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Intervención económica conductual para mejorar los comportamientos relacionados con el VIH en personas de minorías sexuales

21 de septiembre de 2026 actualizado por: Chukwuemeka Okafor, The University of Texas Health Science Center at San Antonio

Desarrollo de una intervención económica conductual para mejorar los comportamientos relacionados con el VIH entre personas de minorías sexuales

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Emeka Okafor, PhD, MPH
  • Número de teléfono: 210-450-7377
  • Correo electrónico: okaforcn@uthscsa.edu

Ubicaciones de estudio

    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • Reclutamiento
        • University of Texas Health Science Center at San Antonio
        • Contacto:
          • Chukwuemeka N Okafor, PhD, MPH

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 34 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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

Otros nombres:
  • Pensamiento futuro episódico
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dried Blood Spot Analysis for STI adherence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rapid HIV test
Periodo de tiempo: Day 30 to Day 180

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

Day 30 to Day 180
Delayed Discounting
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de marzo de 2025

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de diciembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

19 de diciembre de 2024

Publicado por primera vez (Actual)

20 de diciembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY00000869
  • R34DA060078 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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