Clinical trial NCT05314088: Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging with HIV
Official title: Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging with HIV
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Resilience
HIV-1-infection
Stress, Psychological
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.
Primary purpose: PREVENTION

Brief summary: This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.

Detailed description: A two-group RCT will enroll 100 older (aged 50+) people living with HIV (PLHIV), who will be recruited from the UAB HIV outpatient clinic. Eligible participants will complete a baseline assessment including a 14-day experience sampling method (ESM) protocol, and then be randomized to either the intervention group (n=50) or an attention-matched control group (n=50). We will block randomize groups based on race, sex, and self-reported resilience (Connor Davidson Resilience Scale). If differences are found between groups on influential variables (e.g., SES), such factors will be controlled in analyses and exploratory aim analyses will examine treatment moderators (e.g., sex, race). Both groups will return for four weekly two-hour group visits, followed by a one-month post intervention assessment (including qualitative and quantitative feedback) and a second ESM protocol. A three-month follow-up (comparable to baseline) will assess health outcomes. A blinded research assistant will conduct follow-ups. Our Primary Aims will use ESM via text messaging, and focus on intervention effects on the use of resilience resources following times when stressors are reported and whether such increases drive improved affective stress reactivity and recovery (Aim 1). Our secondary aim will examine effects on health outcomes at three months. Our exploratory aim will examine moderators of treatment response.

Eligibility criteria: Inclusion Criteria:

* current UAB HIV Clinic patient
* age 50+
* have a recent history (within the past 12 months) of suboptimal HIV management, defined as having either ≥one record of detectable viral load or ≥one missed clinic visit without prior cancellation/reschedule

Exclusion Criteria:

* neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders

Primary outcomes:
measure: resilience resources
timeFrame: immediately following the 4 week intervention
measure: stress reactivity
timeFrame: immediately following the 4 week intervention
Secondary outcomes:
measure: health related quality of life
timeFrame: 3 months after intervention
measure: depressive symptoms
timeFrame: 3 months after intervention
measure: HIV medication adherence
timeFrame: 3 months after intervention
measure: HIV Treatment Management Abilities
timeFrame: 3 months after intervention
measure: HIV Viral Load
timeFrame: 3 months after intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Holley Mears Building
state: Alabama
Study officials:
References: