Strengthening capacity of researchers in Uganda to conduct HIV treatment and prevention clinical trials in perinatal, paediatric, adolescent, and at risk populations including women and their partners - Project Summary: There has been steady progress over the past 3 decades in both HIV treatment and prevention based on clinical trials leading to major breakthroughs in pediatric and maternal HIV treatment; and HIV prevention among at-risk women and adolescent females. These include new interventions with long acting ARVs for both treatment and prevention. However, there are unique aspects to the conduct of HIV clinical trials in perinatal, pediatric, adolescent and at risk populations including regulatory/ethical considerations; counseling approaches; assessing safety, dose finding and pharmacokinetics of new HIV therapeutics in these populations; which require specific training and practicum experiences. The MU-JHU Research Collaboration/MU-JHU Care has over 30 years’ experience conducting HIV perinatal and pediatric treatment trials; and more recently, HIV prevention trials among at-risk adolescent and young women. Thus MU-JHU is well positioned to be a Centre of Excellence to train other Ugandan researchers/research teams to carry out HIV clinical trials in these populations; and to further strengthen its own research capacity, with doctoral level behavioral and biostatistics expertise. Toward the goals of training other Ugandan researches/research teams in conducting perinatal, pediatric and adolescent HIV treatment and prevention trials; and of increasing MU-JHU’s biostatistics and behavioral research capacity, MU-JHU proposes with this D43 application training program to serve as a training center to offer short term, and medium term didactic and practicum trainings; and support long term training addressing the unique aspects of conducting HIV perinatal, pediatric, adolescent and adult treatment/prevention clinical trials. The specific AIMS of this D43 application are: 1) Offer short term (<3 months) training to MU-JHU and other Ugandan research teams on the unique aspects of conducting HIV clinical trials among pregnant women, pediatric/ adolescents, at risk women and partners including ethic issues, pharmacokinetics/ safety and trial design. 2) Provide core didactic and practicum medium term 3-6month) training for MU-JHU and other Ugandan researchers on conducting HIV related clinical trials-- emphasizing the unique aspects of implementing trials in these populations. 3) Support long term training for doctoral degrees in biostatistics, pharmacology and behavioral topics relevant to perinatal, pediatric, and adolescent HIV prevention and treatment trials. 4) Provide postdoctoral fellowship research support to early career Ugandan investigators for research supporting HIV treatment and prevention studies among pregnant women, children, adolescents and at-risk women and their partners.
