ClinicalTrials.gov
ClinicalTrials.gov Menu

Multimedia WORTH With Black Drug-Involved Women on Probation (E-WORTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02391233
Recruitment Status : Active, not recruiting
First Posted : March 18, 2015
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Fortune Society
University of Pennsylvania
State University of New York - Downstate Medical Center
RTI International
Duke University
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Louisa Gilbert, Columbia University

Brief Summary:
The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as Black) women drug users in probation sites in New York City (NYC), compared to streamlined HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. The primary outcomes will be to reduce cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex acts.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infections HIV Gonorrhea Trichomonas Chlamydia Trachomatis Drug Use Behavioral: E-WORTH Behavioral: Streamlined HIV Testing Not Applicable

Detailed Description:
This randomized controlled trial will be conducted with 420 drug-involved Black women at 5 probation sites located in communities in NYC heavily affected by HIV and STIs. Eligible women will be randomly assigned to: (1) WORTH consisting of an individual evidence-based Streamlined HIV Testing session followed by a 4-session group-based multimedia HIV intervention (WORTH) or (2) an individual Streamlined HIV Testing session alone (Streamlined HIV Testing), which will serve as the comparison condition. Both conditions will be delivered by Fortune providers at the 5 sites. Self-reported data on behavioral outcomes will be collected from participants via audio computer-assisted self-interview (ACASI). Primary STI outcomes will be measured via biological assay for infection by Neisseria gonorrhea, trichomonas, and Chlamydia trachomatis, the most common STIs found among women in NYC. Women who meet eligibility criteria will undergo a pre-intervention assessment. This assessment will last approximately 60 minutes, consisting of demographic information, history of criminal justice involvement, drug and alcohol use and dependence, sexual and drug-related HIV behaviors, HIV treatment and care, intimate partner violence, depression and posttraumatic Stress Disorder (PTSD) , service utilization, and social support. Research assistants (RAs) will schedule repeated assessments with participants that will take place at baseline and at 3, 6, and 12 months post-intervention. Each participant will be asked to obtain one vaginal specimen for STI testing by inserting a sterile Dacron-tipped swab about 2.5 inches or as far as comfortable into the vagina, rotating it for 15 to 30 seconds, and removing it. The vaginal swabs are placed into separate specimen transport packaging.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Multimedia HIV/STI Prevention for Black Drug-Involved Women on Probation
Actual Study Start Date : November 15, 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIV/STI Risk Reduction
This intervention tests the comparative effectiveness of E-WORTH, streamlined HIV Testing and a 5-week multimedia intervention on primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation.
Behavioral: E-WORTH
E-WORTH (Empowering African-American Women on the Road to Health) consists of 1 Streamlined HIV Testing session followed by 5 one-and-a-half hour group sessions that will be delivered by a probation provider at the probation site. The main multimedia components used in the E-WORTH: (1) Narrativity; (2) Skill acquisition using simulated video vignettes that provides instruction and demonstration of core skills (e.g., safer sex negotiation and problem-solving skills, technical condom use skills) using culturally congruent role models; (3) Individual interactive exercises and logs that are designed to enhance participant's recall of core knowledge and tracking of their individual progress in reducing risky behaviors and achieving risk reduction goals; and a (4) Facilitator interactive guide.

Behavioral: Streamlined HIV Testing
In this intervention Black Women on Probation receive streamlined HIV Testing alone to test primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation.

Active Comparator: Streamlined HIV Testing Alone
This intervention tests the comparative effectiveness of streamlined HIV Testing alone on primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation.
Behavioral: Streamlined HIV Testing
In this intervention Black Women on Probation receive streamlined HIV Testing alone to test primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation.




Primary Outcome Measures :
  1. Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas. [ Time Frame: Baseline and 12 months post-intervention ]
  2. Change in the number of unprotected sex acts [ Time Frame: Baseline and 12 months post-intervention ]

Secondary Outcome Measures :
  1. Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas as moderated by participant race, age and other socio-demographics and psychosocial client characteristics [ Time Frame: 12-months ]
  2. Change in the number of unprotected sex acts as moderated by participant race, age and other socio-demographics and psychosocial client characteristics infection rates, drug use and projected number of HIV cases averted at the 12-month follow-up. [ Time Frame: 12-month ]
  3. Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas. [ Time Frame: 12-month ]
  4. Comparative change in the number of unprotected sex acts [ Time Frame: 12-month ]
  5. Change in cumulative incidence of biologically confirmed STIs as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society [ Time Frame: 6-month ]
  6. Change in the number of unprotected sex acts as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society [ Time Frame: 6-month ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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:

  • 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.

Information from the National Library of Medicine

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): NCT02391233


Locations
United States, New York
Columbia University
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Fortune Society
University of Pennsylvania
State University of New York - Downstate Medical Center
RTI International
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Louisa Gilbert, Ph.D. Columbia University
Principal Investigator: Nabila El-Bassel, Ph.D. Columbia University
Study Director: Elwin Wu, Ph.D. Columbia University
Study Director: Timothy Hunt, LCSW Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louisa Gilbert, Co-Director, Social Intervention Group, Columbia University School of Social Work, New York / Associate Professor, Columbia University School of Social Work, New York, Columbia University
ClinicalTrials.gov Identifier: NCT02391233     History of Changes
Other Study ID Numbers: AAAN8409
1R01DA038122-01 ( U.S. NIH Grant/Contract )
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Louisa Gilbert, Columbia University:
Effectiveness intervention
Cost-effectiveness intervention
HIV prevention
Sexually transmitted infections prevention
Multimedia evidence-based intervention
Drug-users
Black/African-American women
Probation
HIV testing

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Trichomonas Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Protozoan Infections
Gonorrhea
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Parasitic Diseases