Hiv, Mental Health Issue
Conditions
Keywords
HIV, Black women, Trauma, Intersectional, Discrimination, Stigma, Medication adherence
Brief summary
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines
Interventions
BEHAVIORALSTEP-AD
This in-person STEP-AD intervention will consist of 10 sessions. Session 1: Life Steps Adherence Session 2: Psychoeducation on the treatment model Session 3: Substance Use and Enhancing Resilience Session 4: Trauma Impact Session 5: Cognitive Restructuring Session 6: Racial Discrimination Impact and Coping Session 7: HIV Stigma Impact and Coping Session 8: Gender-related Stressors and Coping Session 9: Body Image and Healthy Relationships Session 10: Practice, Review, and Relapse Prevention. Each session lasts for about 40 to 60 minutes.
BEHAVIORALEnhanced treatment as usual (E-TAU)
Participants assigned to the E-TAU condition will receive 10 in person sessions to ensure comparable contact time with study staff and identical incentives. The first session will consist of a session on healthy living with HIV (CDC content on HIV 101 \[highlights importance of engaging in care, adhering to medication, finding support\], nutrition, and physical activity. The remaining 9 sessions will consist of neutral (daily events) writing. Women will be asked to write a description of their plans for the next 24 hours.
Sponsors
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Black 2. Living with HIV 3. Cis-gender female 4. Age 18 or older 5. English speaking 6. Viral load non-suppression (\>200 ml) within the past year or a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months 7. History of trauma/abuse 8. Capable of completing and fully understanding the informed consent process and study procedures
Exclusion criteria
1. Unable to completely and fully understand the informed consent process and the study procedures 2. Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in viral suppression | Baseline up to 1.5 years | HIV viral load \<200 copies/ml time averaged. Measured by blood specimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in adherence to anti-retroviral medications questionnaire | Baseline up to 1.5 years | A list of 12 reasons why individuals may miss taking their ART (e.g., forgot, change in routine) will be used from the AIDS Clinical Trials Group. The minimum score is 0 (no endorsed reasons for missing medication) and maximum score is 36 (endorsing more reasons for missing ART medication). |
| Change in engagement in HIV care | Baseline up to 1.5 years | Number of kept versus number of scheduled visits verified by self-report. |
| Change in antiretroviral (ART) adherence | Baseline up to 1.5 years | A 3-item self-report instrument that will measure reported adherence to ART. Responses range from 1 to 6. Responses will be averaged (min average of 1, max average of 6) across items with higher scores indicating higher adherence to ART medication. |
| Change in Post-traumatic cognitions measured by PTCI | Baseline up to 1.5 years | The Posttraumatic Cognitions Inventory (PTCI) is a 36-item, self-report questionnaire, and each item is rated on a 7-point Likert scale that ranges from 1 (totally agree) to 7 (totally disagree). |
| Change in Post-traumatic Stress Disorder Diagnosis | Baseline up to 1.5 years | A structured mental health diagnostic interview will be administered to evaluate participants' mental health symptoms and whether they meet criteria for mental health diagnoses (e.g. Post-traumatic Stress Disorder). |
| Change in PTSD as measured by PCL-5 | Baseline up to 1.5 years | Measured by the Posttraumatic Stress Disorder Checklist (PCL)-5, a 20-item self-report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD severity. |
Countries
United States
Contacts
Primary ContactSannisha Dale, PhD
Backup ContactShine Research
Outcome results
None listed