NC Young Women's CoOp

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02965014
• Other study ID #: R01DA041009
• Status: Terminated
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: March 17, 2020

Study information

• Verified date: November 2023
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 652
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol and Drug Use
• Condomless Sex
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes
• Sexually Transmitted Diseases
• Sexually Transmitted Infection (STI)

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

Locations

Country	Name	City	State
United States	Durham County Department of Public Health	Durham	North Carolina
United States	Guilford County Department of Public Health - Greensboro	Greensboro	North Carolina
United States	Guilford County Department of Public Health - High Point	High Point	North Carolina
United States	Wake County Human Services	Raleigh	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	Durham County Department of Public Health, Guilford County Department of Public Health, Wake County Human Services

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condomless Sex	Self-reported frequency of condomless sex	Baseline
Primary	Condomless Sex	Self-reported frequency of condomless sex	6-month follow-up
Primary	Condomless Sex	Self-reported frequency of condomless sex	12-month follow-up
Primary	Frequency of Substance Use	Frequency of using illicit drugs and alcohol	Baseline
Primary	Frequency of Substance Use	Frequency of using illicit drugs and alcohol	6-month follow-up
Primary	Frequency of Substance Use	Frequency of using illicit drugs and alcohol	12-month follow-up
Secondary	Increased Sexual Negotiation	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner	Baseline
Secondary	Increased Sexual Negotiation	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner	6-month follow-up
Secondary	Increased Sexual Negotiation	Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner	12-month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Reduced Violence and Victimization for a Subsample of Participants	Self-reported experiences of emotional, physical, and sexual abuse	Baseline
Secondary	Reduced Violence and Victimization for a Subsample of Participants	Self-reported experiences of emotional, physical, and sexual abuse	6-month follow-up
Secondary	Reduced Violence and Victimization for a Subsample of Participants	Self-reported experiences of emotional, physical, and sexual abuse	12-month follow-up