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OpenTrials
Completed

NCT Number: NCT02923141

Trauma Intervention for Affect Regulation, AIDS, and Substances

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Post Traumatic Stress Disorder RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance Related Disorder Substance-Related Disorders Trauma and Stressor Related Disorders Urogenital Diseases Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Building

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neutral writing

Behavioral

Expressive writing

Behavioral

Contingency Management

Behavioral

Primary outcomes

  1. Reduction in HIV RNA Copies/mL

    Time frame: 6 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: TIARAS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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