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NCT02923141 Clinical Trial

Trauma Intervention for Affect Regulation, AIDS, and Substances

Post Traumatic Stress Disorder Clinical Trial

— TIARAS  

Official title:
Trauma Intervention for Affect Regulation, AIDS, and Substances

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02923141
Other study ID # 20160744
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date July 2018

Study information
Verified date September 2018
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HIV positive

- woman or trans woman

- substance use

- elevated PTSD symptoms

- HIV care difficulties

Exclusion Criteria:

- not HIV positive

- no substance use

- men

- no HIV care difficulties

- no history of trauma

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Neutral Writing

• Expressive Writing

• Contingency Management

Locations
Country Name City State
United States Clinical Research Building Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in HIV RNA Copies/mL 6 months
Secondary Increase in T-helper (CD4+) cell count 6 months
Secondary Reduction in HIV transmission risk self-reported condomless, serodiscordant sex and HIV viral load greater than 200 copies/mL 6 months
Secondary Decrease in stimulant use self-report 6 months
Secondary Decrease in stimulant use urine toxicology screening 6 months
Secondary Decrease in post-traumatic stress disorder (PTSD) symptoms self-report measure: PTSD Checklist for DSM-5 6 months
Secondary Decrease in depressive symptoms self-report measure: Centers for the Epidemiologic Study of Depression (CES-D) 6 months
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