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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Columbia University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01690494
First received: September 19, 2012
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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 Intervention
Sexually Transmitted Diseases
Unsafe Sex
Substance-Related Disorders
Behavioral: PACT
Behavioral: TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Columbia University:

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

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

Estimated Enrollment: 480
Study Start Date: June 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 ( US NIH Grant/Contract Award Number )
Study First Received: September 19, 2012
Last Updated: January 26, 2017
Individual Participant Data  
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 Columbia University:
STI
sexually transmitted infection
HIV
criminal justice
probation
couples
drug use

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

ClinicalTrials.gov processed this record on April 21, 2017