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Clinical Trials/NCT05314088
NCT05314088
Completed
N/A

Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

University of Alabama at Birmingham1 site in 1 country106 target enrollmentFebruary 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Resilience
Sponsor
University of Alabama at Birmingham
Enrollment
106
Locations
1
Primary Endpoint
resilience resources
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2023
End Date
May 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pariya L. Fazeli, PhD

Associate Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • current UAB HIV Clinic patient
  • 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

Outcomes

Primary Outcomes

resilience resources

Time Frame: immediately following the 4 week intervention

we will use daily text messaging after the intervention to assess use of resilience resources following stressors. Participants will be texted daily to ask if they experienced a stressor (YES/NO) and then they respond on a 5 pt Likert scale on their levels of 7 resilience resources: hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores will be a total average score and individual average scores for each resource.

stress reactivity

Time Frame: immediately following the 4 week intervention

we will use daily text messaging after the intervention to assess use of stress reactivity following stressors. Participants will be texted daily to ask if they experienced a stressor (YES/NO) and then they respond on a Visual Analog Scale of their positive and negative affect. Their are 10 items for positive affect and 10 for negative affect. Total average positive and negative affect scores will be used.

Secondary Outcomes

  • health related quality of life(3 months after intervention)
  • depressive symptoms(3 months after intervention)
  • HIV Viral Load(3 months after intervention)
  • HIV Treatment Management Abilities(3 months after intervention)
  • HIV medication adherence(3 months after intervention)

Study Sites (1)

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