Trial Outcomes & Findings for Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study) (NCT NCT03826199)

NCT ID: NCT03826199

Last Updated: 2023-12-01

Results Overview

number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 200 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2023-12-01

Participant Flow

Participant milestones

Measure	Pregnant Women Offered PrEP Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
Overall Study STARTED	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

Baseline characteristics by cohort

Measure	Pregnant Women Offered PrEP n=200 Participants Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	190 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	200 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	200 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	200 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Participants who were retained on PrEP study and were on PrEP

number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP

Outcome measures

Measure	Pregnant Women Offered PrEP n=200 Participants Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
PrEP Retention	100 participants

PRIMARY outcome

Timeframe: 3 months

Population: Women who were adherent on PrEP at 3 months per DBS measure of TFV-DP (equivalent to 2+ days/week by pregnant or postpartum)

number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)

Outcome measures

Measure	Pregnant Women Offered PrEP n=78 Participants Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
PrEP Adherence	25 participants

SECONDARY outcome

Timeframe: 18 months

Population: Pregnant women who enrolled in study and were offered PrEP

number of women who initiate PrEP over time/ total number of women in active cohort

Outcome measures

Measure	Pregnant Women Offered PrEP n=200 Participants Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
PrEP Initiation	180 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 78 DBS drawn from participants on PrEP at 3m visit

number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)

Outcome measures

Measure	Pregnant Women Offered PrEP n=78 Participants Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
PrEP Adherence (Peri-sexual)	25 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Participants who started PrEP at baseline

number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)

Outcome measures

Measure	Pregnant Women Offered PrEP n=194 Participants Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study
PrEP Adherence (Subjective, Self-reported)	118 Participants

Adverse Events

Pregnant Women Offered PrEP

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregnant Women Offered PrEP n=200 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 Stillbirth	0.50% 1/200 • Number of events 1 • We collected data every study visit (quarterly) until 12 months postpartum (up to 18 months from baseline enrollment in study) Adverse events included all pregnancy and birth outcomes in the cohort
Pregnancy, puerperium and perinatal conditions Miscarriage	2.5% 5/200 • Number of events 5 • We collected data every study visit (quarterly) until 12 months postpartum (up to 18 months from baseline enrollment in study) Adverse events included all pregnancy and birth outcomes in the cohort
Pregnancy, puerperium and perinatal conditions Infant low birthweight or preterm	2.0% 4/200 • Number of events 4 • We collected data every study visit (quarterly) until 12 months postpartum (up to 18 months from baseline enrollment in study) Adverse events included all pregnancy and birth outcomes in the cohort

Other adverse events

Adverse event data not reported

Additional Information

Dvora Joseph Davey

UCLA

Phone: 3107011526

Email: dvoradavey@ucla.edu

Results disclosure agreements

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