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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Sexually Transmitted Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multimedia HIV/STI prevention

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

Group Type EXPERIMENTAL

Multimedia WORTH

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Traditional WORTH

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Wellness Promotion

Intervention Type BEHAVIORAL

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Wellness Promotion

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes