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

Primary Purpose

Resilience, HIV-1-infection, Stress, Psychological

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISE+
Stress Reduction Control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Resilience

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Holley Mears Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RISE+ Resilience Intervention

Stress Reduction Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

health related quality of life
Medical Outcomes Study HIV Health Survey
depressive symptoms
Centers for Epidemiological Studies Depression Scale
HIV medication adherence
Visual Analogue Scale ART adherence
HIV Treatment Management Abilities
HIV Treatment Adherence Self-Efficacy Scale
HIV Viral Load
HIV plasma viral load (copies per mL of plasma) extracted from medical records

Full Information

First Posted
March 21, 2022
Last Updated
February 8, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05314088
Brief Title
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
Acronym
RISE+
Official Title
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resilience, HIV-1-infection, Stress, Psychological

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RISE+ Resilience Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Stress Reduction Control
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
RISE+
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
resilience resources
Description
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.
Time Frame
immediately following the 4 week intervention
Title
stress reactivity
Description
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.
Time Frame
immediately following the 4 week intervention
Secondary Outcome Measure Information:
Title
health related quality of life
Description
Medical Outcomes Study HIV Health Survey
Time Frame
3 months after intervention
Title
depressive symptoms
Description
Centers for Epidemiological Studies Depression Scale
Time Frame
3 months after intervention
Title
HIV medication adherence
Description
Visual Analogue Scale ART adherence
Time Frame
3 months after intervention
Title
HIV Treatment Management Abilities
Description
HIV Treatment Adherence Self-Efficacy Scale
Time Frame
3 months after intervention
Title
HIV Viral Load
Description
HIV plasma viral load (copies per mL of plasma) extracted from medical records
Time Frame
3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Holley Mears Building
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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