Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders

Study Overview
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Brief Summary
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This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.

Detailed Description
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HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical intersecting public health issues for drug-involved men. Low income, Black and Hispanic men especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data suggest that the health disparity in HIV rates is actually increasing for Black men: current estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time. These HIV/STI transmission risks are fueled by high rates of poverty, incarceration, unemployment, and lack of access to health care and prevention services. The proposed study thus targets an underserved population at the epicenter of the epidemic in the U.S.

Official Title
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Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial

Conditions
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Sexually Transmitted Diseases, Unsafe Sex, Substance-Related Disorders

Intervention / Treatment
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* Behavioral: PACT
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples Both partners are aged 18 or older Identify each other as their primary sexual partner of opposite sex Relationship has existed at least 3 months At least one partner reports having unprotected vaginal or anal intercourse with the other partner in the past 90 days At least one partner reports exposure to an outside HIV risk in the past year Male partner reports and is verified by court records of being charged with a misdemeanor Male partner is currently under court supervision or probation Exclusion Criteria: Either partner shows evidence of significant psychiatric or could impairment as confirmed by the MacArthur Competence Assessment Tool during the screening eligibility interview. Either partner reports severe physical or sexual violence perpetrated by the other partner in the past year as measured on the Revised Conflict Tactics Scale Either partner is unable to commit to participate in the study through to completion Either partner reports that the couple is planning a pregnancy within the next 12 months Either partner is not fluent in English as determined during Informed Consent

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACT + TAU<br>4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant | Behavioral: PACT<br>* Couple-based behavioral HIV/STI preventive intervention<br>Behavioral: TAU<br>* Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites<br>|
| Active Comparator: TAU<br>TAU control condition delivered to the male participant | Behavioral: TAU<br>* Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biologically confirmed sexually transmitted infections |  | Baseline and up to 12 months post intervention | 
| Change in proportion of unprotected sexual acts |  | Baseline and up to 12 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in drug use |  | Baseline and up to 12 months post intervention | 
| Change in utilization of drug treatment |  | Baseline and up to 12 months post intervention | 
| Change in recidivism |  | Up to 12 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STI, sexually transmitted infection, HIV, criminal justice, probation, couples, drug use