Botswana Combination Prevention Project (BCPP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Botswana-Harvard AIDS Institute Partnership
Botswana Ministry of Health
Harvard School of Public Health
Tebelopele
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01965470
First received: October 16, 2013
Last updated: October 31, 2013
Last verified: October 2013

October 16, 2013
October 31, 2013
October 2013
October 2016   (final data collection date for primary outcome measure)
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, cumulative HIV incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01965470 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Population-level uptake of HIV testing and counseling (HTC), ART, male circumcision, and PMTCT services [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Botswana Combination Prevention Project
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
HIV
  • Other: Combination Prevention
  • Other: Enhanced Care
  • Experimental: Combination Prevention
    • Rapid scale-up of HTC services during two annual HTC campaigns, with a target of ensuring >90% of adults aged 16-64 have documentation of their HIV-infected status or documentation of an HIV-negative test in the preceding 12 months.
    • Rapid scale-up of ART for adults with CD4≤350 cells/µL, or WHO Stage III/IV, with a target of ensuring that >90% of these ART-eligible adults are receiving ART.
    • Rapid scale-up of ART for adults with a viral load ≥10,000 copies/ml, CD4>350, and WHO Stage I/II with a target of ensuring that >80% of these ART-eligible adults are receiving ART.
    • Rapid scale-up of male circumcision service uptake, with a target of ensuring >80% of HIV-negative men (aged 16-49) are circumcised.
    • Rapid scale-up of PMTCT services, with a target of ensuring >90% of pregnant women with HIV receive recommended PMTCT antiretrovirals before 28 weeks gestation, and >90% continue ART indefinitely after starting ART for PMTCT if otherwise ineligible for treatment.
    Intervention: 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.
    Intervention: Other: Enhanced Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
Not Provided
Not Provided
October 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Protocol #1 - Baseline Household Survey (BHS): Permanent or part-time study community resident in any of the 30 study communities; Botswana citizen or spouse of a Botswana citizen; able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).
  • Protocol #2 - Closed clinical cohort: Eligible household members identified during the initial year BHS who are permanent study community residents, intend to be permanent study community residents for the next 12 months, with HIV-1 infection, CD4 >350 cells/µL and WHO State I/II, ART naïve, and able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).
  • Protocol #3 - Expanded treatment cohort: HIV-infected persons in Combination Prevention communities identified after the initial BHS who are not yet on ART, have CD4>350 cells/µL and WHO Stage I/II, and 1) have HIV-1 RNA>10,0000 copies/mL or 2) are pregnant, and are able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).

Exclusion Criteria:

  • Persons who do not meet inclusion criteria.
Both
16 Years to 64 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT01965470
CDC-CGH-6475
Yes
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Botswana-Harvard AIDS Institute Partnership
  • Botswana Ministry of Health
  • Harvard School of Public Health
  • Tebelopele
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
Centers for Disease Control and Prevention
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP