NC Young Women's CoOp

NCT02965014 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2025-01-08

No results posted yet for this study

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.

Conditions

  • Condomless Sex
  • Human Immunodeficiency Virus (HIV)
  • Sexually Transmitted Infection (STI)
  • Alcohol and Drug Use

Interventions

BEHAVIORAL

Face-to-Face Young Women's CoOp (YWC)

Participants will be offered HIV counseling and testing (HCT) and a two-session face-to-face YWC intervention. The face-to-face sessions will include information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal.

BEHAVIORAL

mHealth Young Women's CoOp (YWC)

Participants will be offered HIV counseling and testing (HCT) and training on the mHealth application, which will include all content addressed in the face-to-face YWC delivery format. Participants will also be offered a tablet to complete the two-session intervention.

BEHAVIORAL

HIV Counseling and Testing

Participants will be offered standard HIV counseling and testing (HCT).

Sponsors & Collaborators

  • Durham County Department of Public Health

    collaborator UNKNOWN
  • Guilford County Department of Public Health

    collaborator UNKNOWN
  • Wake County Human Services

    collaborator UNKNOWN
  • RTI International

    lead OTHER

Principal Investigators

  • Felicia Browne, ScD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2020-03-17
Completion
2020-03-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965014 on ClinicalTrials.gov