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Completed

NCT Number: NCT01690494

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACT

Behavioral

Couple-based behavioral HIV/STI preventive intervention

TAU

Behavioral

Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites

Primary outcomes

  1. Change in biologically confirmed sexually transmitted infections

    Time frame: Baseline and up to 12 months post intervention

  2. Change in proportion of unprotected sexual acts

    Time frame: Baseline and up to 12 months post intervention

Secondary outcomes

  1. Change in drug use

    Time frame: Baseline and up to 12 months post intervention

  2. Change in utilization of drug treatment

    Time frame: Baseline and up to 12 months post intervention

  3. Change in recidivism

    Time frame: Up to 12 months post intervention

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PACT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2012
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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