The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders (Project WORTH)

Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

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.

Study Overview

• Status: Completed
• Conditions: HIV; Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: Multimedia WORTH; Behavioral: Traditional WORTH; Behavioral: Wellness Promotion

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.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimedia HIV/STI prevention; Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.	Behavioral: Multimedia WORTH; The Multimedia WORTH intervention features the same core elements as the original version, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance group learning and individualized feedback. Participants will interact with Multimedia WORTH at two levels: (1) group materials will be delivered via computer projection onto a screen and (2) participants will complete individual activities and create journal logs tracking their progress on personalized goals on their personal user accounts using laptop computers. The computer multimedia support tool includes text, imagery, animations, audio and video in a format that guide the facilitator's delivery of the intervention. ***To view pilot features of the Multimedia WORTH intervention in development, please visit the following web address: http://ccnmtl.columbia.edu/projects/worth/presentation
Active Comparator: Traditional HIV/STI prevention; Traditional WORTH is a 4-session group-based HIV/STI and drug abuse prevention intervention that covers the same content as Multimedia WORTH without the use of interactive videos, computerized assessments, and other audiovisual tools.	Behavioral: Traditional WORTH; The basic format of each WORTH session remains consistent following a sequence of 5 steps: (1) an opening (quote, song, poem) which will provide a brief culturally relevant point of inspiration to engage participants (2) Check-in to review material from the previous session, and to discuss any incidents where participants engaged in risk behaviors and to acknowledge positive ways in which women used new skills to avoid HIV risk; (3) a discussion to raise awareness of links between IPV, drug-related activities, and HIV risks; (4) a skills-building component relevant to the discussion; and (5) review and update participant needs, homework assigned for skills-building at home, and a closing ritual. The WORTH intervention consists of four 2-hour group sessions that are led by a female facilitator.
Placebo Comparator: Wellness Promotion; Wellness Promotion is a 4-session group based intervention that aims to improve diet, physical fitness and well-being which is designed as an attentional control condition.	Behavioral: Wellness Promotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of condom protected acts of vaginal and anal intercourse	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)	Up to 12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA); Center for Court Innovation; Bronx Community Solutions; New York City Department of Probation
• Investigators: Principal Investigator: Nabila El-Bassel, Ph.D., Columbia University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 25, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: HIV; STIs; Criminal Justice; Condom Use; Drug Use
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: AAAD5608; R01DA025878 (U.S. NIH Grant/Contract)