NC Young Women's CoOp



Status:Recruiting
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 25
Updated:3/17/2019
Start Date:January 18, 2017
End Date:July 2020
Contact:Wendee Wechsberg, PhD
Email:wmw@rti.org
Phone:919-541-6422

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

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.

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.

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
We found this trial at
4
sites
Raleigh, North Carolina 27610
Phone: 919-798-6780
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Raleigh, NC
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Durham, North Carolina
Phone: 919-886-8813
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Durham, NC
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1203 Maple Street
Greensboro, North Carolina 27405
Phone: 336-686-7049
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Greensboro, NC
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501 East Green Drive
High Point, North Carolina 27260
Phone: 336-686-7049
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High Point, NC
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