Botswana Combination Prevention Project (BCPP)
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|ClinicalTrials.gov Identifier: NCT01965470|
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : November 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: Combination Prevention Other: Enhanced Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Combination Prevention
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
- 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.
- 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 ]
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|Ages Eligible for Study:||16 Years to 64 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- Persons who do not meet inclusion criteria.
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
|Botswana communities and Botswana Ministry of Health clinics|
|Multiple Locations, Multiple, Botswana|
|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|
Documents provided by Centers for Disease Control and Prevention:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Centers for Disease Control and Prevention|
|Other Study ID Numbers:||
|First Posted:||October 18, 2013 Key Record Dates|
|Last Update Posted:||November 14, 2022|
|Last Verified:||November 2022|