Clinical trial NCT04549259: Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
Official title: Testing a Multi-Component Intervention to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 pilot test four intervention components designed to improve care engagement and medication adherence to determine their impact on health outcomes and quality of life among rural, older PLH. The four intervention components, adapted from evidence-based interventions and delivered remotely, are: (1) counselor-facilitated peer social support, (2) HIV stigma reduction, (3) strengths-based case management, and (4) individually-tailored technology use optimization. The investigators hypothesize that components will be acceptable to participants, will be feasible to administer remotely, and will show preliminary impact on (1) the proportion of participants that have viral suppression and (2) health-related quality of life. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.


Eligibility criteria: Inclusion Criteria:

* Age 50 years or greater
* Living in a zip code classified as a "Small and Isolated Small Rural Town" area by Rural-Urban Commuting Area Codes (RUCAs), and/or in a county classified as rural based on RUCAs, and/or in a county with a score of .4 or higher on the index of relative rurality (IRR)
* Living in Alabama, Arkansas, Georgia, Kentucky, Mississippi, Missouri, Oklahoma, South Carolina, or Tennessee
* Living with HIV
* Indicates willingness to participate in support groups
* Indicates willingness to self-collect a dried blood spot sample
* Has a telephone at home
* Able to provide informed consent

Exclusion Criteria:

* Not meeting eligibility criteria described above

Primary outcomes:
measure: Proportion of Participants With HIV Viral Load ≥832 Copies/mL (HemaSpot DBS)
timeFrame: 3 months following enrollment/baseline survey
measure: Health-Related Quality of Life
timeFrame: 3 months following enrollment/baseline survey
Secondary outcomes:
measure: Medication Adherence
timeFrame: 3 months following enrollment/baseline survey
measure: Depressive Symptoms
timeFrame: 3 months following enrollment/baseline survey
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Center for AIDS Intervention Research, Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Center for AIDS Intervention Research, Medical College of Wisconsin
name: Jennifer Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for AIDS Intervention Research, Medical College of Wisconsin
name: Andrew Petroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.