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

Not Applicable

Completed

• Conditions: Substance-Related Disorders; Sexually Transmitted Diseases; Unsafe Sex
• Interventions: Behavioral: PACT; Behavioral: TAU

• Registration Number: NCT01690494
• Lead Sponsor: Columbia University

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.

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 Timeline

• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-21
• Study Start: 2013-06-11
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACT + TAU	PACT	4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
TAU	TAU	TAU control condition delivered to the male participant
PACT + TAU	TAU	4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in utilization of drug treatment	Baseline and up to 12 months post intervention
Change in recidivism	Up to 12 months post intervention
Change in drug use	Baseline and up to 12 months post intervention

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States