Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

NCT ID: NCT06745947

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2027-07-01

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.

Conditions

HIV Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Episodic Future Thinking App

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.

Group Type: EXPERIMENTAL

EFT

Intervention Type: BEHAVIORAL

Participants who meet the eligibility criteria will receive the EFT intervention, a cognitive training exercise designed to help them generate and visualize future events or goals. The intervention will be administered individually, in person, by a trained counselor

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EFT

Participants who meet the eligibility criteria will receive the EFT intervention, a cognitive training exercise designed to help them generate and visualize future events or goals. The intervention will be administered individually, in person, by a trained counselor

Intervention Type: BEHAVIORAL

Other Intervention Names

Episodic Future Thinking

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Chukwuemeka Okafor

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emeka Okafor, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emeka Okafor, PhD, MPH

Role: CONTACT

okaforcn@uthscsa.edu

210-450-7377

Facility Contacts

Chukwuemeka N Okafor, PhD, MPH

Role: primary

Other Identifiers

R34DA060078

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000869

Identifier Type: -

Identifier Source: org_study_id