The Test-to-PrEP Study

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

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 Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Test-to-PrEP; Behavioral: Access by Referral

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Doblecki-Lewis, MD; Phone Number: 3052434037; Email: SDoblecki@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Stefani Butts, MPH; Phone Number: Dobleck-Lewis 305243997; Email: sab321@med.miami.edu
      • Contact: Claudia Santos, MBA; Phone Number: 305-243-9034; Email: csantos15@miami.edu
      • Principal Investigator: Susanne Dobleck-Lewis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test-to-PrEP group; Participants in this group will receive the Test-to-PrEP intervention for up to 1 year	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 to distribute the Test-to-PrEP Packs to Social Network Contacts (peers), called Alters.
Experimental: Access by Referral group; Participants in this group will receive the Access by Referral intervention for up to 1 year	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, including the HIV self-test and HIV prevention education material, that will be mailed to an address of the Alter's choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP	Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Alters per ego initiating PrEP	Number of Alters per ego initiating PrEP	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.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Susanne Dobleck-Lewis, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 20240478; R01MH138190-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No