Recruiting

Health Outcomes & Quality of Life

Sponsor:

Medical College of Wisconsin

Code:

NCT06269081

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Supportive-Expressive Peer Social Support Group Intervention

Individual Strengths-Based Case Management Intervention

Study Details

Brief summary:

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.

Conditions

HIV

Study ID

NCT06269081

Start date

Apr 10, 2024

Status verified date

Sep, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management

experimental: Supportive-Expressive Peer Social Support Group

experimental: Individual Strengths-Based Case Management

no intervention: HIV Information Only

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

Interventions

Supportive-Expressive Peer Social Support Group Intervention

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.

Individual Strengths-Based Case Management Intervention

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.

Primary outcome measure

  • Viral Suppression [ Time Frame: 4 and 12 month follow-ups ]
  • Antiretroviral Treatment Medication Adherence [ Time Frame: 4, 8, and 12 month follow-ups ]
  • Health-Related Quality of Life [ Time Frame: 4, 8, and 12 month follow-ups ]
  • Depressive Symptoms [ Time Frame: 4, 8, and 12 month follow-ups ]

Central Contacts and Locations

Central contacts

Jennifer Walsh, PhD

414-955-7710jwalsh@mcw.edu

Locations

Center for AIDS Intervention Research, Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53202

Contacts

Jennifer Walsh

4149557710jwalsh@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-09-23.