Botswana Combination Prevention Project

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
  • Study Primary Completion Date: July 26, 2018

Interventions

  • Other: Combination Prevention
  • Other: Enhanced Care

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • Cost per additional infection averted
    • Time Frame: 3 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centers for Disease Control and Prevention
  • Collaborator
    • Botswana Harvard AIDS Institute Partnership
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janet S Moore, PhD, Principal Investigator, Centers for Disease Control and Prevention
    • Myron Essex, DVM, PhD, Principal Investigator, Harvard School of Public Health (HSPH)
    • Refeletswe Lebelonyane, MD, Principal Investigator, Botswana Ministry of Health
    • Shenaaz El Halabi, MPH, Principal Investigator, Botswana Ministry of Health
    • Joseph Makhema, MBChB, FRCP, Principal Investigator, Botswana Harvard AIDS Institute Partnership
    • Shahin Lockman, MD, MS, Principal Investigator, Harvard School of Public Health (HSPH)
    • Eric Tchetgen Tchetgen, PhD, Principal Investigator, Harvard School of Public Health (HSPH)
    • Molly Pretorius Holme, MS, Principal Investigator, Harvard School of Public Health (HSPH)
    • Pam Bachanas, PhD, Principal Investigator, Centers for Disease Control and Prevention
    • Tafireyi Marukutira, MD, Principal Investigator, Centers for Disease Control and Prevention

References

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Seatla KK, Maruapula D, Choga WT, Morerinyane O, Lockman S, Novitsky V, Kasvosve I, Moyo S, Gaseitsiwe S. Limited HIV-1 Subtype C nef 3'PPT Variation in Combination Antiretroviral Therapy Naive and Experienced People Living with HIV in Botswana. Pathogens. 2021 Aug 13;10(8):1027. doi: 10.3390/pathogens10081027.

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