The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders (Project WORTH)
|ClinicalTrials.gov Identifier: NCT01784809|
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Sexually Transmitted Infections||Behavioral: Multimedia WORTH Behavioral: Traditional WORTH Behavioral: Wellness Promotion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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:
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|
- 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 ]
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|