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

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ClinicalTrials.gov Identifier: NCT01690494

Recruitment Status : Recruiting

First Posted : September 21, 2012

Last Update Posted : January 27, 2017

See Contacts and Locations

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Nabila El-Bassel, PhD, Columbia University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Sexually Transmitted Diseases Unsafe Sex Substance-Related Disorders	Behavioral: PACT Behavioral: TAU	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	480 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
Study Start Date :	June 2013
Estimated Primary Completion Date :	July 2017
Estimated Study Completion Date :	July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted:	September 21, 2012 Key Record Dates
Last Update Posted:	January 27, 2017
Last Verified:	January 2017
Individual Participant Data (IPD) Sharing Statement:
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 Nabila El-Bassel, PhD, Columbia University:


STI sexually transmitted infection HIV criminal justice	probation couples drug use

Additional relevant MeSH terms:


Substance-Related Disorders Sexually Transmitted Diseases Chemically-Induced Disorders Mental Disorders	Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female

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