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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 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: February 2, 2015

Last verified: February 2015

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: PACT Behavioral: TAU


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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:

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

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:	June 2013
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

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

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:

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.


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
Study First Received:	September 19, 2012
Last Updated:	February 2, 2015
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 Chemically-Induced Disorders Genital Diseases, Female	Genital Diseases, Male Infection Mental Disorders Virus Diseases

ClinicalTrials.gov processed this record on March 01, 2015

To Top