Writing to Alleviate Violence Exposure for Transgender Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Locations
- 1
- Primary Endpoint
- Percentage of participant satisfaction
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
WAVE-TW Arm
All participants will receive the WAVE-TW intervention.
Intervention: WAVE-TW (Behavioral)
Outcomes
Primary Outcomes
Percentage of participant satisfaction
Time Frame: Up to 11 months
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.
Number of Completed visits
Time Frame: Up to 11 months
Mean number of visits attended by participants with an attendance rate of 70% or above as an indicator of good attendance.
Secondary Outcomes
- Number of Participants with Viral load suppression(Up to 6 months)
- Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5(Baseline, 9 months)
- Change in Depressive symptoms as assessed by the CES-D Scale(Baseline, 9 months)
- Change in HIV viral load levels(Baseline, Up to 6 months)
Investigators
Sannisha K Dale
Associate Professor
University of Miami