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

NCT03086200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2021-09-13

No results posted yet for this study

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.

Conditions

  • Patient Adherence
  • HIV Seronegativity

Interventions

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.

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • Los Angeles LGBT Center

    collaborator OTHER

  • Family Health Centers of San Diego

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Sheldon Morris, MD MPH · CCTG, UCSD AVRC

  • David Moore, PhD · CCTG, UCSD HNRP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2020-09-30
Completion
2020-12-18

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086200 on ClinicalTrials.gov