The effectiveness of a group-based computerized HIV/STI prevention intervention for black women who use drugs in the criminal justice system: study protocol for E-WORTH (Empowering African-American Women on the Road to Health), a Hybrid Type 1 randomized controlled trial

Karen Johnson, Louisa Gilbert, Timothy Hunt, Elwin Wu, Lisa Metsch, Dawn Goddard-Eckrich, Stanley Richards, Rick Tibbetts, Jessica C Rowe, Milton L Wainberg, Nabila El-Bassel, Karen Johnson, Louisa Gilbert, Timothy Hunt, Elwin Wu, Lisa Metsch, Dawn Goddard-Eckrich, Stanley Richards, Rick Tibbetts, Jessica C Rowe, Milton L Wainberg, Nabila El-Bassel

Abstract

Background: This paper describes the study protocol of a hybrid type I randomized controlled trial that evaluates the effectiveness and cost-effectiveness of implementing Empowering African-American Women on the Road to Health (E-WORTH), an Afrocentric, group-based, computerized human immunodeficiency virus (HIV)/sexually transmitted infection (STI) prevention intervention for controlled substance-using black women in community corrections settings in New York City.

Methods/design: We provide an overview of E-WORTH's hybrid type I design, which is guided by the Consolidated Framework for Implementation Research (CFIR). E-WORTH combines HIV/STI and intimate partner violence (IPV) prevention components and tests the comparative effectiveness of E-WORTH and streamlined HIV testing versus streamlined HIV testing alone in decreasing biologically confirmed HIV and STI incidence, sexual risk, and IPV, as well as in improving access to HIV and STI prevention services and care.

Discussion: This paper provides an overview of E-WORTH's intervention protocol and serves as a framework for using hybrid type I designs, guided by the CFIR conceptual framework, to evaluate HIV/STI and IPV prevention interventions in community corrections settings. We discuss how E-WORTH's hybrid type I design advances implementation science through its effectiveness and cost-effectiveness aims as well as through a mixed-methods study that evaluates multilevel theory-driven factors (structural, organizational, staffing, and client) guided by the CFIR that influences the implementation of E-WORTH in a criminal justice setting. This study also addresses the novel challenges and opportunities of implementing an intervention that targets specific racial subgroup(s) in a community corrections setting that services all populations, implementing a group-based intervention with technological components in such settings, and employing community-based participatory research strategies to guide recruitment and retention efforts.

Trial registration: ClinicalTrials.gov, NCT02391233 . Registered on 17 March 2015.

Conflict of interest statement

Ethics approval and consent to participate

This research was performed in accordance with the Declaration of Helsinki and approved by the institutional review board at Columbia University (no. AAAN8409). Informed consent to participate in the study was obtained from participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Conceptual framework for hybrid type I features the multilevel conceptual framework for the E-WORTH intervention and identifies applicable key Consolidated Framework for Implementation Research (CFIR) constructs [52] that enhance or diminish the delivery of Empowering African-American Women on the Road to Health (E-WORTH) and streamlined HIV testing in community corrections sites from early engagement through adoption. The figure also depicts the study’s intervention and control arms along with the primary and secondary outcomes. ART Antiretroviral therapy, HIV Human immunodeficiency virus, STI Sexually transmitted infection
Fig. 2
Fig. 2
Empowering African-American Women on the Road to Health (E-WORTH) intervention flow. The figure depicts E-WORTH’s Consolidated Standards of Reporting Trials (CONSORT) diagram and provides a visual overview of all key stages in the intervention and control arms from outreach and screening through the 12-month follow-up assessment. HIV Human immunodeficiency virus
Fig. 3
Fig. 3
Empowering African-American Women on the Road to Health (E-WORTH) participant Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. Provides an overview of the schedule and time commitment related to the intervention and control arms
Fig. 4
Fig. 4
Empowering African-American Women on the Road to Health (E-WORTH) core elements and sessions. The figure provides an overview of each intervention session. It also provides an overview of the core elements (components) of the intervention. HIV Human immunodeficiency virus, IPV Intimate partner violence, STI Sexually transmitted infection
Fig. 5
Fig. 5
Empowering African-American Women on the Road to Health (E-WORTH) project Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. Provider study-related items. The figure provides an overview of each study time point related to provider assessments and interviews. CASI Computer-assisted self-interview, NGO Nongovernmental organization

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