Completed research

Below you will find information about completed research on cervical barriers and female condoms. CBAS maintains bibliographies of published research on diaphragms and female condoms, which are updated on a yearly basis. The most recent published abstracts are available below.

cervical barriers

An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe

Results of a safety and feasibility study of the diaphragm used with ACIDFORM gel or K-Y Jelly®

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

Vaginal practices and associations with barrier methods and gel use among sub-Saharan African women enrolled in an HIV prevention trial

Barriers to diaphragm use: The views of advanced practice nurses

BIBLIOGRAPHY OF PUBLISHED DIAPHRAGM RESEARCH THROUGH DECEMBER 2009

Female Condoms

Three new female condoms: Which do South-African women prefer?

BIBLIOGRAPHY OF PUBLISHED FEMALE CONDOM RESEARCH THROUGH MAY 2010

CErvical Barriers

An acceptability and safety study of the Duet® cervical barrier and gel delivery system in Zimbabwe. Montgomery ET, Woodsong C, Musara P, Cheng H, Chipato T, Moench T, Spielberg F, van der Straten A. Journal of the International AIDS Society 2010;13:30.

Background: Adherence problems with coitally dependent, female-initiated HIV prevention methods have
contributed to several trials’ failure to establish efficacy. Continuous use of a cervical barrier with once-daily
cleaning and immediate reinsertion may simplify use for women and improve adherence. We assessed the
acceptability and safety of precoital and continuous use of the Duet®, a cervical barrier and gel delivery system, in
Zimbabwean women.

Methods: Using a two-arm crossover design with a parallel observation group, we randomized 103 women in a
2:2:1 ratio: (1) to use the Duet continuously for 14 days, followed by a minimum of seven days of washout and
then 14 days of precoital use; (2) to use the same Duet regimens in reverse order; or (3) for observation only.
Women were aged 18 to 40 years; half were recruited from a pool of previous diaphragm study participants and
the other half from the general community. Acceptability and adherence were assessed through an interviewer administered questionnaire at each of two follow-up visits. Safety was monitored through pelvic speculum exams
and report of adverse events.

Results: The proportion of women who reported consistent Duet use during sex was virtually identical during
continuous and precoital regimens (88.6% vs. 88.9%). Partner refusal was the most common reason cited for nonuse during sex in both use regimens. Not having the device handy was the most common reason cited for nondaily
use (in the continuous regimen). Most women were “very comfortable” using it continuously (86.3%) and
inserting it precoitally (92.8%). The most favoured Duet attribute was that it did not interfere with “natural” sex
(55%). The least favoured Duet attribute was the concern that it might come out during sex (71.3%). No serious
adverse events were reported during the study; 57 participants reported 90 adverse events classified as mild or
moderate. There were no statistically significant differences in: (1) the proportion of women reporting adverse
events; (2) the severity of events among those using the Duet and observational controls; or (3) event severity
reported during each regimen use period.

Conclusions: In this study, the Duet was found to be acceptable and safe when inserted precoitally or used
continuously for 14 days. Assignment to use of the Duet continuously did not increase adherence to the Duet
during sex. Future HIV prevention trials should evaluate use of the Duet (precoitally and continuously) with
promising microbicide candidates.

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Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y® Jelly. von Mollendorf CE, Van Damme L, Moyes JA, Rees VH, Callahan MM, Mauck CK, Puren AJ, Tweedy K, Taylor D. Contraception. 2010;81(3):232-239.

Background: New strategies are needed for preventing HIV infection in women. One potential approach is female-initiated use of an effective topical microbicidal gel in combination with a cervical barrier such as the diaphragm.

Study design: Randomized, placebo-controlled safety and feasibility trial of diaphragm with vaginal gel during 6 months of use among 120 HIV-negative sexually active women in Johannesburg, South Africa.

Results: Pelvic event rates were 338.3 and 247.1 per 100 women-years in the ACIDFORM gel (plus diaphragm) and K-Y® Jelly (plus diaphragm) groups, respectively, with a rate ratio of 1.37 (95% CI: 0.89-2.11). Most women found diaphragm with gel use acceptable.

Conclusion: There was a trend towards more safety events in the ACIDFORM plus diaphragm group, although no primary comparisons achieved statistical significance. Adding an effective microbicidal gel to a mechanical barrier may still prove to be an important and acceptable combination method to help prevent pregnancy and HIV/sexually
transmitted infection transmission.

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Wear and care of the SILCS diaphragm: Experience from three countries. Coffey PS, Kilbourne-Brook M. Sexual Health. 2010;7:159-164.

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.

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Vaginal practices and associations with barrier methods and gel use among sub-Saharan African women enrolled in an HIV prevention trial. van der Straten A, Cheng H, Chidanyika A, De Bruyn G, Padian N, MIRA Team. AIDS Behavior. 2010;14(3):590-9.

Vaginal practices may interfere with the use and/or the effectiveness of female-initiated prevention methods. We investigated whether vaginal practices differed by randomization group in a phase III trial of the diaphragm with lubricant gel (MIRA) in Sub-Saharan Africa (n = 4925), and if they were associated with consistent use of study methods. At baseline, vaginal practices were commonly reported: vaginal washing (82.77%), wiping (56.47%) and insertion of dry or absorbent materials (20.58%). All three practices decreased during the trial. However, women in the
intervention group were significantly more likely to report washing or wiping during follow-up compared to those in the control group. Additionally, washing, wiping, and insertion were all independently and inversely associated with
consistent diaphragm and gel use and with condom use as well, regardless of study arm. A better understanding of the socio-cultural context in which these practices are embedded could improve educational strategies to address these
potentially modifiable behaviors, and may benefit future HIV prevention interventions of vaginal methods.

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Barriers to diaphragm use: The views of advanced practice nurses. Kulczycki A, Qu H, Bosarge PM, Shewchuk RM. Journal of Family Planning and Reproductive Health Care. 2010;36(2):79-82.

Background and Methodology: Women have used the contraceptive diaphragm for decades. Although use has recently declined, the diaphragm may find a new role in STI/HIV and dualprevention programmes when microbicides
become available. We developed a questionnaire to examine seven provider issues identified as possible barriers to diaphragm use among advanced practice nurses (APNs) specialising in women's health. The perceived degree to which each issue represented a barrier was examined.
Non-parametric correlations were calculated between diaphragm fitting history, demographic and practice characteristics, and the response ratings for each issue.

Results: Responses were analysed for 204 APNs who averaged 15 years' experience in women's health care; 87% had fitted a diaphragm at least once, but 40% had not
prescribed one in the past year. The degree to which each issue was perceived as a barrier varied. Based on respondents' ratings of a 'more than moderate barrier,' diaphragm non-promotion by women's health providers, effectiveness doubts, unfamiliarity and lack of access to educational materials were more often perceived as impeding
diaphragm use. Other results indicated that APNs with recent diaphragm fitting history perceived five of the seven issues to be less of a barrier: nonpromotion by women's health providers, lack of access to educational materials and to a fitting set, unfamiliarity, and inadequate reimbursement.

Discussion and Conclusions: Formulation of successful strategies to reintroduce the diaphragm will depend on better identification and understanding of provider-perceived barriers. This paper offers new insights about such barriers and guidance for the development of strategies for
diaphragm reintroduction.

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Female Condoms

Three new female condoms: Which do South-African women prefer? Joanis C, Beksinska M, Hart C, Tweedy K, Linda J, Smit J. Contraception. 2010 (published online ahead of print)

Background: The widespread distribution of female condoms (FCs) in developing countries has been hindered by high unit cost, making new, less expensive devices a priority for donor agencies.

Study design: Randomized, crossover study assessing product preference, safety, acceptability, and function of three new FCs (PATH Woman's Condom, FC2, and V-Amour) among 170 women in Durban, South Africa. A subsequent “simulated market” study provided participants with free choice of FCs and assessed condom uptake over three months.

Results: Of the 160 women who used at least one FC of each type, 47.5% preferred the PATH Woman's Condom (WC), 35.6% preferred FC2, and 16.3% preferred V-Amour (p<.001). Women rated the WC better than FC2 and V-Amour for appearance, ease of use, and overall fit and better than V-Amour for feel. WC was rated worse than FC2 and V-Amour for lubrication volume. The simulated market demonstrated similar preferences. Total clinical failure rates (i.e., the types of failures that could result in pregnancy or STI) were low (<4%), regardless of condom type.

Conclusions: Three new FC types functioned similarly and were generally acceptable. Most participants preferred WC and FC2 over V-Amour, and WC was preferred over FC2 in several acceptability measures.

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• Ongoing Research
• Planned Research