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
  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 #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

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, 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)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
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 #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.
  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
Botswana-Harvard AIDS Institute Partnership
Botswana Ministry of Health
Harvard School of Public Health
Tebelopele
Investigators
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
  More Information

No publications provided

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 31, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on August 28, 2014