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

Purpose

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	Intervention	Phase
HIV Sexually Transmitted Infections	Behavioral: Multimedia WORTH Behavioral: Traditional WORTH Behavioral: Wellness Promotion	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

The proportion of condom protected acts of vaginal and anal intercourse [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]


Enrollment:	306
Study Start Date:	November 2009
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

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.


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
Study First Received:	February 4, 2013
Last Updated:	February 25, 2014
Health Authority:	United States: National Institute on Drug Abuse

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016

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