CCTG 603: Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals (The iM-PrEPT Study)
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|ClinicalTrials.gov Identifier: NCT03086200|
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Patient Adherence HIV Seronegativity||Behavioral: brief Motivational Interviewing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CCTG 603: Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals (The iM-PrEPT Study)|
|Actual Study Start Date :||June 23, 2017|
|Estimated Primary Completion Date :||April 6, 2020|
|Estimated Study Completion Date :||April 6, 2021|
No Intervention: iTAB + SOC Control Arm
Participants will receive PrEP and standard of care (SOC) including health education, clinical assessments, laboratory safety monitoring, STI and HIV screening, HIV risk reduction counseling, assessment of psychosocial barriers, and adherence counseling. In addition to SOC, participants will receive daily text messages (iTAB) as reminders for medication adherence. Text messages will be setup during the Baseline visit in coordination with the participant's preferences.
Experimental: iTAB + MI-b Intervention Arm
Participants will receive the same PrEP, SOC procedures, and iTAB support as that of the Control Arm. Participants in the Intervention Arm will also receive brief motivational interviewing counseling sessions if adherence becomes suboptimal. Adherence will be monitored by responses to the iTAB system; if Intervention Arm participants reply with 3 consecutive negative or non-responses, MI-b counselors will perform 15-minute over-the-phone motivational interviewing counseling sessions with the participant.
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.
- PrEP Adherence [ Time Frame: Baseline up to Week 48 ]To compare adherence to fixed dose TDF/FTC, as measured by intracellular levels of TFV-DP > 1246 fmol/punch, between subjects randomized to receive iTAB with versus without brief Motivational Interviewing, when used for adherence support to pre-exposure prophylaxis among transgender individuals at elevated risk for HIV acquisition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086200
|Contact: Sheldon Morris, MD MPHfirstname.lastname@example.org|
|Contact: Eric E Ellorin, MASemail@example.com|
|United States, California|
|Los Angeles Lesbian, Gay, Bisexual, and Transgender Center||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Ali Talan firstname.lastname@example.org|
|Principal Investigator: Robert Bolan, MD|
|University of Southern California||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Connie Funk, RN 323-343-8282 email@example.com|
|Principal Investigator: Michael Dube, MD|
|Family Health Centers of San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Luis Salazar firstname.lastname@example.org|
|Principal Investigator: Joel Trambley, MD|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Leah Burke, MPH email@example.com|
|Principal Investigator: Sheldon Morris, MD MPH|
|LA Biomed at Harbor-UCLA||Recruiting|
|Torrance, California, United States, 90502|
|Contact: Ramiro Correa firstname.lastname@example.org|
|Principal Investigator: Katya Corado, MD|
|Study Chair:||Sheldon Morris, MD MPH||CCTG, UCSD AVRC|
|Study Chair:||David Moore, PhD||CCTG, UCSD HNRP|