HIV-1-infection, Resilience, Stress, Psychological
Conditions
Brief summary
This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.
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.
Interventions
BEHAVIORALRISE+
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.
BEHAVIORALStress Reduction Control
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.
Sponsors
University of Alabama at Birmingham
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Experience Sampling Method (ESM) Resilience Resources-Hardiness | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcome Study RAND 36-Item Short-Form Health Survey (RAND 36SF)-Physical Health Related QOL Composite | 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. |
| Centers for Epidemiological Studies Depression Scale (CESD) | 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 |
| HIV Medication Adherence Visual Analogue Scale (VAS) | 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. |
| HIV Treatment Adherence Self Efficacy Scale (ASES) | 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. |
| HIV Viral Load | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between 03/2023 and 05/2025 via our university HIV clinic by queries of electronic medical record (EMR) data yielding a list of patients meeting basic criteria that have consented to be contacted for future studies. Patients meeting basic eligibility criteria were called to gauge interest and if interested, completed a brief phone screen to determine final eligibility.
Pre-assignment details
One hundred and six participants were screened as eligible, meaning they met all eligibility criteria and were scheduled for a baseline visit. Of these, 82 completed baseline and were randomized (i.e., they were enrolled). No significant events occurred after enrollment but prior to assignment to a group/randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| 3-Item HIV Medication Adherence Scale | 85.1 Units on a scale STANDARD_DEVIATION 19.8 |
| Age, Continuous | 57.2 Years STANDARD_DEVIATION 6.7 |
| Brief Cope Avoidant | 1.9 Units on a scale STANDARD_DEVIATION 0.5 |
| Brief Cope Emotion Focused | 2.4 Units on a scale STANDARD_DEVIATION 0.6 |
| Brief Cope Problem Focused | 2.8 Units on a scale STANDARD_DEVIATION 0.6 |
| Center for Epidemiologic Studies Depression Scale (CESD) | 13.2 Units on a scale STANDARD_DEVIATION 8 |
| Connor Davidson Resilience Scale 10-item Scale (CDRS10) | 30.2 Unit on a scale STANDARD_DEVIATION 6.9 |
| Duke Social Support Index (DSSI) | 27.2 Units on a scale STANDARD_DEVIATION 6.7 |
| HIV Treatment Adherence Self Efficacy Scale (ASES) | 9.0 Units on a scale STANDARD_DEVIATION 1.4 |
| HIV Visual Analog Scale (HIV-VAS) | 91.0 Units on a scale STANDARD_DEVIATION 18.8 |
| Perceived Stress Scale | 14.7 Unit on a scale STANDARD_DEVIATION 8 |
| Personality in Intellectual Aging Contexts (PIC) Inventory Control Scale: Internal Locus of Control | 7.5 Units on a scale STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 41 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 26 Participants |
| The Revised HIV Stigma Scale (HSS-32) | 33.7 Units on a scale STANDARD_DEVIATION 7.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
None listed