Table 2.
Study timeline including randomisation, enrolment and follow-up visits
| Timepoint | Allocation | Enrolment | Study period | |||||||
| Postallocation | Close-out | |||||||||
| 0 | ANC visit* | Postnatal care visits | ||||||||
| 1 | 2 | 3 | 4 | 6 weeks | 14 weeks | 6 months | 9 months | |||
| Enrolment | ||||||||||
| Facility allocation | X | |||||||||
| Eligibility screen | X | |||||||||
| Informed consent | X | |||||||||
| Interventions | ||||||||||
| Universal PrEP offer | U | |||||||||
| Risk score guided PrEP offer | T | |||||||||
| Self-test kit distribution | T | |||||||||
| PrEP refill | P | P | P | P | P | P | P | P | ||
| Assessments | ||||||||||
| Demographic | X | X | X | |||||||
| Medical | X | X | X | |||||||
| Psychosocial | X | X | X | |||||||
| Partner characteristics | X | X | X | |||||||
| Risk assessment | X | X | X | X | X | X | X | X | X | |
| HIV testing | X | X | X | X | X | X | X | X | X | |
| Birth and infant growth outcomes | X | X | X | X | ||||||
| DBS for adherence | P | P | P | P | P | P | P | P | ||
*Number of ANC visits depends on gestational age at enrolment.
ANCA, antenatal care; DBS, dried blood spots; P, PrEP users; PrEP, pre-exposure prophylaxis; T, targeted arm participants only; U, universal arm participants only; X, all study participants.