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3Ps for Prevention Study (Perception, Partners, Pills) (3P)

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ClinicalTrials.gov Identifier: NCT03142256
Recruitment Status : Unknown
Verified February 2019 by Desmond Tutu HIV Centre.
Recruitment status was:  Active, not recruiting
First Posted : May 5, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
National Institute of Mental Health (NIMH)
University of Washington
Information provided by (Responsible Party):
Desmond Tutu HIV Centre

Brief Summary:
This study has two phases. It will be conducted in one site in CT only. Phase I is to enumerate interest in PrEP uptake among young South African women exposed to a culturally-appropriate social marketing campaign. This enumeration will also serve as a recruitment strategy for a cohort with open-label PrEP access in Phase II. The cohort will assess PrEP acceptability and adherence among 200 HIV-uninfected young women who are offered open-label daily oral PrEP and randomized to receive or not receive a short term cash incentive conditional on study drug adherence.

Condition or disease Intervention/treatment Phase
Adherence Behavioral: Incentivised - Conditional Cash Transfer Drug: Truvada 200Mg-300Mg Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Prospective Cohort Evaluation of Uptake and Adherence to PrEP in Young South African Women
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
Active Comparator: Incentivised - Conditional Cash Transfer
Cash incentive for good drug levels assed by Dried Blood Spot
Behavioral: Incentivised - Conditional Cash Transfer
Participant will be randomized to receive a cash transfer conditional on drug levels at months 1, 2, and 3 versus no cash transfer
Other Name: Truvada 200Mg-300Mg Tablet

Drug: Truvada 200Mg-300Mg Tablet
Both study arms will be offered Truvada as PrEP. Only one arm will be randomized to the conditional cash transfer.
Other Name: Incentivised - Conditional Cash Transfer

No Intervention: No incentive
Truvada 200Mg-300Mg Tablet



Primary Outcome Measures :
  1. Drug adherence [ Time Frame: 3 months ]
    200 women measuring cash incentive for drug adherence with half the Cohort



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female at birth
  • HIV uninfected at screening and enrollment
  • Age 16-25 years old at screening, inclusive
  • Per participant report, sexually active, defined as having vaginal or anal intercourse with a male partner at least once in the month prior to screening
  • Willing and able to provide informed consent
  • Able and willing to provide adequate locator information

Exclusion Criteria:

  • Not planning to be in the area for periods longer than a month in the first three months and longer than 3 months from Month 3 - 12
  • A positive HIV test at Enrollment, even if subsequent testing indicates that the person is HIV-1 uninfected
  • Renal dysfunction (Creatinine Clearance <60 mL/min, Cockroft Gault equation)
  • Previous participation in an oral PrEP study

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): NCT03142256


Locations
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South Africa
Desmond Tutu HIV Foundation
Cape Town, Western Cape, South Africa, 7975
Desmond Tutu HIV Centre
Cape Town, South Africa
Sponsors and Collaborators
Desmond Tutu HIV Centre
Bill and Melinda Gates Foundation
National Institute of Mental Health (NIMH)
University of Washington
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Desmond Tutu HIV Centre
ClinicalTrials.gov Identifier: NCT03142256    
Other Study ID Numbers: 3P
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents