HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial

Trials

Mokgweetsi Masisi³  Ditiro Laetsang⁴  Nobantu Marokoane¹  Lehana Thabane⁵  Anne Cockcroft⁴  Neil Andersson² 

[1] CIET Trust, 71 Oxford Road, Johannesburg 2196, South Africa;Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Calle Pino, El Roble, Acapulco, Mexico;Minister for Presidential Affairs and Public Administration, Office of the President, Private Bag 001, Gaborone, Botswana;CIET Trust Botswana, P.O. Box 1240, Gaborone, Botswana;McMaster University, Hamilton, ON, Canada

关键词: Cluster randomised controlled trial;    Southern Africa;    Gender violence;    HIV prevention;   

Others  :  1093155
DOI  :  10.1186/1745-6215-14-274

 received in 2013-02-13, accepted in 2013-08-12,  发布年份 2013

【 摘 要 】

Background

Most HIV prevention strategies assume beneficiaries can act on their prevention decisions. But some people are unable to do so. They are ‘choice-disabled’. Economic and educational interventions can reduce sexual violence, but there is less evidence that they can reduce HIV. There is little research on complex interventions in HIV prevention, yet all countries in southern Africa implement combination prevention programmes.

Methods/Design

The primary objective is to reduce HIV infections among women aged 15 to 29 years. Secondary objectives are reduction in gender violence and improvement in HIV-related knowledge, attitudes and practices among youth aged 15 to 29 years.

A random sample of 77 census enumeration areas in three countries (Botswana, Namibia and Swaziland) was allocated randomly to three interventions, alone or in combination, in a factorial design stratified by country, HIV rates (above or below average for country), and urban/rural location. A baseline survey of youth aged 15 to 29 years provided cluster specific rates of HIV. All clusters continue existing prevention efforts and have a baseline and follow-up survey. Cluster is the unit of allocation, intervention and analysis, using generalised estimating equations, on an intention-to-treat basis.

One intervention discusses evidence about choice disability with local HIV prevention services, to help them to serve the choice-disabled. Another discusses an eight-episode audio-docudrama with community groups, of all ages and both sexes, to generate endogenous strategies to reduce gender violence and develop an enabling environment. A third supports groups of women aged 18 to 25 years to build self-esteem and life skills and to set up small enterprises to generate income.

A survey in all clusters after 3 years will measure outcomes, with interviewers unaware of group assignment of the clusters. The primary outcome is HIV infection in women aged 15 to 29 years. Secondary outcomes in youth aged 15 to 29 years are gender violence and protective knowledge, attitudes, subjective norms, intention to change, agency, discussion of prevention and practices related to HIV and gender violence.

Trial registration

Trial registration number: ISRCTN28557578

【 授权许可】

   
2013 Andersson et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Andersson N: Prevention for those who have freedom of choice - or among the choice-disabled: Confronting equity in the AIDS epidemic. AIDS Res Ther 2006, 3:23. BioMed Central Full Text
• [2]Robin L, Dittus P, Whitaker D, Crosby R, Ethier K, Mezoff J, Miller K, Pappas-Deluca K: Behavioral interventions to reduce incidence of HIV, STI and pregnancy: a decade in review. J Adolesc Heal 2004, 34:3-26.
• [3]Mullen PD, Ramirez G, Strouse D, Hedges LV, Sogolow E: Meta-analysis of the effects of behavioral HIV prevention interventions on the sexual risk behavior of sexually experienced adolescents in controlled studies in the United States. J Acquir Immune Defic Syndr 2002, 30((Suppl l)):S94-S105.
• [4]Johnson B, Michael C, Marsh K, Levin K, Scott-Sheldon L: Interventions to reduce sexual risk for the Human Immunodeficiency Virus in adolescents, 1985–2000. Arch Pediatric Adolesc Med 2003, 157:381-388.
• [5]Microbicideshttp://www.who.int/hiv/topics/microbicides/microbicides/en/ webcite
• [6]Herbst JH, Sherba RT, Crepaz N, DeLuca JB, Zohrabyan L, Stall RD, Lyles CM, HIV/AIDS Prevention Research Synthesis Team: A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men. J Acq Immun Def Synd 2005, 39:228-241.
• [7]Agha S, Van Rossem R: Impact of a school-based peer sexual health intervention on normative beliefs, risk perceptions, and sexual behavior of Zambian adolescents. J Adolesc Heal 2004, 34:441-452.
• [8]Kirby DB, Baumel E, Coyle KK, Basen-Engquist K, Parcel GS, Harrist R, Banspach SW: The “Safer Choices” intervention: its impact on the sexual behaviors of different subgroups of high school students. J Adolesc Heal 2004, 35:442-452.
• [9]Andersson N, Ho-Foster A, Matthis J, Marokoane N, Mashiane V, Mhatre S, Mitchell S, Mokoena T, Monasta L, Ngxowa N, Pascual Salcedo M, Sonnekus H: National cross sectional study of views on sexual violence and risk of HIV infection and AIDS among South African school pupils. BMJ 2004, 329:952-954.
• [10]Andersson N, Ho-Foster A, Mitchell S, Scheepers E, Goldstein S: Risk factors for domestic violence: eight national cross-sectional household surveys in southern Africa. BMC Womens Health 2007, 7:11. BioMed Central Full Text
• [11]Dunkle KL, Jewkes R, Nduna M, Jama N, Levin J, Sikweyiya Y, Koss MP: Transactional sex with casual and main partners among young South African men in the rural Eastern Cape: prevalence, predictors, and associations with gender-based violence. Soc Sci Med 2007, 65:1235-1248.
• [12]Epstein H: The fidelity fix. New York Times; 2004. http://www.ph.ucla.edu/epi/faculty/frerichs/fidelityfix.html webcite
• [13]Swidler A, Watkins SC: Ties of dependence: AIDS and transactional sex in rural Malawi, Califorina Center for Population Research. 2007. [On-line Working Paper Series] [http://papers.ccpr.ucla.edu/papers/PWP-CCPR-2007-025/PWP-CCPR-2007-025.pdf webcite]
• [14]MacDonald TK, MacDonald G, Zanna MP, Fong GT: Alcohol, sexual arousal, and intentions to use condoms in young men: applying alcohol myopia theory to risky sexual behavior. Health Psychol 2000, 19:290-298.
• [15]Donovan C, McEwan R: A review of the literature examining the relationship between alcohol use and HIV-related sexual risk-taking in young people. Addiction 1995, 90:319-328.
• [16]Kalichman SC, Simbayi L, Kaufman M, Cain D, Jooste S: Alcohol use and sexual risks for HIV/AIDS in Sub-Saharan Africa: systematic review of empirical findings. Prev Sci 2007, 8:141-151.
• [17]Samet JH, Freedberg KA, Stein MD, Lewis R, Savetsky J, Sullivan L, Levenson SM, Hingson R: Trillion virion delay: time from testing positive for HIV to presentation for primary care. Arch Intern Med 1998, 158:734-740.
• [18]Cook RL, Sereika SM, Hunt SC, Woodward WC, Erlen JA, Conigliaro J: Problem drinking and medication adherence among patients with HIV infection. J Gen Intern Med 2001, 16:83-88.
• [19]Garcia-Moreno C, Watts CH: Violence against women: its importance for HIV/AIDS prevention. AIDS 2000, 14((Suppl 3)):S253-S265.
• [20]Noll JG, Trickett PK, Putnam FW: A prospective investigation of the impact of childhood sexual abuse on the development of sexuality. J Consult Clin Psychol 2003, 71:575-586.
• [21]Zierler S, Feingold L, Laufer D, Velentgas P, Kantrowitz-Gordon I, Mayer K: Adult survivors of childhood sexual abuse and subsequent risk of HIV Infection. Am J Public Health 1991, 81:572-575.
• [22]Andersson N, Cockcroft A, Shea B: Gender-based violence and HIV: relevance for HIV prevention in hyperendemic countries of southern Africa. AIDS 2008, 22((Suppl 4)):S73-S86.
• [23]Pronyk PM, Hargreaves JR, Kim JC, Morison LA, Phetla G, Watts C, Busza J, Porter JDH: Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial. Lancet 2006, 368:1973-1983.
• [24]Jewkes R, Nduna M, Levin J, Jama N, Dunkle K, Khuzwayo N: Impact of stepping stones on incidence of HIV and HSV-2 and sexual behaviour in rural South Africa: cluster randomised controlled trial. BMJ 2008, 337:a506.
• [25]South Africa: Education on sexual violence. http://www.ciet.org/en/project/south-africa-education-on-sexual-violence-and-hiv-aids-beyond/ webcite
• [26]Andersson N, Cockcroft A, Ho-Foster A, Masisi M, Laetsang D: Survey of HIV and AIDS related knowledge, attitudes and practice, Botswana 2007: summary of key findings. http://hiv.cietresearch.org/files/2012/12/Botswana-SR2-summary-report-30May08.pdf webcite
• [27]CIET: Survey of HIV and AIDS related knowledge, attitudes and practice, Namibia 2007: summary of key findings. http://hiv.cietresearch.org/files/2012/12/Namibia-SR2-summary-report-9May08.pdf webcite
• [28]CIET: Survey of HIV and AIDS related knowledge, attitudes and practice, Swaziland 2007: summary of key findings. http://hiv.cietresearch.org/files/2012/12/Swaziland-SR2-summary-report-9May08.pdf webcite
• [29]Lew J, Reichelderfer P, Fowler M, Bremer J, Carrol R, Cassol S, Chernoff D, Coombs R, Cronin M, Dickover R, Fiscus S, Herman S, Jackson B, Kornegay J, Kovacs A, McIntosh K, Meyer W, Michael N, Mofenson L, Moye J, Quinn T, Robb M, Vahey M, Weiser B, Yeghiazarian T: Determination of levels of HIV type 1 RNA in plasma: reassessment of parameters affecting assay outcome. J Clin Microbiol 1998, 36:1471-1479.
• [30]Solomon SS, Rodriguez II, McGarvey T, Ganesh AK, Thyagarajan SP, Mahajan PA, Mayer KH: Dried Blood Spots (DBS): a valuable tool for HIV surveillance in developing/tropical countries. Int J STD and AIDS 2002, 13:25-28.
• [31]Schulz KF, Grimes DA: Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002, 359:515-519.
• [32]UNAIDS: Report on the global AIDS epidemic, Annex 1: HIV and AIDS estimates 2007 and 2001. http://www.unaids.org/en/media/unaids/contentassets/restore/jc1510_2008_global_report_pp211_234_en.pdf webcite
• [33]Taylor DW, Bosch EG: CTS: a clinical trials simulator. Stat Med 1990, 9:787-801.
• [34]Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. BMJ 2004, 328:702-708.
• [35]Little RJA, Rubin DB: Statistical analysis with missing data. New York: Wiley; 1987.
• [36]Andersson N, Mitchell S: Epidemiological geomatics in evaluation of mine risk education in Afghanistan: introducing population weighted raster maps. Int J Health Geogr 2006, 5:1. BioMed Central Full Text
• [37]Peters TJ, Richards SH, Bankhead CR, Ades AE, Sterne JAC: Comparison of methods for analysing cluster randomized trials: an example involving a factorial design. Int J Epidemiol 2003, 3:840-846.
• [38]Hardin JW: Generalized Estimating Equations. New York: Chapman and Hall and CRC; 2001.
• [39]Kim JC, Watts CH: Gaining a foothold: tackling poverty, gender inequality, and HIV in Africa. BMJ 2005, 331:769-772.
• [40]Solomon SS, Pulimi S, Rodriguez II, Chaguturu SK, Satish Kumar SK, Mayer KH, Solomon S: Dried blood spots are an acceptable and useful HIV surveillance tool in a remote developing world setting. Int J of STD & AIDS 2004, 15:658-661.
• [41]Link BG, Phelan J: Social conditions as fundamental causes of disease. J Health Soc Behav 1995, Extra Issue:80-94.
• [42]Leclerc-Madlala S: Youth, HIV/AIDS and the importance of sexual culture and context. Soc Dyn 2002, 28:20-41.