Behavioral Economic Intervention for HIV Prevention in Sexual Minority Individuals

This study is testing a new behavioral therapy called Episodic Future Thinking (EFT) to see if it can help young adults (ages 18-34) who identify as gay or bisexual, use methamphetamine, and have had trouble taking their HIV prevention medication (PrEP). You would need to be HIV-negative, currently taking PrEP, and have reported not taking it regularly in the past three months. The study will compare standard care, which includes counseling on HIV prevention and sexual health, with standard care plus the EFT program. EFT involves using a mobile app and counseling to help you think about and plan for your future goals. Success in this study will be measured by how well participants take their PrEP medication, and by checking for drug use and sexually transmitted infections (STIs) over 180 days. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It is a pilot randomized controlled trial with two groups: one receiving standard care and the other receiving standard care plus the EFT intervention.
What's involved
You would fill out surveys, provide blood, urine, and swab samples for testing, and use the EFT app if you are in that group. These procedures would occur over 180 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 180 days, with PrEP adherence, drug screening, and STI testing measured at Day 1 to Day 180.

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NCT06745947

Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

Recruiting
NAAges 18–34InterventionalPrevention
The University of Texas Health Science Center at San Antonio
~60 participants
Updated 2025-06-22 on ClinicalTrials.gov
What's tested:EFT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dried Blood Spot Analysis for PrEP adherence
Measured over Day 1 to Day 180
+7 more outcomes measured
HIV Prevention
1 sites across 1 states
Texas1
  • Emeka Okafor, PhD, MPH · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

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Eligibility criteria

Inclusion

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

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)
  • Dried Blood Spot Analysis for PrEP adherenceDay 1 to Day 180

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

  • Urine Collection for Drug ScreeningDay 1 to Day 180

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

  • Urine Collection for Sexually Transmitted Infections (STIs)Day 1 to Day 180

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

  • Rectal Swab for STI testingDay 1 to Day 180

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

  • Pre-exposure Prophylaxis (PrEP) Related IntentionsDay 1 to Day 180

    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.

  • PrEP AttitudesDay 1 to Day 180

    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.

  • PrEP StigmaDay 1 to Day 180

    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.

  • PrEP Self-efficacyDay 1 to Day 180

    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.