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NC Young Women's CoOp

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ClinicalTrials.gov Identifier: NCT02965014
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Durham County Department of Public Health
Guilford County Department of Public Health
Wake County Human Services
Information provided by (Responsible Party):
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 substance-using women. 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, reduce substance use, and increase sexual negotiation among young (18-25 years) substance-using African American women who are sexually active and have not recently been tested for HIV in three NC counties.

Condition or disease Intervention/treatment Phase
Condomless Sex Human Immunodeficiency Virus (HIV) Sexually Transmitted Infection (STI) Alcohol and Drug Use Behavioral: Face-to-Face Young Women's CoOp (YWC) Behavioral: mHealth Young Women's CoOp (YWC) Behavioral: HIV Counseling and Testing Not Applicable

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 intervention to reduce sexual risk and increase sexual negotiation among up to 700 young sexually active and drug-using, African American women aged 18 to 25 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 substance-using young African American women who 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Young Women-Focused HIV Prevention: Seek & Test in North Carolina (NC) Clinics
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Face-to-Face Young Women's CoOp (YWC)
Participants will engage in a two-session face-to-face Young Women's CoOp (YWC) intervention.
Behavioral: Face-to-Face Young Women's CoOp (YWC)
Participants will receive HIV counseling and testing (HCT) and engage in 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 will receive training on the mobile health application mHealth Young Women's CoOp (YWC) and be given tablets with the mHealth application to complete the two-session intervention.
Behavioral: mHealth Young Women's CoOp (YWC)
Participants will receive 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 receive a tablet to complete the two-session intervention.

Active Comparator: HIV Counseling and Testing
Participants will receive standard HIV counseling and testing services.
Behavioral: HIV Counseling and Testing
Participants will receive standard HIV counseling and testing (HCT).




Primary Outcome Measures :
  1. Condomless Sex [ Time Frame: Baseline ]
    Self-reported frequency of condomless sex

  2. Condomless Sex [ Time Frame: 6 month follow up ]
    Self-reported frequency of condomless sex

  3. Condomless Sex [ Time Frame: 12 month follow up ]
    Self-reported frequency of condomless sex

  4. Frequency of Substance Use [ Time Frame: Baseline ]
    Frequency of using illicit drugs and alcohol

  5. Frequency of Substance Use [ Time Frame: 6 month follow up ]
    Frequency of using illicit drugs and alcohol

  6. Frequency of Substance Use [ Time Frame: 12 month follow up ]
    Frequency of using illicit drugs and alcohol


Secondary Outcome Measures :
  1. Increased Sexual Negotiation [ Time Frame: Baseline ]
    Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner

  2. Increased Sexual Negotiation [ Time Frame: 6 month follow up ]
    Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner

  3. Increased Sexual Negotiation [ Time Frame: 12 month follow up ]
    Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner

  4. Reduced Alcohol and Illicit Drug Use for a Subsample of Participants [ Time Frame: Baseline ]
    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

  5. Reduced Alcohol and Illicit Drug Use for a Subsample of Participants [ Time Frame: 6 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

  6. Reduced Alcohol and Illicit Drug Use for a Subsample of Participants [ Time Frame: 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

  7. Reduced Violence and Victimization for a Subsample of Participants [ Time Frame: Baseline ]
    Self-reported experiences of emotional, physical, and sexual abuse

  8. Reduced Violence and Victimization for a Subsample of Participants [ Time Frame: 6 month follow up ]
    Self-reported experiences of emotional, physical, and sexual abuse

  9. Reduced Violence and Victimization for a Subsample of Participants [ Time Frame: 12 month follow up ]
    Self-reported experiences of emotional, physical, and sexual abuse



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965014


Contacts
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Contact: Wendee Wechsberg, PhD 919-541-6422 wmw@rti.org

Locations
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United States, North Carolina
Durham County Department of Public Health Recruiting
Durham, North Carolina, United States, 27701
Contact    919-886-8813      
Guilford County Department of Public Health - Greensboro Recruiting
Greensboro, North Carolina, United States, 27405
Contact    336-686-7049      
Guilford County Department of Public Health - High Point Recruiting
High Point, North Carolina, United States, 27260
Contact    336-686-7049      
Wake County Human Services Recruiting
Raleigh, North Carolina, United States, 27610
Contact    919-798-6780      
Sponsors and Collaborators
RTI International
Durham County Department of Public Health
Guilford County Department of Public Health
Wake County Human Services
Investigators
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Principal Investigator: Wendee Wechsberg, PhD RTI International

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT02965014     History of Changes
Other Study ID Numbers: R01DA041009 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RTI International:
Human Immunodeficiency Virus (HIV)
Sexually transmitted infections (STI)
mHealth
Substance abuse
Violence
Victimization
Sexual Risk

Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Sexually Transmitted Diseases
Immune System Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Infection