Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

Not Applicable

Recruiting

• Conditions: HIV Prevention

• Registration Number: NCT06745947
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-20
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-01-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dried Blood Spot Analysis for PrEP adherence	Day 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 Screening	Day 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 testing	Day 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 Intentions	Day 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 Attitudes	Day 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 Stigma	Day 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-efficacy	Day 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.

Secondary Outcome Measures

Name	Time	Method
Rapid HIV test	Day 30 to Day 180	Test for HIV infection. Number of negative results will be reported.
Delayed Discounting	Day 1 to Day 180	Delay discounting tasks will consist of 1) a standard adjusting-amount monetary tasks presenting repeated choices between various amounts of money now ($0 to $1,000) and $1,000 after a fixed delay (1 day to 25 years); 2) a cross-commodity task presenting choices between various amounts of methamphetamine now and money later in which the values are made equivalent with the monetary task; and 3) a condom delay discounting task assessing the likelihood that the participant would have sex with their ideal partner immediately with no condom vs. with a condom following a delay. Delayed discounting rate (or k) is an index of the devaluation of a rewards over time, with higher k values representing steeper discounting rates and a greater preferences for immediate rewards.
Demand	Day 1 to Day 180	Demand tasks will consist of hypothetical purchasing tasks assessing 1) Methamphetamine demand (grams of methamphetamine purchased as a function of increasing price); 2) condom demand (likelihood of purchasing condoms as a function of increasing price, with the follow-up question of whether they do not have sex or have sex without a condom when the likelihood of condom purchasing goes to zero); and 3) PrEP demand (likelihood of purchasing a one-month supply of PrEP as a function of increasing price). Demand data will be fit to an exponentiated demand model: Q=Q0\*10k(e-αQ0C-1), where Q represents consumption/use of the commodity as a function of increasing cost (C).
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-TR Self-rated Level 1	Day 1 to Day 180	This adult version of the measure consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Each item inquires about how much (or how often) the individual has been bothered by the specific symptom during the past 2 weeks. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day).; Scoring: Scoring can be done at three levels: Item Level: Review individual item scores. Domain Level: Sum item scores within each domain. Full Survey Level: Sum all item scores.
Generalized Anxiety Disorder Screener (GAD-7)	Day 1 to Day 180	The GAD-7 will be used to assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed up to obtain a total severity score between 0 and 28. Scores reflect no significant anxiety symptoms (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms (10-14), and severe anxiety symptoms (\>15)

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States