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

Stress, Psychological Clinical Trial

— RISE+  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05314088
• Other study ID #: 1R21AG076377-01A1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection
• Resilience
• Stress, Psychological

Intervention

Behavioral:
• RISE+
The intervention includes psychoeducational videos and written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience.
• Stress Reduction Control
Placebo Comparator: Stress Reduction Control Control participants will complete an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games.

Locations

Country	Name	City	State
United States	Holley Mears Building	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resilience resources	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.	immediately following the 4 week intervention
Primary	stress reactivity	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.	immediately following the 4 week intervention
Secondary	health related quality of life	Medical Outcomes Study HIV Health Survey	3 months after intervention
Secondary	depressive symptoms	Centers for Epidemiological Studies Depression Scale	3 months after intervention
Secondary	HIV medication adherence	Visual Analogue Scale ART adherence	3 months after intervention
Secondary	HIV Treatment Management Abilities	HIV Treatment Adherence Self-Efficacy Scale	3 months after intervention
Secondary	HIV Viral Load	HIV plasma viral load (copies per mL of plasma) extracted from medical records	3 months after intervention