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Randomisation ceremonies: from ping-pong to football matches Richard Hayes.

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1 Randomisation ceremonies: from ping-pong to football matches Richard Hayes

2 JAMA 1995; 273: 408-4122,838 citations

3 Aims of public randomisation ceremonies To explain background to trial To explain need for random allocation and procedures to be used for this To carry out randomisation using transparent procedure, involving key stakeholders Rationale is to ensure fairness, transparency, buy-in, engagement Stakeholders: Government representatives, community leaders, community representatives

4 Ghana bednet trial Rural area of Northern Ghana Widely scattered households Divided into 96 clusters of geographically contiguous households - average of 1400 persons per cluster 48 clusters: impregnated bednets 48 clusters: control arm – bednets at end of trial Mortality in children (6-59m) reduced by 17% Randomisation carried out by lottery in 10 paramount chiefdoms in study area Binka et al, TMIH 1996, 1: 147-154

5 Ghana bednet trial

6 MEMA kwa Vijana trial 20 rural communities in Mwanza Region, Tanzania Adolescent sexual health intervention –In-school sexual health education –Youth-friendly services –Youth condom distributors Cohort of 9,645 young people (Av age 15.5y) followed up for 36 months Further cross-sectional survey carried out 5-6y later Effects on knowledge, attitudes and some reported sexual behaviours No impact on HIV, pregnancy, other STIs Ross et al, AIDS 2007, 21:1943 Doyle et al, PLoSMed 2010, 7:e1000287

7 MEMA kwa Vijana trial

8 MkV randomisation scheme 20 clusters divided into three strata based on initial survey of HIV prevalence –High-risk: 6 clusters –Medium-risk: 8 clusters –Low-risk: 6 clusters Stratified randomisation Possible allocations = 6 C 4 x 8 C 3 x 6 C 3 = 28,000

9 MkV restricted randomisation Restricted randomisation –Used to ensure adequate balance across study arms Restriction criteria –Mean HIV prevalence similar –Mean chlamydia prevalence similar –Two communities near mines evenly distributed –Even distribution over four districts 953 of the 28,000 allocations satisfied criteria Hayes et al, Contemporary Clinical Trials 2005, 26:430

10 MkV randomisation ceremony Held with senior stakeholders List of allocations presented, numbered 001–953 Stakeholders asked to draw ping-pong balls numbered 0-9 from bucket Number 039 selected: divides 20 communities into two sets of 10 Final draw of ping-pong ball used to decide which set of 10 receives intervention

11 Zamstar trial Impact of 2 intensive TB control strategies evaluated in 2x2 factorial CRT –Arm 1: Enhanced case finding –Arm 2: Household intervention –Arm 3: ECF + household –Arm 4: Neither intervention 24 communities in Zambia and S Africa Household intervention decreased TB prevalence by 20% and reduced transmission to children No effect of ECF Ayles et al, Trials 2008, 9:63

12 Zamstar randomisation scheme 24 clusters divided into 4 strata based on initial TST survey in schoolchildren –Zambia/High TST: 8 clusters –Zambia/Low TST: 8 clusters –S Africa/High TST: 4 clusters –S Africa/Low TST: 4 clusters Stratified randomisation Possible allocations = = 3,657,830,400

13 Zamstar restricted randomisation Restriction criteria –Similar number with high estimated HIV prevalence in each arm –Similar mean TST prevalence –Similar number of “open” communities –Similar number of urban communities –Political constraints Randomly selected allocations until 1,000 which satisfied restriction criteria Sismanidis et al, Clin Trials 2008, 5:316

14 Zamstar randomisation ceremony Held on football pitch during tournament in Zambia List of acceptable allocations numbered 000-999 24 volunteers representing clusters Senior officials asked to draw footballs numbered 0-9 from sack Number 773 selected: volunteers divided into four groups labelled A-D More footballs drawn to determine study arm allocated to each group

15 Special thanks to Fred Binka for the Ghana video Babis Sismanidis for the Zamstar video The PIs and investigators of the Ghana bednet, MkV and Zamstar trials

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