Evidence map›Paper›PMID 33341883›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa.

Lynda Stranix-Chibanda, Peter L Anderson, Deborah Kacanek, Sybil Hosek, Sharon Huang, Teacler G Nematadzira, Frank Taulo, Violet Korutaro, Clemensia Nakabiito, Maysebole Masenya and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03386578 (Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants), which is not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 15% of its field
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.

NCT03386578 phase2completednot on this map

Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2024Enrolled780ConditionsHIV InfectionsArmsEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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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

22 authors at 16 institutions in 5 countries.

Lynda Stranix-ChibandaUniversity of Zimbabwe, Harare, Zimbabwe.ORCID 0000-0003-3566-1688
Peter L AndersonUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Deborah KacanekHarvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Sybil HosekJohn H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, USA.
Sharon HuangHarvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Teacler G NematadziraUniversity of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
Frank TauloCollege of Medicine-Johns Hopkins Research Project, Blantyre, Malawi.
Violet KorutaroBaylor College of Medicine Children's Foundation-Uganda, Kampala, Uganda.
Clemensia NakabiitoMakerere University-Johns Hopkins University, Kampala, Uganda.
Maysebole MasenyaWits Reproductive Health and HIV Institute, Johannesburg, South Africa.
Kathryn LypenFHI 360, Durham, North Carolina, USA.
Emily BrownFHI 360, Durham, North Carolina, USA.
Mustafa E IbrahimUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Jenna YagerUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-9070-8699
Benjamin JohnstonFrontier Science Foundation, Inc, Amherst, New York, USA.
K Rivet AmicoUniversity of Michigan, Ann Arbor, Michigan, USA.
James F RooneyGilead Sciences, Inc, Foster City, California, USA.
Nahida ChakhtouraNational Institute of Child Health and Human Development, Bethesda, Maryland, USA.
Hans M L SpiegelKelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, Maryland, USA.
Benjamin H ChiUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
IMPAACT 2009 Team
University of Colorado Anschutz Medical Campus · USFamily Health International 360 · USHarvard University · USUniversity of Zimbabwe · ZWBaylor College of Medicine Children’s Foundation · UGEunice Kennedy Shriver National Institute of Child Health and Human Development · USFrontier Science & Technology Research Foundation · USGilead Sciences (United States) · USJohn H. Stroger, Jr. Hospital of Cook County · USMUJHU Research Collaboration · UGNational Institutes of Health · USPerinatal HIV Research Unit · ZAUniversity of Cape Town · ZAUniversity of Malawi · MWUniversity of Michigan · USUniversity of North Carolina at Chapel Hill · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI069436NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INIH HHS UM1AI068632
6 · The paper itself

Abstract

backgroundIntracellular tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is used to monitor cumulative pre-exposure prophylaxis (PrEP) adherence. We evaluated TFV-DP in DBSs following daily oral PrEP (emtricitabine 200 mg/tenofovir diphosphate 300 mg) among pregnant and postpartum adolescent girls and young women (AGYW).

methodsDirectly observed PrEP was administered for 12 weeks in a pregnancy (14-24 weeks' gestation, n = 20) and postpartum (6-12 weeks postpartum, n = 20) group of AGYW aged 16-24 years in sub-Saharan Africa. Weekly DBS TFV-DP was measured by validated liquid chromatography-tandem mass spectrometry assay. Week 12 TFV-DP distributions were compared between groups with Wilcoxon test. Population pharmacokinetic models were fit to estimate steady-state concentrations and create benchmarks for adherence categories. Baseline correlates of TFV-DP were evaluated.

resultsMedian age was 20 (IQR, 19-22) years. Of 3360 doses, 3352 (>99%) were directly observed. TFV-DP median (IQR) half-life was 10 (7-12) days in pregnancy and 17 (14-21) days postpartum, with steady state achieved by 5 and 8 weeks, respectively. Observed median (IQR) steady-state TFV-DP was 965 fmol/punch (691-1166) in pregnancy versus 1406 fmol/punch (1053-1859) postpartum (P = .006). Modeled median steady-state TFV-DP was 881 fmol/punch (667-1105) in pregnancy versus 1438 fmol/punch (1178-1919) postpartum. In pooled analysis, baseline creatinine clearance was associated with observed TFV-DP concentrations.

conclusionsTFV-DP in African AGYW was approximately one-third lower in pregnancy than postpartum. These Population-specific benchmarks can be used to guide PrEP adherence support in pregnant/postpartum African women. CLINICAL TRIALS REGISTRATION: NCT03386578.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisAdenineAdolescentAfrica South of the SaharaFemaleHumansMedication AdherenceOrganophosphatesPostpartum PeriodPregnancyYoung AdultAdenineAnti-HIV AgentsOrganophosphatestenofovir diphosphateadolescenceintracellular TFV-DPPrEP in pregnancy

Identifiers

PMID33341883
PMCPMC8492211
OpenAlexW3114015419

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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.