Ignoring the group in group-level HIV/AIDS intervention trials: A review of reported design and analytic methods

AIDS

Volumn 25, Issue 7, 2011, Pages 989-996

  Pals, Sherri L ^a   Wiegand, Ryan E ^a   Murray, David M ^b  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b OHIO STATE UNIVERSITY   (United States)

Author keywords

group randomized trials; individually randomized group treatment trials; review; statistical methods

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANALYTIC METHOD; CORRELATION COEFFICIENT; GROUP RANDOMIZED TRIAL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INDIVIDUALLY RANDOMIZED GROUP TREATMENT TRIAL; INTERVENTION STUDY; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SAMPLE SIZE; STUDY DESIGN;

DATA INTERPRETATION, STATISTICAL; FEMALE; HIV INFECTIONS; HUMANS; MALE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 79954601709     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e3283467198     Document Type: Review

References (80)

1. Semaan S, Kay L, Strouse D, Sogolow E, Mullen PD, Neumann MS, et al. A profile of U.S.-based trials of behavioral and social interventions for HIV risk reduction. J Acquir Immune Defic Syndr 2002; 30 (Suppl 1):S30-S50. (Pubitemid 34774063)
2. Murray DM. Design and analysis of group-randomized trials. New York: Oxford University Press; 1998.
3. Cornfield J. Randomization by group: a formal analysis. Am J Epidemiol 1978; 108:100-102. (Pubitemid 9148062)
4. Murray DM, Hannan PJ, Baker WL. A Monte Carlo study of alternative responses to intraclass correlation in community trials: is it ever possible to avoid Cornfield's penalties? Eval Rev 1996; 20:313-337. (Pubitemid 126704661)
5. RobertsC, RobertsSA. Design and analysis of clinical trials with clustering effect sdueto treatment. Clin Trials2005;2:152-162. (Pubitemid 40637898)
6. Simpson JM, Klar N, Donner A. Accounting for cluster rando-mization: a review of primary prevention trials, 1990 through 1993. Am J Public Health 1995; 85:1378-1383.
7. Varnell SP, Murray DM, Janega JB, Blitstein JL. Design and analysis of group-randomized trials: a review of recent prac-tices. Am J Public Health 2004; 94:393-399. (Pubitemid 38269491)
8. Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL Individually randomized group treatment trials: a critical appraisal of frequently used design and analytic approaches. Am J Public Health 2008; 98:1418-1424.
9. Donner A, Brown KS, Brasher P. A methodological review of nontherapeutic intervention trials employing cluster randomi-zation, 1979-1989. Int J Epidemiol 1990; 19:795-800.
10. Smith PJ, Moffatt ME, Gelskey SC, Hudson S, Kaita K. Are community health interventions evaluated appropriately? A review of six journals. J Clin Epidemiol 1997; 50:137-146. (Pubitemid 27129714)
11. Murray DM, Pals SL, Blitstein JL, Alfano CM, Lehman J. Design and analysis of group-randomized trials in cancer: a review of current practices. J Natl Cancer Inst 2008; 100:483-491.
12. Donner A, Birkett N, Buck C. Randomizationbycluster:sample size requirements and analysis. Am J Epidemiol 1981; 114:906-914.
13. Kish L Survey sampling. New York: John Wiley and Sons; 1965.
14. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold; 2000.
15. Hayes RJ, Moulton LH. Cluster randomised trials. Boca Raton: CRC Press; 2009.
16. Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health 2004; 94:423-429.
17. Hughes JP, Kulich M. Cluster randomized trials for HIV pre-vention. Curr Opin HIVAIDS2006; 1:471-475.
18. Hardin JW, Hilbe J. Generalized estimating equations. Boca Raton, Florida: Chapman & Hall/CRC; 2003.
19. Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schaben-berger O. SAS for mixed models. 2nd ed. Cary, NC: SAS Institute; 2006.
20. Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM. Sample size calculator for cluster randomized trials. Comput Biol Med 2004; 34:113-125. (Pubitemid 38221418)
21. Hintze J. PASS 11. Kaysville, Utah: NCSS, LLC; 2011.
22. Hoover DR. Clinical trials of behavioural interventions with heterogeneous teaching subgroup effects. Stat Med 2002; 21:1351-1364. (Pubitemid 34495604)
23. Lyles CM, Kay LS, Crepaz N, Herbst JH, Passin WF, Kim AS, et al. Best-evidence interventions: findings from a systematic review of HIV behavioral interventions for US populations at high risk, 2000-2004. Am J Public Health 2007; 97:133-143. (Pubitemid 46067695)
24. HerbstJH, BeekerC, MathewA, McNallyT, PassinWF, Kay LS, et al. The effectiveness of individual-, group-, and community-level HIVbehavioral risk-reduction interventions for adult men who have sex with men: a systematic review. Am J Prev Med 2007; 32:S38-67.
25. Simoni JM, Huh D, Frick PA, Pearson CR, Andrasik MP, Dunbar PJ, et al. Peer support and pager messaging to promote anti-retroviral modifying therapy in Seattle: a randomized con-trolled trial. J Acquir Immune Defic Syndr 2009; 52:465-473.
26. van Servellen G, Nyamathi A, Carpio F, Pearce D, Garcia-Teague L, Herrera G, et al. Effects of a treatment adherence enhancement program on health literacy, patient-provider relationships, and adherence to HAART among low-income HIV-positive Spanish-speaking Latinos. AIDS Patient Care STDS 2005; 19:745-759. (Pubitemid 41705171)
27. Mannheimer SB, Morse E, Matts JP, Andrews L, Child C, Schmetter B, et al. Sustained benefit from a long-term antire-troviral adherence intervention. Results of a large randomized clinical trial. J Acquir Immune Defic Syndr 2006; 43 (Suppl 1): S41-S47. (Pubitemid 44885641)
28. Kajubi P, KamyaMR, KamyaS, ChenS, McFarlandW, Hearst N. Increasing condom use without reducing HIV risk: results of a controlled community trial in Uganda. J Acquir Immune Defic Syndr 2005; 40:77-82. (Pubitemid 41233209)
29. Milam J, Richardson JL, McCutchan A, Stoyanoff S, Weiss J, Kemper C, et al. Effect of a brief antiretroviral adherence intervention delivered by HIVcare providers.JAcquir Immune Defic Syndr 2005; 40:356-363. (Pubitemid 41533078)
30. Jones DL, Weiss SM, Bhat GJ, Bwalya V. Influencing sexual practices among HIV-positive Zambian women. AIDS Care 2006; 18:629-634. (Pubitemid 44050521)
31. Johnson MO, Gamarel KE, Dawson RoseC. Changing HIVtreat-ment expectancies: a pilotstudy. AIDSCare2006; 18:550-553.
32. Ironson G, Weiss S, Lydston D, Ishii M, Jones D, Asthana D, et al. The impact of improved self-efficacy on HIV viral load and distress in culturally diverse women living with AIDS: the SMART/EST Women's Project. AIDS Care 2005; 17:222-236. (Pubitemid 40175523)
33. Carballo-Dieguez A, Dolezal C, Leu CS, Nieves L, Diaz F, Decena C, et al. A randomized controlled trial to test an HIV-prevention intervention for Latino gay and bisexual men: lessons learned. AIDS Care 2005; 17:314-328. (Pubitemid 40188913)
34. Amirkhanian YA, KellyJA, Kabakchieva E, Kirsanova AV, Vas-sileva S, Takacs J, et al. A randomized social network HIV prevention trial with young men who have sex with men in Russia and Bulgaria. AIDS 2005; 19:1897-1905. (Pubitemid 41546609)
35. Sikkema KJ, Anderson ES, KellyJA, Winett RA, Gore-Felton C, Roffman RA, et al. Outcomes of a randomized, controlled community-level HIV prevention intervention for adolescents in low-income housing developments. AIDS 2005; 19:1509-1516. (Pubitemid 41400697)
36. Segal-Isaacson CJ, Tobin JN, Weiss SM, Brondolo E, Vaughn A, Wang C, et al. Improving dietary habits in disadvantaged women with HIV/AIDS: the SMART/EST women's project. AIDS Behav 2006; 10:659-670. (Pubitemid 44627815)
37. Stanton B, Guo J, Cottrell L, Galbraith J, Li X, Gibson C, et al. The complex business of adapting effective interventions to new populations: an urban to rural transfer. J Adolesc Health 2005; 37:163.
38. Stanton B, Harris C, Cottrell L, Li X, Gibson C, GuoJ, et al. Trial of an urban adolescent sexual risk-reduction intervention for rural youth: a promising but imperfect fit. J Adolesc Health 2006; 38:55.
39. Borgia P, Marinacci C, Schifano P, Perucci CA. Is peer educa-tion the bestapproach for HIV prevention in schools? Findings from a randomized controlled trial. J Adolesc Health 2005; 36:508-516. (Pubitemid 40719899)
40. Berkman A, Pilowsky DJ, Zybert PA, Herman DB, Conover S, LemelleS, et al. HIVpreventionwithseverelymentallyill men: a randomised controlled trial. AIDS Care 2007; 19:579-588. (Pubitemid 46763744)
41. Coleman CL, Jemmott L, Jemmott JB, Strumpf N, Ratcliffe S. Development of an HIV risk reduction intervention for older seropositive African American men. AIDS Patient Care STDS 2009; 23:647-655.
42. Saleh-Onoya D, Reddy PS, Ruiter RA, Sifunda S, Wingood G, van den Borne B. Condom use promotion among isiXhosa speaking women living with HIV in the Western Cape Pro-vince, South Africa: a pilot study. AIDS Care 2009; 21:817-825.
43. Wu S, Li L, Wu Z, Liang LJ, Cao H, Yan Z, et al. A brief HIV stigma reduction intervention for service providers in China. AIDS Patient Care STDS 2008; 22:513-520.
44. Stephenson R, Mendenhall E, Muzizi L, Vwalika B, Chomba E, Ahmed Y, et al. The influence of motivational messages on future planning behaviors among HIV concordant positive and discordant couples in Lusaka, Zambia. AIDS Care 2008; 20:150-160. (Pubitemid 351651269)
45. Ssewamala FM, Alicea S, Bannon WM Jr, Ismayilova L. A novel economic intervention to reduce HIV risks among school-going AIDS orphans in rural Uganda. J Adolesc Health 2008; 42:102-104. (Pubitemid 350266384)
46. Akpabio II, Asuzu MC, Fajemilehin BR, Ofi AB. Effectsof school health nursing education interventions on HIV/AIDS-related attitudes of students in Akwa Ibom State, Nigeria. J Adolesc Health 2009; 44:118-123.
47. Goldberg E, Millson P, Rivers S, Manning SJ, Leslie K, Read S, et al. A human immunodeficiency virus risk reduction inter-vention for incarcerated youth: a randomized controlled trial. J Adolesc Health 2009; 44:136-145.
48. Heckman TG, Carlson B. A randomized clinical trial of two telephone-delivered, mental health interventions for HIV-infected persons in rural areas of the United States. AIDS Behav 2007; 11:5-14. (Pubitemid 46147348)
49. Jones DL, McPherson-BakerS, Lydston D, CamilleJ, Brondolo E, Tobin JN, et al. Efficacy of a group medication adherence intervention among HIV positive women: the SMART/EST Women's Project. AIDS Behav 2007; 11:79-86. (Pubitemid 46147354)
50. Chen X, Lunn S, Deveaux L, Li X, Brathwaite N, Cottrell L, et al. A cluster randomized controlled trial of an adolescent HIV prevention program among Bahamian youth: effect at 12 months postintervention. AIDS Behav 2009; 13:499-508.
51. Bing EG, Cheng KG, Ortiz DJ, Ovalle-Bahamon RE, Ernesto F, Weiss RE, et al. Evaluation of a prevention intervention to reduce HIV risk among Angolan soldiers. AIDS Behav 2008; 12:384-395.
52. Sampaio-Sa M, Page-Shafer K, Bangsberg DR, EvansJ, Dourado Mde L, Teixeira C, et al. 100% adherence study: educational workshops vs. video sessions to improve adherence among ART-naive patients in Salvador, Brazil. AIDS Behav 2008; 12:S54 S62.
53. Sikkema KJ, Hansen NB, Kochman A, Tarakeshwar N, Neufeld S, Meade CS, et al. Outcomes from a group intervention for copingwith HIV/AIDSand childhoodsexual abuse: reductions in traumatic stress. AIDS Behav 2007; 11:49-60. (Pubitemid 46147351)
54. Pope DS, Deluca AN, Kali P, Hausler H, Sheard C, Hoosain E, et al. A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa. J Acquir Immune Defic Syndr 2008; 48:190-195.
55. Wu Z, Luo W, Sullivan SG, Rou K, Lin P, Liu W, et al. Evaluationof a needle social marketing strategy to control HIV among inject-ing drug users in China. AIDS 2007; 21 (Suppl 8):S115-S122.
56. TrossS, Campbell AN, Cohen LR, Calsyn D, Pavlicova M, Miele GM, et al. Effectiveness of HIV/STD sexual risk reduction groups for women in substance abuse treatment programs: results of NIDAClinical Trials NetworkTrial.JAcquir Immune Defic Syndr 2008; 48:581-589.
57. DiIorio C, McCarty F, Resnicow K, Lehr S, Denzmore P. REAL men: a group-randomized trial of an HIV prevention intervention for adolescent boys. Am J Public Health 2007; 97:1084-1089. (Pubitemid 351181932)
58. Choi KH, HoffC, GregorichSE, GrinsteadO, Gomez C, Hussey W. The efficacy of female condom skills training in HIV risk reduction among women: a randomized controlled trial. Am J Public Health 2008; 98:1841-1848.
59. Kershaw TS, Magriples U, Westdahl C, Rising SS, Ickovics J. Pregnancy as a window of opportunity for HIV prevention: effects of an HIV intervention delivered within prenatal care. Am J Public Health 2009; 99:2079-2086.
60. Berger S, Schad T, von Wyl V, Ehlert U, Zellweger C, Furrer H, et al. Effects of cognitive behavioral stress management on HIV-1 RNA, CD4 cell counts and psychosocial parameters of HIV-infected persons. AIDS 2008; 22:767-775. (Pubitemid 351450646)
61. Romer D, Sznitman S, DiClemente R, Salazar LF, Vanable PA, Carey MP, et al. Mass media as an HIV-prevention strategy: using culturally sensitive messages to reduce HIV-associated sexual behavior of at-risk African American youth. Am J Public Health 2009; 99:2150-2159.
62. Corbett EL, Makamure B, Cheung YB, Dauya E, Matambo R, Bandason T, et al. HIV incidence during a cluster-randomized trial of two strategies providing voluntary counselling and testing at the workplace, Zimbabwe. AIDS 2007; 21:483-489.
63. Pronyk PM, Kim JC, Abramsky T, Phetla G, Hargreaves JR, Morison LA, et al. A combined microfinance and training intervention can reduce HIV risk behaviour in young female participants. AIDS 2008; 22:1659-1665.
64. Tian L, Tang S, Cao W, Zhang K, Li V, Detels R. Evaluation of a web-based intervention for improving HIV/AIDS knowledge in rural Yunnan, China. AIDS 2007; 21 (Suppl 8):S137 S142.
65. Sikkema KJ, Wilson PA, Hansen NB, Kochman A, Neufeld S, Ghebremichael MS, et al. Effects of a coping intervention on transmission risk behavior among people living with HIV/AIDS and a history of childhood sexual abuse. J Acquir Immune Defic Syndr 2008; 47:506-513. (Pubitemid 351366962)
66. Ross DA, Changalucha J, Obasi AI, Todd J, Plummer ML, Cleophas-Mazige B, et al. Biological and behavioural impact of an adolescent sexual health intervention in Tanzania: a community-randomized trial. AIDS 2007; 21:1943-1955. (Pubitemid 47329771)
67. Purcell DW, Latka MH, Metsch LR, Latkin CA, Gomez CA, Mizuno Y, et al. Results from arandomized controlled trial of a peer-mentoring intervention to reduce HIV transmission and increase access to care and adherence to HIV medications among HIV-seropositive injection drug users. J Acquir Immune Defic Syndr 2007; 46:S35-S47. (Pubitemid 350293779)
68. Garfein RS, Golub ET, Greenberg AE, Hagan H, Hanson DL, Hudson SM, et al. A peer-education intervention to reduce injection risk behaviors for HIV and hepatitis C virus infection in young injection drug users. AIDS 2007; 21: 1923-1932. (Pubitemid 47329769)
69. Jemmott LS, Jemmott JB, O'Leary A. Effects on sexual risk behavior and STD rate of brief HIV/STD prevention interven-tions for African American women in primary care settings. Am J Public Health 2007; 97:1034-1040. (Pubitemid 351181925)
70. Wilton L, Herbst JH, Coury-Doniger P, Painter TM, English G, Alvarez ME, et al. Efficacy of an HIV/STI prevention interven-tion for black men who have sex with men: findings from the Many Men, Many Voices (3MV) Project. AIDS Behav 2009; 13:532-544.
71. Murry VM, Berkel C, Brody GH, Gerrard M, Gibbons FX. The Strong African American Families Program: longitudinal path-ways to sexual risk reduction. J Adolesc Health 2007; 41:333-342. (Pubitemid 47391377)
72. Clark LF, Miller KS, Nagy SS, AveryJ, Roth DL, Liddon N, et al. Adult identity mentoring: reducing sexual risk for African-American seventh grade students. J Adolesc Health 2005; 37:337.
73. Wolitski RJ, Gomez CA, Parsons JT, and the SUMIT Study Group. Effects of a peer-led behavioral intervention to reduce HIV transmission and promote serostatus disclosure among HIV-seropositive gay and bisexual men. AIDS 2005; 19:S99-S109.
74. Spielberg F, Branson BM, Goldbaum GM, Lockhart D, Kurth A, Rossini A, et al. Choosing HIVcounselingand testingstrategies for outreach settings: a randomized trial. J Acquir Immune Defic Syndr 2005; 38:348-355. (Pubitemid 40333503)
75. Wingood GM, DiClemente RJ, Harrington KF, Lang DL, Davies SL, Hook EW, et al. Efficacy of an HIV prevention program among female adolescents experiencing gender-based vio-lence. Am J Public Health 2006; 96:1085-1090. (Pubitemid 43825279)
76. HoffCC, Pals SL, Purcell DW, ParsonsJT, Halkitis PN, Remien RH, et al. Examining the role of partner status in an HIV prevention trial targeting HIV-positive gay and bisexual men: the Seropositive Urban Men's Intervention Trial (SUMIT). AIDS Behav 2006; 10:637-648. (Pubitemid 44627813)
77. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285:1987 1991. (Pubitemid 32366951)
78. Campbell MK, Elbourne DR, Altman DG, CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 20:702-708. (Pubitemid 38393415)
79. Varnell SP, Murray DM, Baker WL. An evaluation of analysis options for the one-group-per-condition design: can any of the alternatives overcome the problems inherent in this design? Eval Rev 2001; 25:440-453. (Pubitemid 33609341)
80. Kilmarx PH. Global epidemiology of HIV. Curr Opin HIVAIDS 2009; 4:240-246.