The Test-to-PrEP Study

Official title

Test-to-PrEP: A Randomized Hybrid Implementation/Effectiveness Trial of a Social Network Strategy to Increase Equitable Reach of HIV Testing and PrEP Information

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.

Interventions

• Behavioral 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
• Behavioral 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

Primary outcome measures

• 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]

Secondary outcome measures (2)

• 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. [Time frame: Up to 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Miami — Miami

Identifiers

NCT: NCT06927856 · 20240478 · R01MH138190-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗