Botswana Combination Prevention Project (BCPP)
The BCPP study is designed to test the hypothesis that implementing an enhanced combination prevention package which includes provision of ART as prevention for HIV-infected individuals with HIV-1 RNA ≥10,000 copies/ml will impact the HIV/AIDS epidemic by significantly reducing population-level, cumulative HIV incidence in a defined geographic area over a period of 3 years and will be cost-effective.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Botswana Combination Prevention Project: -Evaluation Protocol (Protocol #1): Research Design and Impact Evaluation -Closed Clinical Cohort Protocol (Protocol #2): Estimating Risks and Benefits for HIV-Infected Adults of Early Initiation of Antiretroviral Therapy at CD4>350 Cells/µl if Viral Load is ≥10,000 Copies/mL: A Cluster-Randomized Trial -Intervention Protocol (Protocol #3) Implementation, Monitoring and Evaluation of Combination HIV Prevention Interventions in Rural and Peri-Urban Communities in Botswana|
- Population-level, cumulative HIV incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]Population-level cumulative HIV incidence will be measured in a cohort of HIV-negative persons identified from a 20% sample of eligible households in the 30 study communities followed annually.
- Population-level uptake of HIV testing and counseling (HTC), ART, male circumcision, and PMTCT services [ Time Frame: 3 years ] [ Designated as safety issue: No ]Population-level uptake of each intervention will be measured in an annual survey of the 20% sample of eligible households in the 30 study communities and through analysis of routine program monitoring data.
- Cost per additional infection averted [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Clinical outcomes for initially ART-naïve, HIV-infected adults, with CD4>350 cells/µL and WHO Stage I/II [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Safety of ART for combination prevention community residents who start ART due to a high viral load (VL≥10,000 copies/ml) when baseline CD4 is >350 cells/µL and WHO Stage is I/II, or who continue ART following PMTCT (Option B+) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Combination Prevention
||Other: Combination Prevention|
Active Comparator: Enhanced Care
Enhanced Care Communities will receive enhancements and improved support for clinical and laboratory data information systems and supply chain management at all local clinics at which individuals receive HIV care and treatment.
|Other: Enhanced Care|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01965470
|Botswana communities and Botswana Ministry of Health clinics|
|Study Director:||Janet S Moore, PhD||Centers for Disease Control and Prevention|
|Study Director:||William C Levine, MD, MSc||Centers for Disease Control and Prevention|
|Principal Investigator:||Myron Essex, DVM, PhD||Harvard School of Public Health|
|Principal Investigator:||Victor DeGruttola, SM, ScD||Harvard School of Public Health|
|Principal Investigator:||Refeletswe Lebelonyane, MD||Botswana Ministry of Health|
|Principal Investigator:||Shenaaz El Halabi, MPH||Botswana Ministry of Health|