Botswana Combination Prevention Project (BCPP)

November 9, 2022 updated by: Centers for Disease Control and Prevention

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 to all participants, regardless of CD4 count or HIV disease severity, 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
    • Multiple
      • Multiple Locations, Multiple, Botswana
        • Botswana communities and Botswana Ministry of Health clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 64 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 universal ART for all HIV-infected adults, with a target of >93% of HIV positive adults receiving ART.
  • Scale-up of retention in care and adherence interventions, with a target of ensuring that >95% of HIV-infected adults are virally suppressed with HIV-1 RNA <400 copies per ML..
  • Scale-up of linkage to MC services, with a target of ensuring >60% of HIV-negative men are circumcised.
  • Rapid 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Population-level, cumulative HIV incidence
Time Frame: 3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. Population-level uptake of HIV testing and counseling (HTC), ART, VL Suppression, male circumcision (MC), and PMTCT services
Time Frame: 3 years
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.
3 years
Cost per additional infection averted
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Harvard School of Public Health (HSPH)
Botswana Harvard AIDS Institute Partnership
Botswana Ministry of 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 (HSPH)
  • 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 Partnership
  • Principal Investigator: Eric Tchetgen Tchetgen, PhD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Molly Pretorius Holme, MS, Harvard School of Public Health (HSPH)
  • Principal Investigator: Pam Bachanas, PhD, Centers for Disease Control and Prevention
  • Principal Investigator: Tafireyi Marukutira, MD, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2013

Primary Completion (ACTUAL)

July 26, 2018

Study Completion (ACTUAL)

July 26, 2018

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (ESTIMATE)

October 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CDC-CGH-6475

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Clinical Trials on Combination Prevention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe