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

Writing to Alleviate Violence Exposure for Transgender Women

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 Overview

• Status: Withdrawn
• Conditions: Depression; PTSD; Virus, Human Immunodeficiency
• Intervention / Treatment: Behavioral: WAVE-TW

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • UHealth Don Soffer Clinical Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WAVE-TW Arm; All participants will receive the WAVE-TW 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Empower U Community Health Center; Miami Center for AIDS Research at the University of Miami Miller School of Medicine
• Investigators: Principal Investigator: Sannisha Dale, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20190722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No