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
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Condition or disease | Intervention/treatment | Phase |
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HIV Sexually Transmitted Infections | Behavioral: Multimedia WORTH Behavioral: Traditional WORTH Behavioral: Wellness Promotion | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Multimedia HIV/STI prevention
Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
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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.
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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.
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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.
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Behavioral: Wellness Promotion |
- The proportion of condom protected acts of vaginal and anal intercourse [ Time Frame: Up to 12 months ]
- Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis) [ Time Frame: Up to 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
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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.

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
United States, New York | |
Columbia University School of Social Work | |
New York, New York, United States, 10027 |
Principal Investigator: | Nabila El-Bassel, Ph.D. | Columbia University |
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 |