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OpenTrials
Completed

NCT Number: NCT05314088

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holley Mears Building

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. resilience resources

    Time frame: immediately following the 4 week intervention

    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.

  2. stress reactivity

    Time frame: immediately following the 4 week intervention

    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 outcomes

  1. health related quality of life

    Time frame: 3 months after intervention

    Medical Outcomes Study HIV Health Survey

  2. depressive symptoms

    Time frame: 3 months after intervention

    Centers for Epidemiological Studies Depression Scale

  3. HIV medication adherence

    Time frame: 3 months after intervention

    Visual Analogue Scale ART adherence

  4. HIV Treatment Management Abilities

    Time frame: 3 months after intervention

    HIV Treatment Adherence Self-Efficacy Scale

  5. HIV Viral Load

    Time frame: 3 months after intervention

    HIV plasma viral load (copies per mL of plasma) extracted from medical records

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: RISE+

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2022
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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