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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06927856
Enrollment
320
Registered
2025-04-15
Start date
2025-04-10
Completion date
2028-07-01
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

BEHAVIORALTest-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.

BEHAVIORALAccess 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.

Sponsors

University of Miami
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Alter participants per ego who use the HIV self-test kitUp to 6 monthsNumber of Alter participants per ego who use an HIV self-test kit, indicated by completion of the Post-Test Survey.
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEPUp to 6 monthsNumber of Alter participants per ego using an HIV self-test who meet criteria for PrEP

Secondary

MeasureTime frameDescription
Number of Alters per ego initiating PrEPUp to 6 monthsNumber of Alters per ego initiating PrEP
Alters' self-reported PrEP knowledge as indicated by the Post-Test Survey.Up to 6 monthsScores on Post-Test Survey range from 0-100. Higher scores indicate higher PrEP knowledge.

Countries

United States

Contacts

CONTACTSusanne Doblecki-Lewis, MD
SDoblecki@med.miami.edu3052434037
PRINCIPAL_INVESTIGATORSusanne Dobleck-Lewis, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026