NC Young Women's CoOp

Not Applicable

Terminated

• Conditions: Condomless Sex; Alcohol and Drug Use; Human Immunodeficiency Virus (HIV); Sexually Transmitted Infection (STI)
• Interventions: Behavioral: mHealth Young Women's CoOp (YWC); Behavioral: Face-to-Face Young Women's CoOp (YWC); Behavioral: HIV Counseling and Testing

• Registration Number: NCT02965014
• Lead Sponsor: RTI International

Brief 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.

Detailed Description

The purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused HIV risk-reduction intervention to reduce sexual risk among up to 700 young sexually active African American women aged 18 to 25 who use drugs in three North Carolina counties. The researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face YWC and mHealth YWC, using a three-arm cross-over randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face YWC; and (3) mHealth YWC that will be delivered on tablets using an interactive app. The researchers will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new YWC intervention and recruitment strategies using formative methods to engage young African American women who use substances and have not recently been tested for HIV, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mHealth YWC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face YWC and mHealth YWC) relative to HCT with up to 700 young women aged 18 to 25 in three North Carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (Aim 3) To estimate the total costs of implementing the face-to-face YWC and mHealth YWC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face YWC and mHealth YWC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-16
• Study Start: 2017-01-18
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 652

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
mHealth Young Women's CoOp (YWC)	mHealth Young Women's CoOp (YWC)	Participants in this arm will be offered training on the mobile health application mHealth Young Women's CoOp (YWC) and offered tablets with the mHealth application to complete the two-session intervention.
Face-to-Face Young Women's CoOp (YWC)	Face-to-Face Young Women's CoOp (YWC)	Participants in this arm will be offered a two-session face-to-face Young Women's CoOp (YWC) intervention.
HIV Counseling and Testing	HIV Counseling and Testing	Participants will be offered standard HIV counseling and testing services.

Primary Outcome Measures

Name	Time	Method
Condomless Sex	12-month follow-up	Self-reported frequency of condomless sex
Frequency of Substance Use	12-month follow-up	Frequency of using illicit drugs and alcohol

Secondary Outcome Measures

Name	Time	Method
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants	12-month follow-up	Self-reported amount of alcohol consumption and drugs used; Urine drug screen will be used to test for recent illicit drug use; Breathalyzer test results will be used to assess recent alcohol use
Reduced Violence and Victimization for a Subsample of Participants	12-month follow-up	Self-reported experiences of emotional, physical, and sexual abuse
Increased Sexual Negotiation	12-month follow-up	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner

Trial Locations

Locations (4)

Guilford County Department of Public Health - Greensboro; 🇺🇸 Greensboro, North Carolina, United States

Wake County Human Services; 🇺🇸 Raleigh, North Carolina, United States

Durham County Department of Public Health; 🇺🇸 Durham, North Carolina, United States

Guilford County Department of Public Health - High Point; 🇺🇸 High Point, North Carolina, United States