PTSDWAVE-TWNCT04305977
Writing to Alleviate Violence Exposure for Transgender Women (WAVE-TW)
A study testing WAVE-TW in people with PTSD and Depression, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PTSD, Depression, Virus, Human Immunodeficiency
- What is being tested?
- WAVE-TW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UHealth Don Soffer Clinical Research Building
Miami, Florida, 33136
About this study
Official title: 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.
- Conditions
- PTSD, Depression, Virus, Human Immunodeficiency
- Being tested
- WAVE-TW
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVE-TWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WAVE-TW Arm | Other | All participants will receive the WAVE-TW intervention. Receives: Behavioral: WAVE-TW |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 11 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start22 Oct 2020
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Empower U Community Health Center, Miami Center for AIDS Research at the University of Miami Miller School of Medicine
- Responsible party
- Principal investigator, Sannisha K Dale, University of Miami
- Investigators
- Sannisha Dale, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305977
- Sponsor's protocol ID
- 20190722
- Acronym
- WAVE-TW
- Status last verified
- Feb 2023
- First submitted
- 6 Mar 2020
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Writing to Alleviate Violence Exposure for Transgender Women
- ClinicalTrials.gov ID
- NCT04305977
- Acronym / sponsor ID
- WAVE-TW / 20190722
- Conditions
- PTSD, Depression, Virus, Human Immunodeficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Empower U Community Health Center, Miami Center for AIDS Research at the University of Miami Miller School of Medicine
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WAVE-TW Arm | Other | Behavioral: WAVE-TWAll participants will receive the WAVE-TW intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Living with HIV
- Age 18 or older
- Detectable viral load within the past year
- Transgender female
- English speaking
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAVE-TWThe 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. | Behavioural | WAVE-TW Arm |
Primary outcome
Percentage of participant satisfaction
Time frame: Up to 11 months
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
Time frame: Up to 11 months
Mean number of visits attended by participants with an attendance rate of 70% or above as an indicator of good attendance.
4 secondary outcomes
Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5
Time frame: Baseline, 9 months
Change in Depressive symptoms as assessed by the CES-D Scale
Time frame: Baseline, 9 months
Change in HIV viral load levels
Time frame: Baseline, Up to 6 months
Number of Participants with Viral load suppression
Time frame: Up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sannisha Dale, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAVE-TW in people with PTSD and Depression, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participant satisfaction (time frame: Up to 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.