Trauma Intervention for Affect Regulation, AIDS, and Substances

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Substance Related Disorder; Post Traumatic Stress Disorder

• Registration Number: NCT02923141
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-10-01
• Study First Posted: 2016-10-04
• Study Start: 2017-01
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in HIV RNA Copies/mL	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Research Building; 🇺🇸 Miami, Florida, United States