Recruiting

Direct Distribution & Referral-Based Distribution

Sponsor:

University of Miami

Code:

NCT06927856

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Test-to-PrEP

Access by Referral

Study Details

Brief summary:

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.

Conditions

HIV Infections

Study ID

NCT06927856

Start date

Apr 10, 2025

Status verified date

Apr, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria - PrEP Clients (Egos):

  • Stated willingness to provide informed consent.
  • Stated willingness to comply with all study procedures.
  • Stated availability for the duration of the study.
  • Ability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
  • Currently prescribed PrEP by RAPID clinics, including those initiating PrEP on the same day as study enrollment.

Inclusion Criteria for Peers (Alters):

\- Provision of electronic informed consent prior to completion of the Quick Response (QR)-linked survey instruments.

Exclusion Criteria for PrEP Clients (Egos):

  • Inability or refusal to provide informed consent (e.g., cognitive impairment).
  • Unable or unwilling to comply with study procedures per study investigator
  • Inability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
  • Aged 17 years or younger.

Exclusion Criteria for Peers (Alters):

  • Failure to provide electronic informed consent prior to starting QR-linked Alter survey tools.
  • Age 17 years or younger.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Test-to-PrEP

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

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.

Primary outcome measure

  • Number of Alter participants per ego who use the HIV self-test kit [ Time Frame: Up to 6 months ]
  • Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Susanne Doblecki-Lewis, MD

3052434037SDoblecki@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Claudia Santos, MBA

305-243-9034csantos15@miami.edu

Stefani Butts, MPH

305243997sab321@med.miami.edu

Principal Investigator:

Susanne Dobleck-Lewis, MD

More Information

Sponsor

University of Miami

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-27.