Botswana Combination Prevention Project

Phase 4

Completed

• Conditions: HIV
• Interventions: Other: Combination Prevention; Other: Enhanced Care

• Registration Number: NCT01965470
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-18
• Study Start: 2013-10-30
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Prevention	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.
Enhanced Care	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.

Primary Outcome Measures

Name	Time	Method
Population-level, cumulative HIV incidence	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 Outcome Measures

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

Trial Locations

Locations (1)

Botswana communities and Botswana Ministry of Health clinics; 🇧🇼 Multiple Locations, Multiple, Botswana