Evidence map›Paper›PMID 35835755›Full record

Trial reportScientific reports2022

Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya.

Smritee Dabee, Nelly Mugo, Victor Mudhune, Eleanor McLellan-Lemal, Sue Peacock, Siobhan O'Connor, Betty Njoroge, Beatrice Nyagol, Andrea R Thurman, Eunice Ouma and 10 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.9field-weighted citation impact, top 16% 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

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Contraceptive effects on the cervicovaginal microbiome: Recent evidence including randomized trials.American journal of reproductive immunology (New York, N.Y. : 1989) · 2023
    Review
  9. Article
  10. 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

20 authors at 9 institutions in 3 countries.

Smritee DabeeSeattle Children's Research Institute, 307 Westlake Ave N, Seattle, WA, USA. smritee.dabee@seattlechildrens.org.
Nelly MugoUniversity of Washington Global Health, 325 Ninth Ave, Box 359927, Seattle, WA, USA. rwamba@uw.edu.
Victor MudhuneCenter for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Eleanor McLellan-LemalDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Sue PeacockUniversity of Washington Global Health, 325 Ninth Ave, Box 359927, Seattle, WA, USA.
Siobhan O'ConnorDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Betty NjorogeCenter for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
Beatrice NyagolCenter for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Andrea R ThurmanCONRAD, Eastern Virginia Medical School, Norfolk, VA, USA.
Eunice OumaCenter for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Renee RidzonDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jeffrey WienerDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Harald S HaugenUniversity of Washington Global Health, 325 Ninth Ave, Box 359927, Seattle, WA, USA.
Melanie GasperSeattle Children's Research Institute, 307 Westlake Ave N, Seattle, WA, USA.
Colin FengSeattle Children's Research Institute, 307 Westlake Ave N, Seattle, WA, USA.
Shannon A AllenUnited States Agency for International Development, Washington, DC, USA.
Gustavo F DoncelCONRAD, Eastern Virginia Medical School, Norfolk, VA, USA.
Heather B JaspanSeattle Children's Research Institute, 307 Westlake Ave N, Seattle, WA, USA.
Renee HeffronUniversity of Washington Global Health, 325 Ninth Ave, Box 359927, Seattle, WA, USA. rheffron@uw.edu.
Kisumu Combined Ring Study Team
Kenya Medical Research Institute · KECenters for Disease Control and Prevention · USEastern Virginia Medical School · USUniversity of Washington · USUnited States Agency for International Development · USOregon National Primate Research Center · USCenter for Infectious Disease Research · USUniversity of Cape Town · ZAFred Hutch Cancer Center · US

Funding

Evaluation of an intravaginal ring for HIV and pregnancy prevention with scientific partnerships and robust systems to strengthen HIV research in Western KenyaU01PS005183 · PS · UNIVERSITY OF WASHINGTON · PI MUGO, NELLY RWAMBA · 2017 to 2019
$1.8M
NCHHSTP CDC HHS U01 PS005183PEPFAR
6 · The paper itself

Abstract

In a phase-IIa trial, we investigated the influence of 90 days continuous-delivery tenofovir (TFV) intravaginal rings (IVRs) with/without levonorgestrel (LNG) on the genital microbiota of Kenyan women. Eligible women (n = 27; 18-34 years; negative for HIV, sexually transmitted infections, and Amsel-bacterial vaginosis) were randomized 2:2:1 to use of IVRs containing TFV, TFV/LNG, or placebo. Using vaginal wall and IVR swabs at IVR insertion and removal, the genital microbial composition was determined using 16S rRNA gene sequencing. The presence of Candida spp. was determined using qPCR. The vaginal total bacterial burden appeared to decrease with TFV and TFV/LNG IVR use (log

Indexed as

HIV InfectionsMicrobiotaAdministration, IntravaginalFemaleHumansKenyaLevonorgestrelRNA, Ribosomal, 16STenofovirVaginaLevonorgestrelRNA, Ribosomal, 16STenofovir

Identifiers

PMID35835755
PMCPMC9283538
OpenAlexW4285387577

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.