Multimedia WORTH With Black Drug-Involved Women on Probation

HIV Clinical Trial

— E-WORTH  

Official title:

Multimedia HIV/STI Prevention for Black Drug-Involved Women on Probation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391233
• Other study ID #: AAAN8409
• Secondary ID: 1R01DA038122-01
• Status: Completed
• Phase: N/A
• Start date: November 15, 2015
• Est. completion date: September 2019

Study information

• Verified date: July 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• 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:

• 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.

Related Conditions & MeSH terms

• Chlamydia Trachomatis
• Drug Use
• Gonorrhea
• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections
• Trichomonas

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Columbia University	Duke University, Fortune Society, National Institute on Drug Abuse (NIDA), RTI International, State University of New York - Downstate Medical Center, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.		Baseline and 12 months post-intervention
Primary	Change in the number of unprotected sex acts		Baseline and 12 months post-intervention
Secondary	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		12-months
Secondary	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.		12-month
Secondary	Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.		12-month
Secondary	Comparative change in the number of unprotected sex acts		12-month
Secondary	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		6-month
Secondary	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		6-month