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

HIV Clinical Trial

— Project WORTH  

Official title:

Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784809
• Other study ID #: AAAD5608
• Secondary ID: R01DA025878
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2013
• Last updated: February 25, 2014
• Start date: November 2009
• Est. completion date: March 2013

Study information

• Verified date: February 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institute on Drug Abuse
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

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
• 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.
• Wellness Promotion

Locations

Country	Name	City	State
United States	Columbia University School of Social Work	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Bronx Community Solutions, Center for Court Innovation, National Institute on Drug Abuse (NIDA), New York City Department of Probation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of condom protected acts of vaginal and anal intercourse		Up to 12 months	No
Secondary	Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)		Up to 12 months	No