Evidence map›Paper›PMID 36480171›Full record

ArticleJournal of the International AIDS Society2022

Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in South African women: a cohort study.

Dvora Joseph Davey, Dorothy C Nyemba, Jose Castillo-Mancilla, Lubbe Wiesner, Jennifer Norman, Rufaro Mvududu, Nyiko Mashele, Leigh F Johnson, Linda-Gail Bekker, Pamina Gorbach and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of the International AIDS Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03902418 (Evaluation of Pre-Exposure Prophylaxis), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 6% 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.

NCT03902418 completednot on this map

Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women

TypeobservationalSponsorUniversity of California, Los AngelesRan2019 to 2024Enrolled1,195ConditionsHIV-I InfectionArmsemtricitabine/tenofovir
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Frontiers in pediatrics · 2024
    Article
  18. Observational
  19. Article
  20. Article
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

12 authors at 4 institutions in 2 countries.

Dvora Joseph DaveyDivision of Infectious Diseases, Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.ORCID 0000-0001-6290-9293
Dorothy C NyembaDivision of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-3391-3223
Jose Castillo-MancillaDivision of Infectious Diseases, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Jennifer NormanDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Rufaro MvududuDivision of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
Nyiko MasheleDivision of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
Leigh F JohnsonCentre for Infectious Disease Epidemiology and Research, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-2717-011X
Linda-Gail BekkerThe Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-0755-4386
Pamina GorbachDivision of Infectious Diseases, Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Thomas J CoatesDivision of Infectious Diseases, Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Landon MyerDivision of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
University of Cape Town · ZADesmond Tutu HIV Foundation · ZAUniversity of California, Los Angeles · USUniversity of Colorado Anschutz Medical Campus · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
UCLA Rapid, Relevant, Rigorous Implementation Science HubP30MH058107 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Nina Thawata Harawa · 1997 to 2026
$53.5M
Influence of HIV infection on vaginal virome and risk of preterm birth in pregnant South African womenR01HD106821 · NICHD · SEATTLE CHILDREN'S HOSPITAL · PI JASPAN, HEATHER BERYL · 2021 to 2025
$3.9M
Evaluating the PrEP cascade in HIV-negative pregnant and breastfeeding women in South Africa (PrEP-PP)R01MH116771 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI JOSEPH DAVEY, DVORA LEAH, MYER, BENJAMIN LANDON · 2018 to 2022
$2.5M
Evaluation of pre-exposure prophylaxis cascade in pregnant and breastfeeding women in Cape Town, South AfricaK01TW011187 · FIC · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI JOSEPH DAVEY, DVORA LEAH · 2018 to 2022
$698k
FIC NIH HHS K01 TW011187FIC NIH HHS K01TW011187NIAID NIH HHS U01 AI068632NICHD NIH HHS R01 HD106821NICHD NIH HHS R01HD106821NIH HHS UM1 AI068634NIH HHS UM1 AI068636NIH HHS UM1 AI106701NIMH NIH HHS P30 MH058107NIMH NIH HHS R01 MH116771NIMH NIH HHS R01MH116771
6 · The paper itself

Abstract

introductionDaily oral pre-exposure prophylaxis (PrEP) can reduce HIV acquisition. However, prevention effectiveness requires daily adherence prior to and during periods of sexual activity. Little is known about pharmacologic measures of PrEP adherence during pregnancy and postpartum and the factors related to optimal adherence during periods of sexual activity in this population.

methodsBetween August 2019 and October 2021, we enrolled pregnant women without HIV at their first antenatal care visit followed-up through 12 months postpartum. Eligible women ≥16 years old received HIV prevention counselling and were offered oral PrEP (TDF-FTC). We quantified tenofovir-diphosphate (TFV-DP) in dried blood spots in women who reported taking PrEP in the past 30 days (at quarterly follow-up visits). We used regression models with generalized estimating equations to evaluate correlates of TFV-DP (any vs. none, and ≥2 vs. <2 doses/week), adjusting for maternal age and pregnancy status. RESULTS AND DISCUSSION: In 382 women who started PrEP in pregnancy, returned for follow-up and reported PrEP use in the past 30 days, the median age was 27 years (interquartile range [IQR] = 23-32), and the median time on PrEP was 168 days (IQR = 84-252 days). Half of the samples had quantifiable TFV-DP at any time point (52%), declining from 67% of pregnant women 3 months post-initiation to 31% of postpartum women by 12 months. Overall, 72% had concentrations corresponding to <2 doses/week; 25% ≥2 doses/week; 3% 7 doses/week. Concentrations were lower in postpartum versus pregnancy (age-adjusted odds ratio [aOR] = 0.44; 95% confidence interval [CI] = 0.35-0.54). The correlation of self-reported adherence and TFV-DP ranged from -0.07 in pregnancy to 0.25 in postpartum women. Variables associated with having quantifiable TFV-DP included partner living with HIV/unknown serostatus (aOR = 1.50; 95% CI = 1.01-2.22), and reported frequency of sexual activity in the past month (aOR sex >5/month vs. no sex or <5 times/month = 2.11; 95% CI = 1.58-2.82) adjusting for age and pregnancy versus postpartum status. TFV-DP concentrations declined over follow-up time (aOR for 6 vs. 3 months = 0.49; 95% CI = 0.36-0.67).

conclusionsObjectively measured adherence to PrEP was low overall and did not correlate with self-reported use. There is an urgent need for objective adherence measures to support clinical decision-making as well as adherence support interventions as part of PrEP services for pregnant and postpartum women at risk of HIV.

Indexed as

HIV InfectionsPre-Exposure ProphylaxisAdolescentAdultCohort StudiesFemaleHumansPostpartum PeriodPregnancyadherencebreastfeedingpre-exposure prophylaxispregnantPrEPSouth Africa

Identifiers

PMID36480171
PMCPMC9731362
OpenAlexW4310873937

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.