Trauma Intervention for Affect Regulation, AIDS, and Substances

Study Overview
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Brief Summary
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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.

Official Title
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Trauma Intervention for Affect Regulation, AIDS, and Substances

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

Intervention / Treatment
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* Behavioral: Neutral Writing
* Behavioral: Expressive Writing
* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neutral Writing + Contingency Management<br>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<br> <br> Behavioral: Contingency Management<br> <br> |
| Active Comparator: Expressive Writing + Contingency Management<br>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<br> <br> Behavioral: Contingency Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in HIV RNA Copies/mL |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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substance use, trauma, HIV, viral load, women