Clinical trial NCT06269081: Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
Official title: Testing the Efficacy of Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-02-21
Enrollment: 352
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Viral Suppression
timeFrame: 4 and 12 month follow-ups
measure: Antiretroviral Treatment Medication Adherence
timeFrame: 4, 8, and 12 month follow-ups
measure: Health-Related Quality of Life
timeFrame: 4, 8, and 12 month follow-ups
measure: Depressive Symptoms
timeFrame: 4, 8, and 12 month follow-ups
Secondary outcomes:
measure: Social Support
timeFrame: 4, 8, and 12 month follow-ups
measure: Loneliness
timeFrame: 4, 8, and 12 month follow-ups
measure: Internalized HIV Stigma
timeFrame: 4, 8, and 12 month follow-ups
measure: General Self-Efficacy
timeFrame: 4, 8, and 12 month follow-ups
measure: HIV Treatment Adherence Self-Efficacy
timeFrame: 4, 8, and 12 month follow-ups
measure: Accessing Needed Social and Medical Services
timeFrame: 4, 8, and 12 month follow-ups
measure: Structural Barriers
timeFrame: 4, 8, and 12 month follow-ups
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Center for AIDS Intervention Research, Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Center for AIDS Intervention Research, Medical College of Wisconsin
name: Jennifer Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for AIDS Intervention Research, Medical College of Wisconsin
name: Andrew Petroll, MD
role: PRINCIPAL_INVESTIGATOR
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