Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders
PACT
2 other identifiers
interventional
480
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedStudy Start
First participant enrolled
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2017
CompletedJuly 18, 2018
July 1, 2018
4.3 years
September 19, 2012
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Study Arms (2)
PACT + TAU
EXPERIMENTAL4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
TAU
ACTIVE COMPARATORTAU control condition delivered to the male participant
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Columbia University
New York, New York, 10027, United States
Related Publications (3)
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.
PMID: 21725249BACKGROUNDWimberly AS, Rose R, Levin K, Goddard-Eckrich D, Gilbert L, Wu E, Dasgupta A, Hunt T, Henry BF, El-Bassel N. Traumatic Life Events and Stressors: Associations With Substance Use Problems of Men Under Community Supervision. J Correct Health Care. 2023 Jun;29(3):190-197. doi: 10.1089/jchc.21.12.0137. Epub 2023 Apr 28.
PMID: 37116052DERIVEDEl-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.
PMID: 30924895DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nabila El-Bassel, DSW
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Social Work
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 21, 2012
Study Start
June 11, 2013
Primary Completion
September 30, 2017
Study Completion
September 30, 2017
Last Updated
July 18, 2018
Record last verified: 2018-07