Botswana Combination Prevention Project (BCPP)

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Other: Enhanced Care; Other: Combination Prevention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01965470

CDC-CGH-6475

Details and patient eligibility

About

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.

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Combination Prevention

Experimental group

Description:

* 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.

Treatment:

Other: Combination Prevention

Enhanced Care

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced Care