Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV

ConditionHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not meeting eligibility criteria described above

Trial design

Design model

Factorial

Treatments tested in this trial

  • Supportive-Expressive Peer Social Support Group Intervention

    Behavioral

    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

    Behavioral

    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.

Treatment groups

352 Participants
are divided into 4 treatment groups
Group A: Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case ManagementExperimental treatment 2 interventions
Group B: Supportive-Expressive Peer Social Support GroupExperimental treatment 1 intervention
Group C: Individual Strengths-Based Case ManagementExperimental treatment 1 intervention
Group D: HIV Information OnlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Viral Suppression

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.

Time frame
4 and 12 month follow-ups
2

Antiretroviral Treatment Medication Adherence

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.

Time frame
4, 8, and 12 month follow-ups
3

Health-Related Quality of Life

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.

Time frame
4, 8, and 12 month follow-ups
4

Depressive Symptoms

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.

Time frame
4, 8, and 12 month follow-ups

Secondary outcomes

1

Social Support

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.

Time frame
4, 8, and 12 month follow-ups
2

Loneliness

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.

Time frame
4, 8, and 12 month follow-ups
3

Internalized HIV Stigma

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.

Time frame
4, 8, and 12 month follow-ups
4

General Self-Efficacy

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.

Time frame
4, 8, and 12 month follow-ups

Other outcomes

Sponsors and contacts

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Medical College of Wisconsin

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator