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

NCT06269081 | Recruiting

• 1 other identifier: R01NR020770
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (4)

• Viral Suppression

  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.

  4 and 12 month follow-ups

• Antiretroviral Treatment Medication Adherence

  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.

  4, 8, and 12 month follow-ups

• Health-Related Quality of Life

  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.

  4, 8, and 12 month follow-ups

• Depressive Symptoms

  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.

  4, 8, and 12 month follow-ups

Secondary Outcomes (7)

• Social Support

  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

• HIV Treatment Adherence Self-Efficacy

  4, 8, and 12 month follow-ups

Study Arms (4)

Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management

EXPERIMENTAL

Behavioral: Supportive-Expressive Peer Social Support Group Intervention; Behavioral: Individual Strengths-Based Case Management Intervention

Supportive-Expressive Peer Social Support Group

EXPERIMENTAL

Behavioral: Supportive-Expressive Peer Social Support Group Intervention

Individual Strengths-Based Case Management

EXPERIMENTAL

Behavioral: Individual Strengths-Based Case Management Intervention

HIV Information Only

NO INTERVENTION

This arm will not receive either of the interventions but will receive information on successfully aging with HIV.

Interventions

Supportive-Expressive Peer Social Support Group Intervention BEHAVIORAL

The social support group intervention involves weekly virtual support group meetings for 8 consecutive weeks. The groups, facilitated by trained research staff, will last approximately 90 minutes each week and include 5-12 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. Facilitators will encourage mutual support among group members, promote 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.

Supportive-Expressive Peer Social Support Group; Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management

Individual Strengths-Based Case Management Intervention BEHAVIORAL

The strengths-based case management (SBCM) intervention helps participants address the multiple structural barriers faced by rural older people living with HIV. This intervention, delivered by trained research staff, includes two 60-minute telephone- or video-based SBCM counseling sessions, with shorter follow-up sessions 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.

Individual Strengths-Based Case Management; Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not meeting eligibility criteria described above

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Center for AIDS Intervention Research, Medical College of Wisconsin

Milwaukee, Wisconsin, 53202, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 27098408 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 21181253 BACKGROUND

• Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.

  PMID: 2035047 BACKGROUND

• Earnshaw VA, Smith LR, Chaudoir SR, Amico KR, Copenhaver MM. HIV stigma mechanisms and well-being among PLWH: a test of the HIV stigma framework. AIDS Behav. 2013 Jun;17(5):1785-95. doi: 10.1007/s10461-013-0437-9.

  PMID: 23456594 BACKGROUND

• Salsman JM, Butt Z, Pilkonis PA, Cyranowski JM, Zill N, Hendrie HC, Kupst MJ, Kelly MA, Bode RK, Choi SW, Lai JS, Griffith JW, Stoney CM, Brouwers P, Knox SS, Cella D. Emotion assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S76-86. doi: 10.1212/WNL.0b013e3182872e11.

  PMID: 23479549 BACKGROUND

• Kidder DP, Wolitski RJ, Campsmith ML, Nakamura GV. Health status, health care use, medication use, and medication adherence among homeless and housed people living with HIV/AIDS. Am J Public Health. 2007 Dec;97(12):2238-45. doi: 10.2105/AJPH.2006.090209. Epub 2007 Oct 30.

  PMID: 17971562 BACKGROUND

• Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). J Behav Med. 2007 Oct;30(5):359-70. doi: 10.1007/s10865-007-9118-3. Epub 2007 Jun 23.

  PMID: 17588200 BACKGROUND

• Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4, 62-83.

  BACKGROUND

• Heckman TG, Heckman BD, Anderson T, Lovejoy TI, Mohr D, Sutton M, Bianco JA, Gau JT. Supportive-expressive and coping group teletherapies for HIV-infected older adults: a randomized clinical trial. AIDS Behav. 2013 Nov;17(9):3034-44. doi: 10.1007/s10461-013-0441-0.

  PMID: 23474642 BACKGROUND

• Petroll AE, Hirshfield S, Quinn KG, John SA, Algiers OH, Randall L, Wyley Long D, McAuliffe T, Walsh JL. Testing the Efficacy of 2 Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 17;14:e71429. doi: 10.2196/71429.

  PMID: 41105943 DERIVED

Study Officials

• Jennifer Walsh, PhD

  Center for AIDS Intervention Research, Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Andrew Petroll, MD

  Center for AIDS Intervention Research, Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Walsh, PhD

CONTACT

414-955-7710; jwalsh@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)