Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders (PACT)
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ClinicalTrials.gov Identifier: NCT01690494 |
Recruitment Status
:
Recruiting
First Posted
: September 21, 2012
Last Update Posted
: January 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexually Transmitted Diseases Unsafe Sex Substance-Related Disorders | Behavioral: PACT Behavioral: TAU | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 480 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial |
Study Start Date : | June 2013 |
Estimated Primary Completion Date : | July 2017 |
Estimated Study Completion Date : | July 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: PACT + TAU
4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
|
Behavioral: PACT
Couple-based behavioral HIV/STI preventive intervention
Behavioral: TAU
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
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Active Comparator: TAU
TAU control condition delivered to the male participant
|
Behavioral: TAU
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
|
- Change in biologically confirmed sexually transmitted infections [ Time Frame: Baseline and up to 12 months post intervention ]
- Change in proportion of unprotected sexual acts [ Time Frame: Baseline and up to 12 months post intervention ]
- Change in drug use [ Time Frame: Baseline and up to 12 months post intervention ]
- Change in utilization of drug treatment [ Time Frame: Baseline and up to 12 months post intervention ]
- Change in recidivism [ Time Frame: Up to 12 months post intervention ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690494
Contact: Nabila El-Bassel, DSW | 212-851-2431 | ne5@columbia.edu |
United States, New York | |
Columbia University | Recruiting |
New York, New York, United States, 10027 | |
Contact: Dawn Goddard, MS 212-851-2120 |
Principal Investigator: | Nabila El-Bassel, DSW | Columbia University |
Publications:
Responsible Party: | Nabila El-Bassel, PhD, Professor of Social Work, Columbia University |
ClinicalTrials.gov Identifier: | NCT01690494 History of Changes |
Other Study ID Numbers: |
AAAK0206 1R01DA033168-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | September 21, 2012 Key Record Dates |
Last Update Posted: | January 27, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Nabila El-Bassel, PhD, Columbia University:
STI sexually transmitted infection HIV criminal justice |
probation couples drug use |
Additional relevant MeSH terms:
Substance-Related Disorders Sexually Transmitted Diseases Chemically-Induced Disorders Mental Disorders |
Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |