Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol

Alison B Hamilton, Brian S Mittman, John K Williams, Honghu H Liu, Alicia M Eccles, Craig S Hutchinson, Gail E Wyatt, Alison B Hamilton, Brian S Mittman, John K Williams, Honghu H Liu, Alicia M Eccles, Craig S Hutchinson, Gail E Wyatt

Abstract

Background: The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US, particularly those located in urban areas. Despite the fact that HIV is often transmitted from one sexual partner to another, most HIV prevention interventions have focused only on individuals, rather than couples. This five-year study investigates community-based implementation, effectiveness, and sustainability of 'Eban II,' an evidence-based risk reduction intervention for African-American heterosexual, serodiscordant couples.

Methods/design: This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model (PCM), a model of phased organizational change from exposure to adoption, implementation, and sustainability. The primary implementation aims are to assist 10 community-based organizations (CBOs) to implement and sustain Eban II; specifically, to partner with CBOs to expose providers to the intervention; facilitate its adoption, implementation and sustainment; and to evaluate processes and determinants of implementation, effectiveness, fidelity, and sustainment. The primary effectiveness aim is to evaluate the effect of Eban II on participant (n = 200 couples) outcomes, specifically incidents of protected sex and proportion of condom use. We will also determine the cost-effectiveness of implementation, as measured by implementation costs and potential cost savings. A mixed methods evaluation will examine implementation at the agency level; staff members from the CBOs will complete baseline measures of organizational context and climate, while key stakeholders will be interviewed periodically throughout implementation. Effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up. Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency- and couples-level characteristics on couples-level outcomes (e.g., condom use).

Discussion: This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse, resource-constrained treatment settings.

Trial registration: NCT00644163.

References

    1. Hall H, Song R, Rhodes P, Prejean J, An Q, Lee LM, Karon J, Brookmeyer R, Kaplan EH, McKenna MT, Janssen RS. HIV Incidence Surveillance Group. Estimation of HIV incidence in the United States. JAMA. 2008;300:520–529. doi: 10.1001/jama.300.5.520.
    1. El-Sadr W, Mayer K, Hodder S. AIDS in America–forgotten but not gone. N Engl J Med. 2010;362(11):967–970. doi: 10.1056/NEJMp1000069.
    1. Laga M, Manoka A, Kivuvu M, Malele B, Tuliza M, Nzila N, Goeman J, Behets F, Batter V, Alary M, Heyward WL, Ryder RW, Piot P. Non-ulcerative sexually transmitted disease as risk factors for HIV-1 transmission in women: results from a cohort study. AIDS. 1993;7(1):95–102. doi: 10.1097/00002030-199301000-00015.
    1. Wasserheit J. Epidemiological synergy. Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases. Sex Transm Dis. 1992;19(2):61–77. doi: 10.1097/00007435-199219020-00001.
    1. Centers for Disease Control and Prevention. New HIV infections in the United State. Available from: .
    1. El-Bassel N, Gilbert L, Wu E, Go H, Hill J. Relationship between drug abuse and intimate partner violence: a longitudinal study among women receiving methadone: El-Bassel et al. respond. Am J Public Health. 2005;95(9):1493–1494. doi: 10.2105/AJPH.2005.069070.
    1. Wyatt GE, Williams J, Myers H. African American sexuality and HIV/AIDS: recommendations for future research. J Natl Med Assoc. 2008;100:44–51.
    1. Catania JA, Coates TJ, Stall R, Turner H, Peterson J, Hearst N, Dolcini MM, Hudes E, Gagnon J, Wiley J. Prevalence of AIDS-related risk factors and condom use in the United States. Science. 1992;258(5085):1101–1106. doi: 10.1126/science.1439818.
    1. Overby KJ, Kegeles SM. The impact of AIDS on an urban population of high-risk female minority adolescents: Implications for intervention. J Adolesc Health. 1994;15(3):216–227. doi: 10.1016/1054-139X(94)90507-X.
    1. Wingood GM, DiClemente RJ. Gender-related correlates and predictors of consistent condom use among young adult African-American women: a prospective analysis. Int J STD AIDS. 1998;9(3):139–145. doi: 10.1258/0956462981921891.
    1. Hunt WK, Myers HF, Dyche M. Living with risk: male partners of HIV-positive women. Cultur Divers Ethnic Minor Psychol. 1999;Special Issue: HIV/AIDS and ethnic minority women, families, and communities. 5(3):276–286.
    1. Wyatt GE, Moe A, Guthrie D. The gynecological, reproductive, and sexual health of HIV-positive wome. Cultur Divers Ethnic Minor Psychol. 1999;Special Issue: HIV/AIDS and ethnic minority women, families, and communities. 5(3):183–196.
    1. Wyatt GE, Forge NG, Guthrie D. Family constellation and ethnicity: current and lifetime HIV-related risk taking. J Fam Psychol. 1998;12(1):93–101.
    1. El-Bassel N, Witte SS, Gilbert L, Wu E, Chang M, Hill J, Steinglass P. The efficacy of a relationship-based HIV/STD prevention program for heterosexual couples. Am J Public Health. 2003;93(6):963–969. doi: 10.2105/AJPH.93.6.963.
    1. Allen S, Tice J, Van de Perre P, Serufilira A, Hudes E, Nsengumuremyi F, Bogaerts J, Lindan C, Hulley S. Effect of serotesting with counselling on condom use and seroconversion among HIV discordant couples in Africa. BMJ. 1992;304(6842):1605–1609. doi: 10.1136/bmj.304.6842.1605.
    1. Glick P. Scaling up HIV voluntary counseling and testing in Africa. Eval Rev. 2005;29:331–357. doi: 10.1177/0193841X05276437.
    1. Altman D. Sustaining interventions in community systems: on the relationship between researchers and communities. Health Psychol. 1995;14(6):526–536.
    1. Bronfenbrenner U. The ecology of human development : experiments by nature and design. Cambridge, Mass: Harvard University Press; 1979. p. 330. xv.
    1. Prochaska JO, DiClemente CC. In: Treating addictive behaviors: processes of change. Applied clinical psychology. Miller WR, Heather N, editor. Plenum Press: New York, NY; 1986. Toward a comprehensive model of change; pp. 3–27.
    1. Pennebaker JW, Kiecolt-Glaser JK, Glaser R. Disclosure of traumas and immune function: health implications for psychotherapy. J Consult Clin Psychol. 1988;56(2):239–245.
    1. El-Bassel N, Jemmott JB, Landis JR, Pequegnat W, Wingood GM, Wyatt GE, Bellamy SL. NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. 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. doi: 10.1001/archinternmed.2010.261.
    1. Stetler CB, McQueen L, Demakis J, Mittman BS. An organizational framework and strategic implementation for system-level change to enhance research-based practice: QUERI Series. Implement Sci. 2008;3:30. doi: 10.1186/1748-5908-3-30.
    1. Flay BR. Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Prev Med. 1986;15(5):451–474. doi: 10.1016/0091-7435(86)90024-1.
    1. Brown CH, Ten Have TR, Jo B, Dagne G, Wyman PA, Muthén B, Gibbons RD. Adaptive designs for randomized trials in public health. Annu Rev Public Health. 2009;30:1–25. doi: 10.1146/annurev.publhealth.031308.100223.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26. doi: 10.1097/MLR.0b013e3182408812.
    1. Kegeles S, Rebchook G, Tebbetts S. Challenges and facilitators to building program evaluation capacity among community-based organizations. AIDS Educ Prev. 2005;17(4):284–299. doi: 10.1521/aeap.2005.17.4.284.
    1. Auerbach AD, Landefeld CS, Shojania KG. The tension between needing to improve care and knowing how to do it. N Engl J Med. 2007;357(6):608–613. doi: 10.1056/NEJMsb070738.
    1. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009;36(1):24–34. doi: 10.1007/s10488-008-0197-4.
    1. Hamilton AB, Cohen AN, Young AS. Organizational readiness in specialty mental health care. J Gen Intern Med. 2010;25(Suppl 1):27–31.
    1. Lehman WE, Greener JM, Simpson DD. Assessing organizational readiness for change. J Subst Abuse Treat. 2002;22(4):197–209. doi: 10.1016/S0740-5472(02)00233-7.
    1. Glisson C, Landsverk J, Schoenwald S, Kelleher K, Hoagwood KE, Mayberg S, Green P. Research Network on Youth Mental Health. Assessing the organizational social context (OSC) of mental health services: implications for research and practice. Adm Policy Ment Health. 2008;35(1–2):98–113.
    1. Curran GM, Mukherjee S, Allee E, Owen RR. A process for developing an implementation intervention: QUERI series. Implement Sci. 2008;3:17. doi: 10.1186/1748-5908-3-17.
    1. Simpson DD. Organizational readiness for stage-based dynamics of innovation implementation. Res Soc Work Pract. 2009;19(Sep):541–551.
    1. Simpson DD. A conceptual framework for transferring research to practice. J Subst Abuse Treat. 2002;22(4):171–182. doi: 10.1016/S0740-5472(02)00231-3.
    1. Wiltsey Stirman S, Kimberly J, Cook N, Calloway A, Castro F, Charns M. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012;7:17. doi: 10.1186/1748-5908-7-17.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. doi: 10.1007/s10488-010-0319-7.
    1. Brown CH, Wyman PA, Guo J, Peña J. Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide. Clin Trials. 2006;3(3):259–271. doi: 10.1191/1740774506cn152oa.
    1. Chamberlain P, Brown CH, Saldana L, Reid J, Wang W, Marsenich L, Sosna T, Padgett C, Bouwman G. Engaging and recruiting counties in an experiment on implementing evidence-based practice in California. Adm Policy Ment Health. 2008;35(4):250–260. doi: 10.1007/s10488-008-0167-x.
    1. Report HA. California Department of Public Health, Office of AIDS, HIV/AIDS Case Registry Section. 2008.
    1. Gonzalez C. In Oakland, AIDS Is Everyone’s Business. 2010. [cited 2011 Jan. 6]; Available from: .
    1. Get Screened Oakland. HIV is everybody's business; 2010. [cited 2014 July 4]; Available from: .
    1. Woodall A. 'Get Screened Oakland' HIV-AIDS Program Unique in Nation; 2008. [cited 2014 July. 4]; Available from: .
    1. Elliot D, Mihalic S. Issues in disseminating and replicating effective prevention programs. Prev Sci. 2004;5(1):47–53.
    1. Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National institutes of health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012;102(7):1274–1281. doi: 10.2105/AJPH.2012.300755.
    1. NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. Methodological overview of an African American couple-based HIV/STD prevention trial. J Acquir Immune Defic Syndr. 2008;49(Suppl 1):S3–14.
    1. Metzger DS, Koblin B, Turner C, Navaline H, Valenti F, Holte S, Gross M, Sheon A, Miller H, Cooley P, Seage GR 3rd. Randomized controlled trial of audio computer-assisted self-interviewing: utility and acceptability in longitudinal studies. Am J Epidemiol. 2000;152(2):99–106. doi: 10.1093/aje/152.2.99.
    1. Koblin B, Chesney M, Coates T. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004;364(9428):41–50. doi: 10.1016/S0140-6736(04)16588-4.
    1. Gold MR, Siegel JE, Russell LB. Cost-effectiveness in Health and Medicine. New York: Oxford University Press; 1996.
    1. Feinberg ME, Bontempo DE, Greenberg MT. Predictors and level of sustainability of community prevention coalitions. Am J Prev Med. 2008;34(6):495–501. doi: 10.1016/j.amepre.2008.01.030.
    1. Aarons GA, Glisson C, Hoagwood K, Kelleher K, Landsverk J, Cafri G. Psychometric properties and U.S. national norms of the evidence-based practice attitude scale (EBPAS) Psychol Assess. 2010;22(2):356–365.
    1. Maslach C, Jackson SA, Leiter MP. Maslach Burnout Inventory Manual. Consulting Psychologists Press; 1996.
    1. TCU Institute of Behavioral Research. Survey of Organizational Functioning. [cited 2014 July 4]; Available from: .
    1. TCU Institute of Behavioral Research. Assessment fact sheet. [cited 2009 December 14]; Available from:
    1. Crowne DP, Marlowe D. A new scale of social desirability independent of psychopathology. J Consult Clin Psychol. 1960;24:349–354.
    1. Wyatt GE, Lawrence J, Vodounon A, Mickey MR. The Wyatt sex history questionnaire: a structured interview for female sexual history taking. J Child Sex Abus. 1992;1(4):51–68.
    1. Straus MA. Measuring intrafamily conflict and violence: the conflict tactics (CT) scales. J Marriage Family Vol. 1979;41(1):75–88. doi: 10.2307/351733.
    1. Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986;51(6):1173–1182.
    1. O’Leary A, Wingood GM. In: Handbook of HIV prevention. AIDS prevention and mental health. Peterson JL, DiClemente RJ, editor. Dordrecht, Netherlands: Kluwer Academic Publishers; 2000. Interventions for sexually active heterosexual women; pp. 179–200.
    1. Jemmott JB 3rd, Jemmott LW, Spears H, Hewitt N, Cruz-Collins M. Self-efficacy, hedonistic expectancies, and condom-use intentions among inner-city Black adolescent women: a social cognitive approach to AIDS risk behavior. J Adolesc Health. 1992;13(6):512–519. doi: 10.1016/1054-139X(92)90016-5.
    1. DiClemente RJ, Wingood GM, Harrington KF, Lang DL, Davies SL, Hook EW 3rd, Oh MK, Crosby RA, Hertzberg VS, Gordon AB, Hardin JW, Parker S, Robillard A. Efficacy of an HIV prevention intervention for African American adolescent girls a randomized controlled trial. JAMA. 2004;292(2):171–179. doi: 10.1001/jama.292.2.171.
    1. Gómez CA, Hernández M, Faigeles B. Sex in the New World: an empowerment model for HIV prevention in Latina immigrant women. Health Educ Behav. 1999;26(2):200–12. doi: 10.1177/109019819902600204.
    1. Spanier GB, Thompson L. A confirmatory analysis of the dyadic adjustment scale. J Marriage Fam. 1982;44(3):731–738. doi: 10.2307/351593.
    1. Ewing JA. Detecting alcoholism: the CAGE questionnaire. JAMA. 1984;252(14):1905–1907. doi: 10.1001/jama.1984.03350140051025.
    1. Dowling-Guyer S, Johnson ME, Fisher DG, Needle R, Watters J, Andersen M, Williams M, Kotranski L, Booth R, Rhodes F, Weatherby N, Estrada AL, Fleming D, Deren S, Tortu S. Reliability of drug users’ self-reported HIV risk behaviors and validity of self-reported recent drug use. Assessment. 1994;1(4):383–392.
    1. Diggle PJ, Liang KY, Zeger SL. The Analysis of Longitudinal Data. Oxford: Oxford University Press; 1994.
    1. PASS. Power Analysis and Sample Size for Windows. Kaysville, Utah: NCSS; 2002.
    1. McCullagh P, Nelder J. Generalized linear models. New York: ChapmanandHall; 1989.
    1. McCulloch C, Searle S. Generalized, linear and mixed models. New York, NY: Wiley; 2001.
    1. Strauss A, Corbin J. Basics of Qualitative Research: Grounded Theory Procedures and Techniques. Newbury Park, CA: SAGE Publications Inc; 1990.
    1. Bickel R. Multilevel analysis for applied research: It’s just regression. New York, NY: Guilford Press; 2007.
    1. Gelman A, Hill J. Data analysis using regression and multilevel/ hierarchical models. New York, NY: Cambridge University Press; 2006.
    1. Raudenbush SW, Bryk AS. Hierarchical Linear Models: Applications and Data Analysis Methods. Newbury Park, CA: SAGE Publications Inc; 2002.
    1. Lawson AB, Browne WJ, Rodeiro CLV. Disease Mapping with WinBUGS and MLwiN. West Sussex, England: John Wiley & Sons Ltd; 2003.
    1. Johnston J, Dinardo J. Econometric Methods. 4. New York: McGraw-Hill; 1997.
    1. Kmenta J. Elements of Econometrics. Second. Ann Arbor, MI: University of Michigan Press; 1997.
    1. Glasgow RE, Chambers D. Developing robust, sustainable, implementation systems using rigorous, rapid and relevant science. Clin Transl Sci. 2012;5(1):48–55. doi: 10.1111/j.1752-8062.2011.00383.x.

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