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

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.

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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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