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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 50 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

HIV

Being tested

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Group-Based Social SupportBehavioural

  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 ReductionBehavioural

  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)Behavioural

  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 DetailingBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 3 months following enrollment/baseline survey

2. 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.

   Measured: 3 months following enrollment/baseline survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Sep 2020
2. Study start14 Apr 2021
3. Primary completion9 May 2022
4. Study completion9 May 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for HIVStudies of the same condition, open and under way.
• More trials run by Medical College of WisconsinThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.