Table 3 SCOPE-PP Step 1 and Step 2 Study populations, Intervention, Outcomes and Hypotheses

Step 1:

N = 650 pregnant women at enrollment

Persistence biofeedback

PrEP continuation and persistence (urine TFV at 6 months postpartum & verified post hoc via DBS of TFV-DP)

Persistence biofeedback will improve PrEP continuation & persistence by > 15% compared to standard of care (no intervention) in pregnant and early postpartum women

Step 2^a:

N = Approximately 325 postpartum women at enrollment

Composed of ALL women who want to use PrEP but are struggling to engage w/PrEP from Step 1 (EARLY-PREP-P)

Differentiated PrEP delivery (in community pick up points) with HIVST (for participant and partner)

Vs.

Persistence biofeedback

PrEP continuation and persistence through 12-months follow up per urine TFV (post hoc DBS analysis)

In postpartum women who want to use PrEP but struggle to engage with initial use, PrEP use continues and improves by > 15% differentiated PrEP delivery (in community pick up points) at longer time periods (through 12-months follow up)