Statistical Analysis Software, Cary, NC). To minimize a potential learning effect, couples were randomly assigned to the sequence of use of each of the three gel scenarios according to a computer-generated randomization list. To ensure an equal number of scenario sequences, the randomization list used a block size of six. Study staff did not know the sequence assignment until after the participant received their enrollment identification number linked to a specific sequence assignment. Enrollment identification numbers were allocated in consecutive order. Ethical approval for this study was obtained from the California Family Health Council Institutional Review Board and the PATH Research Ethics Committee.

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3. Results 

Thirty-four (94%) of the 36 couples that were enrolled completed the study. The study was conducted from July to December 2009. Of the two couples that left the study early, one was unable to complete the gel delivery scenarios within the study follow-up period and one woman experienced vaginal discharge and decided not to continue in the study.

3.1. Sociodemographic and reproductive health characteristics 

The sociodemographic profile of eligible participants is presented in Table 1. The majority of the participants were white (61%), well educated (86% completed at least some college) and averaged 25.4 years old. Three quarters of the couples were married or living with their partner (75%). The study population was racially and ethnically diverse and included 17% Hispanic, 10% African American, 4% Asian and 8% other (or multiple) minority participants. Seventy-three percent of participants were employed on either a full- or part-time basis and 15% were currently enrolled as students. Twenty-six percent of participants had an annual household income of less the $20,000, while 21% had an annual household income of over $60,000.

Table 1. Sociodemographic characteristics of participants

As required by the study protocol, all participants reported having had only one sexual partner in the previous 6 months. Seventy-five percent of couples reported a frequency of intercourse of at least 7 times per month. Forty-two percent of couples reported that they never used additional lubrication during sex, 28% of couples reported that they used additional lubrication rarely, 19% reported occasional use (sometimes) and 11% of couples reported frequent use (often). Most couples (81%) reported using oral contraceptives, followed by 11% intrauterine device, 6% injection and 3% sterilization. Seventeen percent of the female partners reported having children (14% one child and 3% two children).

None of the participants had ever used the SILCS diaphragm and only two women had ever used an Ortho diaphragm. One of these women had only used a diaphragm once or twice, while the other woman had used a diaphragm for less than 6 months. Both characterized their experience with the Ortho diaphragm as “neutral.” Only two women had ever used a female condom. All participants reported previous experience using tampons with 72% indicating that they used tampons “lots of the time.” Eighty-three percent described their tampon experience as “positive.”

During the enrollment visit, women were fit with an Ortho diaphragm. Approximately two-thirds of women (64%) were fitted with a 70-mm diaphragm, 17% with a 65-mm diaphragm and 14% with a 75-mm diaphragm. One woman was fit with a 60-mm diaphragm (3%) and one woman was fit with a 80-mm diaphragm (3%).

3.2. Acceptability of gel delivery systems 

After trying each gel delivery scenario twice, female partners were asked to rate the ease of following instructions using a five-point scale where 1 represented completely easy and 5 represented completely difficult. Women rated instructions as easily understood for all three gel delivery scenarios (mean ratings ranging from 1.0 to 1.1). All three gel delivery scenarios received mean scores consistent with ease of use. There were no statistically significant differences between the ratings of the three gel delivery scenarios.

Both male and female participants were asked to rate the gel delivery scenarios on a variety of acceptability measures using a five-point scale where 1 represented completely acceptable and 5 represented completely unacceptable. All three gel delivery scenarios received average acceptability scores on the acceptable end of the range (i.e., all mean scores were lower than 3 or neutral) (Table 2). However, the acceptability ratings of both male and female participants were significantly poorer for the two SILCS gel delivery scenarios compared with the applicator only gel delivery scenario. The exception was acceptability measures involving messiness and gel awareness during intercourse and removal where the gel applicator scenario was rated more poorly than the SILCS gel delivery scenarios. Although there were no statistically significant differences between the acceptability ratings given to the two SILCS scenarios, the SILCS double-sided scenario tended to receive better ratings than the SILCS single-sided scenario, particularly from female participants.

Table 2. Acceptability ratings by sex

Mean score using five-point scale where 1=completely acceptable and 5=completely unacceptable.

aSignificant difference female B vs. C, p<.05, paired t test.

bSignificant difference male B vs. C, p<.05, paired t test.

cSignificant difference female A vs. C, p<.05, paired t test.

dSignificant difference male A vs. C, p<.05, paired t test.

3.3. Preference of gel delivery systems 

After couples used all three gel delivery systems, each participant was asked to select their preferred method. In terms of overall preference, a higher percentage of female participants chose the gel applicator over the two SILCS gel delivery systems although this difference was not statistically significant (Table 3). Males were significantly more likely to prefer the gel applicator over the two SILCS delivery systems (p<.05). The preference for the gel applicator was reflected in the individual measures of acceptability and performance. With the exception of “less messy during intercourse” (females) and “best packaging” (both sexes), preferences for the gel applicator scenario were statistically significant (p<.05). In the other direction, participants preferred the SILCS delivery systems for best protection against pregnancy and STDs, as well as “less leakage after intercourse.” The preference for the SILCS scenario for pregnancy protection was statistically significant for both sexes, as was “least gel leakage after intercourse” for females who favored the SILCS single-sided system (p<.05). Male participants were also significantly more likely to prefer the SILCS single-sided delivery system to the gel applicator for STI protection (p<.05).

Table 3. Preferred method for gel delivery by sex (N=35 females, N=35 males)

=Applicator alone not statistically preferred over SILCS gel delivery scenarios (chi-square, p=>.05).

=SILCS gel delivery scenarios significantly preferred over applicator alone (chi-square, p=<.05).

When asked whether they would be willing to purchase gel, over half of the women who preferred the gel applicator (55%) or the SILCS double-sided system (80%) responded positively (Table 4). Between a third and one-half of male participants indicated they would buy gel (50% SILCS double-sided, 33% SILCS single-sided and 44% gel applicator). Of the 12 women who preferred one of the SILCS gel delivery systems, 8 (67%) indicated that they would be willing to buy the SILCS and 4 (33%) indicated that they would consider buying the SILCS. In contrast, only 2 (10%) of the 20 women who preferred the gel applicator reported that they would be willing to buy the SILCS.

Table 4. Reasons for preference by sex

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4. Discussion 

All three scenarios received favorable ratings from both sexes for ease of application (instructions, handling of study products, confidence in correct placement), acceptability (ease of carrying, messiness, comfort, awareness of study products, sensation, overall sexual experience) and perceived effectiveness for pregnancy and disease prevention. There were no statistically significant differences in the ratings awarded to the two SILCS gel delivery scenarios. This was surprising as we hypothesized that the delivery of 8 mL of gel using both sides of the diaphragm cup may have been messier and therefore less acceptable than delivery of 5 mL of gel on one side of the diaphragm cup.

Both female and male participants tended to rate the gel applicator significantly more favorably than either SILCS gel delivery scenarios for all attributes except messiness/leakage and effectiveness. Additionally, about 60% of female participants and about half of male participants preferred the gel applicator to either of the gel delivery systems using SILCS. Acceptability of the gel delivery system may have been linked to participant familiarity with the vaginal applicators in the study. As such, participant lack of familiarity with barrier methods and diaphragms, in particular, may have skewed their ability to objectively assess the SILCS delivery methods. Women in our study had little previous experience using barrier methods such as the diaphragm or the female condom. Since most of the participants used hormonal methods for contraception, the lack of experience inserting a diaphragm and the extra steps required to insert the SILCS device were perceived as bothersome, relative to the ease of inserting the vaginal applicator. Similarly, in a study among 405 Brazilian couples to compare three microbicide delivery options (diaphragm, vaginal ring and disposable applicator), the diaphragm was the least preferred device primarily due to problems women experienced while inserting or removing it [16]. In addition, participants in our study reported difficulty handling and applying gel from the sachet and then inserting the SILCS for the double-sided SILCS delivery system. This may have contributed to the relatively low acceptability of the double-sided delivery system compared to the applicator.

The focus group discussion provided further insight into women's experience with the gel and sachet (small plastic packet filled with gel). Many women said the amount of gel required was too much and it did not seem to “stay slippery” during sex. Women described difficulty using the sachets to load gel onto the diaphragm and found it messy to insert the SILCS with gel. These comments highlight not only the need to consider user perception of gel characteristics but also to ensure the packaging is easy to use. Some women reported gel characteristics they found bothersome, including “clumping “and “leaky discharge” from the vagina. Interestingly, in other studies where women have perceived themselves at risk of STIs, women have not had such a negative reaction to the characteristics of this same gel [17], [18], [19]. This suggests that acceptability is influenced by a range of factors, including a woman's expectations about sex, previous experiences with products as well as perception of risk of infection or desire for barrier protection. These motivations could offset some of the negative perceptions of the gel for some women.

Interestingly, both sexes overwhelmingly preferred the SILCS delivery systems to the gel applicator for pregnancy protection. Male participants were also significantly more likely to prefer the SILCS single-sided delivery system to the gel applicator for STI protection. This suggests that greater awareness-raising and education about the SILCS as a microbicide delivery system may be warranted.

These findings are based on the experience of 34 couples that tried each of three gel delivery systems, each during two acts of intercourse. Participants did not have a great deal of time to become familiar with the study products so their acceptance of the SILCS and the gel delivery systems may not be representative of couples who choose barrier methods of protection in their personal lives. In this light, future research of the SILCS as a microbicide delivery system could be implemented among diverse potential user groups from both low and high HIV prevalence settings including HIV-positive populations and with and without experience using female barrier methods [20].

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Acknowledgments 

PATH would like to acknowledge the effort and commitment of our research partners and the women and men who shared their experience and insight with these products for the potential benefit of women in the future. We also acknowledge Thomas R. Moench of ReProtect, Inc. for his contribution to study design and for provision of BufferGel. Support for this project is made possible by the generous support of the American people through the U.S. Agency for International Development (USAID) under the terms of the HealthTech IV Cooperative Agreement #GPH-A-00-01-00005-00. The contents are the responsibility of the authors and do not necessarily reflect the views of USAID, or the U.S. Government. The authors are grateful to Clarissa Lord Brundage for preparation of this manuscript.

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