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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

Conditions

Resilience Behavior Behavioral Symptoms HIV-1-infection Stress, Psychological

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 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.

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. Experience Sampling Method (ESM) Resilience Resources-Hardiness

    Time frame: immediately following the 4 week intervention

    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.

  2. Experience Sampling Method (ESM) Negative Stress Reactivity

    Time frame: immediately following the 4 week intervention

    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.

Secondary outcomes

  1. Medical Outcome Study RAND 36-Item Short-Form Health Survey (RAND 36SF)-Physical Health Related QOL Composite

    Time frame: 1 month after intervention

    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.

  2. Centers for Epidemiological Studies Depression Scale (CESD)

    Time frame: 1 month after the intervenion

    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

  3. HIV Medication Adherence Visual Analogue Scale (VAS)

    Time frame: 1 month after intervention

    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.

  4. HIV Treatment Adherence Self Efficacy Scale (ASES)

    Time frame: 1 month after intervention

    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.

  5. HIV Viral Load

    Time frame: 3 months after intervention

    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).

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 4, 2026

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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