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

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ClinicalTrials.gov Identifier: NCT01784809
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 27, 2014
Sponsor:
Collaborators:
Center for Court Innovation
Bronx Community Solutions
New York City Department of Probation
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Sexually Transmitted Infections Behavioral: Multimedia WORTH Behavioral: Traditional WORTH Behavioral: Wellness Promotion Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Study Start Date : November 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of condom protected acts of vaginal and anal intercourse [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis) [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784809


Locations
United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Center for Court Innovation
Bronx Community Solutions
New York City Department of Probation
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Nabila El-Bassel, Ph.D. Columbia University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nabila El-Bassel, PhD, Willma and Albert Musher Professor of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT01784809     History of Changes
Other Study ID Numbers: AAAD5608
R01DA025878 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by Nabila El-Bassel, PhD, Columbia University:
HIV
STIs
Condom Use
Criminal Justice
Drug Use

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female