Evidence map›Paper›PMID 34454678›Full record

ReviewThe lancet. HIV2021

Ethical issues in establishing the efficacy and safety of long-acting injectable pre-exposure prophylaxis for HIV prevention: the HPTN 083 trial.

Jeremy Sugarman, Deborah J Donnell, Brett Hanscom, Marybeth McCauley, Beatriz Grinsztejn, Raphael J Landovitz

Open access · greenAbstract readReview
In one paragraph

Review in The lancet. HIV, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
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

6 authors at 5 institutions in 2 countries.

Jeremy SugarmanBerman Institute of Bioethics and Department of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: jsugarman@jhu.edu.
Deborah J DonnellVaccine and Infectious Disease Division, Fred Hutchison Cancer Research Center, Seattle, WA, USA.
Brett HanscomVaccine and Infectious Disease Division, Fred Hutchison Cancer Research Center, Seattle, WA, USA.
Marybeth McCauleyHIV Prevention Trials Network Leadership and Operations Center, Washington, DC, USA.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil.
Raphael J LandovitzUCLA Center for Clinical AIDS Research and Education, Los Angeles, CA, USA.
Fred Hutch Cancer Center · USAIDS Clinical Trials Group · USAPLA Health · USInstituto Evandro Chagas · BRJohns Hopkins Berman Institute of Bioethics · US

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619
6 · The paper itself

Abstract

Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). These results will alter the landscape of HIV prevention and related research. Nevertheless, designing and conducting this research involved several ethical issues. This Viewpoint describes how we managed ethical issues over the duration of one of these trials (HPTN 083). Specifically, we discuss the rationale for pursuing a long-acting injectable agent in the presence of effective oral PrEP, trial design choices, site selection and local standards of prevention, data monitoring and early stopping, effects of the COVID-19 pandemic, post-trial access, and assessment of long-term safety.

Indexed as

COVID-19Anti-HIV AgentsHealth Services AccessibilityHIV InfectionsHumansPandemicsPre-Exposure ProphylaxisSARS-CoV-2Anti-HIV Agents

Identifiers

PMID34454678
PMCPMC11015900
OpenAlexW3197990344

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.