NC Young Women's CoOp

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2020-03-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

mHealth Young Women's CoOp (YWC)

Intervention Type 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.

HIV Counseling and Testing

Participants will be offered standard HIV counseling and testing services.

Group Type ACTIVE_COMPARATOR

HIV Counseling and Testing

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

HIV Counseling and Testing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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