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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269081
• Other study ID #: R01NR020770
• Secondary ID: R01NR020770
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: May 2024
• Source: Medical College of Wisconsin
• Contact: Jennifer Walsh, PhD
• Phone: 414-955-7710
• Email: jwalsh[@]mcw.edu
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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 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.
• 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 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — 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	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
Primary	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
Primary	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
Primary	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	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.	4, 8, and 12 month follow-ups
Secondary	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.	4, 8, and 12 month follow-ups
Secondary	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.	4, 8, and 12 month follow-ups
Secondary	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.	4, 8, and 12 month follow-ups
Secondary	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.	4, 8, and 12 month follow-ups
Secondary	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).	4, 8, and 12 month follow-ups
Secondary	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.	4, 8, and 12 month follow-ups