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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549259
• Other study ID #: R56NR019443
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: June 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Group-Based Social Support
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 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. Therapists will facilitate mutual support among group members, encourage 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 (Heckman et al., 2013).
• HIV Stigma Reduction
This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of "Ending Self Stigma" (Lucksted et al., 2011).
• Strengths-Based Case Management (SBCM)
The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls 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.
• Personalized Technology Detailing
Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.

Locations

Country	Name	City	State
United States	Center for AIDS Intervention Research, Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

O'Connell KA, Skevington SM. An international quality of life instrument to assess wellbeing in adults who are HIV-positive: a short form of the WHOQOL-HIV (31 items). AIDS Behav. 2012 Feb;16(2):452-60. doi: 10.1007/s10461-010-9863-0. — View Citation

Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With HIV Viral Load =832 Copies/mL (HemaSpot DBS)	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.	3 months following enrollment/baseline survey
Primary	Health-Related Quality of Life	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.	3 months following enrollment/baseline survey
Secondary	Medication Adherence	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; as = .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.	3 months following enrollment/baseline survey
Secondary	Depressive Symptoms	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; as = .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.	3 months following enrollment/baseline survey