The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Project WORTH
Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
2 other identifiers
interventional
306
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv
Started Nov 2009
Typical duration for phase_2 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 27, 2014
February 1, 2014
3.3 years
February 4, 2013
February 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of condom protected acts of vaginal and anal intercourse
Up to 12 months
Secondary Outcomes (1)
Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)
Up to 12 months
Study Arms (3)
Multimedia HIV/STI prevention
EXPERIMENTALMultimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
Traditional HIV/STI prevention
ACTIVE COMPARATORTraditional 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.
Wellness Promotion
PLACEBO COMPARATORWellness 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Center for Court Innovationcollaborator
- Bronx Community Solutionscollaborator
- New York City Department of Probationcollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Columbia University School of Social Work
New York, New York, 10027, United States
Related Publications (3)
Slavin MN, West BS, Schreiber-Gregory D, Levin FR, Wingood G, Martino S, Tzilos Wernette G, Black C, El-Bassel N. Correlates of Unmet Need for Modern Contraception Among Reproductive-Aged Women Involved in New York City Criminal Legal Systems. Womens Health Rep (New Rochelle). 2024 Feb 16;5(1):132-142. doi: 10.1089/whr.2023.0177. eCollection 2024.
PMID: 38404679DERIVEDHochstatter 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.
PMID: 35171362DERIVEDEl-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.
PMID: 25372149DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nabila El-Bassel, Ph.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Willma and Albert Musher Professor of Social Work
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
November 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 27, 2014
Record last verified: 2014-02