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
  Purpose
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.

Condition Intervention Phase
HIV
Other: Combination Prevention
Other: Enhanced Care
Phase 4

Study Type: Interventional
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 #3) Implementation, Monitoring and Evaluation of Combination HIV Prevention Interventions in Rural and Peri-Urban Communities in Botswana

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Study Start Date: October 2013
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: Enhanced Care

  Eligibility

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965470

Locations
Botswana
Botswana communities and Botswana Ministry of Health clinics
Multiple, Botswana
Sponsors and Collaborators
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
Investigators
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
  More Information

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01965470     History of Changes
Other Study ID Numbers: CDC-CGH-6475 
Study First Received: October 16, 2013
Last Updated: October 9, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 27, 2016