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Recruiting NCT06745947

Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

No phase Interventional HIV Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EFT.
Who it may be relevant to
Registry conditions: HIV Prevention. Basic parameters: 18 years — 34 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Development of a Behavioral Economic Intervention to Improve HIV-related Behaviors Among Sexual Minority Individuals

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • Dried Blood Spot Analysis for PrEP adherence [Time frame: Day 1 to Day 180]
  • Urine Collection for Drug Screening [Time frame: Day 1 to Day 180]
  • Urine Collection for Sexually Transmitted Infections (STIs) [Time frame: Day 1 to Day 180]
  • Rectal Swab for STI testing [Time frame: Day 1 to Day 180]
  • Pre-exposure Prophylaxis (PrEP) Related Intentions [Time frame: Day 1 to Day 180]
  • PrEP Attitudes [Time frame: Day 1 to Day 180]
  • PrEP Stigma [Time frame: Day 1 to Day 180]
  • PrEP Self-efficacy [Time frame: Day 1 to Day 180]
Secondary outcome measures (5)
  • Rapid HIV test [Time frame: Day 30 to Day 180]
  • Delayed Discounting [Time frame: Day 1 to Day 180]
  • Demand [Time frame: Day 1 to Day 180]
  • Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-TR Self-rated Level 1 [Time frame: Day 1 to Day 180]
  • Generalized Anxiety Disorder Screener (GAD-7) [Time frame: Day 1 to Day 180]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Texas Health Science Center at San Antonio — San Antonio

Identifiers

NCT: NCT06745947 · STUDY00000869 · R34DA060078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗