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

Not Applicable

Completed

Conditions: HIV

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

Registration Number: NCT04549259

Lead Sponsor: Medical College of Wisconsin

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

Inclusion Criteria

Age 50 years or greater
Living in a zip code classified as a "Small and Isolated Small Rural Town" area by Rural-Urban Commuting Area Codes (RUCAs), and/or in a county classified as rural based on RUCAs, and/or in a county with a score of .4 or higher on the index of relative rurality (IRR)
Living in Alabama, Arkansas, Georgia, Kentucky, Mississippi, Missouri, Oklahoma, South Carolina, or Tennessee
Living with HIV
Indicates willingness to participate in support groups
Indicates willingness to self-collect a dried blood spot sample
Has a telephone at home
Able to provide informed consent

Exclusion Criteria

Not meeting eligibility criteria described above

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Social Support + Stigma Reduction + SBCM + Tech Detailing	Group-Based Social Support	-
Social Support + Stigma Reduction + SBCM + Tech Detailing	HIV Stigma Reduction	-
Social Support + Stigma Reduction + SBCM	Strengths-Based Case Management (SBCM)	-
Social Support + SBCM + Technology Detailing	Personalized Technology Detailing	-
Social Support + Stigma Reduction + SBCM + Tech Detailing	Strengths-Based Case Management (SBCM)	-
Social Support + Stigma Reduction	Group-Based Social Support	-
Social Support + Stigma Reduction + SBCM + Tech Detailing	Personalized Technology Detailing	-
Social Support + Stigma Reduction + SBCM	Group-Based Social Support	-
Social Support + Stigma Reduction + Technology Detailing	Group-Based Social Support	-
Social Support + Stigma Reduction	HIV Stigma Reduction	-
Social Support + SBCM + Technology Detailing	Group-Based Social Support	-
Social Support + SBCM + Technology Detailing	Strengths-Based Case Management (SBCM)	-
Social Support + SBCM	Group-Based Social Support	-
Social Support + Stigma Reduction + SBCM	HIV Stigma Reduction	-
Social Support + Stigma Reduction + Technology Detailing	HIV Stigma Reduction	-
Social Support + Stigma Reduction + Technology Detailing	Personalized Technology Detailing	-
Social Support + Technology Detailing	Group-Based Social Support	-
Social Support	Group-Based Social Support	-
Stigma Reduction + SBCM + Technology Detailing	Personalized Technology Detailing	-
Social Support + SBCM	Strengths-Based Case Management (SBCM)	-
Social Support + Technology Detailing	Personalized Technology Detailing	-
Stigma Reduction + SBCM	HIV Stigma Reduction	-
Stigma Reduction + SBCM + Technology Detailing	HIV Stigma Reduction	-
Stigma Reduction + SBCM	Strengths-Based Case Management (SBCM)	-
Stigma Reduction + SBCM + Technology Detailing	Strengths-Based Case Management (SBCM)	-
Stigma Reduction + Technology Detailing	HIV Stigma Reduction	-
Stigma Reduction + Technology Detailing	Personalized Technology Detailing	-
SBCM + Technology Detailing	Strengths-Based Case Management (SBCM)	-
SBCM + Technology Detailing	Personalized Technology Detailing	-
Technology Detailing	Personalized Technology Detailing	-
Stigma Reduction	HIV Stigma Reduction	-
SBCM	Strengths-Based Case Management (SBCM)	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With HIV Viral Load ≥832 Copies/mL (HemaSpot DBS)	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 assay, with 832 copies/mL limit of detection. DBS viral load results were classified in three categories: 1. Detected and quantifiable at ≥832 copies/mL; 2. Detected and non-quantifiable, estimated between \<832 and \>300 copies/mL; and 3. Not detected, estimated to be \<300 copies/mL.
Health-Related Quality of Life	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 composite quality of life score by equally weighting the 6 domains, overall quality of life item, and general health item. The composite score was rescaled such that overall scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.

Secondary Outcome Measures

Name	Time	Method
Medication Adherence	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.
Depressive Symptoms	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.