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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
Sponsor:
Collaborators:
University of Southern California
LA Biomed at Harbor-UCLA
The Los Angeles Lesbian, Gay, Bisexual, and Transgender Center
The Family Health Centers of San Diego
Information provided by (Responsible Party):
California Collaborative Treatment Group

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 22, 2017
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE June 23, 2017
Estimated Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03086200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CCTG 603: Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals (The iM-PrEPT Study)
Official Title  ICMJE CCTG 603: Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals (The iM-PrEPT Study)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Patient Adherence
  • HIV Seronegativity
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: brief Motivational Interviewing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 6, 2021
Estimated Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  1. any condomless anal or vaginal sex in the past 12 months
  2. any STI diagnosed or reported in the past 12 months
  3. 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

Exclusion Criteria:

  • 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
    • cisplatin
    • foscarnet
    • IV pentamidine
    • IV vancomycin
    • oral or IV gancyclovir
    • other agents with significant nephrotoxic potential
    • drugs that slow renal excretion
    • probenecid
    • immune system modulators
    • systemic chemotherapeutic agents (i.e. cancer treatment medications)
    • ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).
    • interleukin-2 (IL-2)
    • interferon (alpha, beta, or gamma)
    • other agent known to have a significant interaction with TDF or FTC
  • Proteinuria 2+ or greater by urine dipstick
  • Pregnancy (if individual has a uterus)
  • Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Transgender or Gender Non-conforming, defined as identifying with a gender different from sex assigned at birth.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sheldon Morris, MD MPH 619.543.8080 shmorris@ucsd.edu
Contact: Eric E Ellorin, MAS 619.543.5011 eellorin@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03086200
Other Study ID Numbers  ICMJE CCTG 603
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party California Collaborative Treatment Group
Study Sponsor  ICMJE California Collaborative Treatment Group
Collaborators  ICMJE
  • University of Southern California
  • LA Biomed at Harbor-UCLA
  • The Los Angeles Lesbian, Gay, Bisexual, and Transgender Center
  • The Family Health Centers of San Diego
Investigators  ICMJE
Study Chair: Sheldon Morris, MD MPH CCTG, UCSD AVRC
Study Chair: David Moore, PhD CCTG, UCSD HNRP
PRS Account California Collaborative Treatment Group
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP