NCT02965014

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
652

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.2 years

First QC Date

November 14, 2016

Last Update Submit

January 6, 2025

Conditions

Condomless SexHuman Immunodeficiency Virus (HIV)Sexually Transmitted Infection (STI)Alcohol and Drug Use

Keywords

Human Immunodeficiency Virus (HIV)Sexually transmitted infections (STI)mHealthSubstance abuseViolenceVictimizationSexual Risk

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (9)

  • Increased Sexual Negotiation

    Baseline

  • Increased Sexual Negotiation

    6-month follow-up

  • Increased Sexual Negotiation

    12-month follow-up

  • Reduced Alcohol and Illicit Drug Use for a Subsample of Participants

    Baseline

  • Reduced Alcohol and Illicit Drug Use for a Subsample of Participants

    6-month follow-up

  • +4 more secondary outcomes

Study Arms (3)

Face-to-Face Young Women's CoOp (YWC)

EXPERIMENTAL

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)

mHealth Young Women's CoOp (YWC)

EXPERIMENTAL

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)

HIV Counseling and Testing

ACTIVE COMPARATOR

Participants will be offered standard HIV counseling and testing services.

Behavioral: HIV Counseling and Testing

Interventions

Face-to-Face Young Women's CoOp (YWC)BEHAVIORAL

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.

Face-to-Face Young Women's CoOp (YWC)
mHealth Young Women's CoOp (YWC)BEHAVIORAL

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.

mHealth Young Women's CoOp (YWC)
HIV Counseling and TestingBEHAVIORAL

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

HIV Counseling and Testing

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Identify as female
  • Identify as Black or African American
  • 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

You may not qualify if:

  • Participants may not be non-Black/African American

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Durham County Department of Public Health

Durham, North Carolina, 27701, United States

Location

Guilford County Department of Public Health - Greensboro

Greensboro, North Carolina, 27405, United States

Location

Guilford County Department of Public Health - High Point

High Point, North Carolina, 27260, United States

Location

Wake County Human Services

Raleigh, North Carolina, 27610, United States

Location

Related Publications (5)

  • 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.

    PMID: 37615878RESULT

  • 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. 2024 Aug;11(4):2256-2264. doi: 10.1007/s40615-023-01693-4. Epub 2023 Jul 26.

    PMID: 37495904RESULT

  • 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.

    PMID: 35532978RESULT

  • Opper CA, Browne FA, Howard BN, Zule WA, Wechsberg WM. Assessing Differences in mHealth Usability and App Experiences Among Young African American Women: Secondary Analysis of a Randomized Controlled Trial. JMIR Hum Factors. 2024 Apr 16;11:e51518. doi: 10.2196/51518.

    PMID: 38625721DERIVED

  • 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.

    PMID: 30081868DERIVED

MeSH Terms

Conditions

Unsafe SexAcquired Immunodeficiency SyndromeSexually Transmitted DiseasesSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Felicia Browne, ScD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 16, 2016

Study Start

January 18, 2017

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(4)