Skip to main content
OpenTrials
Completed

NCT Number: NCT01965470

Botswana Combination Prevention Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Botswana communities and Botswana Ministry of Health clinics

Multiple Locations, Multiple, Botswana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination Prevention

Other

Enhanced Care

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Cost per additional infection averted

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Botswana Harvard AIDS Institute Partnership
  • Botswana Ministry of Health
  • Harvard School of Public Health (HSPH)
  • Tebelopele Voluntary Counseling and Testing Center

Registry information

Official study 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

Acronym: BCPP

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2013
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.