Recruiting

CM & MI

Sponsor:

Florida International University

Code:

NCT06637436

Conditions

HIV

Methamphetamine Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Motivational Interviewing (MI)

Contingency Management (CM)

Study Details

Brief summary:

This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via telehealth. Monthly follow-up assessments will be completed over 12 months to examine effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).

Conditions

HIV

Methamphetamine Disorders

Study ID

NCT06637436

Start date

Jan 28, 2025

Status verified date

May, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older
  • Assigned male a birth
  • Self-reported methamphetamine use in the past 3 months
  • HIV-negative or unknown serostatus at baseline
  • Has not filled a PrEP prescription in the past 6 months

Exclusion Criteria:

  • Unwilling or unable to provide informed consent

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Contingency Management

Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.

experimental: MI+CM

Two session MI counseling intervention delivered in the three months after randomization with CM.

Interventions

Motivational Interviewing (MI)

This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.

Contingency Management (CM)

Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.

Primary outcome measure

  • Proportion of Participants with Verified PrEP or ART Use [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Adam Carrico Professor, PhD

305-348-7887acarrico@fiu.edu

Locations

Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

Adam Carrico Professor, PhD

786-725-2034acarrico@fiu.edu

More Information

Sponsor

Florida International University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • HIV prevention
  • Methamphetamine
  • Motivational Interviewing
  • Contingency Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2026-05-07.