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Patient AdherenceNCT03086200

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

A study testing brief Motivational Interviewing in people with Patient Adherence and HIV Seronegativity, run by University of California, San Diego at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Patient Adherence, HIV Seronegativity
What is being tested?
brief Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
263 participants
Where
5 sitesUnited States
Study dates
23 Jun 2017to 18 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Los Angeles Lesbian, Gay, Bisexual, and Transgender Center

    Los Angeles, California, 90027

  • University of Southern California

    Los Angeles, California, 90033

  • Family Health Centers of San Diego

    San Diego, California, 92103

  • University of California, San Diego

    San Diego, California, 92103

  • LA Biomed at Harbor-UCLA

    Torrance, California, 90502

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
brief Motivational Interviewing
Keywords
PrEP, Pre-exposure Prophylaxis, Text messaging, Truvada, Motivational interviewing, Transgender, Gender Non-conforming
Medical subject headings
Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brief Motivational InterviewingBehavioural

    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 groups in NCT03086200
Study groupRoleWhat they receive
iTAB + SOC Control ArmNo interventionParticipants 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 ArmExperimentalParticipants 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.
Receives: Behavioral: brief Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study start23 Jun 2017
  3. Primary completion30 Sep 2020
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086200
Sponsor's protocol ID
CCTG 603
Status last verified
Sep 2021
First submitted
16 Mar 2017
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing brief Motivational Interviewing in people with Patient Adherence and HIV Seronegativity, run by University of California, San Diego at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP Adherence (time frame: Baseline up to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03086200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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