NC Young Women's CoOp

Young Women-Focused HIV Prevention: Seek & Test in North Carolina (NC) Clinics

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 652
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Durham County Department of Public Health
    • Greensboro, North Carolina, United States, 27405
      • Guilford County Department of Public Health - Greensboro
    • High Point, North Carolina, United States, 27260
      • Guilford County Department of Public Health - High Point
    • Raleigh, North Carolina, United States, 27610
      • Wake County Human Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Active Comparator: HIV Counseling and Testing; Participants will be offered standard HIV counseling and testing services.	Behavioral: HIV Counseling and Testing; Participants will be offered standard HIV counseling and testing (HCT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condomless Sex	Self-reported frequency of condomless sex	Baseline
Condomless Sex	Self-reported frequency of condomless sex	6-month follow-up
Condomless Sex	Self-reported frequency of condomless sex	12-month follow-up
Frequency of Substance Use	Frequency of using illicit drugs and alcohol	Baseline
Frequency of Substance Use	Frequency of using illicit drugs and alcohol	6-month follow-up
Frequency of Substance Use	Frequency of using illicit drugs and alcohol	12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased Sexual Negotiation	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner	Baseline
Increased Sexual Negotiation	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner	6-month follow-up
Increased Sexual Negotiation	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner	12-month follow-up
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants	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	Baseline
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants	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	6-month follow-up
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants	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	12-month follow-up
Reduced Violence and Victimization for a Subsample of Participants	Self-reported experiences of emotional, physical, and sexual abuse	Baseline
Reduced Violence and Victimization for a Subsample of Participants	Self-reported experiences of emotional, physical, and sexual abuse	6-month follow-up
Reduced Violence and Victimization for a Subsample of Participants	Self-reported experiences of emotional, physical, and sexual abuse	12-month follow-up

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: Durham County Department of Public Health; Guilford County Department of Public Health; Wake County Human Services
• Investigators: Principal Investigator: Wendee Wechsberg, PhD, RTI International

Publications and helpful links

General Publications

• Browne FA, Wechsberg WM, Kizakevich PN, Zule WA, Bonner CP, Madison AN, Howard BN, Turner LB. mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina. BMC Public Health. 2018 Aug 6;18(1):982. doi: 10.1186/s12889-018-5796-8.
• Browne FA, Washio Y, Zule WA, Wechsberg WM. HIV-related risk among justice-involved young African American women in the U.S. South. Health Justice. 2023 Aug 24;11(1):32. doi: 10.1186/s40352-023-00228-7.
• Osakwe CE, van der Drift I, Opper CA, Zule WA, Browne FA, Wechsberg WM. Condom Use at Last Sex and Sexual Negotiation Among Young African American Women in North Carolina: Context or Personal Agency. J Racial Ethn Health Disparities. 2023 Jul 26. doi: 10.1007/s40615-023-01693-4. Online ahead of print.
• Watkins RL, Browne FA, Kizakevich PN, Howard BN, Turner LB, Eckhoff R, Wechsberg WM. An Evidence-Based HIV Risk-Reduction Intervention for Young African American Women in the US South Using mHealth: Adaptation and Development Study. JMIR Form Res. 2022 May 9;6(5):e34041. doi: 10.2196/34041.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimated): November 16, 2016

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: mHealth; Violence; Human Immunodeficiency Virus (HIV); Sexual Risk; Victimization; Substance abuse; Sexually transmitted infections (STI)
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Disease Attributes; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Sexually Transmitted Diseases
• Other Study ID Numbers: R01DA041009 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Analytic data sets will be prepared in accordance with the "Privacy Rule" of the Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/) as "limited data sets" in which names and other personal health identifiers are removed, birthdays have been converted to age at intake, and other dates have been changed to be days before or after the date of intake. Because there are fewer than 20,000 people in the data set, HIPAA says we cannot ensure that it is completely "de-identified"; consequently, HIPAA requires that we treat it as a "limited data set" and that we have a data sharing agreement (DSA) in place before giving anyone access to the client-level data. After the main findings are published, we will welcome other researchers who want to analyze the data in other ways. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and seeking the permission of the PI and her team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No