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RecruitingNCT06269081Updated Oct 6, 2026

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

An interventional study of Supportive-Expressive Peer Social Support Group Intervention and Individual Strengths-Based Case Management Intervention in HIV, sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Updated Oct 6, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV
03

In context

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Not meeting eligibility criteria described above
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
352 participants (estimated)

Study arms

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

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

  • Experimental
    Supportive-Expressive Peer Social Support Group

    Behavioral: Supportive-Expressive Peer Social Support Group Intervention

  • Experimental
    Individual Strengths-Based Case Management

    Behavioral: Individual Strengths-Based Case Management Intervention

  • No intervention
    HIV Information Only

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

Interventions

  • BehavioralSupportive-Expressive Peer Social Support Group Intervention

    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.

  • BehavioralIndividual Strengths-Based Case Management Intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 and 12 month follow-ups

  2. 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.

    Time frame: 4, 8, and 12 month follow-ups

  3. 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.

    Time frame: 4, 8, and 12 month follow-ups

  4. 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.

    Time frame: 4, 8, and 12 month follow-ups

Secondary outcomes

  1. Social Support

    Social support will be self-reported using the 19-item Medical Outcomes Study (MOS) Social Support Scale. Scale scores range from 1-5, with higher scores indicating more social support.

    Time frame: 4, 8, and 12 month follow-ups

  2. Loneliness

    Loneliness will be self-reported using the 5-item Loneliness survey from the National Institutes of Health (NIH) Toolbox. Scale scores range from 1-5, with higher scores indicating greater loneliness.

    Time frame: 4, 8, and 12 month follow-ups

  3. Internalized HIV Stigma

    Internalized HIV stigma will be self-reported using the 6-item internalized stigma subscale of the HIV Stigma Mechanisms scale. Scale scores range from 1-5, with higher scores indicating more internalized stigma.

    Time frame: 4, 8, and 12 month follow-ups

  4. General Self-Efficacy

    General self-efficacy will be self-reported using the 8-item New General Self-Efficacy Scale. Scale scores range from 1-5, with higher scores indicating greater self-efficacy.

    Time frame: 4, 8, and 12 month follow-ups

  5. HIV Treatment Adherence Self-Efficacy

    HIV treatment adherence self-efficacy will be self-reported using the 8-item HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Scale scores range from 0-4, with higher scores indicating greater self-efficacy.

    Time frame: 4, 8, and 12 month follow-ups

  6. Accessing Needed Social and Medical Services

    Participants will self-report which of 12 HIV-related social and medical services they have needed during the previous 3 months, and which of these needed services they were able to obtain. A composite variable will indicate whether participants successfully accessed at least one needed service (0 = no, 1 = yes).

    Time frame: 4, 8, and 12 month follow-ups

  7. Structural Barriers

    Participants will self-report structural barriers they have faced in the past 3 months, with items assessing the following barriers: not having current health insurance, transportation as a barrier to health care, finances as a barrier to health care, not having enough food to eat, not having stable housing, and lacking eHealth literacy. Participants will be coded as having faced or not having faced each barrier, and barriers will be summed to indicate a score from 0-6, with higher scores indicating more structural barriers.

    Time frame: 4, 8, and 12 month follow-ups

07

Study locations

1 of 1 sites recruiting
  • Center for AIDS Intervention Research, Medical College of Wisconsin
    Milwaukee, Wisconsin 53202, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27098408 ↗
  • 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. PubMed 11556941 ↗
  • 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. PubMed 21181253 ↗
  • 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. PubMed 2035047 ↗
  • 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. PubMed 23456594 ↗
  • 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. PubMed 23479549 ↗
  • 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. PubMed 17971562 ↗
  • 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. PubMed 17588200 ↗
  • Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4, 62-83.
  • 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. PubMed 23474642 ↗
  • 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. PubMed 41105943 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Jan 31, 2027→Jan 31, 2028
Oct 6, 2026
Study completion
Jan 31, 2027→Jan 31, 2028
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary completion Jan 31, 2027→Jan 31, 2028
    Study completion Jan 31, 2027→Jan 31, 2028
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06269081
Lead sponsor
Medical College of Wisconsin
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Jennifer Walsh (Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
Feb 21, 2024
Start date
Apr 10, 2024
Primary completion
Jan 31, 2028 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Jennifer Walsh, PhD
Contact
jwalsh@mcw.edu
414-955-7710
Jennifer Walsh, PhD
principal investigator · Center for AIDS Intervention Research, Medical College of Wisconsin
Andrew Petroll, MD
principal investigator · Center for AIDS Intervention Research, Medical College of Wisconsin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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