NCT04549259

Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV

Completed NA Results posted Last updated 12 July 2023

What this trial tests

NA trial testing Group-Based Social Support in HIV in 61 participants. Completed in 9 May 2022.

Timeline

14 April 2021

Primary endpoint
9 May 2022

9 May 2022

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	14 April 2021
Primary completion	9 May 2022
Estimated completion	9 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Group-Based Social Support
• HIV Stigma Reduction
• Strengths-Based Case Management (SBCM)
• Personalized Technology Detailing

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Medical College of Wisconsin

Who can join

50 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants With HIV Viral Load ≥832 Copies/mL (HemaSpot DBS) Primary · 3 months following enrollment/baseline survey

Proportion of participants with HIV viral load ≥832 copies/mL, as measured through use of HemaSpot dried blood spot (DBS) testing. At baseline and follow-up, participants were sent dried blood spot (DBS) kits by mail to complete self-collection of blood samples for HIV viral load testing. Following specimen collection, participants placed the filled HemaSpot container into the shipping envelope, which sent the specimen directly to the clinical laboratory for testing. HemaSpot devices with sufficient blood volume were tested using Abbott m2000 RealTime HIV-1 dried blood spot (DBS) quantitative

Group	Value	95% CI
Social Support Intervention: Yes	5
Social Support Intervention: No	7
Stigma Reduction Intervention: Yes	8
Stigma Reduction Intervention: No	4
Strengths-Based Case Management Intervention: Yes	6
Strengths-Based Case Management Intervention: No	6
Technology Detailing Intervention: Yes	8
Technology Detailing Intervention: No	4

Health-Related Quality of Life Primary · 3 months following enrollment/baseline survey

Based on full scale scores from the 31-item WHOQOL-HIV BREF (O'Connell \& Skevington, 2012), with scores ranging from 0 to 100. Higher scores indicate higher (better) quality of life. Quality of life was assessed with 31 items from the WHOQOL-HIV BREF (O'Connell \& Skevington, 2012). Domains assessed include physical health; psychological health; level of independence; social relationships; environmental health; and personal beliefs. Additionally, two individual items focus on overall quality of life and general health. Domain scores were created as described by the WHO, and we created a comp

Group	Value	95% CI
Social Support Intervention: Yes	68.54	± 15.37
Social Support Intervention: No	64.97	± 15.32
Stigma Reduction Intervention: Yes	65.83	± 13.96
Stigma Reduction Intervention: No	67.51	± 16.82
Strengths-Based Case Management Intervention: Yes	66.50	± 16.75
Strengths-Based Case Management Intervention: No	66.81	± 13.96
Technology Detailing Intervention: Yes	68.01	± 15.64
Technology Detailing Intervention: No	65.00	± 15.04

Medication Adherence Secondary · 3 months following enrollment/baseline survey

Adherence to HIV antiretroviral medications in the past 30 days was assessed with the 3 items from the Wilson adherence scale (Wilson et al., 2017; αs = .71-.79). This scale was scored in line with Wilson et al., with scores ranging from 0 to 100 and higher scores indicating better adherence. Due to significant skew in this outcome, we created a binary variable indicating perfect adherence to HIV medications.

Group	Value	95% CI
Social Support Intervention: Yes	13
Social Support Intervention: No	14
Stigma Reduction Intervention: Yes	13
Stigma Reduction Intervention: No	14
Strengths-Based Case Management Intervention: Yes	14
Strengths-Based Case Management Intervention: No	13
Technology Detailing Intervention: Yes	14
Technology Detailing Intervention: No	13

Depressive Symptoms Secondary · 3 months following enrollment/baseline survey

Depressive symptoms during the past 2 weeks were assessed with the 9 items from the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; αs = .87-.90). Participants indicated how often they had experienced different depressive symptoms (e.g., "Feeling down, depressed, or hopeless"). Responses ranged from not at all (0) to nearly every day (3). Items were summed to yield scores ranging from 0 to 27, with higher scores indicating more depressive symptoms.

Group	Value	95% CI
Social Support Intervention: Yes	6.84	± 6.62
Social Support Intervention: No	9.33	± 6.74
Stigma Reduction Intervention: Yes	8.47	± 6.59
Stigma Reduction Intervention: No	7.84	± 7.00
Strengths-Based Case Management Intervention: Yes	8.08	± 7.32
Strengths-Based Case Management Intervention: No	8.25	± 6.22
Technology Detailing Intervention: Yes	7.50	± 7.43
Technology Detailing Intervention: No	8.96	± 5.84

Sponsor's own description

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 pilot test four intervention components designed to improve care engagement and medication adherence to determine their impact on health outcomes and quality of life among rural, older PLH. The four intervention components, adapted from evidence-based interventions and delivered remotely, are: (1) counselor-facilitated peer social support, (2) HIV stigma reduction, (3) strengths-based case management, and (4) individually-tailored technology use optimization. The investigators hypothesize that components will be acceptable to participants, will be feasible to administer remotely, and will show preliminary impact on (1) the proportion of participants that have viral suppression and (2) health-related quality of life. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acceptability, Feasibility, and Preliminary Impact of 4 Remotely-Delivered Interventions for Rural Older Adults Living with HIV.
   Walsh JL, Quinn KG, Hirshfield S, John SA, et al · · 2024 · cited 9× · PMID 38170275 · DOI 10.1007/s10461-023-04227-5
2. Acceptability and Feasibility of Self-Collected Dried Blood Spot Specimens for Viral Load Monitoring among Rural Older People Living with HIV.
   Walsh JL, Hirshfield S, John SA, Quinn KG, et al · · 2025 · cited 2× · PMID 39865197 · DOI 10.1007/s10461-024-04599-2