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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2022 |
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Main ID: |
NCT01965470 |
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Date of registration:
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16/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Botswana Combination Prevention Project
BCPP |
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Scientific title:
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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 |
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Date of first enrolment:
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October 30, 2013 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01965470 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention.
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Phase:
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Phase 4
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Countries of recruitment
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Botswana
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Contacts
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Name:
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Eric Tchetgen Tchetgen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harvard School of Public Health (HSPH) |
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Name:
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Janet S Moore, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centers for Disease Control and Prevention |
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Name:
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Myron Essex, DVM, PhD |
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Address:
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Email:
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Affiliation:
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Harvard School of Public Health (HSPH) |
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Name:
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Shahin Lockman, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harvard School of Public Health (HSPH) |
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Name:
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Joseph Makhema, MBChB, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Botswana Harvard AIDS Institute Partnership |
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Name:
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Shenaaz El Halabi, MPH |
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Address:
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Email:
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Affiliation:
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Botswana Ministry of Health |
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Name:
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Tafireyi Marukutira, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centers for Disease Control and Prevention |
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Name:
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Refeletswe Lebelonyane, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Botswana Ministry of Health |
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Name:
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Pam Bachanas, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centers for Disease Control and Prevention |
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Name:
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Molly Pretorius Holme, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harvard School of Public Health (HSPH) |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Other: Combination Prevention
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Other: Enhanced Care
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Primary Outcome(s)
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Population-level, cumulative HIV incidence
[Time Frame: 3 years]
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Secondary Outcome(s)
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2. Population-level uptake of HIV testing and counseling (HTC), ART, VL Suppression, male circumcision (MC), and PMTCT services
[Time Frame: 3 years]
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Cost per additional infection averted
[Time Frame: 3 years]
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Secondary ID(s)
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CDC-CGH-6475
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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