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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923141
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Adam Carrico, 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Substance Related Disorder Post Traumatic Stress Disorder Behavioral: Neutral Writing Behavioral: Expressive Writing Behavioral: Contingency Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Trauma Intervention for Affect Regulation, AIDS, and Substances
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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: Neutral Writing
Behavioral: Contingency Management
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: Expressive Writing
Behavioral: Contingency Management



Primary Outcome Measures :
  1. Reduction in HIV RNA Copies/mL [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Increase in T-helper (CD4+) cell count [ Time Frame: 6 months ]
  2. Reduction in HIV transmission risk [ Time Frame: 6 months ]
    self-reported condomless, serodiscordant sex and HIV viral load greater than 200 copies/mL

  3. Decrease in stimulant use [ Time Frame: 6 months ]
    self-report

  4. Decrease in stimulant use [ Time Frame: 6 months ]
    urine toxicology screening

  5. Decrease in post-traumatic stress disorder (PTSD) symptoms [ Time Frame: 6 months ]
    self-report measure: PTSD Checklist for DSM-5

  6. Decrease in depressive symptoms [ Time Frame: 6 months ]
    self-report measure: Centers for the Epidemiologic Study of Depression (CES-D)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Identify as a woman (cisgender or transgender)
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923141


Locations
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United States, Florida
Clinical Research Building
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Adam Carrico, Ph.D. University of Miami

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adam Carrico, Associate Professor of Public Health Sciences and Psychology, University of Miami
ClinicalTrials.gov Identifier: NCT02923141    
Other Study ID Numbers: 20160744
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adam Carrico, University of Miami:
substance use
trauma
HIV
viral load
women
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Disease
Substance-Related Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Immunologic Deficiency Syndromes
Immune System Diseases
Trauma and Stressor Related Disorders
Mental Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Chemically-Induced Disorders