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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA033168-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACT + TAU | Experimental | 4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant |
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| TAU | Active Comparator | TAU control condition delivered to the male participant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACT | Behavioral | Couple-based behavioral HIV/STI preventive intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabila El-Bassel, DSW | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21725249 | Background | 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. | |
| 42366304 | Derived | Goddard-Eckrich D, Sardana SM, Henry BF, Downey DL, Gilbert L, Stringer KL, Chang M, Wu E, Thomas BV, Bolden LA, Mckenna N, Abbas BT, Prichard C, Baholli B, El-Bassel N, Hunt T. "Why not take that pill?": A Mixed-Methods Study of Gender, Risk Perception, and PrEP Uptake Among Drug-Involved Heterosexual Couples Under Community Supervision. AIDS Behav. 2026 Jun 29. doi: 10.1007/s10461-026-05169-4. Online ahead of print. |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D047568 | Unsafe Sex |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| TAU |
| Behavioral |
Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites |
|
| Up to 12 months post intervention |
| 37116052 | Derived | Wimberly 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. |
| 30924895 | Derived | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |