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Acceptability among sex workers in the Dominican Republic Acceptability Study Started in 2006, the objective of this ongoing study is to test the acceptability of the Ortho All-Flex® diaphragm and the FC female condom as potential STI prevention methods among sex workers. A total of 250 women aged 18 to 35 are being enrolled in this randomized control trial based on the introduction of methods. Participants are sex workers, not pregnant at enrollment, plan to live in the area for at least six months, and do not have untreated C. trachomatis or N. gonorrhea at enrollment. Participants will be followed for 5.5 months. Key Findings: This study is still ongoing. This study is being conducted by researchers at the Population Council and Ibis Reproductive Health and is funded by the Bill and Melinda Gates Foundation. Methods for Improving Reproductive health in Africa (MIRA) Phase III Started in 2003, the objective of this ongoing study is to measure the effectiveness of the Ortho All-Flex® diaphragm with Replens® lubricant gel for the prevention of heterosexual acquisition of HIV among at-risk women. Additionally, sub studies include: effectiveness of diaphragm and gel in preventing Chlamydia, gonorrhea and trichomoniasis; long-term acceptability of the diaphragm; diaphragm safety; and feasibility of diaphragm and gel as a sustainable HIV prevention method. A total of 5,042 women over the age of 18 were enrolled in this multi-site randomized, controlled trial. Participants were sexually active, tested negative for HIV, chlamydia and gonorrhea, and were willing to be randomly assigned either to use or not use the latex diaphragm with lubricant gel during the study. Participants are enrolled for up to 24 months. Key Findings: This study is not yet completed. Results are expected in 2007. This trial is being conducted by researchers at the University of California, San Francisco (UCSF), Women’s Global Health Imperative; Ibis Reproductive Health; the Medical Research Council of South Africa; the Perinatal HIV Research Unit of South Africa; and the University of Zimbabwe-UCSF. The study is being funded by the Bill and Melinda Gates Foundation. Provider’s perceptions of the diaphragm in Southern Africa and the United States Key Informant Interview and Survey Study Started in 2004, the objective of this ongoing study is to evaluate providers’ perceptions of the diaphragm and their counseling practices for HIV and pregnancy prevention. Approximately 3,600 physicians and nurses are being enrolled in this study. Participants are residents in training, retired, or holding research-only positions, as well as reproductive endocrinologists and maternal-fetal medicine specialists. Key Findings: This study is not yet completed. Results are expected in 2007. This study is being conducted by researchers at the University of California, San Francisco and Ibis Reproductive Health and is funded by NICHD. Feasibility and Acceptability of Cervical Barriers among Vulnerable Youth in Africa Acceptability Study The objective of this study is to explore the feasibility and acceptability of cervical barriers for HIV prevention among female youth. Approximately 40 sexually-experienced female youth ages 16 to 21 are being enrolled in the study in addition to approximately 20 female adult relatives (mothers or aunts) of female youth (who are not related to youth participants). This qualitative exploratory behavioral study will assess device preference, including focus group discussions and follow-up insertion/removal practice sessions. The study products being tested are the Ortho All-Flex® diaphragm, the SILCS diaphragm and the FemCap®. This study was initiated in 2006 and will continue for about eight months. Key Findings: The study is not yet completed. This study is being conducted by the University of California, San Francisco (UCSF) Women’s Global Health Imperative and the University of Zimbabwe-UCSF Collaborative Research Programme. Link to: |
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