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Prueba de dos intervenciones para mejorar los resultados de salud y la calidad de vida entre los adultos mayores de zonas rurales que viven con el VIH

5 de octubre de 2026 actualizado por: Jennifer Walsh, Medical College of Wisconsin

Prueba de la eficacia de dos intervenciones para mejorar los resultados de salud y la calidad de vida entre los adultos mayores de zonas rurales que viven con el VIH

Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

352

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: Jennifer Walsh, PhD
  • Número de teléfono: 414-955-7710
  • Correo electrónico: jwalsh@mcw.edu

Ubicaciones de estudio

    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53202
        • Reclutamiento
        • Center for AIDS Intervention Research, Medical College of Wisconsin
        • Contacto:
          • Jennifer Walsh
          • Número de teléfono: 4149557710
          • Correo electrónico: jwalsh@mcw.edu

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

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Aged 50 years or greater
  • Living in a county with a score of .4 or higher on the index of relative rurality (IRR)
  • Living in Alabama, Arkansas, Delaware, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia
  • Living with HIV
  • Has a telephone at home
  • Able to provide informed consent

Exclusion Criteria:

  • Not meeting eligibility criteria described above

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Grupo de apoyo social de pares expresivo y de apoyo + Gestión de casos basada en fortalezas individuales

The social support group intervention involves weekly virtual support group meetings for 8 consecutive weeks. The groups, facilitated by trained research staff, will last approximately 90 minutes each week and include 5-12 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Facilitators will encourage mutual support among group members, promote greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy.

The strengths-based case management (SBCM) intervention helps participants address the multiple structural barriers faced by rural older people living with HIV. This intervention, delivered by trained research staff, includes two 60-minute telephone- or video-based SBCM counseling sessions, with shorter follow-up sessions to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.

Experimental: Grupo de apoyo social de pares expresivo y solidario

The social support group intervention involves weekly virtual support group meetings for 8 consecutive weeks. The groups, facilitated by trained research staff, will last approximately 90 minutes each week and include 5-12 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Facilitators will encourage mutual support among group members, promote greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy.

Experimental: Gestión de casos basada en fortalezas individuales

The strengths-based case management (SBCM) intervention helps participants address the multiple structural barriers faced by rural older people living with HIV. This intervention, delivered by trained research staff, includes two 60-minute telephone- or video-based SBCM counseling sessions, with shorter follow-up sessions to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.

Sin intervención: HIV Information Only

This arm will not receive either of the interventions but will receive information on successfully aging with HIV.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Viral Suppression
Periodo de tiempo: 4 and 12 month follow-ups

HIV viral load will be assessed using self-collected dried blood spot (DBS) samples, with samples collecting using HemaSpot devices. Viral suppression will be defined as a measured viral load less than or equal to 839 copies/mL.

4 and 12 month follow-ups
Antiretroviral Treatment Medication Adherence
Periodo de tiempo: 4, 8, and 12 month follow-ups

Recent (past 30 day) antiretroviral treatment adherence will be self-reported using the 3-item Wilson Medication Adherence Scale. The calculated scale range is 0-100, with higher scores indicating more consistent medication adherence.

4, 8, and 12 month follow-ups
Health-Related Quality of Life
Periodo de tiempo: 4, 8, and 12 month follow-ups

Health-related quality of life will be self-reported using the 31-item World Health Organization Quality of Life Brief Assessment for PLH (WHOQOL-HIV BREF). The calculated scale range is 0-100, with higher scores indicating better quality of life. Composite scores will be calculated in line with Walsh et al., 2024.

4, 8, and 12 month follow-ups
Depressive Symptoms
Periodo de tiempo: 4, 8, and 12 month follow-ups

Depressive symptoms during the past 2 weeks will be self-reported via completion of the 9-item Patient Health Questionnaire-9 (PHQ-9). The calculated scale range is 0-27, with higher scores indicating more depressive symptoms.

4, 8, and 12 month follow-ups

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Social Support
Periodo de tiempo: 4, 8, and 12 month follow-ups

Social support will be self-reported using the 19-item Medical Outcomes Study (MOS) Social Support Scale. Scale scores range from 1-5, with higher scores indicating more social support.

4, 8, and 12 month follow-ups
Loneliness
Periodo de tiempo: 4, 8, and 12 month follow-ups

Loneliness will be self-reported using the 5-item Loneliness survey from the National Institutes of Health (NIH) Toolbox. Scale scores range from 1-5, with higher scores indicating greater loneliness.

4, 8, and 12 month follow-ups
Internalized HIV Stigma
Periodo de tiempo: 4, 8, and 12 month follow-ups

Internalized HIV stigma will be self-reported using the 6-item internalized stigma subscale of the HIV Stigma Mechanisms scale. Scale scores range from 1-5, with higher scores indicating more internalized stigma.

4, 8, and 12 month follow-ups
General Self-Efficacy
Periodo de tiempo: 4, 8, and 12 month follow-ups

General self-efficacy will be self-reported using the 8-item New General Self-Efficacy Scale. Scale scores range from 1-5, with higher scores indicating greater self-efficacy.

4, 8, and 12 month follow-ups
HIV Treatment Adherence Self-Efficacy
Periodo de tiempo: 4, 8, and 12 month follow-ups

HIV treatment adherence self-efficacy will be self-reported using the 8-item HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Scale scores range from 0-4, with higher scores indicating greater self-efficacy.

4, 8, and 12 month follow-ups
Accessing Needed Social and Medical Services
Periodo de tiempo: 4, 8, and 12 month follow-ups

Participants will self-report which of 12 HIV-related social and medical services they have needed during the previous 3 months, and which of these needed services they were able to obtain. A composite variable will indicate whether participants successfully accessed at least one needed service (0 = no, 1 = yes).

4, 8, and 12 month follow-ups
Structural Barriers
Periodo de tiempo: 4, 8, and 12 month follow-ups

Participants will self-report structural barriers they have faced in the past 3 months, with items assessing the following barriers: not having current health insurance, transportation as a barrier to health care, finances as a barrier to health care, not having enough food to eat, not having stable housing, and lacking eHealth literacy. Participants will be coded as having faced or not having faced each barrier, and barriers will be summed to indicate a score from 0-6, with higher scores indicating more structural barriers.

4, 8, and 12 month follow-ups

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jennifer Walsh, PhD, Center for AIDS Intervention Research, Medical College of Wisconsin
  • Investigador principal: Andrew Petroll, MD, Center for AIDS Intervention Research, Medical College of Wisconsin

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

10 de abril de 2024

Finalización primaria (Estimado)

31 de enero de 2028

Finalización del estudio (Estimado)

31 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de febrero de 2024

Primero enviado que cumplió con los criterios de control de calidad

13 de febrero de 2024

Publicado por primera vez (Actual)

21 de febrero de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

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

5 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R01NR020770 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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