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Botswana Combination Prevention Project (BCPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965470
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : November 14, 2022
Sponsor:
Collaborators:
Botswana Harvard AIDS Institute Partnership
Botswana Ministry of Health
Harvard School of Public Health (HSPH)
Tebelopele Voluntary Counseling and Testing Center
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Other: Combination Prevention Other: Enhanced Care Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
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
Actual Study Start Date : October 30, 2013
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Combination Prevention
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.
 Other: Enhanced Care


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Cost per additional infection averted [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965470


Locations
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Botswana
Botswana communities and Botswana Ministry of Health clinics
Multiple Locations, Multiple, Botswana
Sponsors and Collaborators
Centers for Disease Control and Prevention
Botswana Harvard AIDS Institute Partnership
Botswana Ministry of Health
Harvard School of Public Health (HSPH)
Tebelopele Voluntary Counseling and Testing Center
Investigators
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Principal Investigator: Janet S Moore, PhD Centers for Disease Control and Prevention
Principal Investigator: Myron Essex, DVM, PhD Harvard School of Public Health (HSPH)
Principal Investigator: Refeletswe Lebelonyane, MD Botswana Ministry of Health
Principal Investigator: Shenaaz El Halabi, MPH Botswana Ministry of Health
Principal Investigator: Joseph Makhema, MBChB, FRCP Botswana Harvard AIDS Institute Partnership
Principal Investigator: Shahin Lockman, MD, MS Harvard School of Public Health (HSPH)
Principal Investigator: Eric Tchetgen Tchetgen, PhD Harvard School of Public Health (HSPH)
Principal Investigator: Molly Pretorius Holme, MS Harvard School of Public Health (HSPH)
Principal Investigator: Pam Bachanas, PhD Centers for Disease Control and Prevention
Principal Investigator: Tafireyi Marukutira, MD Centers for Disease Control and Prevention
  Study Documents (Full-Text)

Documents provided by Centers for Disease Control and Prevention:
Study Protocol  [PDF] January 16, 2019

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01965470    
Other Study ID Numbers: CDC-CGH-6475
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022