Clinical trial NCT01784809: The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Official title: Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Sexually Transmitted Infections
Keywords: HIV
STIs
Condom Use
Criminal Justice
Drug Use
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Center for Court Innovation
name: Bronx Community Solutions
name: New York City Department of Probation
name: National Institute on Drug Abuse (NIDA)
First posted: 2013-02-06
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.

Detailed description: While it is clear that women inmates in jails and prisons bear a high burden of Human immunodeficiency virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), the effective development of prevention interventions for this high-risk group require an understanding of HIV risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system. HIV prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors. This study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.

Eligibility criteria: Inclusion Criteria:

* She is 18 or older.
* She is currently supervised by a criminal justice entity, such as a community court or probation.
* She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
* She reports any illicit drug use or binge drinking in the past 6 months.

Exclusion Criteria:In addition, potential participants will be ineligible if any of the following criteria are met:

* Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
* The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:

  * Having sex with more than one partner
  * Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
  * Sharing injection drug use needles or equipment
* The woman is actively trying to get pregnant/have a baby.
* Inability to complete informed consent process due to a psychiatric or cognitive impairment.
* The participant was born male.

Primary outcomes:
measure: The proportion of condom protected acts of vaginal and anal intercourse
timeFrame: Up to 12 months
Secondary outcomes:
measure: Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Social Work
state: New York
Study officials:
affiliation: Columbia University
name: Nabila El-Bassel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hochstatter KR, Slavin MN, Gilbert L, Goddard-Eckrich D, El-Bassel N. Availability of informal social support and the impact on health services utilization among women in community corrections who engage in substance use and risky sexual behavior: New York City, 2009-2012. Health Justice. 2022 Feb 16;10(1):6. doi: 10.1186/s40352-022-00170-0.
citation: El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Hunt T, Epperson M, Shaw SA, Rowe J, Almonte M, Witte S. Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH. PLoS One. 2014 Nov 5;9(11):e111528. doi: 10.1371/journal.pone.0111528. eCollection 2014.