TerminatedNot Applicable

NC Young Women's CoOp

Stopped: Due to the COVID-19 pandemic, this health department-based trial ended early to limit utilizing clinic services and resources and to ensure participant and staff safety. This termination primarily affected the 12-month follow-up appointments.

United States652 participantsStarted 2017-01-18

Plain-language summary

This three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. The current study will develop a revised version of the YWC and evaluate the relative efficacy of a face-to-face (face-to-face YWC), mobile Health application (mHealth YWC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) African American women who use substances and are sexually active and have not recently been tested for HIV in three NC counties.

Who can participate

Age range

18 Years – 25 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.

Selected Inclusion Criteria: * Identify as female * Identify as Black or African American * 18-25 years of age * Have used alcohol or drugs in greater quantity or for a longer period of time than intended within the past 30 days Exclusion Criteria: * Participants may not be non-Black/African American

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

Condomless Sex

Timeframe: Baseline

Condomless Sex

Timeframe: 6-month follow-up

Condomless Sex

Timeframe: 12-month follow-up

Frequency of Substance Use

Timeframe: Baseline

Frequency of Substance Use

Timeframe: 6-month follow-up

Frequency of Substance Use

Timeframe: 12-month follow-up

Trial details

NCT IDNCT02965014

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-17

View on ClinicalTrials.gov More Condomless Sex trials

Plain-language summary

Who can participate

Age range

18 Years – 25 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.