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

Implementation Science

Volumn 9, Issue 1, 2014, Pages

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

^a UNIVERSITY OF CALIFORNIA   (United States)

^b VA GREATER LOS ANGELES HEALTHCARE SYSTEM   (United States)

Author keywords

African Americans; Behavioral intervention; Couples; HIV prevention; Hybrid design; Implementation science; Serodiscordance; Sustainability

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; AFRICAN AMERICAN; ARTICLE; COMMUNITY CARE; CONDOM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ETHNOLOGY; EVIDENCE BASED MEDICINE; FEMALE; HEALTH PROMOTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IN SERVICE TRAINING; MALE; METHODOLOGY; MULTICENTER STUDY; ORGANIZATION AND MANAGEMENT; PROGRAM EVALUATION; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SAFE SEX; SEXUALITY; STATISTICS; UNITED STATES; UTILIZATION REVIEW;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; AFRICAN AMERICANS; COMMUNITY HEALTH SERVICES; CONDOMS; COST-BENEFIT ANALYSIS; EVIDENCE-BASED MEDICINE; FEMALE; HEALTH PROMOTION; HIV INFECTIONS; HUMANS; INSERVICE TRAINING; MALE; PROGRAM EVALUATION; RESEARCH DESIGN; RISK REDUCTION BEHAVIOR; SAFE SEX; SEXUAL PARTNERS; UNITED STATES;

EID: 84902726956     PISSN: None     EISSN: 17485908     Source Type: Journal    
DOI: 10.1186/1748-5908-9-79     Document Type: Article

References (76)

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. 10.1001/jama.300.5.520, 2919237, 18677024, HIV Incidence Surveillance Group.
2. El-Sadr W, Mayer K, Hodder S. AIDS in America-forgotten but not gone. N Engl J Med 2010, 362(11):967-970. 10.1056/NEJMp1000069, 20147707.
3. 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. 10.1097/00002030-199301000-00015, 8442924.
4. Wasserheit J. Epidemiological synergy. Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases. Sex Transm Dis 1992, 19(2):61-77. 10.1097/00007435-199219020-00001, 1595015.
5. Centers for Disease Control and Prevention New HIV infections in the United State. Available from: http://www.cdc.gov/nchhstp/newsroom/docs/2012/hiv-infections-2007-2010.p df, Centers for Disease Control and Prevention.
6. 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. 10.2105/AJPH.2005.069070, 1449382, 16051926.
7. Wyatt GE, Williams J, Myers H. African American sexuality and HIV/AIDS: recommendations for future research. J Natl Med Assoc 2008, 100:44-51.
8. 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. 10.1126/science.1439818, 1439818.
9. 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. 10.1016/1054-139X(94)90507-X, 8075092.
10. 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. 10.1258/0956462981921891, 9530898.
11. 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.
12. 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.
13. 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.
14. 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. 10.2105/AJPH.93.6.963, 1447878, 12773363.
15. 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. 10.1136/bmj.304.6842.1605, 1881972, 1628088.
16. Glick P. Scaling up HIV voluntary counseling and testing in Africa. Eval Rev 2005, 29:331-357. 10.1177/0193841X05276437, 15985523.
17. Altman D. Sustaining interventions in community systems: on the relationship between researchers and communities. Health Psychol 1995, 14(6):526-536.
18. Bronfenbrenner U. The ecology of human development : experiments by nature and design 1979, 330. Cambridge, Mass: Harvard University Press, xv.
19. Prochaska JO, DiClemente CC. Toward a comprehensive model of change. Treating addictive behaviors: processes of change. Applied clinical psychology 1986, 3-27. Plenum Press: New York, NY, Miller WR, Heather N.
20. 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.
21. 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. 10.1001/archinternmed.2010.261, 4011550, 20625011, NIMH Multisite HIV/STD Prevention Trial for African American Couples Group.
22. 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. 10.1186/1748-5908-3-30, 2430586, 18510750.
23. 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. 10.1016/0091-7435(86)90024-1, 3534875.
24. 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. 10.1146/annurev.publhealth.031308.100223, 2778326, 19296774.
25. 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. 10.1097/MLR.0b013e3182408812, 3731143, 22310560.
26. 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. 10.1521/aeap.2005.17.4.284, 16178701.
27. 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. 10.1056/NEJMsb070738, 17687138.
28. 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. 10.1007/s10488-008-0197-4, 3808121, 19104929.
29. Hamilton AB, Cohen AN, Young AS. Organizational readiness in specialty mental health care. J Gen Intern Med 2010, 25(Suppl 1):27-31. 2806963, 20077148.
30. Lehman WE, Greener JM, Simpson DD. Assessing organizational readiness for change. J Subst Abuse Treat 2002, 22(4):197-209. 10.1016/S0740-5472(02)00233-7, 12072164.
31. 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. Research Network on Youth Mental Health.
32. Curran GM, Mukherjee S, Allee E, Owen RR. A process for developing an implementation intervention: QUERI series. Implement Sci 2008, 3:17. 10.1186/1748-5908-3-17, 2278163, 18353186.
33. Simpson DD. Organizational readiness for stage-based dynamics of innovation implementation. Res Soc Work Pract 2009, 19(Sep):541-551.
34. Simpson DD. A conceptual framework for transferring research to practice. J Subst Abuse Treat 2002, 22(4):171-182. 10.1016/S0740-5472(02)00231-3, 12072162.
35. 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. 10.1186/1748-5908-7-17, 3317864, 22417162.
36. 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. 10.1007/s10488-010-0319-7, 3068522, 20957426.
37. 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. 10.1191/1740774506cn152oa, 16895043.
38. 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. 10.1007/s10488-008-0167-x, 2562896, 18302015.
39. Report HA. California Department of Public Health, Office of AIDS, HIV/AIDS Case Registry Section 2008,
40. Gonzalez C. In Oakland, AIDS Is Everyone's Business 2010, [cited 2011 Jan. 6]; Available from: http://www.poz.com/articles/get_screened_oakland_401_19080.shtml.
41. Get Screened Oakland HIV is everybodys business; 2010, [cited 2014 July 4]; Available from: http://getscreenedoakland.org/about.html, Get Screened Oakland.
42. Woodall A. Get Screened Oakland HIV-AIDS Program Unique in Nation; 2008 [cited 2014 July. 4]; Available from: http://www.contracostatimes.com/oakland/ci_11123513.
43. Elliot D, Mihalic S. Issues in disseminating and replicating effective prevention programs. Prev Sci 2004, 5(1):47-53.
44. 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. 10.2105/AJPH.2012.300755, 3478005, 22594758.
45. 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. 2910525, 18724188, NIMH Multisite HIV/STD Prevention Trial for African American Couples Group.
46. Metzger DS, Koblin B, Turner C, Navaline H, Valenti F, Holte S, Gross M, Sheon A, Miller H, Cooley P, Seage GR. Randomized controlled trial of audio computer-assisted self-interviewing: utility and acceptability in longitudinal studies. Am J Epidemiol 2000, 152(2):99-106. 10.1093/aje/152.2.99, 10909945.
47. 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. 10.1016/S0140-6736(04)16588-4, 15234855.
48. Gold MR, Siegel JE, Russell LB. Cost-effectiveness in Health and Medicine 1996, New York: Oxford University Press.
49. Feinberg ME, Bontempo DE, Greenberg MT. Predictors and level of sustainability of community prevention coalitions. Am J Prev Med 2008, 34(6):495-501. 10.1016/j.amepre.2008.01.030, 18471585.
50. 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. 3841109, 20528063.
51. Maslach C, Jackson SA, Leiter MP. Maslach Burnout Inventory Manual 1996, Consulting Psychologists Press.
52. TCU Institute of Behavioral Research Survey of Organizational Functioning [cited 2014 July 4]; Available from: http://www.ibr.tcu.edu/pubs/datacoll/commtrt.html#Form-PTN, TCU Institute of Behavioral Research.
53. TCU Institute of Behavioral Research Assessment fact sheet [cited 2009 December 14]; Available from: http://ibr.tcu.edu/forms/organizational-staff-assessments/, TCU Institute of Behavioral Research.
54. Crowne DP, Marlowe D. A new scale of social desirability independent of psychopathology. J Consult Clin Psychol 1960, 24:349-354.
55. 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.
56. Straus MA. Measuring intrafamily conflict and violence: the conflict tactics (CT) scales. J Marriage Family Vol 1979, 41(1):75-88.
57. 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.
58. O'Leary A, Wingood GM. Interventions for sexually active heterosexual women. Handbook of HIV prevention. AIDS prevention and mental health 2000, 179-200. Dordrecht, Netherlands: Kluwer Academic Publishers, Peterson JL, DiClemente RJ.
59. Jemmott JB, 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. 10.1016/1054-139X(92)90016-5, 1390819.
60. DiClemente RJ, Wingood GM, Harrington KF, Lang DL, Davies SL, Hook EW, 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. 10.1001/jama.292.2.171, 15249566.
61. 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. 10.1177/109019819902600204, 10097964.
62. Spanier GB, Thompson L. A confirmatory analysis of the dyadic adjustment scale. J Marriage Fam 1982, 44(3):731-738.
63. Ewing JA. Detecting alcoholism: the CAGE questionnaire. JAMA 1984, 252(14):1905-1907. 10.1001/jama.1984.03350140051025, 6471323.
64. 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.
65. Diggle PJ, Liang KY, Zeger SL. The Analysis of Longitudinal Data 1994, Oxford: Oxford University Press.
66. PASS Power Analysis and Sample Size for Windows 2002, Kaysville, Utah: NCSS, PASS.
67. McCullagh P, Nelder J. Generalized linear models 1989, New York: ChapmanandHall.
68. McCulloch C, Searle S. Generalized, linear and mixed models 2001, New York, NY: Wiley.
69. Strauss A, Corbin J. Basics of Qualitative Research: Grounded Theory Procedures and Techniques 1990, Newbury Park, CA: SAGE Publications Inc.
70. Bickel R. Multilevel analysis for applied research: It's just regression 2007, New York, NY: Guilford Press.
71. Gelman A, Hill J. Data analysis using regression and multilevel/ hierarchical models 2006, New York, NY: Cambridge University Press.
72. Raudenbush SW, Bryk AS. Hierarchical Linear Models: Applications and Data Analysis Methods 2002, Newbury Park, CA: SAGE Publications Inc.
73. Lawson AB, Browne WJ, Rodeiro CLV. Disease Mapping with WinBUGS and MLwiN 2003, West Sussex, England: John Wiley & Sons Ltd.
74. Johnston J, Dinardo J. Econometric Methods 1997, New York: McGraw-Hill, 4.
75. Kmenta J. Elements of Econometrics 1997, Ann Arbor, MI: University of Michigan Press, Second.
76. Glasgow RE, Chambers D. Developing robust, sustainable, implementation systems using rigorous, rapid and relevant science. Clin Transl Sci 2012, 5(1):48-55. 10.1111/j.1752-8062.2011.00383.x, 22376257.