The Test-to-PrEP Study

University of Miami

Status: Enrolling

Conditions: HIV Infections

Treatments: Behavioral: Access by Referral; Behavioral: Test-to-PrEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06927856

20240478

R01MH138190-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Test-to-PrEP group

Experimental group

Description:

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

Treatment:

Behavioral: Test-to-PrEP

Access by Referral group

Experimental group

Description:

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

Treatment:

Behavioral: Access by Referral