Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06927856

The Test-to-PrEP Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Claudia Santos, MBA

CONTACT

[email protected]

305-243-9034

Stefani Butts, MPH

CONTACT

[email protected]

305243997 ext. Dobleck-Lewis

Susanne Dobleck-Lewis, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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 who use an HIV self-test kit, indicated by completion of the Post-Test Survey.

  2. Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP

    Time frame: Up to 6 months

    Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP

Secondary outcomes

  1. Number of Alters per ego initiating PrEP

    Time frame: Up to 6 months

    Number of Alters per ego initiating PrEP

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

    Time frame: Up to 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Susanne Doblecki-Lewis, MD

CONTACT

[email protected]

3052434037

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.