| 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 |