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Couple HIV Prevention for Drug Involved Male Offenders

This study is not yet open for participant recruitment.
Verified October 2012 by Columbia University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, DSW, Columbia University
ClinicalTrials.gov Identifier:
NCT01690494
First received: September 19, 2012
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Sexually Transmitted Diseases
Unsafe Sex
Substance-Related Disorders
 Behavioral: Connect II
Behavioral: TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Couple HIV Prevention for Drug Involved Male Offenders: An Effectiveness Trial

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 480
Study Start Date: February 2013
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Connect II + TAU
4-session Connect II delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
New York, New York, United States, 10027
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, DSW, Professor of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT01690494     History of Changes
Other Study ID Numbers: AAAK0206, 1R01DA033168-01A1
Study First Received: September 19, 2012
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

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
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013