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Atferdsmessig økonomisk intervensjon for å forbedre HIV-atferd hos seksuelle minoritetsindivider

21. september 2026 oppdatert av: Chukwuemeka Okafor, The University of Texas Health Science Center at San Antonio

Utvikling av en atferdsmessig økonomisk intervensjon for å forbedre HIV-relatert atferd blant seksuelle minoritetsindivider

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Texas
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • University of Texas Health Science Center at San Antonio
        • Ta kontakt med:
          • Chukwuemeka N Okafor, PhD, MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 34 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Episodic Future Thinking App

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.

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

Andre navn:
  • Episodisk fremtidstenkning
Ingen inngripen: Control Group

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dried Blood Spot Analysis for STI adherence
Tidsramme: Day 1 to Day 180

Blood spots will be collected and assessed for sexually transmitted infections (STI).

Day 1 to Day 180
Urine Collection for Drug Screening
Tidsramme: 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.

Day 1 to Day 180
Urine Collection for Sexually Transmitted Infections (STIs) and Pre-exposure Prophylaxis (PrEP) adherence
Tidsramme: Day 1 to Day 180

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
Tidsramme: Day 1 to Day 180

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
Tidsramme: 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.

Day 1 to Day 180
PrEP Attitudes
Tidsramme: 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.

Day 1 to Day 180
PrEP Stigma
Tidsramme: 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.

Day 1 to Day 180
PrEP Self-efficacy
Tidsramme: 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.

Day 1 to Day 180

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rapid HIV test
Tidsramme: Day 30 to Day 180

Test for HIV infection. Number of negative results will be reported.

Day 30 to Day 180
Delayed Discounting
Tidsramme: 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.

Day 1 to Day 180
Demand
Tidsramme: 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).

Day 1 to Day 180
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-TR Self-rated Level 1
Tidsramme: 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.

Day 1 to Day 180
Generalized Anxiety Disorder Screener (GAD-7)
Tidsramme: 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)

Day 1 to Day 180

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Emeka Okafor, PhD, MPH, The University of Texas Health Science Center at San Antonio

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. mars 2025

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

13. desember 2024

Først innsendt som oppfylte QC-kriteriene

19. desember 2024

Først lagt ut (Faktiske)

20. desember 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • STUDY00000869
  • R34DA060078 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Publication policy will focus on ensuring that all dissemination of research findings from this study is conducted in an accurate, transparent and ethical manner. Authorship will be determined based on significant contributions to the study's conception, design, data acquisition, analysis or interpretation as well as in drafting and critically revising the manuscript. During this review process any potentially identifiable information will be carefully reviewed and anonymized if necessary.

IPD-delingstidsramme

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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