The Test-to-PrEP Study

University of Miami320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

320

Conditions

HIV Infections

Interventions

Test-to-PrEPBEHAVIORAL

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 ReferralBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Number of Alter participants per ego who use the HIV self-test kit

Number of Alter participants per ego who use an HIV self-test kit, indicated by completion of the Post-Test Survey.

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

Secondary Outcomes

Number of Alters per ego initiating PrEP

Time frame: Up to 6 months

Alters' self-reported PrEP knowledge as indicated by the Post-Test Survey.

Scores on Post-Test Survey range from 0-100. Higher scores indicate higher PrEP knowledge.

Time frame: Up to 6 months

Central Contacts

Susanne Doblecki-Lewis, MD

CONTACT

3052434037 SDoblecki@med.miami.edu

Data from ClinicalTrials.gov

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