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Recruiting NCT06269081

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

No phase Interventional HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supportive-Expressive Peer Social Support Group Intervention, Individual Strengths-Based Case Management Intervention.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Supportive-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
  • Behavioral Individual 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

Primary outcome measures

  • Viral Suppression [Time frame: 4 and 12 month follow-ups]
  • Antiretroviral Treatment Medication Adherence [Time frame: 4, 8, and 12 month follow-ups]
  • Health-Related Quality of Life [Time frame: 4, 8, and 12 month follow-ups]
  • Depressive Symptoms [Time frame: 4, 8, and 12 month follow-ups]
Secondary outcome measures (7)
  • Social Support [Time frame: 4, 8, and 12 month follow-ups]
  • Loneliness [Time frame: 4, 8, and 12 month follow-ups]
  • Internalized HIV Stigma [Time frame: 4, 8, and 12 month follow-ups]
  • General Self-Efficacy [Time frame: 4, 8, and 12 month follow-ups]
  • HIV Treatment Adherence Self-Efficacy [Time frame: 4, 8, and 12 month follow-ups]
  • Accessing Needed Social and Medical Services [Time frame: 4, 8, and 12 month follow-ups]
  • Structural Barriers [Time frame: 4, 8, and 12 month follow-ups]

Eligibility criteria

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

  • Not meeting eligibility criteria described above

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Center for AIDS Intervention Research, Medical College of Wisconsin — Milwaukee

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17588200

Identifiers

NCT: NCT06269081 · R01NR020770 · R01NR020770

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗