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

NCT ID: NCT04305977

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-10-15

Brief Summary

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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

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Conditions

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PTSD Depression Virus, Human Immunodeficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WAVE-TW Arm

All participants will receive the WAVE-TW intervention.

Group Type OTHER

WAVE-TW

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Empower U Community Health Center

UNKNOWN

Sponsor Role collaborator

Miami Center for AIDS Research at the University of Miami Miller School of Medicine

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Sannisha K Dale

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sannisha Dale, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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UHealth Don Soffer Clinical Research Building

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20190722

Identifier Type: -

Identifier Source: org_study_id

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