Multimedia WORTH With Black Drug-Involved Women on Probation

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections; Chlamydia Trachomatis; Drug Use; HIV; Gonorrhea; Trichomonas
• Interventions: Behavioral: E-WORTH; Behavioral: Streamlined HIV Testing

• Registration Number: NCT02391233
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Study Start: 2015-11-15
• Primary Completion: 2019-06
• Study Completion: 2019-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 354

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV/STI Risk Reduction	Streamlined HIV Testing	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.
Streamlined HIV Testing Alone	Streamlined HIV Testing	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.
HIV/STI Risk Reduction	E-WORTH	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.

Primary Outcome Measures

Name	Time	Method
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.	Baseline and 12 months post-intervention
Change in the number of unprotected sex acts	Baseline and 12 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.	12-month
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
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
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
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
Comparative change in the number of unprotected sex acts	12-month

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States