NC Young Women's CoOp

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Behavioral: Face-to-Face Young Women's CoOp (YWC)
* Behavioral: mHealth Young Women's CoOp (YWC)
* Behavioral: HIV Counseling and Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-to-Face Young Women's CoOp (YWC)<br>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)<br>* 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.<br>|
| Experimental: mHealth Young Women's CoOp (YWC)<br>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)<br>* 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.<br>|
| Active Comparator: HIV Counseling and Testing<br>Participants will be offered standard HIV counseling and testing services. | Behavioral: HIV Counseling and Testing<br>* Participants will be offered standard HIV counseling and testing (HCT).<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Immunodeficiency Virus (HIV), Sexually transmitted infections (STI), mHealth, Substance abuse, Violence, Victimization, Sexual Risk