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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

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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.
Appendix
Available only for authorised users
Literature
1.
Altice FL, et al. Correlates of HIV infection among incarcerated women: implications for improving detection of HIV infection. J Urban Health. 2005;82(2):312–26.CrossRefPubMedPubMedCentral
2.
3.
El-Bassel N, et al. Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH. PLoS One. 2014;9(11):e111528.CrossRefPubMedPubMedCentral
4.
Rowell-Cunsolo TL, El-Bassel N, Hart CL. Black Americans and incarceration: a neglected public health opportunity for HIV risk reduction. J Health Care Poor Underserved. 2016;27(1):114–30.CrossRefPubMedPubMedCentral
5.
El-Bassel N, et al. Women in community corrections in New York City: HIV infection and risks. Int J STD AIDS. 2017;28(2):160–9.CrossRefPubMed
6.
Pelligrino N, et al. Incarcerated black women in the southern USA: a narrative review of STI and HIV risk and implications for future public health research, practice, and policy. J Racial Ethn Health Disparities. 2017;4(1):9–18.CrossRefPubMed
7.
8.
9.
10.
11.
12.
13.
14.
Koch DW, Lee J, Lee K. Coloring the war on drugs: arrest disparities in black, brown, and white. Race Soc Probl. 2016;8(4):313–25.CrossRef
15.
16.
17.
Belenko S, et al. HIV risk behaviors, knowledge, and prevention education among offenders under community supervision: a hidden risk group. AIDS Educ Prev. 2004;16(4):367–85.CrossRefPubMed
18.
Adimora AA, Schoenbach VJ. Social context, sexual networks, and racial disparities in rates of sexually transmitted infections. J Infect Dis. 2005;191(Suppl 1):115–22.CrossRef
19.
Adimora AA, Schoenbach VJ, Doherty IA. HIV and African Americans in the southern United States: sexual networks and social context. Sex Transm Dis. 2006;33(Suppl 7):39–45.CrossRef
20.
Adimora AA, Schoenbach VJ, Floris-Moore MA. Ending the epidemic of heterosexual HIV transmission among African Americans. Am J Prev Med. 2009;37(5):468–71.CrossRefPubMedPubMedCentral
21.
Gilbert L, et al. Efficacy of a computerized intervention on HIV and intimate partner violence among substance-using women in community corrections: a randomized controlled trial. Am J Public Health. 2016;106(7):1278–86.CrossRefPubMedPubMedCentral
22.
Beckwith CG, et al. Opportunities to diagnose, treat, and prevent HIV in the criminal justice system. J Acquir Immune Defic Syndr. 2010;55(Suppl 1):S49–55.CrossRefPubMedPubMedCentral
23.
Kramer K, Comfort M. Considerations in HIV prevention for women affected by the criminal justice system. Womens Health Issues. 2011;21(Suppl 6):272–7.CrossRef
24.
25.
Belenko S, Hiller M, Hamilton L. Treating substance use disorders in the criminal justice system. Curr Psychiatry Rep. 2013;15(11):414.CrossRefPubMed
26.
Haley DF, et al. Multilevel challenges to engagement in HIV care after prison release: a theory-informed qualitative study comparing prisoners’ perspectives before and after community reentry. BMC Public Health. 2014;14(1):1253.CrossRefPubMedPubMedCentral
27.
Painter TM, et al. Community-based program to prevent HIV/STD infection among heterosexual black women. MMWR Suppl. 2014;63(01):15–20.PubMed
28.
Alemagno SA, et al. Brief motivational intervention to reduce HIV risk and to increase HIV testing among offenders under community supervision. J Correct Health Care. 2009;15(3):210–21.CrossRefPubMed
29.
Prendergast M, et al. A multi-site, randomized study of strengths-based case management with substance-abusing parolees. J Exp Criminol. 2011;7(3):225–53.CrossRefPubMedPubMedCentral
30.
31.
32.
Nydegger LA, et al. Effects of a one-hour intervention on condom implementation intentions among drug users in Southern California. AIDS Care. 2013;25(12):1586–91.CrossRefPubMedPubMedCentral
33.
Lichtenstein B, Barber BW, West Alabama AIDS Outreach Partnership Group. A partnership approach to providing on-site HIV services for probationers and parolees: a pilot study from Alabama, USA. J Int AIDS Soc. 2016;19(4 Suppl 3):20868.PubMedPubMedCentral
34.
DiClemente RJ, et al. Efficacy of an HIV prevention intervention for African American adolescent girls: a randomized controlled trial. JAMA. 2004;292(2):171–9.CrossRefPubMed
35.
Crepaz N, et al. The efficacy of HIV/STI behavioral interventions for African American females in the United States: a meta-analysis. Am J Public Health. 2009;99(11):2069–78.CrossRefPubMedPubMedCentral
36.
El-Bassel N, et al. National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV serodiscordant couples: a cluster randomized trial. Arch Intern Med. 2010;170(17):1594–601.CrossRefPubMedPubMedCentral
37.
Adimora AA, Schoenbach VJ. Contextual factors and the black-white disparity in heterosexual HIV transmission. Epidemiology. 2002;13(6):707–12.CrossRefPubMed
38.
El-Bassel N, et al. Correlates of crack abuse among drug-using incarcerated women: psychological trauma, social support, and coping behavior. Am J Drug Alcohol Abuse. 1996;22(1):41–56.CrossRefPubMed
39.
40.
Weir BW, et al. Reducing HIV and partner violence risk among women with criminal justice system involvement: a randomized controlled trial of two Motivational Interviewing-based interventions. AIDS Behav. 2009;13(3):509–22.CrossRefPubMed
41.
Kalichman SC, et al. Sexual coercion, domestic violence, and negotiating condom use among low-income African American women. J Womens Health. 1998;7(3):371–8.CrossRefPubMed
42.
El-Bassel N, et al. Correlates of partner violence among female street-based sex workers: substance abuse, history of childhood abuse, and HIV risks. AIDS Patient Care STDS. 2001;15(1):41–51.CrossRefPubMed
43.
Gielen AC, et al. HIV/AIDS and intimate partner violence: intersecting women's health issues in the United States. Traum Viol Abuse. 2007;8(2):178–98.CrossRef
44.
Mittal M, Senn TE, Carey MP. Intimate partner violence and condom use among women: does the Information–Motivation–Behavioral Skills Model explain sexual risk behavior? AIDS Behav. 2012;16(4):1011–9.CrossRefPubMedPubMedCentral
45.
Gilbert L, et al. Targeting the SAVA (substance abuse, violence and AIDS) syndemic among women and girls: a global review of epidemiology and integrated interventions. J Acquir Immune Defic Syndr. 2015;69(Suppl 2):118–27.CrossRef
46.
Curran GM, et al. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26.CrossRefPubMedPubMedCentral
47.
Metsch LR, et al. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health. 2012;102(6):1160–7.CrossRefPubMedPubMedCentral
48.
Metsch LR, et al. Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial. JAMA. 2013;310(16):1701–10.CrossRefPubMedPubMedCentral
49.
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84(2):191–215.CrossRefPubMed
50.
Bandura A. Social cognitive theory of self-regulation. Organ Behav Hum Decis Process. 1991;50(2):248–87.CrossRef
51.
Peled E, et al. Choice and empowerment for battered women who stay: toward a constructivist model. Soc Work. 2000;45(1):9–25.CrossRefPubMed
52.
Damschroder LJ, et al. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4(1):50.CrossRefPubMedPubMedCentral
53.
El-Bassel N, et al. Preventing HIV/AIDS in drug-abusing incarcerated women through skills building and social support enhancement: preliminary outcomes. Soc Work Res. 1995;19(3):131–41.PubMed
54.
Schilling RF, et al. Correlates of drug use, sexual behavior, and attitudes toward safer sex among African-American and Hispanic women in methadone maintenance. J Drug Issues. 1991;21(4):685–98.CrossRef
55.
56.
Daveson B, et al. Translating care into outcomes: a grounded theory study using the Consolidated Framework for Implementation Research (CFIR) [abstract PO51]. Palliat Med. 2016;30(6):NP269–70.
57.
58.
Liang S, et al. Integrating evidence-based practices for increasing cancer screenings in safety net health systems: a multiple case study using the Consolidated Framework for Implementation Research. Implement Sci. 2016;11:109.CrossRefPubMedPubMedCentral
59.
Northridge ME, et al. Third places for health promotion with older adults: using the Consolidated Framework for Implementation Research to enhance program implementation and evaluation. J Urban Health. 2016;93(5):851–70.CrossRefPubMedPubMedCentral
60.
Birken SA, et al. Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. Implement Sci. 2017;12:2.CrossRefPubMedPubMedCentral
61.
Klafke N, et al. How the Consolidated Framework for Implementation Research can strengthen findings and improve translation of research into practice: a case study. Oncol Nurs Forum. 2017;44(5):E223–31.CrossRefPubMed
62.
VanDevanter N, et al. Application of the Consolidated Framework for Implementation Research to assess factors that may influence implementation of tobacco use treatment guidelines in the Viet Nam public health care delivery system. Implement Sci. 2017;12:27.CrossRefPubMedPubMedCentral
63.
Lewin K. Frontiers in group dynamics: II. Channels of group life; social planning and action research. Hum Relat. 1947;1(2):143–53.CrossRef
64.
Khan MR, et al. The promise of multimedia technology for STI/HIV prevention: frameworks for understanding improved facilitator delivery and participant learning. AIDS Behav. 2012;16(7):1949–60.CrossRefPubMedPubMedCentral
65.
Rollnick S, Miller WR. What is Motivational Interviewing? Behav Cogn Psychother. 1995;23(4):325–34.CrossRef
66.
Dowding D. Best Practices for Mixed Methods Research in the Health Sciences [book review]. Qual Soc Work. 2013;12(4):541–5.CrossRef
67.
68.
Musgrove P, Fox-Rushby J. Cost-effectiveness analysis for priority setting. In Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, editors. Disease control priorities in developing countries. 2nd ed. Washington, DC: International Bank for Reconstruction and Development/The World Bank Group and New York: Oxford University Press; 2006.
69.
Pinkerton SD, et al. Toward a standard sexual behavior data set for HIV prevention evaluation. Am J Health Behav. 1998;22(4):259–66.
70.
Cohen DA, Wu SY, Farley TA. Comparing the cost-effectiveness of HIV prevention interventions. J Acquir Immune Defic Syndr. 2004;37(3):1404–14.CrossRefPubMed
71.
72.
Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. The PTSD Checklist (PCL): Reliability, validity and diagnostic utility. Paper presented at the Annual Meeting of the International Society for Traumatic Stress Studies; San Antonio. 1993;1993.
73.
Kraanen FL, Vedel E, Scholing A, & Emmelkamp PM. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (IStoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189. https://​doi.​org/​10.​1186/​1471-244X-13-189.
74.
Metadata
Title
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
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2792-3

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