Resilience-Building Intervention for Aging Individuals with HIV

(RISE+ Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neurological, Schizophrenia, Bipolar, Depression, others

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called RISE+ can boost resilience in older adults living with HIV. The goal is to determine if this intervention improves coping strategies and overall mental well-being. Participants will either attend sessions with educational videos and activities or engage in stress reduction activities without a resilience focus. It suits individuals over 50 who are current patients at the UAB HIV Clinic and have recently struggled with managing their HIV, such as missing appointments or having a detectable viral load. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental well-being for others in similar situations.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this resilience-building intervention is safe for aging individuals with HIV?

Research has shown that the RISE+ program is being tested to help older adults with HIV become more resilient and reduce stress. Similar programs have reported no serious side effects or harm. Participants in these activities have found them safe and acceptable.

The RISE+ program involves watching videos and engaging in activities independently to improve coping skills and social connections. These non-invasive activities, such as watching videos and writing, pose a lower risk compared to treatments involving medication or surgery.

Overall, safety information suggests that RISE+ is well-tolerated. Participants can feel confident that they are unlikely to experience negative effects from joining this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RISE+ Resilience Intervention because it takes a holistic approach to building resilience among aging individuals with HIV, focusing on psychoeducation and personal reflection. Unlike traditional treatments that may emphasize solely medical or pharmaceutical approaches, RISE+ integrates cognitive and social strategies, such as coping mechanisms and fostering social connections, to enhance overall well-being. This method empowers participants to actively engage in their mental and emotional health, potentially leading to more sustainable and meaningful improvements in their quality of life.

What evidence suggests that the RISE+ intervention could be effective for aging individuals with HIV?

In this trial, participants will join one of two groups: the RISE+ resilience intervention or the Stress Reduction Control. Research has shown that the RISE+ resilience program aids older people living with HIV by teaching coping skills and fostering social connections. Early results from past studies suggest these programs can enhance mental health and overall well-being for this group. The program includes activities such as educational videos and writing exercises that focus on stress management and strengthening social ties. Participants in previous studies demonstrated improvements in handling daily challenges and stress. Ongoing interest in further testing its effectiveness exists, but early signs are promising for its potential benefits. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people over 50 with HIV who are patients at the UAB HIV Clinic. They should have had some trouble managing their HIV in the last year, like missing a clinic visit or having a detectable viral load. People with serious mental health conditions like schizophrenia, bipolar disorder, or major depression cannot join.

Inclusion Criteria

My HIV has not been well-managed in the past year, with missed appointments or detectable viral loads.

I am 50 years old or older.

Current UAB HIV Clinic patient

Exclusion Criteria

Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression)

I have a neurological disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including a 14-day experience sampling method (ESM) protocol

2 weeks

1 visit (in-person)

Treatment

Participants attend four weekly two-hour group sessions, either in the RISE+ Resilience Intervention or Stress Reduction Control group

4 weeks

4 visits (in-person)

Post-Intervention Assessment

Participants complete a one-month post-intervention assessment including qualitative and quantitative feedback and a second ESM protocol

1 month

1 visit (in-person)

Follow-up

A three-month follow-up to assess health outcomes, including HIV treatment management abilities, health-related quality of life, depressive symptoms, HIV viral load, and medication adherence

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RISE+
• Stress Reduction Control

Trial Overview

The study is testing RISE+, an intervention designed to help build resilience and reduce stress in older adults living with HIV. It will be compared to a control group that receives standard stress reduction guidance.

How Is the Trial Designed?

Group I: RISE+ Resilience Intervention Experimental Treatment 1 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.

Group II: Stress Reduction Control Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

tandfonline.com

tandfonline.com/doi/full/10.2147/NRR.S538597?src=

Full article: Protocol for a Pilot Randomized Controlled Trial ...

This study tests a novel resilience intervention among older PLHIV and has several strengths, including focusing on an at-risk and understudied ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05314088

Study Details | NCT05314088 | Testing the Efficacy and ...

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

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8257766/

Examining the acceptability of a resilience building ...

Few interventions have targeted resilience resources in people living with HIV (PLWH). We tested the acceptability of an existing resilience intervention in ...

4.

researchgate.net

researchgate.net/publication/394985461_Protocol_for_a_Pilot_Randomized_Controlled_Trial_of_a_Resilience_Intervention_Adapted_for_Older_People_Living_with_HIV_Resilience_Intervention_for_Successful_Aging_Enhancement_RISE

(PDF) Protocol for a Pilot Randomized Controlled Trial of a ...

Patients and Methods This study plans to randomize 100 older PLHIV aged 45+ years with suboptimal HIV treatment management to either an ...

5.

doaj.org

doaj.org/article/8dd6510c942643fa88f13a2acde5ff7a

Resilience Intervention for Successful Aging Enhancement ...

Protocol for a Pilot Randomized Controlled Trial of a Resilience Intervention Adapted for Older People Living with HIV: Resilience Intervention for Successful ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40950841/

Resilience Intervention for Successful Aging Enhancement ...

This study tests a novel resilience intervention among older PLHIV and has several strengths, including focusing on an at-risk and understudied population, ...

7.

dovepress.com

dovepress.com/article/download/106216

Protocol for a Pilot Randomized Controlled Trial of a ...

The long-term goal of this study is to inform the development of effective and scalable interventions for building resilience among older PLHIV.

8.

withpower.com

withpower.com/trial/phase-human-immunodeficiency-virus-type-1-hiv-1-infection-5-2022-35e5d

Resilience-Building Intervention for Aging Individuals with ...

Trial Overview The study is testing RISE+, an intervention designed to help build resilience and reduce stress in older adults living with HIV. It will be ...