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

Primary Purpose

HIV, Sexually Transmitted Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multimedia WORTH
Traditional WORTH
Wellness Promotion
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, STIs, Condom Use, Criminal Justice, Drug Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Columbia University School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Multimedia HIV/STI prevention

Traditional HIV/STI prevention

Wellness Promotion

Arm Description

Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.

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.

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.

Outcomes

Primary Outcome Measures

The proportion of condom protected acts of vaginal and anal intercourse

Secondary Outcome Measures

Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)

Full Information

First Posted
February 4, 2013
Last Updated
February 25, 2014
Sponsor
Columbia University
Collaborators
Center for Court Innovation, Bronx Community Solutions, New York City Department of Probation, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01784809
Brief Title
The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Acronym
Project WORTH
Official Title
Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Center for Court Innovation, Bronx Community Solutions, New York City Department of Probation, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Infections
Keywords
HIV, STIs, Condom Use, Criminal Justice, Drug Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimedia HIV/STI prevention
Arm Type
Experimental
Arm Description
Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
Arm Title
Traditional HIV/STI prevention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wellness Promotion
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Multimedia WORTH
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Traditional WORTH
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wellness Promotion
Primary Outcome Measure Information:
Title
The proportion of condom protected acts of vaginal and anal intercourse
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabila El-Bassel, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35171362
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.
Results Reference
derived
PubMed Identifier
25372149
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.
Results Reference
derived

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The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

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