Clinical trial NCT01965470: Botswana Combination Prevention Project
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Botswana Harvard AIDS Institute Partnership
name: Botswana Ministry of Health
name: Harvard School of Public Health (HSPH)
name: Tebelopele Voluntary Counseling and Testing Center
First posted: 2013-10-18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Population-level, cumulative HIV incidence
timeFrame: 3 years
Secondary outcomes:
measure: 2. Population-level uptake of HIV testing and counseling (HTC), ART, VL Suppression, male circumcision (MC), and PMTCT services
timeFrame: 3 years
measure: Cost per additional infection averted
timeFrame: 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: Botswana
facility: Botswana communities and Botswana Ministry of Health clinics
state: Multiple
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Janet S Moore, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Myron Essex, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Botswana Ministry of Health
name: Refeletswe Lebelonyane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Botswana Ministry of Health
name: Shenaaz El Halabi, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Botswana Harvard AIDS Institute Partnership
name: Joseph Makhema, MBChB, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Shahin Lockman, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Eric Tchetgen Tchetgen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Molly Pretorius Holme, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Pam Bachanas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Tafireyi Marukutira, MD
role: PRINCIPAL_INVESTIGATOR
References:
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