What does sexual & reproductive health have to do with clinical trials? - PowerPoint PPT Presentation

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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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What does sexual reproductive health have to do with clinical trials l.jpg

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.


Mapping the standards of care in late stage microbicide trials l.jpg

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


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Findings: HIV Risk Reduction & Family Planning Services


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Findings: Provision of STI & Cervical Care


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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.


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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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