Trial · NCT03070600
PrEP Implementation for Mothers in Antenatal Care
NCT03070600, Phase 4, Completed, University of Washington; results first posted 2022-05-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. PrEP Implementation for Mothers in Antenatal Care. Trials, record NCT03070600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03070600
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PrEP Implementation for Mothers in Antenatal Care
- NCT number
- NCT03070600
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 4,447 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- HIV Infections, Pregnancy Related
- Interventions
- Universal PrEP Counseling, Targeted PrEP Counseling
- First posted
- 2017-03-03
- Last updated
- 2022-07-12
- Results first posted
- 2022-05-10
- Limitations and caveats
Low HIV incidence limited power of the primary outcome; however, similar HIV incidence in both arms suggest that meaningful differences are unlikely. Changing MoH policies and the COVID-19 pandemic affected study operations. Our observed rates of PrEP adherence and persistence could have been influenced by efforts to optimize study retention, and PrEP adherence relied on self-report, which can overestimate adherence.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maternal HIV Incidence | 6 weeks, 6 months, 9 months postpartum | Maternal HIV Incidence |
| Primary | Appropriate PrEP Decision | Enrollment 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 |
| Secondary | PrEP Adherence | Enrollment 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. |
| Secondary | PrEP Duration | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | Number of months on PrEP |
| Secondary | Partner With Known HIV Status | At 9 months postpartum | Participants report of partner's HIV status |
| Secondary | Infant Birthweight | time of delivery | Infant Birthweight |
| Secondary | Infant Growth | 9 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. |
| Secondary | PrEP Use | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | PrEP Utilization by participants |
| Secondary | PrEP Acceptance | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | PrEP accepted by participants |
| Secondary | Preterm Birth | At birth | Birth \<37 weeks gestation |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maternal HIV Incidence | 6 weeks, 6 months, 9 months postpartum | incidence/100 Person years | NUMBER | |
| PRIMARY | Appropriate PrEP Decision | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PrEP Adherence | Enrollment to 9 months postpartum | Of the 186 participants sampled for this analyses, 427 DBS samples were analyzed (232 universal arm, 195 targeted arm). | Samples w/ adherence at ~7dose/week | NUMBER |
| SECONDARY | PrEP Duration | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | This analysis is restricted to participants who initiated PrEP during the study period. | months | MEDIAN |
| SECONDARY | Partner With Known HIV Status | At 9 months postpartum | This analysis is restricted to participants who reported having a partner at 9-months postpartum. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Infant Birthweight | time of delivery | This analysis is restricted to mothers with live born infants with birth weight data available in their clinical records. | kg | MEDIAN |
| SECONDARY | Infant Growth | 9 months of age | Length measurements could not be ascertained from all infants | z-score | MEDIAN |
| SECONDARY | PrEP Use | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PrEP Acceptance | Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preterm Birth | At birth | This analysis is restricted to participants who reported a live birth and had gestational age at birth data available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maternal HIV Incidence | Universal PrEP Counselling | 0.38 | 95% Confidence Interval 0.20 to 0.73 | incidence/100 Person years | |
| Maternal HIV Incidence | Targeted PrEP Clinics | 0.31 | 95% Confidence Interval 0.15 to 0.65 | incidence/100 Person years | |
| Appropriate PrEP Decision | Universal PrEP Counselling | 1535 | Participants | ||
| Appropriate PrEP Decision | Targeted PrEP Clinics | 1299 | Participants | ||
| PrEP Adherence | Universal Arm- DBS Samples Selected | 7 | Samples w/ adherence at ~7dose/week | ||
| PrEP Adherence | Targeted Arm- DBS Samples Selected | 9 | Samples w/ adherence at ~7dose/week | ||
| PrEP Duration | Universal Arm- PrEP Initiated | 8.6 | Inter-Quartile Range 3.2 to 11.4 | months | |
| PrEP Duration | Targeted Arm- PrEP Initiated | 9.0 | Inter-Quartile Range 3.8 to 11.9 | months | |
| Partner With Known HIV Status | Universal PrEP Counselling | 1680 | Participants | ||
| Partner With Known HIV Status | Targeted PrEP Clinics | 1648 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Universal PrEP Counselling | 2,250 | |
| Overall Study | STARTED | Targeted PrEP Clinics | 2,197 | |
| Overall Study | COMPLETED | Universal PrEP Counselling | 2,156 | |
| Overall Study | COMPLETED | Targeted PrEP Clinics | 2,032 | |
| Overall Study | NOT COMPLETED | Universal PrEP Counselling | 94 | |
| Overall Study | NOT COMPLETED | Targeted PrEP Clinics | 165 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Kicked out of home | Pregnancy, puerperium and perinatal conditions | Universal PrEP Counselling | 2 | 2,250 | 2 |
| other | Kicked out of home | Pregnancy, puerperium and perinatal conditions | Targeted PrEP Clinics | 3 | 2,197 | 3 |
| other | Experienced violence of abuse | Pregnancy, puerperium and perinatal conditions | Universal PrEP Counselling | 5 | 2,250 | 5 |
| other | Experienced violence of abuse | Pregnancy, puerperium and perinatal conditions | Targeted PrEP Clinics | 4 | 2,197 | 4 |
| other | Breach of confidentiality | Pregnancy, puerperium and perinatal conditions | Universal PrEP Counselling | 0 | 2,250 | 0 |
| other | Breach of confidentiality | Pregnancy, puerperium and perinatal conditions | Targeted PrEP Clinics | 1 | 2,197 | 1 |
| other | Suicidal behavior | Psychiatric disorders | Universal PrEP Counselling | 0 | 2,250 | 0 |
| other | Suicidal behavior | Psychiatric disorders | Targeted PrEP Clinics | 1 | 2,197 | 1 |
| other | Persistent or significant psychosocial distress | Psychiatric disorders | Universal PrEP Counselling | 3 | 2,250 | 3 |
| other | Persistent or significant psychosocial distress | Psychiatric disorders | Targeted PrEP Clinics | 1 | 2,197 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Universal PrEP Counselling | 2 | 2,250 |
| Total, all-cause mortality | Targeted PrEP Clinics | 2 | 2,197 |
| Total, other adverse events | Universal PrEP Counselling | 7 | 2,250 |
| Total, other adverse events | Targeted PrEP Clinics | 7 | 2,197 |
| Total, serious adverse events | Universal PrEP Counselling | 132 | 2,250 |
| Total, serious adverse events | Targeted PrEP Clinics | 118 | 2,197 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AI125498 | Delivering PrEP in Pregnancy | JOHN-STEWART, GRACE C. | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Universal PrEP Counselling vs Targeted PrEP Clinics: Appropriate PrEP Decision | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: PrEP Acceptance | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: Preterm Birth | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: PrEP Use | Trial comparisons |
| Universal Arm- PrEP Initiated vs Targeted Arm- PrEP Initiated: PrEP Adherence by Self-report | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: Partner on ART if HIV Positive | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: deaths from any cause | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: Partner With Known HIV Status | Trial comparisons |
| Universal PrEP Counselling vs Targeted PrEP Clinics: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03070600
GET https://conductscience.org/api/trials/v1/NCT03070600/results?page=2