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This three-arm cluster randomized trial will develop, test, and compare the efficacy of two delivery formats of the Women's CoOp (WC), 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 WC and evaluate the relative efficacy of a face-to-face (face-to-face WC), mobile Health application (mHealth WC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors, reduce substance use, and increase linkages to care 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 the receipt of health services among 700 young sexually active and drug-using, African American women aged 18 to 25 in three North Carolina counties. We will test the delivery of the woman-focused intervention conducted in two formats, face- to-face WC and mHealth WC, using a three-arm cluster-randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face WC; and (3) mobile health application mHealth WC that will be delivered on tablets using an interactive app. We will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new WC 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 WC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face WC and mHealth WC) relative to HCT with 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: and to assess access to, referral, and retention in health services, such as substance abuse treatment, reproductive health care, and other health care; (Aim 3) To estimate the total costs of implementing the face-to-face WC and mHealth WC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face WC and mHealth WC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Face-to-Face Women's CoOperative (WC), mHealth Women's CoOperative (WC), HIV Counseling and Testing
Not yet recruiting
Published on BioPortfolio: 2016-11-17T11:38:21-0500
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