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

Depression Clinical Trial

— WAVE-TW  

Official title:

Writing to Alleviate Violence Exposure for Transgender Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04305977
• Other study ID #: 20190722
• Status: Withdrawn
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: February 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression
• HIV Infections
• PTSD
• Virus, Human Immunodeficiency

Intervention

Behavioral:
• WAVE-TW
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.

Locations

Country	Name	City	State
United States	UHealth Don Soffer Clinical Research Building	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Empower U Community Health Center, Miami Center for AIDS Research at the University of Miami Miller School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 (a = .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
Secondary	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
Secondary	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
Secondary	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