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Developing and Delivering a Prevention Package for HIV Prevention Clinical Trials

Developing and Delivering a Prevention Package for HIV Prevention Clinical Trials. Dr. Dawn K. Smith The BOTUSA Project. Who speaks?. As many voices as possible… Those identified as having a stake in trial procedures or results Those who advocate for Those who provide services to

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Developing and Delivering a Prevention Package for HIV Prevention Clinical Trials

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  1. Developing and Delivering a Prevention Package for HIV Prevention Clinical Trials Dr. Dawn K. Smith The BOTUSA Project

  2. Who speaks? • As many voices as possible… • Those identified as having a stake in trial procedures or results • Those who advocate for • Those who provide services to • Those who make policy about • Community members themselves

  3. Identify local prevention needs • Research • Rapid assessment • BAIS I and II • Segmentation study • Syndromic treatment evaluation

  4. Identify and localize resources • Government policy • Partner notification • Existing resources • Institute for Development Management • Recruited resources • Respect II • CDC counseling expertise

  5. Create a spirit of inquiry • Casual “informants” • Mokgomiso • Formal solicitation of advice • Joint CAG discussion of proverbs and messages • Kgetsi ya tsie e kgonwa ke go tshwaraganelwa • Setshwarwa ke ntsa pedi ga se thata • A true man doesn’t bring HIV home • Focus groups to inform their use

  6. Hi prevalence Untested partners Hi likelihood of exposure Inconsistent/incorrect condom use Multiple partners Interconnected networks (relatively) closed community Exposure Rapid spread Ongoing transmission Infectivity Susceptibility Hi incidence Lack of circumcision Hi viral load in genital tract Early sexual debut (cervical ectopy, trauma) Untreated late infection Co-occurring STI Co-occurring STI

  7. Hi prevalence Untested partners Inconsistent/incorrect condom use Multiple partners (relatively) closed community Exposure Rapid spread Ongoing transmission Infectivity Susceptibility Hi incidence Lack of circumcision Early sexual debut (cervical ectopy, trauma) Untreated late infection Co-occurring STI Co-occurring STI

  8. Inconsistent/incorrect condom use Multiple partners Exposure Rapid spread Ongoing transmission Infectivity Susceptibility Untreated late infection Co-occurring STI Co-occurring STI

  9. Individualized Risk Reduction Counseling Family planning services Free male and female condoms Trial education Inconsistent/incorrect condom use Multiple partners Exposure Adherence Counseling Tenofovir Infectivity Susceptibility Disclosure counseling (HIV and STI) Partner-delivered STI treatment Educate about and identify discordancy Laboratory STI diagnosis STAT dose treatment Acyclovir treatment Co-occurring STI Co-occurring STI

  10. Continuous re-evaluation • Assess quality of intervention delivery • Relevant expertise • Staff • evaluators • Regular observation and retraining • Assess acceptability of intervention delivery • Participant choices • Participant reports • Assess impact on risk • Self-reported behavior • Validation markers • DSMB safety parameters

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