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

NCT05314088 | Completed DMC

• 2 other identifiers: IRB-3000087401R21AG076377-01A1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Resilience; HIV-1-infection; Stress, Psychological

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• health related quality of life

  3 months after intervention

• depressive symptoms

  3 months after intervention

• HIV medication adherence

  3 months after intervention

• HIV Treatment Management Abilities

  3 months after intervention

• HIV Viral Load

  3 months after intervention

Study Arms (2)

RISE+ Resilience Intervention

EXPERIMENTAL

Participants in the intervention group will come to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention will be facilitated by a trained research assistant but as in the pilot study, he/she will be minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants will be given handouts with summaries of the program material. We will gather qualitative and quantitative feedback on the intervention at the one-month posttest.

Behavioral: RISE+

Stress Reduction Control

PLACEBO COMPARATOR

Control participants will complete an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games. As with the intervention group, participants in the control group will come to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement will be the same as the intervention group (e.g., the research assistant will explain computer activities and games but will otherwise not interact with the participant).

Behavioral: Stress Reduction Control

Interventions

RISE+ BEHAVIORAL

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.

RISE+ Resilience Intervention

Stress Reduction Control BEHAVIORAL

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.

Stress Reduction Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Holley Mears Building

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 6, 2022
• Study Start: February 3, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)