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What does sexual & reproductive health have to do with clinical trials?

Providing contraception and reproductive health care can aid in the recruitment and retention of women in clinical trials. Lower pregnancy rates also improve the effectiveness of the study. The Global Campaign for Microbicides documented strategies for provision of care and prevention services in late-stage microbicide trials, identifying successful strategies and areas for improvement. Findings include the importance of HIV risk reduction, family planning services, and provision of STI and cervical care. Recommendations include lab screening and treatment for STIs, advocacy for cervical cancer prevention services, training site staff in contraception counseling, provision of emergency contraception, and ensuring monitoring and study benefits for pregnant and seroconverting women.

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What does sexual & reproductive health have to do with clinical trials?

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  1. What does sexual & reproductive health have to do with clinical trials? • Providing contraception & reproductive health care helps with recruitment and retention • women want to be in trial. • Lower pregnancy rates improve trial’s power • so researchers can answer study questions more effectively.

  2. Mapping the Standards of Care in Late-stage Microbicide Trials 2006 –Global Campaign for Microbicides undertook to: • Document & learn from existing strategies for provision of care & prevention services at trial sites • Identify successful strategies & those needing improvement • Provide input useful for future trial design • Collect evidence-based examples to inform international discussions of Standards of Care

  3. Findings: HIV Risk Reduction & Family Planning Services

  4. Findings: Provision of STI & Cervical Care

  5. Sample of Post-Mapping Recommendations • Lab screening and treatment for STIs should be provided to all women screened -- as a community service. • Researchers should work with the community to help ratchet up STI services in appropriate and sustainable ways. • Trials should provide cervical screening if some publicly supported cervical cancer prevention services exist. Where none are available, investigators should advocate for initiation of such services. • Trials should train relevant site staff to ensure their competency in contraception counseling and provision; site-specific pregnancy termination options; and how these relate to other study procedures. • Trials should consider providing emergency contraception • Women who fall pregnant and those who seroconvert should be able to stay in the study to receive monitoring and study-related benefits.

  6. A few words on circumcision…. Monitor resource allocation: balance increased spending on circumcision with increases in prevention resources for women, e.g. • Increased access to female, as well as male, condoms • Provision of vaginal lubricants • Diagnosis and treatment of STI • Provision of safe spermicides (like BufferGel) -- used with cervical barrier methods for contraception; may also reduce STI/HIV risk Monitor & minimize potentially harmful outcomes for women – e.g. • decreases in condom use by men • increases of sexual violence; GBV against women seen as “vectors” • Blaming of HIV positive women for “bringing HIV into the relationship”

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