The PrEP (Pre-exposure Prophylaxis) SMART Study

Sponsor
University of Washington
Study ID
NCT04038060
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • WhatsApp Group — BEHAVIORAL
    Participants will receive peer adherence support through WhatsApp groups
  • 2-way SMS — BEHAVIORAL
    Participants will receive healthcare worker adherence support through 2-way SMS
  • Drug level feedback — BEHAVIORAL
    Participants will receive adherence counseling based on tenofovir drug levels
  • Monthly counseling sessions — BEHAVIORAL
    Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence

Study Details

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.

Key Dates

Start date
May 16, 2019
Status verified
Apr 2025
Primary completion
Oct 27, 2021
Completion
Jan 25, 2022

Study Design

Enrollment
360 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: WhatsApp Group
    Participants will be assigned to participate in a WhatsApp Group
  • Experimental: 2-way SMS
    Participants will be assigned to receive weekly 2-way SMS initiated by the study team
  • Experimental: 2-way SMS and monthly counseling sessions
    Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
  • Experimental: 2-way SMS and drug level feedback
    Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
  • Experimental: WhatsApp Group and monthly counseling sessions
    Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
  • Experimental: WhatsApp Group and drug level feedback
    Participants will be assigned to participate in a WhatsApp Group and drug level feedback

Primary Outcome Measure

PrEP Adherence [ Time Frame: 9 months ]

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