Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

NCT06745947 | Recruiting DMC

• 2 other identifiers: STUDY00000869R34DA060078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Keywords

HIV negative; Methamphetamine use; HIV PrEP medication

Outcome Measures

Primary Outcomes (8)

• Dried Blood Spot Analysis for PrEP adherence

  Blood spots will be collected and assessed for PrEP adherence. Number of subjects adhering to PrEP will be reported.

  Day 1 to Day 180

• Urine Collection for Drug Screening

  Urine will be tested for drug screening. Number of subjects that result in a negative drug screening will be reported.

  Day 1 to Day 180

• Urine Collection for Sexually Transmitted Infections (STIs)

  Urine will be tested for STIs. Number of subjects that test negative for STIs will be reported.

  Day 1 to Day 180

• Rectal Swab for STI testing

  A rectal swab will be obtained for STI. Number of subjects that test negative for STIs will be reported.

  Day 1 to Day 180

• Pre-exposure Prophylaxis (PrEP) Related Intentions

  A 3-item scale to measure PrEP-related intentions (e.g., "During the next three months, I will talk to a health care provider about PrEP"; "During the next three months, I will seek out more information about PrEP" and "During the next three months, I will get a prescription for PrEP"). Response options will be 1 = No, definitely not; 2 = No, probably not; 3 = Yes, probably and 4=Yes, definitely. A total range of scores is 3-12 with a higher score indication a greater intention of taking preventative measures.

  Day 1 to Day 180

• PrEP Attitudes

  A 5-item scale to evaluate attitudes regarding PrEP use (e.g., "People who take PrEP are responsible"; "Taking PrEP is safe"). Response options will range from 1=strongly disagree to 5=strongly agree. Total scores will range between 5 and 25, with higher scores indicating more favorable attitudes toward PrEP use.

  Day 1 to Day 180

• PrEP Stigma

  A 5-item scale to assess PrEP stigma (e.g., "People who take PrEP are promiscuous"). Responses will be on a 5-point scale, ranging from 1=strongly disagree to 5=strongly disagree. The total range of scores is 5-25, where higher scores denote greater stigma associated with PrEP.

  Day 1 to Day 180

• PrEP Self-efficacy

  Participants will self-report the level of difficulty they anticipate in performing 8 behaviors associated with PrEP use (e.g., "How difficult would it be for you to seek out more information about PrEP to decide if it is right for you?"). Responses will be on a scale from 1=very hard to do to 4=very easy to do. Total scores range from 8-32, where higher scores suggest higher levels of self-efficacy.

  Day 1 to Day 180

Secondary Outcomes (5)

• Rapid HIV test

  Day 30 to Day 180

• Delayed Discounting

  Day 1 to Day 180

• Demand

  Day 1 to Day 180

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-TR Self-rated Level 1

  Day 1 to Day 180

• Generalized Anxiety Disorder Screener (GAD-7)

  Day 1 to Day 180

Study Arms (2)

Episodic Future Thinking App

EXPERIMENTAL

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.

Behavioral: EFT

Control Group

NO INTERVENTION

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.

Interventions

EFT 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

Also known as: Episodic Future Thinking

Episodic Future Thinking App

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: The proposed research will specifically target sexual minority individuals (SMI) for recruitment including individuals who are cisgender and transgender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

• Emeka Okafor, PhD, MPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emeka Okafor, PhD, MPH

CONTACT

210-450-7377; okaforcn@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Although it is not possible to fully blind participants due to the nature of the EFT intervention, research staff responsible for outcome assessments (e.g., PrEP adherence, methamphetamine use, and sexual risk behaviors) will be blinded to the participants' group assignment to minimize assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A two-arm pilot randomized controlled trial

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 20, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Summary results will be published through ClinicalTrials.gov and the study results will be published in a peer review journal after study completion and data analysis.

Locations

US (1)