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

September 25, 2018 updated by: Adam Carrico, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Clinical Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neutral Writing + 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.
Behavioral: Contingency Management
Behavioral: Neutral Writing
Active Comparator: Expressive Writing + 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.
Behavioral: Contingency Management
Behavioral: Expressive Writing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in HIV RNA Copies/mL
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Adam Carrico, Ph.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 1, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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