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

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Sexually Transmitted Diseases; Unsafe Sex
• Intervention / Treatment: Behavioral: PACT; Behavioral: TAU

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 Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in biologically confirmed sexually transmitted infections	Baseline and up to 12 months post intervention
Change in proportion of unprotected sexual acts	Baseline and up to 12 months post intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in drug use	Baseline and up to 12 months post intervention
Change in utilization of drug treatment	Baseline and up to 12 months post intervention
Change in recidivism	Up to 12 months post intervention

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General 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.
• El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Goodwin S, Tibbetts R, Almonte-Weston M, Hunt T. Effectiveness of a Couple-Based HIV and Sexually Transmitted Infection Prevention Intervention for Men in Community Supervision Programs and Their Female Sexual Partners: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191139. doi: 10.1001/jamanetworkopen.2019.1139.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2013
• Primary Completion (ACTUAL): September 30, 2017
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (ESTIMATE): September 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: HIV; STI; criminal justice; drug use; couples; probation; sexually transmitted infection
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Substance-Related Disorders; Sexually Transmitted Diseases
• Other Study ID Numbers: AAAK0206; 1R01DA033168-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No