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

This study is currently recruiting participants.
Verified January 2017 by Nabila El-Bassel, PhD, Columbia University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690494
First Posted: September 21, 2012
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University
September 19, 2012
September 21, 2012
January 27, 2017
June 2013
July 2017   (Final data collection date for primary outcome measure)
  • 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 ]
  • Decrease in biologically confirmed sexually transmitted infections [ Time Frame: Baseline and up to 12 months post intervention ]
  • Decrease in proportion of unprotected sexual acts [ Time Frame: Baseline and up to 12 months post intervention ]
Complete list of historical versions of study NCT01690494 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Decrease in drug use [ Time Frame: Baseline and up to 12 months post intervention ]
  • Increase in utilization of drug treatment [ Time Frame: Baseline and up to 12 months post intervention ]
  • Decrease in recidivism [ Time Frame: Up to 12 months post intervention ]
Not Provided
Not Provided
 
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Sexually Transmitted Diseases
  • Unsafe Sex
  • Substance-Related Disorders
  • 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
  • Experimental: PACT + TAU
    4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
    Interventions:
    • Behavioral: PACT
    • Behavioral: TAU
  • Active Comparator: TAU
    TAU control condition delivered to the male participant
    Intervention: Behavioral: TAU
El-Bassel N, Gilbert L, Wu E, Witte SS, Chang M, Hill J, Remien RH. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):198-206. doi: 10.1097/QAI.0b013e318229eab1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
July 2017
July 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Nabila El-Bassel, DSW 212-851-2431 ne5@columbia.edu
United States
 
 
NCT01690494
AAAK0206
1R01DA033168-01A1 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Nabila El-Bassel, PhD, Columbia University
Columbia University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Nabila El-Bassel, DSW Columbia University
Columbia University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP