Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Center for Court Innovation
Bronx Community Solutions
New York City Department of Probation
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01784809
First received: February 4, 2013
Last updated: February 25, 2014
Last verified: February 2014

February 4, 2013
February 25, 2014
November 2009
March 2013   (final data collection date for primary outcome measure)
The proportion of condom protected acts of vaginal and anal intercourse [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01784809 on ClinicalTrials.gov Archive Site
Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV
  • Sexually Transmitted Infections
  • 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

  • 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.
  • Behavioral: Wellness Promotion
  • Experimental: Multimedia HIV/STI prevention
    Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
    Intervention: Behavioral: Multimedia WORTH
  • 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.
    Intervention: Behavioral: Traditional WORTH
  • 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.
    Intervention: Behavioral: Wellness Promotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01784809
AAAD5608, R01DA025878
No
Nabila El-Bassel, PhD, Columbia University
Columbia University
  • Center for Court Innovation
  • Bronx Community Solutions
  • New York City Department of Probation
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Nabila El-Bassel, Ph.D. Columbia University
Columbia University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP