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Trial · NCT03070600

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMaternal HIV Incidence6 weeks, 6 months, 9 months postpartumMaternal HIV Incidence
PrimaryAppropriate PrEP DecisionEnrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).Scored 1 for high risk women using PrEP and low risk women not using PrEP; 0 for high risk women NOT on PrEP and low risk women using PrEP
SecondaryPrEP AdherenceEnrollment to 9 months postpartum
Sequential dried blood spots, PrEP adherence by DBS dichotomous by pregnancy or postpartum thresholds equivalent to \~7 doses per week (≥650 fmol/punch during pregnancy or ≥950 fmol/punch postpartum) based on the thresholds established by the 2009 IMPAACT directly observed PrEP PK study.
SecondaryPrEP DurationEnrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).Number of months on PrEP
SecondaryPartner With Known HIV StatusAt 9 months postpartumParticipants report of partner's HIV status
SecondaryInfant Birthweighttime of deliveryInfant Birthweight
SecondaryInfant Growth9 months of age
Infant height, weight, and age (Weight-for-Age \[WAZ\], Height-for-Age \[HAZ\], Weight-for-Height \[WHZ\] Z-scores). A Z-score of 0 represents the population mean. Indicators of infant malnutrition are defined as Underweight- WAZ Z-score\<-2; Stunting-HAZ Z-Score \<-2; Wasting- WHZ Z-Score \<-2.
SecondaryPrEP UseEnrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).PrEP Utilization by participants
SecondaryPrEP AcceptanceEnrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).PrEP accepted by participants
SecondaryPreterm BirthAt birthBirth \<37 weeks gestation
OtherPrEP Adherence by Self-reportEnrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).Any missed doses in the last month reported by participants
OtherPartner on ART if HIV PositiveEnrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).Participant report of partner ART use if partner is HIV positive

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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