The Test-to-PrEP Study

NCT06927856 | Recruiting

• 2 other identifiers: 20240478R01MH138190-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Alters per ego initiating PrEP

  Up to 6 months

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

  Up to 6 months

Study Arms (2)

Test-to-PrEP group

EXPERIMENTAL

Participants in this group will receive the Test-to-PrEP intervention for up to 1 year

Behavioral: Test-to-PrEP

Access by Referral group

EXPERIMENTAL

Participants in this group will receive the Access by Referral intervention for up to 1 year

Behavioral: Access by Referral

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.

Test-to-PrEP group

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.

Access by Referral group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Susanne Dobleck-Lewis, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Doblecki-Lewis, MD

CONTACT

3052434037; SDoblecki@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)