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

Columbia University

Status: Completed

Conditions: Sexually Transmitted Diseases; Substance-Related Disorders; Unsafe Sex

Treatments: Behavioral: TAU; Behavioral: PACT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01690494

1R01DA033168-01A1 (U.S. NIH Grant/Contract)

AAAK0206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 2 patient groups

PACT + TAU

Experimental group

Description:

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

Treatment:

Behavioral: PACT

Behavioral: TAU

TAU

Active Comparator group

Description:

TAU control condition delivered to the male participant

Treatment:

Behavioral: TAU