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

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ClinicalTrials.gov Identifier: NCT01690494
Recruitment Status : Recruiting
First Posted : September 21, 2012
Last Update Posted : January 27, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases Unsafe Sex Substance-Related Disorders Behavioral: PACT Behavioral: TAU Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
Study Start Date : June 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PACT + TAU
4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
 Behavioral: PACT
Couple-based behavioral HIV/STI preventive intervention

Behavioral: TAU
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
Active Comparator: TAU
TAU control condition delivered to the male participant
 Behavioral: TAU
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites


Outcome Measures
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Primary Outcome Measures :
  1. Change in biologically confirmed sexually transmitted infections [ Time Frame: Baseline and up to 12 months post intervention ]
  2. Change in proportion of unprotected sexual acts [ Time Frame: Baseline and up to 12 months post intervention ]

Secondary Outcome Measures :
  1. Change in drug use [ Time Frame: Baseline and up to 12 months post intervention ]
  2. Change in utilization of drug treatment [ Time Frame: Baseline and up to 12 months post intervention ]
  3. Change in recidivism [ Time Frame: Up to 12 months post intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01690494


Contacts
Contact: Nabila El-Bassel, DSW 212-851-2431 ne5@columbia.edu

Locations
United States, New York
Columbia University Recruiting
New York, New York, United States, 10027
Contact: Dawn Goddard, MS    212-851-2120      
Sponsors and Collaborators
Columbia University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Nabila El-Bassel, DSW Columbia University
More Information
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Publications:

Responsible Party: Nabila El-Bassel, PhD, Professor of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT01690494     History of Changes
Other Study ID Numbers: AAAK0206
1R01DA033168-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nabila El-Bassel, PhD, Columbia University:
STI
sexually transmitted infection
HIV
criminal justice
 probation
couples
drug use

Additional relevant MeSH terms:
Substance-Related Disorders
Sexually Transmitted Diseases
Chemically-Induced Disorders
Mental Disorders
 Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female