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

NCT ID: NCT01690494

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-11
• Study Completion Date: 2017-09-30

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.

Conditions

Sexually Transmitted Diseases; Unsafe Sex; Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PACT + TAU

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

Group Type: EXPERIMENTAL

PACT

Intervention Type: BEHAVIORAL

Couple-based behavioral HIV/STI preventive intervention

TAU

Intervention Type: BEHAVIORAL

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

TAU

TAU control condition delivered to the male participant

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: BEHAVIORAL

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

Interventions

PACT

Couple-based behavioral HIV/STI preventive intervention

Intervention Type: BEHAVIORAL

TAU

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nabila El-Bassel, PhD

Professor of Social Work

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nabila El-Bassel, DSW

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21725249 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37116052 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30924895 (View on PubMed)

Other Identifiers

1R01DA033168-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAK0206

Identifier Type: -

Identifier Source: org_study_id