Back to resultsWriting to Alleviate Violence Exposure for Transgender Women (WAVE-TW) (WAVE-TW)
Primary Purpose
PTSD, Depression, Virus, Human Immunodeficiency
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WAVE-TW
Sponsored by
About this trial
This is an interventional treatment trial for PTSD
Eligibility Criteria
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
Sites / Locations
- UHealth Don Soffer Clinical Research Building
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
WAVE-TW Arm
Arm Description
All participants will receive the WAVE-TW intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Change in HIV viral load levels
Viral suppression will be reported as the change in HIV viral load levels obtained from blood samples.
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.
Full Information
NCT ID
NCT04305977
First Posted
March 6, 2020
Last Updated
February 15, 2023
Sponsor
University of Miami
Collaborators
Empower U Community Health Center, Miami Center for AIDS Research at the University of Miami Miller School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04305977
Brief Title
Writing to Alleviate Violence Exposure for Transgender Women (WAVE-TW)
Acronym
WAVE-TW
Official Title
Writing to Alleviate Violence Exposure for Transgender Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
There was enrollment in the qualitative phase that proceeded this planned open pilot trial. However, community partner experienced barriers to recruitment and enrollment in the context of COVID and needed prioritize non-research functions.
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Empower U Community Health Center, Miami Center for AIDS Research at the University of Miami Miller School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Virus, Human Immunodeficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WAVE-TW Arm
Arm Type
Other
Arm Description
All participants will receive the WAVE-TW intervention.
Intervention Type
Behavioral
Intervention Name(s)
WAVE-TW
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participant satisfaction
Description
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.
Time Frame
Up to 11 months
Title
Number of Completed visits
Description
Mean number of visits attended by participants with an attendance rate of 70% or above as an indicator of good attendance.
Time Frame
Up to 11 months
Secondary Outcome Measure Information:
Title
Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5
Description
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.
Time Frame
Baseline, 9 months
Title
Change in Depressive symptoms as assessed by the CES-D Scale
Description
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.
Time Frame
Baseline, 9 months
Title
Change in HIV viral load levels
Description
Viral suppression will be reported as the change in HIV viral load levels obtained from blood samples.
Time Frame
Baseline, Up to 6 months
Title
Number of Participants with Viral load suppression
Description
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.
Time Frame
Up to 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sannisha Dale, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHealth Don Soffer Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Writing to Alleviate Violence Exposure for Transgender Women (WAVE-TW)
We'll reach out to this number within 24 hrs