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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

United States1 site

Holley Mears Building
Birmingham, Alabama, 35294

Other trials in United States

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 groups in NCT05314088
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.

3 Feb 202331 May 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
ClinicalTrials.gov ID: NCT05314088
Acronym / sponsor ID: RISE+ / IRB-300008740
Conditions: Resilience, HIV-1-infection, Stress, Psychological
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 3 Feb 2023 (actual)
Primary completion: 31 May 2025 (actual)
Study completion: 31 May 2025 (actual)
First posted: 6 Apr 2022 (actual)
Results: Posted 4 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.

Arm	Type	Receives
RISE+ Resilience Intervention	Experimental	Behavioral: RISE+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.
Stress Reduction Control	Placebo comparator	Behavioral: Stress Reduction ControlControl 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 may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RISE+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.	Behavioural	RISE+ Resilience Intervention
Stress Reduction ControlPlacebo 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.	Behavioural	Stress Reduction Control

Primary outcome

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.
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.

5 secondary outcomes

Medical Outcome Study RAND 36-Item Short-Form Health Survey (RAND 36SF)-Physical Health Related QOL Composite
Time frame: 1 month after intervention
Centers for Epidemiological Studies Depression Scale (CESD)
Time frame: 1 month after the intervenion
HIV Medication Adherence Visual Analogue Scale (VAS)
Time frame: 1 month after intervention
HIV Treatment Adherence Self Efficacy Scale (ASES)
Time frame: 1 month after intervention
HIV Viral Load
Time frame: 3 months after intervention

Results and safety

Results posted to the registry on 4 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RISE+ Resilience Intervention	41	25
Stress Reduction Control	41	32

Primary outcome: Experience Sampling Method (ESM) Resilience Resources-Hardiness

Time frame: immediately following the 4 week intervention. Mean (Standard Error). Unit: Units on a scale

Measure	RISE+ Resilience Intervention n = 25	Stress Reduction Control n = 21
baseline	2.56 (0.12)	2.53 (0.12)
1 month	2.53 (0.13)	2.63 (0.14)

Population analysed: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Only 36 control completed baseline texting, and 34 completed 1 month texting. While 41 in the RISE group completed baseline texting, only 31 completed 1 month texting. Furthermore, for resilience resources, participants had to have at least one text messaging instance with a stressor, which explains the analyzed sample sizes.

Primary outcome: Experience Sampling Method (ESM) Negative Stress Reactivity

Time frame: immediately following the 4 week intervention. Mean (Standard Error). Unit: Units on a scale

Measure	RISE+ Resilience Intervention n = 23	Stress Reduction Control n = 18
baseline	3.18 (0.60)	3.53 (0.61)
1 month	3.17 (0.72)	3.37 (0.92)

Population analysed: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Only 36 control completed baseline texting, and 34 completed 1 month texting. While 41 in the RISE group completed baseline texting, only 31 completed 1 month texting. Furthermore, for stress reactivity, participants had to have at least one text messaging instance with a stressor and one without a stressor, which explains the analyzed sample sizes.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RISE+ Resilience Intervention	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Stress Reduction Control	0 of 41 (0%)	0 of 41 (0%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Experience Sampling Method (ESM) Resilience Resources-Hardiness (time frame: immediately following the 4 week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.