Writing to Alleviate Violence Exposure for Transgender Women (WAVE-TW)
- Conditions
- PTSDDepressionVirus, Human Immunodeficiency
- Interventions
- Behavioral: WAVE-TW
- Registration Number
- NCT04305977
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WAVE-TW Arm WAVE-TW All participants will receive the WAVE-TW intervention.
- Primary Outcome Measures
Name Time Method Percentage of participant satisfaction 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 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 Outcome Measures
Name Time Method Number of Participants with Viral load suppression Up to 6 months 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.
Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5 Baseline, 9 months 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.
Change in Depressive symptoms as assessed by the CES-D Scale Baseline, 9 months 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.
Change in HIV viral load levels Baseline, Up to 6 months Viral suppression will be reported as the change in HIV viral load levels obtained from blood samples.
Trial Locations
- Locations (1)
UHealth Don Soffer Clinical Research Building
🇺🇸Miami, Florida, United States