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Newsletter Several times a year, CBAS distributes an electronic newsletter to subscribers. The newsletter is designed to keep subscribers abreast of new research, activities in the field, and relevant events. Recipients are encouraged to share the newsletter with others. All CBAS members receive the newsletter, but you don’t need to be a member to subscribe. Note: We are currently updating our research listings on the CBAS website. Please contact us at info@cervicalbarriers.org with study updates or information on new research related to cervical barriers. If you have input on the content of the newsletter or have an item of interest to include, contact us at info@cervicalbarriers.org. The current issue is shown below and can also be downloaded in PDF format (pdf). Past issues will be archived and available for download.
The following are published abstracts of research studies on topics related to cervical barrier methods. Evidence-Based Planning of a Randomized Controlled Trial on Diaphragm Use for Prevention of Sexually Transmitted Infections. Behets F, Van Damme K, Turner A, Rabenja N, Ravelomanana N, Raharinivo M, Zeller K, Rennie S, Swezey T. Sexually Transmitted Diseases. 2008; 35(3): 238-242. Objectives: We conducted formative research to evaluate the acceptability and feasibility of continuous diaphragm use among low-income women highly exposed to sexually transmitted infections (STIs) in Madagascar. Goal: To identify potential obstacles to researching the effectiveness of diaphragm use for STI prevention in a randomized controlled trial. Study Design: Mixed methods to collect complex information. In a quantitative pilot study, women were asked to use diaphragms continuously (removing once daily for cleaning) for 8 weeks and promote consistent male condom use; they were interviewed and examined clinically during follow-up. Focus group discussions (FGDs) were conducted pre-/post-pilot study. Audio-taped FGDs were transcribed, translated, coded, and analyzed. Results: Ninety-three women participated in pre-pilot FGDs, 91 in the pilot study, and 82 in post-pilot FGDs. Diaphragm use was acceptable and feasible, but participants reported lower condom use in FGDs than during interviews. Most participants reported in interviews that they used their diaphragms continuously, but FGDs revealed that extensive intra-vaginal hygiene practices may impede effective continuous diaphragm use. Despite counseling by study staff, FGDs revealed that participants believed the diaphragm provided effective protection against STIs and pregnancy. Conclusions: Mixed methods formative research generated information that the prospective pilot study alone could not provide and revealed contradictory findings. Results have methodological and ethical implications that affect trial design including provision of free hormonal contraceptives, and additional instructions for vaginal hygiene to avoid displacing the diaphragm. Mixed methods formative research should be encouraged to promote evidence-based study design and implementation. A Phase I Study of the Functional Performance, Safety and Acceptability of the BufferGel Duet. Ballagh SA, Brache V, Mauck C, Callahan MM, Cochon L, Wheelessd A, Moench TR. Contraception. 2008; 77(2):130-137. The purpose of this study was to assess the functional performance of the BufferGel Duet, a buffering microbicide and spermicide gel applied to the cervix and vagina by a novel applicator that also serves as a mechanical barrier. This was a noncomparative Phase I safety trial in 30 healthy couples, aged 20-50 years, at low risk for sexually transmitted infections, who agreed to use the gel-device combination twice in 1 week and respond to detailed questionnaires about their experience. The female participants were examined with colposcopy before and 6-18 hours after using the second device. Based on written instructions alone, 25 women successfully placed and 28 women successfully removed the device. Three women reported feeling the device dislodge around the time of intercourse. The product was equally acceptable to both men and women. Most users concluded that intercourse was the same or better with the device than with no product. About 73% would choose Duet over male condoms, and no one preferred the standard diaphragm. Colposcopic findings were noted in 79% of women with external genital findings (9) or cervicovaginal peeling (18) predominating. Only one finding breached the epithelium. Most product-related adverse events were mild (10/11) and confined to the genitourinary tract. The successful placements and acceptability suggest that further product development is warranted and could target over-the-counter use. During increased duration of use or more frequent dosing, cervicovaginal monitoring is advised based on the extent of peeling and external colposcopic findings in this short-term study. Analyzing Direct Effects in Randomized Trials with Secondary Interventions. Rosenblum M, Jewell N, van der Laan M, Shiboski S, van der Straten A, Padian N. U.C. Berkeley Division of Biostatistics Working Paper Series. 2007; Working Paper 223. The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counseling and provision, the "gold standard" HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the "direct effects" of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed. Summary of Results: Though both point estimates are in the direction of assignment to the diaphragm arm being protective in these scenarios, neither is close to statistical significance. Also, based on the bootstrap estimates of standard errors, both of the direct effects relative risk point estimates are within one standard error of the value corresponding to no effect of assignment to the diaphragm arm. We therefore conclude that the direct effects analysis provides no evidence in support of, nor in refutation of, diaphragms providing a protective effect against HIV infection. See full text: http://www.bepress.com/ucbbiostat/paper223 Female Condom Uptake and Acceptability in Zimbabwe As the first phase of a two-phase prospective cohort study to assess the acceptability of the diaphragm as a potential HIV/STI prevention method, we conducted a 2-month prospective study and examined the effect of a male and female condom intervention on female condom (FC) use among 379 sexually active women in Harare, Zimbabwe. Reported use of FC increased from 1.1% at baseline to 70.6% at 2-month follow-up. Predictors of FC uptake immediately following the intervention included interest in using FC, liking FC better than male condoms, and believing one could use them more consistently than male condoms. Women reported 28.8% of sex acts protected by FC in the 2 weeks prior to last study visit. Though FC may not be the preferred method for the majority of women, with access, proper education, and promotion they may be a valuable option for some Zimbabwean women. FemCap as a Novel Delivery System for Microbicides The FemCap cervical barrier was featured in “A Novel Delivery System for Microbicides,” a poster presented by Dr. Alfred Shihata at the National HIV Prevention Conference in Atlanta, Georgia, in December 2007. Dr. Shihata’s research highlights the role of the FemCap in protecting the cervix while serving as an applicator for a microbicide designed to prevent HIV infection. Given that irritation to the cervix that can occur from contact with microbicides causes immune cells to migrate to the cervix, and that immune cells are the primary targets for HIV invasion, deleterious effects of microbicides as demonstrated in trials of Nonoxynol-9 and Cellulose Sulphate could possibly be avoided by protecting the cervix from contact with the microbicide. Amphora (ACIDFORM) is a microbicide that protects the mucous membrane from HIV invasion and preserves vaginal acidity, while also killing sperm and HIV organisms. Dr. Shihata’s poster featured a test with ten women in which he mixed five grams of ACIDFORM with ten drops of Gentian violet (a dye) and applied the mixture to the storage groove on the vaginal side of the FemCap. The cervix and vagina were photographed before insertion, upon insertion, six hours after insertion, and upon removal of the FemCap. In all women, no staining was detected over the cervix while the vaginal walls were lightly stained with Gentian violet (see photo). These findings highlight the potential for FemCap to protect the cervix from possible irritation by microbicides. Dr. Shihata encourages this novel use of a cervical barrier in clinical trials to show microbicides’ success in reducing the risk of transmission of HIV. Photograph highlighting the protective effect of the FemCap as a vehicle for microbicides. FemCap with microbicide and dye. Implementation of Female Condom Programs Worldwide According to the Female Health Company website, 40 countries around the globe are currently implementing female condom programs. These initiatives are part of the worldwide effort to place female-initiated HIV/STI prevention and family planning methods into the hands of women. Several countries have recently begun to launch new programs, and we highlight a few of these new and exciting initiatives below. The Times of India (March 6, 2008) and Kaiser Network (March 7, 2008) report that the Indian National AIDS Control Organisation (Naco) plans to scale up an acceptability and feasibility pilot project completed in 2006 that demonstrated that 98% of users found the female condom comfortable and 60% re-purchased the female condom after receiving it as part of the pilot project. The initiative will include training for women on how to use the female condom and distribution of five-rupee female condoms (about 12 cents) in four states to sex workers and married women, the two groups of women in India at highest risk for HIV infection. The project also will include the manufacture of 10 million female condoms annually in Kochi, India, which, although each one will cost 40 rupees to manufacture, will continue to be available for five rupees through 200 NGO-led interventions. Another article in the Times of India (April 21, 2008) reports that the manufacturing company Hindustan Latex Ltd. has begun to place female condom machines in wash rooms of elite urban night clubs in an effort to target upper-class women as well. The Jamaica Gleaner (April 21, 2008) and Kaiser Network (April 22, 2008) report that the new female condom, the FC2, will be the focus of a workshop put on by Jamaica’s National Family Planning Board to promote its use and address the negative stigma surrounding the contraceptive, such as its association with prostitution and its perceived high cost. The workshop will highlight the improved features of the FC2, which include being less noisy, stronger, hypoallergenic, and able to be used for five years with no special storage conditions. The Daily Times (April 30, 2008) and the International Planned Parenthood Federation (May 2, 2008) report that Population Services International (PSI), with support from the Ministry of Health in Malawi and the United Nations Population Fund (UNFPA), have launched a social marketing program for the Care female condom in up to 2,800 hair salons in the four major urban centers of Malawi. According to the Daily Times, PSI Malawi says that experiences in Zimbabwe and Zambia, countries that have sold a total of over 7 million female condoms since the mid-late 1990’s, indicate that hair salons are an effective venue for creative, targeted marketing programs that build upon existing social networks in gathering places for women. PSI Malawi trains promoters who in turn educate hair salon workers on how to explain to women the correct use of female condoms and encourage them to protect themselves against unplanned pregnancies, STIs, and HIV. According to one promoter, “The salon is a place where most women throw away any inhibitions and are able to talk to fellow women on a lot of important issues including sexual health.” The same promoter also reported to the Daily Times that she was making a good profit from sales of the female condom, which she is able to buy at K23 (approximately 16 cents) from PSI and sell for K35 (approximately 24 cents) to customers. PSI currently has 15 country programs worldwide distributing female condoms through creative approaches that integrate peer education, mass media communications, and innovative strategies for distribution. Led by the Center for Health and Gender Equity (CHANGE) in partnership with global advocates, the Prevention Now! Campaign aims to prevent the spread of HIV, reduce unintended pregnancy, and advance the sexual and reproductive health and rights of all people worldwide. Specifically, the campaign calls on governments and donor agencies to increase their investment in efforts to improve access to female condoms and other existing HIV prevention options. The campaign works towards this goal by building partnerships among national and international efforts and through education and advocacy. As part of the Prevention Now! Campaign, CHANGE has developed a resource entitled, “Saving Lives Now: Female Condoms and the Role of US Foreign Aid,” that documents US investment in global female condom procurement, distribution, and programming and provides recommendations for removing barriers to access to female condoms and ensuring US support for female condoms in the future, given that female condoms still represent less than 2% of the total US international condom procurement. For more information on the campaign and to download this report, visit: http://www.preventionnow.net. Members of U.K. Parliament Call for Women-Centered HIV/AIDS Efforts Approximately 175 members of parliament in the United Kingdom have signed a motion for the United Kingdom’s Department of International Development to put women at the center of the new global HIV/AIDS strategy and to encourage other international agencies to follow suit, the Herald Express reports (April 7, 2008). The motion is part of the “Women Matter” campaign run by the international development charity VSO (Voluntary Service Oversees). This campaign seeks to highlight the fact that women in sub-Saharan Africa are more likely than men to become infected with HIV due to violence, discrimination, and inequality.
Event: Implementing Best Practices (IBP) in Reproductive Health Knowledge Gateway Diaphragm Forum
Event: Reproductive Health in Emergencies Conference
Event: XVII International AIDS Conference
Event: Women’s Global Network for Reproductive Rights (WGNRR) Regional Consultation Meeting
Event: Association for Women’s Rights in Development (AWID) XI International Forum on Women's Rights and Development To comment on anything you read in the CBAS newsletter or to contribute a story, event, or news item, please email CBAS. |
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