Multimedia WORTH With Black Drug-Involved Women on Probation



Status:Active, not recruiting
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:7/21/2018
Start Date:November 15, 2015
End Date:June 2019

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

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.

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.

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.
We found this trial at
1
site
116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-851-2395
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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mi
from
New York, NY
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