1. www.global-campaign.org 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 trials power so researchers can answer study questions more effectively.

2. www.global-campaign.org 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. www.global-campaign.org Findings: HIV Risk Reduction & Family Planning Services Risk ReductionContraceptionPregnancy Risk reduction counseling at all sites Male condom demo & provision at all sites Female condoms available at most sites– but not promoted or demonstrated Most (5 of 7) sites provided family planning counseling & contraception. Some sites started contraception mid-way through trial (in part due to high pregnancy rates) None provided emergency contraception Pregnancy tests frequent – provided monthly or quarterly In most (6 of 7), pregnant women allowed to continue study visits off gel; 1 did not All studies offered referral to antenatal care & PMTCT None provided full info. on a.termination of pregnancy; b.risks of unsafe abortion; and c.access to post-abortion care

4. www.global-campaign.org Findings: Provision of STI & Cervical Care STI Screening & Treatment At 6 of 7, screening visit offers laboratory STI screening and treatment At all sites, enrolled women got ongoing STI screening and treatment Some sites also screened for and treated vaginal infections (BV, etc.) Cervical Screening & Treatment 4 of 7 studies provided a Pap smear at least once 3 of 7 paid for diagnosis and treatment of detected lesions In trial sites with no established national cervical cancer screening program, often nowhere to refer women who have abnormal findings Is it appropriate to do cervical screening in those settings??

5. www.global-campaign.org 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. www.global-campaign.org 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