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

Substance-Related Disorders Clinical Trial

— PACT  

Official title:

Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690494
• Other study ID #: AAAK0206
• Secondary ID: 1R01DA033168-01A
• Status: Completed
• Phase: N/A
• Start date: June 11, 2013
• Est. completion date: September 30, 2017

Study information

• Verified date: July 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Substance-Related Disorders
• Unsafe Sex

Intervention

Behavioral:
• PACT
Couple-based behavioral HIV/STI preventive intervention
• TAU
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biologically confirmed sexually transmitted infections		Baseline and up to 12 months post intervention
Primary	Change in proportion of unprotected sexual acts		Baseline and up to 12 months post intervention
Secondary	Change in drug use		Baseline and up to 12 months post intervention
Secondary	Change in utilization of drug treatment		Baseline and up to 12 months post intervention
Secondary	Change in recidivism		Up to 12 months post intervention