NCT06927856 · University of Miami
The Test-to-PrEP Study
What this study is about
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.
View original scientific description
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 to distribute the Test-to-PrEP Packs to Social Network Contacts (peers), called Alters.
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.
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 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 PrEP
Time frame: Up to 6 months
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations