HIV Infections, Medication Adherence, Substance Use, Trauma
Conditions
Brief summary
The goal of this combination Type 1 hybrid and observational study is to evaluate the impact of a peer delivered intervention of acceptance and commitment therapy (ACT) + exercise + social support to address the substance (ab)use, violence, and AIDS/HIV (SAVA) to improve medication adherence for women living with HIV (WLWH). This intervention will be implemented by community based organizations that focus on WLWH across four counties. The main question it aims to answer are: * Will peer provision of ACT, exercise, and social support improve medication adherence for WLWH? * Will community based organizations be able to sustain the intervention after research is completed, and what changes will need to be made to sustain the intervention.
Detailed description
In the U.S. women living with HIV (WLWH) are less likely to engage in HIV care, be on antiretroviral therapy (ART), and achieve sustained viral suppression compared to men. The Substance (Ab)use, Violence/trauma, and HIV/AIDS (SAVA) syndemic is proposed to primarily contribute to gender-based differences in HIV outcomes.To meaningful address SAVA requires interventions that focus on each epidemic and transdiagnostic processes (shared mediators) including mood (depression/anxiety), negative beliefs and thoughts about HIV, and loneliness. The Women focused Encounters for Resilience, Independence, Strength, and Eudaimonia (WE RISE) intervention addresses SAVA by employing peer navigator (PN) delivered group-based acceptance and commitment therapy (ACT) + exercise + empathetic social support. The goal of this proposal is to evaluate and implement WE RISE for WLWH across four sites in Ending the HIV Epidemic (EHE) jurisdictions (San Diego, CA; Charlotte, NC; Atlanta, GA and Los Angeles, CA). This study is guided by a study advisory board (SAB) of 12 women living with and/or otherwise affected by HIV. At each site peers will be trained at the University of California San Diego (UCSD) to provide ACT, exercise and social support through didactic and experiential experiences and a workbook that guides them through the intervention. WE RISE delivery will be monitored by experts at UCSD and peers provided feedback through 6 months to encourage the development of mastery. The first phase of WE RISE is a type 1 hybrid study that will involve randomizing participants 1:1 to the WE RISE intervention or a local curated list of resources that focus on providing HIV care, therapy, exercise and social support. All participants in this phase will undergo assessments (HIV adherence, trauma symptoms, substance use, depression, anxiety, loneliness and others) at weeks 0, 8 (end of intervention), 24 and 48. All participants in this arm will also receive a Fitbit to track objective activity (e.g. step counts). This phase will pursue the following Aims: Aim 1: Evaluate short (week 8) and longer term (weeks 12, 24) effectiveness of WE RISE on HIV (↑ ART adherence, ↑ continuous viral suppression), trauma (↓ trauma symptoms), substance use (↓ days and amount of substance use) and transdiagnostic factors such as mood (↓depression, ↓anxiety), stigma and loneliness. Aim 2: Document the WE RISE implementation process by characterizing reach, effectiveness, adoption, implementation and maintenance (RE-AIM) by site for 24 weeks. Phase 2 of WE RISE is an observational study that will focus on sustainability of WE RISE once research funding is completed. We will encourage our partnering community based organizations to adapt WE RISE as they see fit to enable them to continue to provide the intervention. Participants will undergo the same assessment schedule as in phase 1. In this phase, the study team will continue to observe and document the intervention for adaptations made and persistence of intervention fidelity. This phase will focus on Aim 3. Aim 3: Transcreate alternate or additional IS that address site specific barriers and facilitators to optimize the effectiveness, maintenance and broader dissemination of WE RISE at 24 weeks while documenting the implementation process (RE-AIM) and site-specific adaptations using the Framework for Recording Adaptations and Modifications-Enhanced (FRAME) through 48 weeks.
Interventions
BEHAVIORALAcceptance and Commitment Therapy (ACT)
Participants will undergo ACT in combination with exercise and social support.
BEHAVIORALBody weight circuit training
Participants will learn and undergo body weight circuit training in combination with ACT and social support.
BEHAVIORALEmpathetic social support
Study participants will participate in empathetic social support
OTHERControl - list of resources
A local list of resources to access exercise, therapy and social support will be provided.
Sponsors
University of California, San Diego
Christie's Place
By His Stripes Wellness Center
Sister Love
APLA Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Study investigators and outcomes assessors will be blinded.
Intervention model description
Type 1 hybrid study randomizing particpants 1:1 to either WE RISE or control (list of resources). Followed by one arm observational study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is a woman 2. Able to read and understand English 3. Able to participate in a low intensity exercise program 4. HIV-seropositive 5. At risk substance use (any illegal or unprescribed drug), tobacco, marijuana or alcohol use (four or more drinks in one day or 8 or more in one week). 6. Reports missing more ART doses than previous months, or \> 5 in a month, or has a detectable HIV viral load 7. Experienced interpersonal violence 8. Able and willing to provide informed consent
Exclusion criteria
1. Unwilling to participate in video record sessions (used to evaluate the quality of the intervention) 2. Enrolled in hospice 3. Not willing or not able to comply with study advisory board group participation agreement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral therapy (ART) adherence by drug levels | Weeks 0, 8, 24 and 48. | All participants will undergo testing for ART in hair samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral therapy (ART) adherence by visual analog scale | Weeks 0, 8, 24 and 48. | Self reported measure of adherence on a scale (score range 0 to 100 higher scores indicate higher adherence) |
| Generalized Anxiety Disorder-7 | Weeks 0, 8, 24 and 48. | Measure of anxiety (score range 0 to 21, sum of items, 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety) |
| Patient Health Questionnaire - 9 | Weeks 0, 8, 24 and 48. | Measure of depression (score range 0-27, sum of items, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression) |
| Timeline follow back substance use | Weekly during weeks 0-8, 24 and 48. | Recall of substance use in the past week |
| International trauma questionnaire | Weeks 0, 8, 24 and 48. | Provides two components of scoring and interpretation: 1) categorical scoring for the diagnosis of post traumatic stress disorder, PTSD (two or more question 1 or 2, two or more question 3 or 4, two of more question 5 or 6, two or more question 7,8,9) and complex post traumatic stress disorder, CPTSD (two or more question 10 or 11, two or more questions 12 or 13, two or more questions 14 or 15, two or more questions 16,17,18). 2) Dimensional scores from 0 to 24 (higher scores indicate higher symptom severity) are also presented for the two subscales. For PTSD sum items 1 to 6, for disturbances of self organization sum items 10 to 15. |
Countries
United States
Contacts
CONTACTLiliana Harkness
CONTACTHelene Le
PRINCIPAL_INVESTIGATORMaile Karris, MD
UCSD
Outcome results
None listed