Clinical trial NCT01690494: Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders
Official title: Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Unsafe Sex
Substance-Related Disorders
Keywords: STI
sexually transmitted infection
HIV
criminal justice
probation
couples
drug use
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-09-21
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in biologically confirmed sexually transmitted infections
timeFrame: Baseline and up to 12 months post intervention
measure: Change in proportion of unprotected sexual acts
timeFrame: Baseline and up to 12 months post intervention
Secondary outcomes:
measure: Change in drug use
timeFrame: Baseline and up to 12 months post intervention
measure: Change in utilization of drug treatment
timeFrame: Baseline and up to 12 months post intervention
measure: Change in recidivism
timeFrame: Up to 12 months post intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Nabila El-Bassel, DSW
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.