Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

The University of Texas System (UT)

Status: Enrolling

Conditions: HIV Prevention

Treatments: Behavioral: EFT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06745947

STUDY00000869

R34DA060078 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18 - 34 years of age
• HIV negative (assessed via Rapid HIV Antibody Test)
• Identify as gay, or bisexual
• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Episodic Future Thinking App

Experimental group

Description:

EFT is a behavioral economic intervention designed to improve decision-making by reducing delay discounting and improving demand. The EFT intervention will be administered through a combination of in-person counseling sessions and mobile health (mHealth) technology via an app platform.

Treatment:

Behavioral: EFT

Control Group

No Intervention group

Description:

Standard of Care: The standard of care group will receive brief information and supportive counseling around PrEP adherence, methamphetamine use reduction and engaging in safe sexual behaviors. Participants will also receive counseling on a topic of concern identified by the participant.