Trauma Intervention for Affect Regulation, AIDS, and Substances

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Substance Related Disorder; Post Traumatic Stress Disorder
• Interventions: Behavioral: Neutral Writing; Behavioral: Expressive Writing; Behavioral: Contingency Management

• 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

Arm && Interventions

Group	Intervention	Description
Neutral Writing + Contingency Management	Contingency Management	Participants will attend four attention-matched control sessions, consisting of face-to-face administration of psychological measures and neutral writing exercises. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result.
Expressive Writing + Contingency Management	Contingency Management	Participants will attend four expressive writing sessions focusing on traumatic or stressful events. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result.
Neutral Writing + Contingency Management	Neutral Writing	Participants will attend four attention-matched control sessions, consisting of face-to-face administration of psychological measures and neutral writing exercises. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result.
Expressive Writing + Contingency Management	Expressive Writing	Participants will attend four expressive writing sessions focusing on traumatic or stressful events. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result.

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