ResilienceRISE+NCT05314088
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
A study testing RISE+ in people with Resilience and HIV-1-infection, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Resilience, HIV-1-infection, Stress, Psychological
- What is being tested?
- RISE+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 31 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.
Read the 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.
- Conditions
- Resilience, HIV-1-infection, Stress, Psychological
- Being tested
- RISE+, Stress Reduction Control
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE+Behavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RISE+ Resilience Intervention | Experimental | 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. Receives: Behavioral: RISE+ |
| Stress Reduction Control | Placebo comparator | 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). Receives: Behavioral: Stress Reduction Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately following the 4 week intervention
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start3 Feb 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Pariya L. Fazeli, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314088
- Sponsor's protocol ID
- IRB-300008740
- Other IDs
- 1R21AG076377-01A1
- Acronym
- RISE+
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2022
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No