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

NCT03142256 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

  • Adherence

Interventions

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

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.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Washington

    collaborator OTHER
  • Desmond Tutu HIV Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142256 on ClinicalTrials.gov