Couple HIV Prevention for Drug Involved Male Offenders

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01690494
First received: September 19, 2012
Last updated: February 25, 2014
Last verified: February 2014

September 19, 2012
February 25, 2014
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 ] [ Designated as safety issue: No ]
  • Change in proportion of unprotected sexual acts [ Time Frame: Baseline and up to 12 months post intervention ] [ Designated as safety issue: No ]
  • Decrease in biologically confirmed sexually transmitted infections [ Time Frame: Baseline and up to 12 months post intervention ] [ Designated as safety issue: No ]
  • Decrease in proportion of unprotected sexual acts [ Time Frame: Baseline and up to 12 months post intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Change in utilization of drug treatment [ Time Frame: Baseline and up to 12 months post intervention ] [ Designated as safety issue: No ]
  • Change in recidivism [ Time Frame: Up to 12 months post intervention ] [ Designated as safety issue: No ]
  • Decrease in drug use [ Time Frame: Baseline and up to 12 months post intervention ] [ Designated as safety issue: No ]
  • Increase in utilization of drug treatment [ Time Frame: Baseline and up to 12 months post intervention ] [ Designated as safety issue: No ]
  • Decrease in recidivism [ Time Frame: Up to 12 months post intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Couple HIV Prevention for Drug Involved Male Offenders
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Sexually Transmitted Diseases
  • Unsafe Sex
  • Substance-Related Disorders
  • Behavioral: Connect II
    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: Connect II + TAU
    4-session Connect II delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
    Interventions:
    • Behavioral: Connect II
    • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
Not Provided
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
Both
18 Years and older
Yes
Contact: Nabila El-Bassel, DSW 212-851-2431 ne5@columbia.edu
United States
 
NCT01690494
AAAK0206, 1R01DA033168-01A1
Not Provided
Nabila El-Bassel, PhD, Columbia University
Columbia University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Nabila El-Bassel, DSW Columbia University
Columbia University
February 2014

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