NCT04305977

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

March 6, 2020

Last Update Submit

February 15, 2023

Conditions

PTSDDepressionVirus, Human Immunodeficiency

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

  • Number of Participants with Viral load suppression

    Up to 6 months

Study Arms (1)

WAVE-TW Arm

OTHER

All participants will receive the WAVE-TW intervention.

Behavioral: WAVE-TW

Interventions

WAVE-TWBEHAVIORAL

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.

WAVE-TW Arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHealth Don Soffer Clinical Research Building

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sannisha Dale, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 12, 2020

Study Start

October 22, 2020

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)