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

NCT03086200 | Completed

• 1 other identifier: CCTG 603
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

PrEP; Pre-exposure Prophylaxis; Text messaging; Truvada; Motivational interviewing; Transgender; Gender Non-conforming

Outcome Measures

Primary Outcomes (1)

• PrEP Adherence

  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.

  Baseline up to Week 48

Study Arms (2)

iTAB + SOC Control Arm

NO INTERVENTION

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.

iTAB + MI-b Intervention Arm

EXPERIMENTAL

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

Interventions

brief Motivational Interviewing BEHAVIORAL

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.

iTAB + MI-b Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender or Gender Non-conforming, defined as identifying with a gender different from sex assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transgender identity, defined as identifying differently from sex assigned at birth
• Age 18 years or older
• Risk of acquisition of HIV as evident by one or more of the following:
• Has at least one HIV infected sexual partner for ≥4 weeks
• OR,
• Anticipated or concern of unprotected anal or vaginal sex with a partner in the next 3 months
• OR,
• Any partner in the past 12 months AND at least one of the following:
• any condomless anal or vaginal sex in the past 12 months
• any STI diagnosed or reported in the past 12 months
• exchange of money, gifts, shelter, or drugs for sex
• OR,
• PEP-use in the past 12 months
• Negative for HIV infection by nucleic acid test (NAT) or other sensitive method such as 4th generation antigen/antibody test
• Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula (eCcr (male) in mL/min = \[(140 - age in years) x (lean body weight in kg)\] / (72 x serum creatinine in mg/dL) in the past 30 days

You may not qualify if:

• Unable to give informed consent
• Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)
• Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by
• gastrointestinal condition that would impair absorption of study drugs
• known condition of reduce bone density (e.g. osteoporosis or osteogenesis imperfect) that significantly elevate the risk of bone fracture
• neurological or severe psychiatric condition that would significantly impair the ability to adhere to PrEP
• tubular or glomerular kidney disease that could be exacerbated by tenofovir
• other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP
• Suspected sensitivity or allergy to the study drug or any of its components
• Currently using an essential product or medication that interacts with the study drug such as the following:
• other antiretroviral agent (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors or investigational antiretroviral agents) - if currently on TDF/FTC for PEP or PrEP they can switch to study provided drug but can not continue any other antiretroviral agent
• agents with known nephrotoxic potential:
• aminoglycoside antibiotics (including gentamicin)
• IV amphotericin B
• cidofovir

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Southern California: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• Los Angeles LGBT Center: collaborator
• Family Health Centers of San Diego: collaborator

Study Sites (5)

Los Angeles Lesbian, Gay, Bisexual, and Transgender Center

Los Angeles, California, 90027, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Family Health Centers of San Diego

San Diego, California, 92103, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

LA Biomed at Harbor-UCLA

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sheldon Morris, MD MPH

  CCTG, UCSD AVRC

  PRINCIPAL INVESTIGATOR

• David Moore, PhD

  CCTG, UCSD HNRP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: June 23, 2017
• Primary Completion: September 30, 2020
• Study Completion: December 18, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)