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Improving PrEP outcomes among pregnant women in Botswana with an integrated STI testing and PrEP delivery model

Award Number: R01HD117702
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/02/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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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 is inadequate. 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $555,945 )
2025	2025	THE BOTSWANA HARVARD HEALTH PARTNERSHIP	PRINCESS MARINA HOSPITAL PLOT 1836 NORTH RING R	BOTSWANA				BWA	Child Health and Human Development Extramural Research	000	2	7/31/2025	NON-COMPETING CONTINUATION	$555,945
														Subtotal = $555,945

Issue Date FY: 2024 ( Subtotal = $573,475 )
2024	2024	BOTSWANA HARVARD AIDS INSTITUTE	PRINCESS MARINA HOSPITAL PLOT 1836 NORTH RING R	BOTSWANA				BWA	Child Health and Human Development Extramural Research	000	1	9/2/2024	NEW	$573,475
														Subtotal = $573,475

Grand Total All Awards = $1,129,420

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Improving PrEP outcomes among pregnant women in Botswana with an integrated STI testing and PrEP delivery model

Award Number: R01HD117702

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/02/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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