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Botswana Combination Prevention Project

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01965470
Acronym
BCPP
Enrollment
Unknown
Registered
2013-10-18
Start date
2013-10-30
Completion date
2018-07-26
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

OTHERCombination Prevention

Sponsors

Botswana Harvard AIDS Institute Partnership
CollaboratorOTHER
Botswana Ministry of Health
CollaboratorOTHER_GOV
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Tebelopele Voluntary Counseling and Testing Center
CollaboratorUNKNOWN
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Population-level, cumulative HIV incidence3 yearsPopulation-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

MeasureTime frameDescription
2. Population-level uptake of HIV testing and counseling (HTC), ART, VL Suppression, male circumcision (MC), and PMTCT services3 yearsPopulation-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 averted3 years

Countries

Botswana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026