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

Primary Purpose

Sexually Transmitted Diseases, Unsafe Sex, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACT
TAU
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring STI, sexually transmitted infection, HIV, criminal justice, probation, couples, drug use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PACT + TAU

TAU

Arm Description

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

TAU control condition delivered to the male participant

Outcomes

Primary Outcome Measures

Change in biologically confirmed sexually transmitted infections
Change in proportion of unprotected sexual acts

Secondary Outcome Measures

Change in drug use
Change in utilization of drug treatment
Change in recidivism

Full Information

First Posted
September 19, 2012
Last Updated
July 16, 2018
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01690494
Brief Title
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders
Acronym
PACT
Official Title
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2013 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Unsafe Sex, Substance-Related Disorders
Keywords
STI, sexually transmitted infection, HIV, criminal justice, probation, couples, drug use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PACT + TAU
Arm Type
Experimental
Arm Description
4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
TAU control condition delivered to the male participant
Intervention Type
Behavioral
Intervention Name(s)
PACT
Intervention Description
Couple-based behavioral HIV/STI preventive intervention
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
Primary Outcome Measure Information:
Title
Change in biologically confirmed sexually transmitted infections
Time Frame
Baseline and up to 12 months post intervention
Title
Change in proportion of unprotected sexual acts
Time Frame
Baseline and up to 12 months post intervention
Secondary Outcome Measure Information:
Title
Change in drug use
Time Frame
Baseline and up to 12 months post intervention
Title
Change in utilization of drug treatment
Time Frame
Baseline and up to 12 months post intervention
Title
Change in recidivism
Time Frame
Up to 12 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabila El-Bassel, DSW
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21725249
Citation
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.
Results Reference
background
PubMed Identifier
30924895
Citation
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.
Results Reference
derived

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

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