Multimedia WORTH With Black Drug-Involved Women on Probation (NCT02391233) | Clinical Trial Compass
CompletedNot Applicable
Multimedia WORTH With Black Drug-Involved Women on Probation
United States354 participantsStarted 2015-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
Timeframe: Baseline and 12 months post-intervention
2
Change in the number of unprotected sex acts
Timeframe: Baseline and 12 months post-intervention