The Test-to-PrEP Study

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06927856
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Test-to-PrEP — BEHAVIORAL
    Participants, called Egos, will come once to the clinic throughout the duration of the study, for up to 1 hour. During the visit, participants will receive up to 4 Test-to-PrEP Packs, which include an HIV self-test kit and HIV prevention education materials and a brief (approximately 15 minutes) training. The training includes instructions on how to initiate conversations related to HIV, HIV testing, and HIV prevention, as well as proper handling of the HIV self-test kit. Participants are asked to distribute the Test-to-PrEP Packs to Social Network Contacts (peers), called Alters.
  • Access by Referral — BEHAVIORAL
    Participants, called Egos, will receive up to 4 Access by Referral Cards once. Participants will receive a brief (approximately 15 minutes) training. The training includes instructions on how to initiate conversations related to HIV, HIV testing, and HIV prevention, as well as proper handling of the HIV self-test kit. Participants are asked to distribute the Access by Referral Cards to Social Network Contacts (peers), also called Alters. The Referral Card can be used to order a Test-to-PrEP Pack, including the HIV self-test and HIV prevention education material, that will be mailed to an address of the Alter's choice.

Study Details

To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.

Key Dates

Start date
Apr 10, 2025
Status verified
Apr 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Test-to-PrEP group
    Participants in this group will receive the Test-to-PrEP intervention for up to 1 year
  • Experimental: Access by Referral group
    Participants in this group will receive the Access by Referral intervention for up to 1 year

Primary Outcome Measure

Number of Alter participants per ego who use the HIV self-test kit [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Claudia Santos, MBA
[email protected]
305-243-9034
Stefani Butts, MPH
[email protected]
305243997
Susanne Dobleck-Lewis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
HIV
By specialty
Infectious disease
By research site
University of Miami· Miami, FL

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