NCT03086200

Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals

CCTG 603: Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals (The iM-PrEPT Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence intervention (iTAB) improves adherence to PrEP among transgender persons.

Detailed description

A total of 300 HIV-uninfected transgender or gender non-conforming individuals, defined as currently identifying as a gender different from sex assigned at birth, with high-risk transmission behavior will be enrolled into this study. Each participant will be followed for a maximum of 48 weeks after enrollment. The primary endpoint will be measured at 48 weeks, or the last week on study if the participant is discontinued early. All participants will start PrEP with TDF / FTC fixed dose combination taken once daily. Subjects will be randomized (1:1) to the iTAB text messaging adherence reminder intervention either with or without brief motivational interviewing (MI-b) for suboptimal adherence. All participants will receive the iTAB system to provide personalized, automated text messages to support and monitor adherence. In the MI-b arm, poor adheres by iTAB reporting will receive targeted MI-b via telephone. Both groups will receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening.

Conditions

• Patient Adherence
• HIV Seronegativity

Interventions

Type	Name	Description
BEHAVIORAL	brief Motivational Interviewing	All study participants will receive daily dosing text message reminders. Participants randomized to the MI-b Intervention and who are persistently non-adherence based on negative or non-responses to iTAB will be sent automated high alert messages notifying the participant to take their study medication and respond to iTAB. Both the study coordinator and the MI counselor will also receive the high alert message. Participants will be contacted by the MI counselor for a phone MI-b session within 72 hours of a high alert message to discuss adherence. Participants who continue to be non-adherent despite receiving these messages will be switched to receive alert messages on a monthly schedule.

Timeline

• Start date: 2017-06-23
• Primary completion: 2020-09-30
• Completion: 2020-12-18
• First posted: 2017-03-22
• Last updated: 2021-09-13

Locations

5 sites across 1 country: United States