About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
EFT
BehavioralParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Dried Blood Spot Analysis for STI adherence
Blood spots will be collected and assessed for sexually transmitted infections (STI).
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.
Urine Collection for Sexually Transmitted Infections (STIs) and Pre-exposure Prophylaxis (PrEP) adherence
Urine will be tested for STIs. Number of subjects that test negative for STIs will be reported.
Rectal Swab for STI testing
A rectal swab will be obtained for STI. Number of subjects that test negative for STIs will be reported.
Secondary outcomes
Rapid HIV test
Test for HIV infection. Number of negative results will be reported.
Delayed Discounting
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
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
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.
Sponsors and contacts
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The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator