Botswana Combination Prevention Project (BCPP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Botswana Harvard Aids Institute
Botswana Ministry of Health
Harvard T.H. Chan School of Public Health
Tebelopele Voluntary Counseling and Testing Center
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01965470
First received: October 16, 2013
Last updated: October 9, 2015
Last verified: February 2015

October 16, 2013
October 9, 2015
October 2013
October 2018   (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 (MC), 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 ]
  • 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 #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
    • Scale-up of HTC services during 2 annual HTC campaigns, with a target of >90% of adults having documentation of their HIV-infected status or documentation of an HIV-negative test in the preceding 12 months.
    • Scale-up of ART for adults according to local standard of care (currently CD4≤350 cells/µL), or WHO Stage III/IV, with a target of >90% of these ART-eligible adults receiving ART.
    • Scale-up of expanded ART for adults (above and beyond the local standard of care): including persons with WHO stage I/II who have 351-500 cells/µL or who have CD4>500 cells/µ plus a viral load ≥10,000 copies/ml, with a target of >80% of these ART-eligible adults receiving ART.
    • Scale-up of MC service uptake, with a target of ensuring >80% of HIV-negative men are circumcised.
    • Strengthening of PMTCT services, with a target of >90% of women initiated on indefinite ART (Option B+) during pregnancy remaining in care and on treatment at 12 months post-delivery.
    Intervention: Other: Combination Prevention
  • Active Comparator: Enhanced Care
    Enhanced Care Communities will receive guidance and improved technical support for quality management and data systems 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 2018   (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 #3 - Expanded treatment cohort: HIV-infected persons in Combination Prevention communities who are not yet on ART, have CD4>350 cells/µL and WHO Stage I/II, 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
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT01965470
CDC-CGH-6475
Yes
Not Provided
Not Provided
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Botswana Harvard Aids Institute
  • Botswana Ministry of Health
  • Harvard T.H. Chan School of Public Health
  • Tebelopele Voluntary Counseling and Testing Center
Principal Investigator: Janet S Moore, PhD Centers for Disease Control and Prevention
Principal Investigator: Myron Essex, DVM, PhD Harvard School of Public Health
Principal Investigator: Refeletswe Lebelonyane, MD Botswana Ministry of Health
Principal Investigator: Shenaaz El Halabi, MPH Botswana Ministry of Health
Principal Investigator: Joseph Makhema, MBChB, FRCP Botswana Harvard Aids Institute
Principal Investigator: Shahin Lockman, MD, MS Harvard T.H. Chan School of Public Health
Principal Investigator: Eric Tchetgen Tchetgen, PhD Harvard T.H. Chan School of Public Health
Principal Investigator: Molly Pretorius Holme, MS Harvard T.H. Chan School of Public Health
Principal Investigator: Lisa Mills, MD Centers for Disease Control and Prevention
Principal Investigator: Pam Bachanas, PhD Centers for Disease Control and Prevention
Principal Investigator: Tafireyi Marukutira, MD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
February 2015

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