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Table 2 Summary of the key characteristics of the PolyIran trial and PASTAL trial

From: Ethical issues in cluster randomized trials conducted in low- and middle-income countries: an analysis of two case studies

  PolyIran trial PASTAL trial
Setting Golestan province, Iran Malawi
Design Parallel-arm, individual-cluster trial Adaptive, parallel, multiarm, two-stage, individual-cluster trial
Design justification Avoid contamination Administrative and logistical reasons
Number of clusters 236 villages Stage 1: 36 antenatal clinic care days
Stage 2: 35 antenatal clinic care days
Number of participants 8410 Stage 1: 1007
Stage 2: 1236
Method of random allocation 1:1 ratio 1:1:1:1:1:1 ratio in stage 1
Data collection procedures Data collected as part of Golestan cohort study Review of health records, interviews
Experimental intervention Polypill plus nonpharmacological prevention Two oral HIV self-test kits only, or two oral HIV self-test kits with an offer of $3, $10 or lottery incentive conditional on clinic attendance, or followed by a phone call reminder
Control intervention Nonpharmacological prevention alone Invitation letter to the male partner offering HIV testing
Primary outcome Major cardiovascular events Proportion of male partners who underwent testing for HIV, regardless of serostatus, and linked to clinic for HIV treatment or prevention within 28 days
REC review Tehran University of Medical Sciences Research Ethics Committee London School of Hygiene & Tropical Medicine Ethics Committee and College of Medicine Research Ethics Committee
Gatekeepers Local health care workers (Behvarz), local religious leaders Local district health officer, health clinic in-charge
Consent model Verbal informed consent with documentation Written informed consent from women; waiver of consent for male partners
  1. REC research ethics committee