Clinical trial NCT06745947: Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals
Official title: Development of a Behavioral Economic Intervention to Improve HIV-related Behaviors Among Sexual Minority Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: HIV negative
Methamphetamine use
HIV PrEP medication
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm pilot randomized controlled trial
Primary purpose: PREVENTION

Brief summary: This research study is testing a new behavioral therapy called Episodic Future Thinking or EFT can help people reduce drug use and risky sexual behaviors while helping them adhere to their HIV prevention medication (PrEP). Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes counseling on HIV prevention, drug use reduction, and sexual health. The other group will receive standard care plus a new program called Episodic Future Thinking (EFT), where participants will think about and plan for their future goals using a mobile app and counseling sessions. Study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the EFT app.

Detailed description: Phase 1 of the study will involve a formative evaluation of the Episodic Future Thinking (EFT) intervention among (n=10) sexual minority individuals (SMIs) utilizing qualitative interviews. (This phase of the study data will not be reported on ClinicalTrials.gov, since it is not part of the randomized controlled trial).

Phase 2 of the study will utilize a two-arm pilot randomized controlled trial of Episodic Future Thinking plus standard of care (intervention) vs. standard of care only (control) condition to improved HIV-related behaviors (PrEP adherence, sexual risk behaviors and methamphetamine use) among sexual minority individuals.

Eligibility criteria: Inclusion Criteria:

* Adults 18 - 34 years of age
* HIV negative (assessed via Rapid HIV Antibody Test)
* Identify as gay, bisexual or transgender
* Recent (past 3 months) methamphetamine use
* Currently prescribed and taking HIV PrEP medication
* Self-reported HIV PrEP nonadherence in the past three months
* Urine screen test for PrEP nonadherence
* Self-reported condomless anal sex or a STI in the past three months
* Able to attend all study visits
* Fluent in English

Exclusion Criteria:

* Currently receiving treatment for any substance use disorder,
* HIV positive
* Having a medical or psychiatric illness that in the opinion of the PI would interfere with study participation
* Unable to provide informed consent
* Unable to attend protocol directed study visits
* Any plans that would preclude study completion (e.g. surgery, major medical treatments such as chemotherapy, incarceration, travel/moving out of San Antonio, Texas)

Primary outcomes:
measure: Dried Blood Spot Analysis for PrEP adherence
timeFrame: Day 1 to Day 180
measure: Urine Collection for Drug Screening
timeFrame: Day 1 to Day 180
measure: Urine Collection for Sexually Transmitted Infections (STIs)
timeFrame: Day 1 to Day 180
measure: Rectal Swab for STI testing
timeFrame: Day 1 to Day 180
measure: Pre-exposure Prophylaxis (PrEP) Related Intentions
timeFrame: Day 1 to Day 180
measure: PrEP Attitudes
timeFrame: Day 1 to Day 180
measure: PrEP Stigma
timeFrame: Day 1 to Day 180
measure: PrEP Self-efficacy
timeFrame: Day 1 to Day 180
Secondary outcomes:
measure: Rapid HIV test
timeFrame: Day 30 to Day 180
measure: Delayed Discounting
timeFrame: Day 1 to Day 180
measure: Demand
timeFrame: Day 1 to Day 180
measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-TR Self-rated Level 1
timeFrame: Day 1 to Day 180
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Day 1 to Day 180
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Emeka Okafor, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: