Evidence map›Paper›PMID 31497242›Full record

ArticleStatistical communications in infectious diseases2019

Advancing Novel PrEP Products - Alternatives to Non-Inferiority.

David V Glidden

Abstract read
In one paragraph

Article in Statistical communications in infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

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

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Background HIV Incidence in PURPOSE 1 and 2 PrEP Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  4. Article
  5. Article
  6. Article
  7. 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

1 author.

David V GliddenUniversity of California San Francisco, San Francisco, CA, USA.

Funding

Statistical methods for clinical trials of novel PrEP agentsR01AI143357 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GLIDDEN, DAVID V. · 2018 to 2021
$483k
NIAID NIH HHS R01 AI143357
6 · The paper itself

Abstract

With the scale-up of HIV pre-exposure prophylaxis (PrEP) with tenofovir (TDF) with or without emtricitabine (FTC), we have entered an era of highly effective HIV prevention with a growing pipeline of potential products to be studied. These studies are likely to be randomized trials with an oral TDF/FTC control arm. These studies require comparison of incident infections and can be time and resource intensive. Conventional approaches for design and analysis active controlled trial can lead to very large sample sizes. We demonstrate the important of assumptions about background infections for interpreting trial results and suggest alternative criteria for demonstrating the efficacy and effectiveness of potential PrEP agents.

Indexed as

active controlledhiv preventionnon-inferioritypre-exposure prophylaxis

Identifiers

PMID31497242
PMCPMC6731035

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.