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

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

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; HIV-1-infection; Resilience
• Intervention / Treatment: Behavioral: RISE+; Behavioral: Stress Reduction Control

Detailed Description

A two-group RCT will enroll 100 older (aged 45+) people living with HIV (PLHIV), who will be recruited from the UAB HIV outpatient clinic. Eligible participants will complete a baseline assessment including a 10-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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Holley Mears Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RISE+ Resilience Intervention; 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+; 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.
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. 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience Sampling Method (ESM) Resilience Resources-Hardiness	Daily text messaging at baseline for 10 days and after the intervention for 10 days assessed use of resilience resources following stressors. Participants were texted twice daily to ask if they experienced a stressor (YES/NO) and if YES, then responded on a 5 pt Likert scale on their use of 7 resilience resources: hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores are average scores for each resource. Higher scores reflect greater levels of the resource (e.g., hardiness), and range from 1-5.	immediately following the 4 week intervention
Experience Sampling Method (ESM) Negative Stress Reactivity	Participants were texted a survey link twice daily for 10 days at baseline and immediately following the intervention which asked if they experienced a stressor (YES/NO) and then they respond on a scale of 1-4 their positive and negative affect (10 items for positive affect and 10 for negative affect). The average difference in negative affect between stressor and non-stressor instances was calculated to reflect negative stress reactivity: Higher scores reflect on average a higher negative emotional state when a stressor is reported vs when a stressor is not reported; scores closer to zero reflect less impact of a stressor on negative affect; lower scores [i.e., below zero] reflect on average lower negative emotional state when a stressor is reported vs when a stressor is not reported. The possible range for the negative affect scale is 10-40, therefore the possible average range for the difference between 2 negative affect occasions is -30 to 30.	immediately following the 4 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Outcome Study RAND 36-Item Short-Form Health Survey (RAND 36SF)-Physical Health Related QOL Composite	The Medical Outcome Study (MOS) RAND 36-Item Short-Form Health Survey (RAND 36SF) is was used to assess Quality of Life (QOL). For the physical health related QOL composite, scores range from 0-100 with higher scores reflecting better QOL.	1 month after intervention
Centers for Epidemiological Studies Depression Scale (CESD)	Centers for Epidemiological Studies Depression Scale assesses depressive symptoms and higher scores reflect greater depressive symptoms. Scores range from 0-60, with higher score reflecting greater depressive symptoms and scores >=16 reflect clinically relevant symptoms	1 month after the intervenion
HIV Medication Adherence Visual Analogue Scale (VAS)	Visual Analogue Scale of HIV ART adherence, higher scores reflect better self reported adherence to HIV medication. Total scores are on a 0-100% scale with a higher score indicating better adherence.	1 month after intervention
HIV Treatment Adherence Self Efficacy Scale (ASES)	HIV Treatment Adherence Self-Efficacy Scale, higher scores reflect higher self efficacy for HIV treatment adherence. Total scores range from 0-10 with higher scores reflecting higher confidence in treatment management abilities.	1 month after intervention
HIV Viral Load	HIV plasma viral load (copies per mL of plasma) extracted from medical records; higher is worse HIV severity; reported in Log10. The clinical quantifiable range for an HIV viral load test typically spans from 1.3 to 7.0 Log10 copies/mL (representing actual raw values from 20 to 10,000,000 copies/mL).	3 months after intervention

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Stress, Psychological
• Other Study ID Numbers: IRB-300008740; 1R21AG076377-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No