Writing to Alleviate Violence Exposure for Transgender Women (WAVE-TW)

Study Overview
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Brief Summary
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WAVE - TW (Writing to Alleviate Violence Exposure for Transgender women living with HIV) is an intervention development study which aims to assess the feasibility and acceptability of a proposed trauma writing and adherence intervention that addresses Post-Traumatic Stress Disorder (PTSD) and depressive symptoms, antiretroviral therapy (ART) adherence and viral suppression among transgender women.

Official Title
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Writing to Alleviate Violence Exposure for Transgender Women

Conditions
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PTSD, Depression, Virus, Human Immunodeficiency

Intervention / Treatment
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* Behavioral: WAVE-TW


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living with HIV Age 18 or older Detectable viral load within the past year Transgender female English speaking Capable of completing and fully understanding the informed consent process and the study procedures History of trauma/abuse Exclusion Criteria: Unable to completely and fully understand the consent process and the study procedures. Significant interfering mental health symptoms (e.g., untreated active psychosis, active suicidality with a plan). Engaged in an intervention to address trauma symptoms and adherence within the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WAVE-TW Arm<br>All participants will receive the WAVE-TW intervention. | Behavioral: WAVE-TW<br>* The WAVE-TW open pilot trial of the intervention consists of 5 sessions conducted individually with each part participant. Each session lasts approximately 30-50 minutes. The first session will be the LifeSteps Adherence session that focuses on cognitive-behavioral and problem-solving techniques to promote adherence. The next four sessions will be dedicated to trauma writing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participant satisfaction | Perceptions about the participants' satisfaction with the proposed trauma writing and integrated adherence training intervention. The percentage of participants who report being either satisfied or very satisfied as captured by the Client Satisfaction Survey. | Up to 11 months | 
| Number of Completed visits | Mean number of visits attended by participants with an attendance rate of 70% or above as an indicator of good attendance. | Up to 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5 | Change in PTSD symptoms will be assessed using the self-reported PTSD Checklist from the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The questionnaire has 20 items with each item having a scoring range of 0-4 with the higher score indicating increased severity of PTSD symptoms. It has demonstrated good validity/reliability (α = .94). Given the small sample size and the primary aim of the open pilot trial of the intervention, we will cautiously examine the quantitative PTSD symptoms. | Baseline, 9 months | 
| Change in Depressive symptoms as assessed by the CES-D Scale | Change in depressive symptoms will be assessed using the self-report Center for Epidemiologic Studies Depression (CES-D) Scale. The CES-D is a 20-item measure with a total score ranging from 0-60 with the higher score indicating increased depressive symptoms. Given the small sample size and the primary aim of the open pilot trial of the intervention, we will cautiously examine the quantitative depressive symptoms. | Baseline, 9 months | 
| Change in HIV viral load levels | Viral suppression will be reported as the change in HIV viral load levels obtained from blood samples. | Baseline, Up to 6 months | 
| Number of Participants with Viral load suppression | Viral load suppression will be reported as the number of participants with detectable and not detectable viral load status as confirmed via laboratory testing of blood draw samples. | Up to 6 months |