Evidence map›Paper›PMID 27490637›Full record

ArticleAIDS (London, England)2016

Advancing HIV research with pregnant women: navigating challenges and opportunities.

Carleigh B Krubiner, Ruth R Faden, R Jean Cadigan, Sappho Z Gilbert, Leslie M Henry, Margaret O Little, Anna C Mastroianni, Emily E Namey, Kristen A Sullivan, Anne D Lyerly

Open access · greenAbstract read
In one paragraph

Article in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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  14. Review
  15. Women's Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy.Journal of empirical research on human research ethics : JERHRE · 2018
    Article
  16. A Community Perspective on the Inclusion of Pregnant Women in Tuberculosis Drug Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
    Article
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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

10 authors at 4 institutions in 1 country.

Carleigh B KrubineraJohns Hopkins Berman Institute of Bioethics, Baltimore, Maryland bDepartment of Social Medicine and Center for Bioethics, University of North Carolina, Chapel Hill, North Carolina cKennedy Institute for Ethics and Department of Philosophy, Georgetown University, Washington, DC dUniversity of Washington School of Law, Seattle, Washington eFHI360, Durham, North Carolina, USA.
Ruth R Faden
R Jean Cadigan
Sappho Z Gilbert
Leslie M Henry
Margaret O Little
Anna C Mastroianni
Emily E Namey
Kristen A Sullivan
Anne D Lyerly
Johns Hopkins Berman Institute of Bioethics · USUniversity of North Carolina at Chapel Hill · USMay Institute · USUniversity of Washington · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
The PHASES Project: Pregnancy and HIV/AIDS-Seeking Equitable StudyR01AI108368 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAY, SUZANNE LOUISE, LYERLY, ANNE DRAPKIN · 2015 to 2024
$6.4M
Integrating Decision Making Studies into HIV Cure Trials: A real-time longitudinal assessmentR01AI127024 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HENDERSON, GAIL E · 2016 to 2019
$2.2M
Advancing HIV Research in Pregnancy; ethics and engagementR56AI108368 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LYERLY, ANNE DRAPKIN · 2013 to 2013
$713k
NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI094189NIAID NIH HHS R01 AI108368NIAID NIH HHS R01 AI127024NIAID NIH HHS R56 AI108368
6 · The paper itself

Abstract

objectiveConcerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research.

methodsWe conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women.

resultsExperts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses.

conclusionInvestigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

Indexed as

Clinical Trials as TopicBiomedical ResearchFemaleHIV InfectionsHumansPregnancyPregnancy Complications, InfectiousPregnant People

Identifiers

PMID27490637
PMCPMC5014683
OpenAlexW2514279789

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.