Maggie Kilbourne-Brook

SILCS diaphragm: postcoital testing of a new single-size contraceptive device

BACKGROUND This study was conducted to compare the effectiveness of a new, single-size silicone contraceptive diaphragm used with either spermicide [2% nonoxynol-9 (N-9)] or lubricant in preventing sperm from penetrating midcycle cervical mucus. STUDY DESIGN A crossover postcoital test (PCT) in healthy, sexually active women not at risk for pregnancy due to tubal occlusion was conducted. Couples had a baseline PCT without a device to verify normal fertility parameters. Qualified couples underwent up to two test cycles using the SILCS diaphragm with a metal spring. A subgroup of couples underwent a third test cycle with the SILCS polymer spring diaphragm used with N-9 gel. RESULTS Fifteen couples completed a baseline cycle and were randomized to order of study gel. Of these, 14 couples completed a baseline cycle and at least one test cycle, 12 couples completed a baseline cycle and two test cycles and 8 couples completed a third test cycle with the polymer spring prototype. Sperm was detected in the vaginal pool in all completed test cycles. The SILCS metal spring diaphragms used with N-9 gel reduced the average number of progressively motile sperm per high power field in the cervical mucus from a baseline of 12.5 to 0, while use of this device with lubricant reduced the number to 0.5. The SILCS polymer spring diaphragm used with N-9 performed the same as the metal spring used with N-9. CONCLUSION The SILCS diaphragm used with N-9 gel performed well. It is likely that the SILCS diaphragm will give acceptable results in a contraceptive effectiveness study but that adjunctive use of a chemical barrier such as N-9 gel will be necessary for it to be most effective.

A review of the effectiveness and acceptability of the female condom for dual protection

The female condom remains the sole female-initiated method of dual protection against unintended pregnancy and sexually transmissible infections (STIs), including HIV. We reviewed published data on the effectiveness and acceptability of the female condom for protection against pregnancy and infection. Overall, use of the female condom is low and several barriers hinder the wider adoption of the use of the method. Research on effectiveness has focussed on pregnancy, STIs and biological markers of semen exposure. Although the data available suggest that female condoms (or a mixture of female and male condoms) may provide similar degrees of protection against pregnancy and STIs as do latex male condoms alone, this conclusion has not been demonstrated and thus comparative research is urgently needed.

Comparative crossover study of the PATH Woman's Condom and the FC Female Condom®

BACKGROUND Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Womans Condom (WC) was developed in an effort to overcome these obstacles. STUDY DESIGN This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC. Seventy-five couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at three centers. Four condoms of the first type were used by couples in four acts of intercourse at home over a 2-4-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of participants (n=25), a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types. Condom performance was evaluated by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy. Acceptability of each given condom type was measured by questionnaire. RESULTS Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1. Total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 [90% CI: -18.5 to -3.3 and -12.6 to -0.8, respectively). Fewer women reported symptoms of urogenital irritation when using the WC vs. the FC1 either overall or when analyzing each use of the condom [woman as unit: -20 percentage points (90% CI: -30.5 to -9.3); condom use as unit: -12.3 percentage points (90% CI: -18.0 to -6.7)]. A similar result was seen for signs of urogenital irritation [woman as unit: -20 percentage points (90% CI: -42.7 to 4.8)]. Among participants with a preference, WC was preferred over the FC1 by twice as many males and by 2.6 times as many females. CONCLUSIONS While both female condoms were safe and acceptable in short-term use, the PATH Womans Condom leads to less failure, was associated with fewer adverse events, and was more acceptable than the FC1 Female Condom.

A modified SILCS contraceptive diaphragm for long-term controlled release of the HIV microbicide dapivirine

BACKGROUND There is considerable interest in developing new multipurpose prevention technologies to address womens reproductive health needs. This study describes an innovative barrier contraceptive device--based on the SILCS diaphragm--that also provides long-term controlled release of the lead candidate anti-HIV microbicide dapivirine. STUDY DESIGN Diaphragm devices comprising various dapivirine-loaded polymer spring cores overmolded with a nonmedicated silicone elastomer sheath were fabricated by injection molding processes. In vitro release testing, thermal analysis and mechanical characterization were performed on the devices. RESULTS A diaphragm device containing a polyoxymethylene spring core loaded with 10% w/w dapivirine provided continuous and controlled release of dapivirine over a 6-month period, with a mean in vitro daily release rate of 174 mcg/day. The mechanical properties of the new diaphragm were closely matched to the SILCS diaphragm. CONCLUSIONS The study demonstrates proof of concept for a dapivirine-releasing diaphragm with daily release quantities potentially capable of preventing HIV transmission. In discontinuous clinical use, release of dapivirine may be readily extended over 1 or more years.

Multipurpose prevention technologies for sexual and reproductive health: gaining momentum and promise

This editorial seeks to convey the key points of the discussions focused on multipurpose prevention technologies that took place at an international symposium on Advancing Prevention Technologies for Sexual and Reproductive Health. It also looks to engage health care professionals in the effort to fulfill the potential that these technologies might offer. Copyright

Couples' acceptability of the SILCS diaphragm for microbicide delivery.

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.

Comparative acceptability of the SILCS and Ortho ALL-FLEX diaphragms among couples in the Dominican Republic

BACKGROUND The SILCS diaphragm is a new, single-size contraceptive diaphragm. The objective of this crossover pilot study was to assess the fit and acceptability of the SILCS diaphragm compared to the Ortho ALL-FLEX diaphragm to validate the product design among parous women in a low-resource setting. STUDY DESIGN Sexually active couples not at risk of pregnancy and at low risk of sexually transmitted infection were recruited and randomly assigned to one of two groups to determine order of device use. Couples used each device four times and provided feedback on key performance indicators via product-use questionnaires, a simple coital log and a gender-specific debriefing interview. RESULTS Twenty couples provided data on a total of 160 product uses (80 for each device). Couples indicated that both diaphragms were acceptable with respect to ease of use, comfort and satisfaction with sex. At the end of the study, 19 of 20 women and 15 of 20 men reported preferring the SILCS diaphragm over the Ortho diaphragm (p<or=.01 for both). CONCLUSION Short-term acceptability of the SILCS and Ortho diaphragms during use was comparable, although overall both women and men preferred the SILCS diaphragm over the Ortho diaphragm. Acceptance of diaphragms in general, and the SILCS diaphragm in particular, is likely among couples willing to use a barrier method.

Short-term acceptability of a single-size diaphragm among couples in South Africa and Thailand

Background The SILCS diaphragm is a new, reusable, single-size cervical barrier device that is designed to offer the same barrier protection as a standard diaphragm with improved user acceptability. Methods This non-randomised, non-blinded, non-significant risk, multi-site pilot study assessed the short-term acceptability of the SILCS diaphragm among women with no previous diaphragm experience. Sites in South Africa and Thailand recruited couples not at risk of pregnancy and at low risk of sexually transmitted infections. Couples used the SILCS diaphragm four times and provided feedback on the ease of handling, comfort, and sensation during sex. Data were collected via detailed product-use questionnaires, simple coital logs and gender-specific debriefing interviews. Results A total of 41 couples completed the study, providing data from 164 product uses. The SILCS device fits women representing a range of diaphragm sizes, parity and body mass index. Women from both sites reported that the SILCS diaphragm was easy to use and provided good comfort and sensation in over 80% of all product uses. Men from both sites reported good comfort and sensation in over 60% of all product uses. Conclusion The SILCS diaphragm appears to be acceptable to women and men in low-resource settings. These data suggest that the SILCS design should be tested in broader populations to assess effectiveness and acceptability.

Development of a microbicide-releasing diaphragm as an HIV prevention strategy

Contraceptive diaphragms offer a discreet method of pregnancy protection that women can use when needed with no side effects. Incorporating antiretroviral HIV microbicides into such devices may also provide protection against HIV infection. The paper gives a brief outline of the work being conducted by PATH, CONRAD and QUB on the development of a microbicide-releasing SILCS diaphragm. The design, engineering and manufacturing challenges that have been encountered will be discussed, as well as the potential impact such a device could have in the developing world.

Wear and care of the SILCS diaphragm: experience from three countries

BACKGROUND Women have been regularly underestimated in their ability to care for and wear cervical barrier devices such as diaphragms appropriately. METHODS Data from two non-randomised, non-blinded, non-significant risk acceptability studies of a novel cervical barrier device, the SILCS diaphragm, conducted in the Dominican Republic (n = 20), South Africa (n = 21) and Thailand (n = 20), are used to provide insights into the fundamental question of how women actually use an intravaginal device within the constraints of low-resource settings. In all sites, couples not at risk of pregnancy and at low risk of sexually transmissible infections used the SILCS diaphragm four times and provided feedback on acceptability, care and use of the device via product use questionnaires and gender-specific debriefing interviews. RESULTS Data from user acceptability studies in these three countries provide an intimate view of how women care for and store the SILCS diaphragm, and both female and male perceptions about handling and re-using it. Results support the view that women are able to wear and care for diaphragms successfully in a variety of settings. In general, male partners were also supportive of care and reuse of the diaphragm. CONCLUSIONS While the results from these studies indicate that women are able to find ways to cope successfully with the logistics of wearing and caring for an intravaginal device, further supportive evidence from a woman-centred perspective is crucial for reproductive health policymakers and program managers. The authors contend that it is time to reassess perceived constraints to barrier protection.