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Planned research Below you will find information about planned research on cervical barriers and female condoms. Cervical Barriers Female Condoms Cervical Barriers A Randomized Clinical Trial of the Diaphragm with a Candidate Microbicide to Prevent Sexually Transmitted Infections Phase III This study is expected to start in the spring of 2009. The objective is to evaluate the effectiveness of the Ortho All-Flex® diaphragm with BufferGel®, a candidate microbicide, at preventing the acquisition of N. gonorrhea and/or C. trachomatis (GC/CT). Approximately 1540 HIV-negative women aged 15 to 55 with laboratory-confirmed GC/CT infection at screening will be enrolled in this randomized controlled trial consisting of four arms: diaphragm plus placebo gel (HEC), diaphragm plus active microbicide, active microbicide alone, placebo gel alone. Participants will be followed for six months. This trial will be conducted by researchers at the University of North Carolina, Chapel Hill; the CDC; and CONRAD. Funding is being provided by the CDC, USAID, and NIAID. Female Condoms A Randomized Controlled Trial of the Functional Performance of New Female Condoms: Evaluation of the Woman’s Condom, FC2, VA w.o.w and Cupid Phase III Location: South Africa and China The objective of the study is to determine functional performance and overall acceptability and safety of new female condoms (FCs) including the Woman’s Condom (WC), FC2, VA w.o.w., and Cupid models. The design will be a randomized cross-over trial to evaluate device function, safety, and acceptability of four new FC types. The target population will be urban, sexually-active women who are either novice or experienced users of FCs. Recruitment will be from family planning clinics associated with MatCH (at the University of the Witwatersrand, Durban, South Africa) and clinics linked with Fudan University (Shanghai, China). Results will be used to complete manufacturer dossiers for WHO pre-qualification. Results are expected at the end of 2011. The study is being conducted by and is funded by the Universal Access to Female Condoms (UAFC) Joint Programme. Link to: |
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