Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06269081
Enrollment
352
Registered
2024-02-21
Start date
2024-04-10
Completion date
2027-01-31
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

BEHAVIORALSupportive-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.

BEHAVIORALIndividual 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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Viral Suppression4 and 12 month follow-upsHIV 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.
Antiretroviral Treatment Medication Adherence4, 8, and 12 month follow-upsRecent (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.
Health-Related Quality of Life4, 8, and 12 month follow-upsHealth-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.
Depressive Symptoms4, 8, and 12 month follow-upsDepressive 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.

Secondary

MeasureTime frameDescription
HIV Treatment Adherence Self-Efficacy4, 8, and 12 month follow-upsHIV 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.
Social Support4, 8, and 12 month follow-upsSocial 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.
Structural Barriers4, 8, and 12 month follow-upsParticipants 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.
Accessing Needed Social and Medical Services4, 8, and 12 month follow-upsParticipants 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).
Loneliness4, 8, and 12 month follow-upsLoneliness 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.
Internalized HIV Stigma4, 8, and 12 month follow-upsInternalized 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.
General Self-Efficacy4, 8, and 12 month follow-upsGeneral 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.

Countries

United States

Contacts

Primary ContactJennifer Walsh, PhD
jwalsh@mcw.edu414-955-7710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026