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The following ongoing studies on cervical barriers and female condoms are listed in reverse chronological order based on the start date of the study.
Acceptability and Performance of a Device for Vaginal Drug Delivery: South Africa Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: The Pivotal Study Providers' HIV/STI and Pregnancy Prevention Practices in Southern Africa and the United States Female Condoms Cervical Barriers Acceptability and Performance of a Device for Vaginal Drug Delivery: South Africa Phase I Location: Durban, South Africa FHI has developed a novel device for vaginal drug delivery (currently called the DVD2) made from a soft, white, medical-grade non-woven textile material. Each packaged device was saturated with 10 mL of an FDA-approved vaginal lubricant, and prepared by an FDA-registered manufacturer. From August to October 2009, FHI conducted a first-in-woman Phase I research study in Durban, South Africa, to assess acceptability and performance of the DVD2. Forty monogamous, non-pregnant women (20 family planning clients and 20 students), aged 18-51, who had previous experience with vaginal hygiene products were recruited for participation in this study, along with 10 of their male partners. Women inserted and removed the first device at the clinic and the second device at home. For the device insertion at home, we asked women to discuss the study with their male partner and wear the device during intercourse if their partner agreed. Female participants’ pelvic and outer genital areas were examined at clinic visits. Both quantitative and qualitative methods were used to collect data in this study. Key Findings: Overall, women and men found the DVD2 easy to use with minimal leakage and acceptable to use for contraception and/or the prevention of STI/HIV. The key factors that appeared to have contributed to the device’s high level of acceptability were:
Conclusion: The results of this research warrant further development of this device for vaginal delivery of antiviral agents, medications for the treatment of bacterial vaginosis or vaginal candidiasis, contraceptives, and perhaps hormone replacement preparations. Related Publication: This study was conducted by researchers at FHI in collaboration with the Maternal, Adolescent and Child Health (MatCH, formerly RHRU, Durban Office), in Durban, South Africa. Support for this research was provided by the International Partnership for Microbicides (IPM), United States Agency for International Development (USAID) under cooperative agreement GPOA-00-05-00022-00, and FHI’s Foundation. An Exploratory, Non-Blinded, Single Center, Randomized, Cross-Over MRI Study of the Delivery of Microbicide by the SILCS Diaphragm Location: University of Pennsylvania, United States Started in 2009, the primary objective of this study is to assess the feasibility of the SILCS diaphragm as a microbicide delivery system and to assess overall user acceptability. Secondary objectives include assessing the gel coverage of the upper vagina (above the pelvic diaphragm) and the entire vagina using three methods of application, assessing distribution of the gel before and after simulated intercourse (immediately after and 6 hours after), and assessing the initial acceptability of the SILCS microbicide delivery system as opposed to pre-filled applicators. Nine women will participate in this study and BufferGel® will be used with the SILCS diaphragm. This study is being conducted by PATH; the University of Pennsylvania Women’s Health Clinical Research Center; and The Miriam Hospital/Brown University Centers for Behavioral & Preventive Medicine, and is funded by USAID. A Randomized, Cross-Over, Couples’ Use Acceptability Study of the SILCS Diaphragm Microbicide Delivery System Location: Los Angeles, United States Started in 2009, the primary objective of this study is to assess the feasibility and acceptability of the SILCS diaphragm as a microbicide delivery system compared to microbicide delivered by a vaginal applicator when used during sexual intercourse. Secondary objectives include assessing preference for applying microbicide gel via the SILCS diaphragm or the microbicide applicator, assessing the relationship between gel application technique and impact on user acceptability, and assessing user perspective of additive value of using SILCS diaphragm to deliver microbicide gel for dual protection. Thirty-six women will participate in this study and BufferGel® will be used with the SILCS diaphragm. This study is being conducted by PATH and the California Family Health Council and is funded by USAID. Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: The Pivotal Study Location: United States The contraceptive diaphragm was widely used in the United States in the mid 20th century but use has decreased in recent years. Novel female-controlled barrier methods with dual method potential are essential contraceptive options for women. A single-size diaphragm available over-the-counter would be an ideal microbicide delivery systems for HIV/STI prevention. In 1994, PATH, an international nonprofit organization based in Seattle, began the development of a single-size silicone contraceptive diaphragm with extensive input from users and clinicians to identify and address necessary improvements over the currently available and approved diaphragms. The SILCS diaphragm was developed based on user evaluations in multiple sites in the US. Additional testing was performed in South Africa, Thailand, and the Dominican Republic to confirm user acceptance. Recent results of a study using magnetic resonance imaging to evaluate the fit of the SILCS in vivo indicate that the device fits women of varying parities and body sizes (See Yang et al. 2007 below). In a postcoital study enrolling 20 couples, the SILCS diaphragm used with nonoxynol-9 during intercourse prevented progressively motile sperm from reaching cervical mucus. A study designed to determine the contraceptive effectiveness of the SILCS device in 450 sexually active couples began enrolling in February 2008 at six different sites in the United States. This study is being conducted by CONRAD, a nonprofit organization that operates within the Eastern Virginia Medical School, with funds provided by the United States Agency for International Development (USAID). Participants in the study are randomly assigned to use one of two gels (either BufferGel®, which is currently in development as a contraceptive; or Gynol II®, which is an FDA-approved contraceptive gel) along with the SILCS diaphragm for a period of six months and at least six menstrual cycles. The clinical portion of the study was complete as of November, 2009 and the study is currently in analysis. Related Publications: Yang C, Maravilla KR, Kilbourne-Brook M, Austin G. Magnetic resonance imaging of SILCS diaphragm: anatomical considerations and corroboration with clinical fit. Contraception 76:3 (2007) 238-244. Providers' HIV/STI and Pregnancy Prevention Practices in Southern Africa and the United States In-depth Interview and Nationally Representative Survey Study Location: United States, South Africa, and Zimbabwe Started in 2004, the objective of this study was to evaluate providers’ counseling practices for HIV and pregnancy prevention and their willingness to integrate new approaches and methods (including new and existing HIV prevention strategies with a range of hypothetical effectiveness) into client-specific prevention messages, counseling, and method provision. Approximately 1,400 physicians and nurses from Southern Africa and 1,200 from the United States were enrolled in this study. Key Findings: Data collection is complete and analysis is underway. This study is being conducted by researchers at the University of California, San Francisco and Ibis Reproductive Health and is funded by NICHD. Female Condoms Vaginal Semen Exposure and Clinical Failure Comparing the PATH Woman's Condom and the FC2 Female Condom Phase III Location: California Family Health Council, United States Up to 425 healthy heterosexual couples at least 18 years of age and at low risk for pregnancy or STIs are being enrolled in this comparative, open-label, two-period, crossover study comparing the PATH Woman’s Condom (WC) to the FC2 female condom. The primary objective of the study is to compare the performance of the WC to the FC2, as assessed by self-reported clinical failure. Secondary objectives are to compare the ability of the WC and the FC2 to prevent vaginal exposure to semen, as indicated by detection of prostate-specific antigen (PSA) within the vagina; to calculate the sensitivity and specificity of reported failures for the presence of semen, using PSA as the indicator of the presence of semen; and to compare acceptability of the WC and FC2. Couples will be randomized to one of two condom use sequences (WC then FC2 or FC2 then WC). Four condoms of each type will be used by couples over two 2-4 week periods. For the first period, one set of pre- and post-coital vaginal swabs will be collected around unprotected intercourse. For each coital act in which a condom is used in the period, pre- and post-coital vaginal swabs and a post-coital condom swab will be collected. A Condom Use Questionnaire will be completed after each condom use. An Acceptability Questionnaire will be completed at the end of each period. After a follow-up visit, these procedures will be repeated with the second four condoms, without collection of vaginal swabs at unprotected intercourse. Final analysis is expected in late 2011. This study is being conducted by CONRAD and is funded by USAID. Link to: |
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