Trial Outcomes & Findings for Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women (NCT NCT03902418)

NCT ID: NCT03902418

Last Updated: 2024-10-23

Results Overview

Percentage of participants initiating pre-exposure prophylaxis during pregnancy

• Recruitment status: COMPLETED
• Target enrollment: 1195 participants
• Primary outcome timeframe: Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant
• Results posted on: 2024-10-23

Participant Flow

Participant milestones

Measure	PrEP Use Evaluation of PrEP use among pregnant and breastfeeding women including initiation, continuation and adherence (self report and objective outcomes)
Overall Study STARTED	1195
Overall Study COMPLETED	1092
Overall Study NOT COMPLETED	103

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

Baseline characteristics by cohort

Measure	PrEP Use n=1195 Participants Evaluation of PrEP use among pregnant and breastfeeding women including initiation, continuation and adherence (self report and objective outcomes)
Age, Continuous	26 years n=5 Participants
Sex: Female, Male Female	1195 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1195 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment South Africa	1195 Participants n=5 Participants

PRIMARY outcome

Timeframe: Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant

Percentage of participants initiating pre-exposure prophylaxis during pregnancy

Outcome measures

Measure	Pregnant Women Initiating PrEP n=1195 Participants Pregnant women in antenatal care (16+ years) who initiated PrEP among all women who were offered oral TDF/FTC as PrEP in a cohort study	Women Receiving STI Syndromic Management Pregnant or postpartum women randomized to receive STI syndromic management
Participants Initiating Pre-exposure Prophylaxis During Pregnancy	1089 Participants	—

PRIMARY outcome

Timeframe: Measured at 3 month follow up visit

Population: 382 women on PrEP with dried blood spots measured for TFV-DP

Percentage of participants with red blood cells with >80% levels at >40ng/mL TDF-DP at 3 months on PrEP

Outcome measures

Measure	Pregnant Women Initiating PrEP n=382 Participants Pregnant women in antenatal care (16+ years) who initiated PrEP among all women who were offered oral TDF/FTC as PrEP in a cohort study	Women Receiving STI Syndromic Management Pregnant or postpartum women randomized to receive STI syndromic management
Adherence to TDF at 3-months on PrEP	256 Participants	—

PRIMARY outcome

Timeframe: Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth

Percentage of women initiating pre-exposure prophylaxis

Outcome measures

Measure	Pregnant Women Initiating PrEP n=1195 Participants Pregnant women in antenatal care (16+ years) who initiated PrEP among all women who were offered oral TDF/FTC as PrEP in a cohort study	Women Receiving STI Syndromic Management Pregnant or postpartum women randomized to receive STI syndromic management
Women Initiating Pre-exposure Prophylaxis Post-partum	1009 Participants	—

PRIMARY outcome

Timeframe: Measured at 6-month post-partum visit

Population: Women with TFV-DP in DBS at 6m visit

Percentage of participants with red blood cells with >80% levels at >40ng/mL TDF-DP at 6 month post-partum visit

Outcome measures

Measure	Pregnant Women Initiating PrEP n=175 Participants Pregnant women in antenatal care (16+ years) who initiated PrEP among all women who were offered oral TDF/FTC as PrEP in a cohort study	Women Receiving STI Syndromic Management Pregnant or postpartum women randomized to receive STI syndromic management
Adherence to TDF at 6 Months Post-partum	51 Participants	—

PRIMARY outcome

Timeframe: Measured at 6-month study visit

Quantifiable TFV (versus none) using dried blood spots (DBS) taken at 6-month study visit among subset of women who reported taking PrEP in the last 30-days at 6-months

Outcome measures

Measure	Pregnant Women Initiating PrEP n=186 Participants Pregnant women in antenatal care (16+ years) who initiated PrEP among all women who were offered oral TDF/FTC as PrEP in a cohort study	Women Receiving STI Syndromic Management Pregnant or postpartum women randomized to receive STI syndromic management
Number of Participants With Adherence to TFV-DP at 6-month Visit	86 Participants	—

SECONDARY outcome

Timeframe: Measured at enrollment and 1 month follow up

Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP

Outcome measures

Measure	Pregnant Women Initiating PrEP n=133 Participants Pregnant women in antenatal care (16+ years) who initiated PrEP among all women who were offered oral TDF/FTC as PrEP in a cohort study	Women Receiving STI Syndromic Management n=135 Participants Pregnant or postpartum women randomized to receive STI syndromic management
PrEP Initiation Among Those With STI POC Testing vs Syndromic Management	89 Participants	84 Participants

Adverse Events

Pregnant Women Offered PrEP

Serious events: 67 serious events

Other events: 201 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregnant Women Offered PrEP n=1082 participants at risk；n=1195 participants at risk Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
Pregnancy, puerperium and perinatal conditions Pregnancy Loss, Miscarriage	3.1% 36/1145 • Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records. Miscarriage or pregnancy loss was defined as noninduced pregnancy loss ≤20 weeks (0/7 days) of gestation. Stillbirth was defined as delivery of a baby with no sign of life \>20 weeks (0/7 days) of gestation, including foetal demise. Neonatal mortality was defined as death of a newborn in the first 28 days of life (days 0-27). Preterm live birth was defined as birth before completion of 37 weeks (0/7 days) of gestation. Low birthweight was defined as an infant birthweight \<2500 grams.
Pregnancy, puerperium and perinatal conditions Pregnancy Loss, Stillbirth	2.2% 25/1145 • Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records. Miscarriage or pregnancy loss was defined as noninduced pregnancy loss ≤20 weeks (0/7 days) of gestation. Stillbirth was defined as delivery of a baby with no sign of life \>20 weeks (0/7 days) of gestation, including foetal demise. Neonatal mortality was defined as death of a newborn in the first 28 days of life (days 0-27). Preterm live birth was defined as birth before completion of 37 weeks (0/7 days) of gestation. Low birthweight was defined as an infant birthweight \<2500 grams.
Pregnancy, puerperium and perinatal conditions Live Birth Outcome, Neonatal Death	0.55% 6/1082 • Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records. Miscarriage or pregnancy loss was defined as noninduced pregnancy loss ≤20 weeks (0/7 days) of gestation. Stillbirth was defined as delivery of a baby with no sign of life \>20 weeks (0/7 days) of gestation, including foetal demise. Neonatal mortality was defined as death of a newborn in the first 28 days of life (days 0-27). Preterm live birth was defined as birth before completion of 37 weeks (0/7 days) of gestation. Low birthweight was defined as an infant birthweight \<2500 grams.
Infections and infestations HIV sero-conversion	1.3% 16/1195 • Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records. Miscarriage or pregnancy loss was defined as noninduced pregnancy loss ≤20 weeks (0/7 days) of gestation. Stillbirth was defined as delivery of a baby with no sign of life \>20 weeks (0/7 days) of gestation, including foetal demise. Neonatal mortality was defined as death of a newborn in the first 28 days of life (days 0-27). Preterm live birth was defined as birth before completion of 37 weeks (0/7 days) of gestation. Low birthweight was defined as an infant birthweight \<2500 grams.

Other adverse events

Measure	Pregnant Women Offered PrEP n=1082 participants at risk；n=1195 participants at risk Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
Pregnancy, puerperium and perinatal conditions Live Birth Outcome, Preterm Delivery	8.4% 91/1082 • Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records. Miscarriage or pregnancy loss was defined as noninduced pregnancy loss ≤20 weeks (0/7 days) of gestation. Stillbirth was defined as delivery of a baby with no sign of life \>20 weeks (0/7 days) of gestation, including foetal demise. Neonatal mortality was defined as death of a newborn in the first 28 days of life (days 0-27). Preterm live birth was defined as birth before completion of 37 weeks (0/7 days) of gestation. Low birthweight was defined as an infant birthweight \<2500 grams.
Pregnancy, puerperium and perinatal conditions Live Birth Outcome, Low Birth Weight	10.2% 110/1082 • Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records. Miscarriage or pregnancy loss was defined as noninduced pregnancy loss ≤20 weeks (0/7 days) of gestation. Stillbirth was defined as delivery of a baby with no sign of life \>20 weeks (0/7 days) of gestation, including foetal demise. Neonatal mortality was defined as death of a newborn in the first 28 days of life (days 0-27). Preterm live birth was defined as birth before completion of 37 weeks (0/7 days) of gestation. Low birthweight was defined as an infant birthweight \<2500 grams.

Additional Information

Landon Myer

University of CApe Town

Phone: 0829430578

Email: landon.myer@uct.ac.za

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place