Understanding the epidemiology of HIV and other emerging infectious diseases is critical to conducting prevention research, vaccine development, and assuring HIV prevention interventions are delivered as effectively as possible. IAVI and its partners have conducted the following observational epidemiology studies related to disease prevention, public health, and vaccine research and development.
| Study Name | Study Details | Status | Countries | Partners |
|---|---|---|---|---|
| Protocol C | Prospective cohort of volunteers with incident HIV infection. 613 volunteers enrolled from nine research centers for long term follow up; 406 suspected transmitting partners for a single visit. | Study closed | Kenya Rwanda South Africa Uganda Zambia |
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| Protocol G | Prevalence/cross-sectional. Single visit of adults with HIV infection for 3+ years with no significant health issues. Those whose screened serum showed neutralizing activity were asked to come back for further testing and follow up. Approximately 2,100 enrolled. | Study closed | Australia India Ivory Coast Kenya Nigeria Rwanda South Africa Thailand Uganda United Kingdom United States Zambia |
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| Protocol N and Acute HIV Infection Studies | Prospective cohort studies of volunteers with incident HIV infection identified prior to, or during antibody seroconversion, using real-time PCR on the GeneXpert platform, or overnight traditional PCR. Dozens of volunteers identified during this acute phase of HIV infection have been offered treatment, and are followed over time. | Studies in Zambia, Kenya and South Africa are active. Studies in Rwanda are complete. Studies in Uganda are in development. Enrollment open. | Kenya Rwanda South Africa Uganda Zambia |
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| Protocol B and HIV Incidence Studies | Incidence/prospective cohorts in higher-risk populations potentially suitable for efficacy trial participation. This family of studies includes nearly three dozen cohorts that have enrolled over 26,000 volunteers including female sex workers, men who have sex with men, at-risk women, married couples, and fishing community members. | Multiple studies conducted. Currently five cohorts ongoing. Enrollment open. | Kenya Rwanda South Africa Uganda Zambia |
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| Protocol D | Cross-sectional study to characterize laboratory reference intervals in health African adults, with a single follow up visit to assess the effect of season in selected sites. 2,105 enrolled with 903 volunteers in the seasonal study and 200 in another study to assess the effect of splenomegaly. | Study completed | Kenya Rwanda Uganda Zambia |
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| Protocol H | Prospective cohort of volunteers with incident HIV infection who had previously participated in HIV vaccine trials with the same schedule of procedures as IAVI’s early HIV infection cohort, Protocol C. | Ongoing; enrollment open. | Kenya Rwanda Uganda Zambia |
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| Protocol I | Convenience sample to characterize gut mucosal immune function. | Ongoing; enrollment open | Kenya | Show Partners |
| Protocol O | Convenience sample to obtain discarded surgical tissue from patients undergoing surgical procedures. | Ongoing; enrollment open | Kenya | Show Partners |
| LTFU | Clinical trial volunteer follow-up. | Enrollment open as trials conclude, follow up ongoing | Kenya Rwanda South Africa Uganda Zambia |
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| Protocol L | Assay characterization and immune responses among volunteers enrolled for sample provision | Over a dozen small studies have been initiated, completed or are in follow up | Kenya Rwanda Uganda United Kingdom Zambia |
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| Protocol A | Prevalence/cross-sectional study. 6,532 volunteers enrolled to estimate HIV prevalence at four sites. | Study completed | Kenya Uganda |
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| Protocol J | Prospective cohort, 45 volunteers enrolled at two research centers in Kenya. | Study completed | Kenya | Show Partners |
| Protocol M | Prospective mucosal sampling sub-study attached to IAVI-sponsored clinical trials, 89 volunteers enrolled. | Study completed | Kenya | Show Partners |
| Studies with adolescent girls and young women (AGYW) | Varies by need; often prospective cohort studies or cross sectional studies. Many include socio-behavioral research elements (e.g., focus group interviews). | Several cohort studies are underway and others are in development | Kenya South Africa Uganda Zambia |
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