Improving PrEP outcomes among pregnant women in Botswana with an integrated STI testing and PrEP delivery model - HIV incidence remains high for women in Southern Africa and HIV acquisition risk doubles during pregnancy
and postpartum compared to non-pregnant periods. HIV pre-exposure prophylaxis (PrEP) is promising, with oral
PrEP pills and the dapivirine vaginal ring (DPV-VR) recommended by WHO and national HIV programs. Yet,
research to improve PrEP use in pregnant and postpartum women lags behind other populations, creating
inequitable PrEP access during periods of high HIV risk. PrEP delivery integrated into antenatal care yields high
oral PrEP uptake among women with known HIV risk, though discontinuation and sub-optimal adherence are
common. Low perceived HIV risk, pill burden, side effects that overlap with pregnancy symptoms (e.g., nausea),
and infant safety concerns are key reasons for declining and discontinuing oral PrEP during pregnancy. Refining
risk perception with diagnostic testing for sexually transmitted infections (STIs) may increase PrEP uptake, yet
syndromic STI management persists as standard of care in the region. Pill burden could be addressed by offering
DPV-VR which also has less systemic side effects, like nausea. Bolstering the safety profile of DPV-VR use in
pregnancy could inform messaging for PrEP choices and scale-up in antenatal care. Strategies to optimize PrEP
use in pregnancy with rigorous safety evaluation are needed to advance delivery of expanded PrEP options. Our
team found high STI prevalence among pregnant women in Botswana, making antenatal STI testing a potentially
high-yield strategy in this setting. Botswana is ideal for expanding PrEP options beyond oral pills in antenatal
care and co-delivering STI testing given its high antenatal care coverage, commitment to improve the HIV/STI
care cascades, and proof-of-concept data for antenatal STI testing. In collaboration with the Botswana Ministry
of Health, we propose a randomized trial to determine the effect of co-offering STI testing with enhanced PrEP
options on PrEP use in pregnancy through postpartum. We will also prospectively gather safety data and
implementation outcomes to expedite translation into practice. Our overarching hypothesis is that STI testing
with expanded PrEP options will improve PrEP use in pregnancy and lactation, will be safe, and will be
acceptable in antenatal care. Aim 1 will conduct a randomized trial among women without HIV seeking antenatal
care at public clinics in Botswana to determine whether the addition of STI testing to antenatal PrEP delivery
with expanded PrEP options improves the proportion of pregnant women who initiate PrEP when offered, persist
with use at 9 months postpartum after self-selecting daily oral PrEP or the DPV-VR, and adhere (quantified by
drug levels). Aim 2 of this study will utilize hair samples collected from mother-infant pairs enrolled in Aim 1 to
quantify DPV exposure and to prospectively evaluate pregnancy and infant safety outcomes following DPV
exposure. Aim 3 will assess implementation outcomes to inform scale up of integrating STI testing and the DPV-
VR into antenatal care. Our study is designed to inform STI testing and DPV-VR delivery for pregnant women
and provide necessary evidence to inform policy decisions in Botswana and other HIV high-burden settings.
