Evidence map›Paper›PMID 36807505›Full record

Trial reportJournal of the International AIDS Society2023

Risk-based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019.

John Kinuthia, Julia C Dettinger, Joshua Stern, Nancy Ngumbau, Ben Ochieng, Laurén Gómez, Felix Abuna, Salphine Watoyi, Mary Marwa, Daniel Odinga and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the International AIDS Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03070600 (Delivering PrEP in Pregnancy), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03070600 phase4completednot on this map

Delivering PrEP in Pregnancy

TypeinterventionalSponsorUniversity of WashingtonRan2018 to 2021Enrolled4,447ConditionsHIV Infections, Pregnancy RelatedArmsUniversal PrEP Counseling, Targeted PrEP Counseling
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

John KinuthiaDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Julia C DettingerDepartment of Global Health, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-9130-2666
Joshua SternDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Nancy NgumbauDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Ben OchiengDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Laurén GómezDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Felix AbunaDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Salphine WatoyiDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Mary MarwaDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.ORCID 0000-0002-8767-1282
Daniel OdingaDepartment of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.
Anjuli D WagnerDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Barbra A RichardsonDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Jillian PintyeDepartment of Global Health, University of Washington, Seattle, Washington, USA.ORCID 0000-0003-1255-7191
Jared M BaetenDepartment of Global Health, University of Washington, Seattle, Washington, USA.ORCID 0000-0001-8242-8438
Grace John-StewartDepartment of Global Health, University of Washington, Seattle, Washington, USA.

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Judith Tsui · 1988 to 2026
$104.9M
Delivering PrEP in PregnancyR01AI125498 · NIAID · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C. · 2016 to 2020
$3.6M
Evaluating Infant PrEP Exposure During Pregnancy and BreastfeedingR01HD100201 · NICHD · UNIVERSITY OF WASHINGTON · PI PINTYE, JILLIAN · 2019 to 2023
$3.4M
PrEP optimized for mothers (PrOM): efficient PrEP integration in MCH clinicsR01HD094630 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C., KOHLER, PAMELA · 2017 to 2021
$3.3M
Testing implementation strategies to improve delivery of PrEP for pregnant and postpartum women in KenyaK01MH121124 · NIMH · UNIVERSITY OF WASHINGTON · PI WAGNER, ANJULI DAWN · 2019 to 2023
$835k
NIAID NIH HHS GJS,JMB-R01AI125498NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI125498NICHD NIH HHS GJS-R01HD094630NICHD NIH HHS JP-R01HD100201NICHD NIH HHS R01 HD094630NICHD NIH HHS R01 HD100201NIH HHS P30AI027757NIMH NIH HHS K01 MH121124
6 · The paper itself

Abstract

introductionIntegrating pre-exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk-guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP.

methodsThe PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self-selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk-scoring tool and an offer of HIV self-tests for at-home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention-to-treat analyses, adjusting for baseline HIV risk and marital status.

resultsAmong 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person-years (p-yr) of follow-up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p-yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p-yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]).

conclusionsGiven comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisAdultChildFemaleHumansInfantKenyaPregnancyPrenatal CareRisk FactorsYoung AdultAnti-HIV AgentsbreastfeedingHIV preventionKenyapostpartumpre-exposure prophylaxispregnancy

Identifiers

PMID36807505
PMCPMC9939942

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.