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Clinical Trials/NCT06269081
NCT06269081
Recruiting
Not Applicable

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

Medical College of Wisconsin1 site in 1 country352 target enrollmentApril 10, 2024
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Medical College of Wisconsin
Enrollment
352
Locations
1
Primary Endpoint
Depressive Symptoms
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2024
End Date
January 31, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Walsh

Associate Professor

Medical College of Wisconsin

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

Outcomes

Primary Outcomes

Depressive Symptoms

Time Frame: 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.

Antiretroviral Treatment Medication Adherence

Time Frame: 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.

Viral Suppression

Time Frame: 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.

Health-Related Quality of Life

Time Frame: 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.

Secondary Outcomes

  • Accessing Needed Social and Medical Services(4, 8, and 12 month follow-ups)
  • Structural Barriers(4, 8, and 12 month follow-ups)
  • HIV Treatment Adherence Self-Efficacy(4, 8, and 12 month follow-ups)
  • Loneliness(4, 8, and 12 month follow-ups)
  • Internalized HIV Stigma(4, 8, and 12 month follow-ups)
  • General Self-Efficacy(4, 8, and 12 month follow-ups)
  • Social Support(4, 8, and 12 month follow-ups)

Study Sites (1)

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