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Trauma Intervention for Affect Regulation, AIDS, and Substances (TIARAS)

Primary Purpose

Human Immunodeficiency Virus, Substance Related Disorder, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neutral Writing
Expressive Writing
Contingency Management
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring substance use, trauma, HIV, viral load, women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neutral Writing + Contingency Management

Expressive Writing + Contingency Management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction in HIV RNA Copies/mL

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2016
Last Updated
September 25, 2018
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02923141
Brief Title
Trauma Intervention for Affect Regulation, AIDS, and Substances
Acronym
TIARAS
Official Title
Trauma Intervention for Affect Regulation, AIDS, and Substances
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Substance Related Disorder, Post Traumatic Stress Disorder
Keywords
substance use, trauma, HIV, viral load, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neutral Writing + Contingency Management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Expressive Writing + Contingency Management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Writing
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Primary Outcome Measure Information:
Title
Reduction in HIV RNA Copies/mL
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Increase in T-helper (CD4+) cell count
Time Frame
6 months
Title
Reduction in HIV transmission risk
Description
self-reported condomless, serodiscordant sex and HIV viral load greater than 200 copies/mL
Time Frame
6 months
Title
Decrease in stimulant use
Description
self-report
Time Frame
6 months
Title
Decrease in stimulant use
Description
urine toxicology screening
Time Frame
6 months
Title
Decrease in post-traumatic stress disorder (PTSD) symptoms
Description
self-report measure: PTSD Checklist for DSM-5
Time Frame
6 months
Title
Decrease in depressive symptoms
Description
self-report measure: Centers for the Epidemiologic Study of Depression (CES-D)
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Identify as a woman (cisgender or transgender)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Carrico, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31407212
Citation
Jemison D, Jackson S, Oni O, Cats-Baril D, Thomas-Smith S, Batchelder A, Rodriguez A, Dilworth SE, Metsch LR, Jones D, Feaster DJ, O'Cleirigh C, Ironson G, Carrico AW. Pilot Randomized Controlled Trial of a Syndemics Intervention with HIV-Positive, Cocaine-Using Women. AIDS Behav. 2019 Sep;23(9):2467-2476. doi: 10.1007/s10461-019-02625-2.
Results Reference
derived

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Trauma Intervention for Affect Regulation, AIDS, and Substances

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