Evidence map›Paper›PMID 35710444›Full record

ArticleTrials2022

Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial.

Jenell Stewart, Elizabeth Bukusi, Fredericka A Sesay, Kevin Oware, Deborah Donnell, Olusegun O Soge, Connie Celum, Josephine Odoyo, Zachary A Kwena, Caitlin W Scoville and 7 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.0field-weighted citation impact, top 12% 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.

NCT04050540 phase4completednot on this map

PrEP and dPEP: Doxycycline Post-exposure Prophylaxis for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV Pre-exposure Prophylaxis

TypeinterventionalSponsorUniversity of WashingtonRan2020 to 2022Enrolled449ConditionsHIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis InfectionArmsDoxycycline
NCT06446752 phase3active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women

TypeinterventionalSponsorUniversity of WashingtonRan2024 to 2027Enrolled1,100ConditionsGonorrhea, Gonorrhea of Pharynx, Gonorrhea of Anus, Gonorrhea of CervixArmsBexsero, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Using doxycycline for prophylaxis of bacterial sexually transmitted infections: considerations for the European Union and European Economic Area.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023
    Article
  8. 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

17 authors at 3 institutions in 2 countries.

Jenell StewartDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA. jenells@uw.edu.ORCID http://orcid.org/0000-0002-8587-1096
Elizabeth BukusiDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Fredericka A SesayDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Kevin OwareKenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Deborah DonnellDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Olusegun O SogeDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Connie CelumDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Josephine OdoyoKenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Zachary A KwenaKenya Medical Research Institute (KEMRI), Kisumu, Kenya.
Caitlin W ScovilleDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Lauren R VioletteDepartment of Medicine (Infectious Diseases), University of Washington, Seattle, USA.
Susan MorrisonDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Jane SimoniDepartment of Psychology, University of Washington, Seattle, USA.
R Scott McClellandDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Ruanne BarnabasDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
Monica GandhiDepartment of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco, San Francisco, USA.
Jared M BaetenDepartment of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.
University of Washington · USKenya Medical Research Institute · KEUniversity of California, San Francisco · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
PrEP and dPEP: Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxisR01AI145971 · NIAID · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED, BUKUSI, ELIZABETH ANNE · 2019 to 2023
$4.0M
Understanding STI and HIV prevention adherence among Kenyan womenK23MH124466 · NIMH · UNIVERSITY OF WASHINGTON · PI STEWART, JENELL · 2020 to 2024
$939k
NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI145971NIMH NIH HHS K23 MH124466NIMH NIH HHS K23MH124466
6 · The paper itself

Abstract

backgroundWomen in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women.

methodsWe are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects. DISCUSSION: The results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women's hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap.

trial registrationClinicalTrials.gov NCT04050540 .

Indexed as

HIV InfectionsSexual and Gender MinoritiesSexually Transmitted DiseasesAdultChlamydia trachomatisDoxycyclineFemaleHomosexuality, MaleHumansKenyaMalePost-Exposure ProphylaxisRandomized Controlled Trials as TopicDoxycyclineAntibioticsDoxycyclineOpen-labelPrEPPreventionRandomized controlled trialSTIsWomen’s health

Identifiers

PMID35710444
PMCPMC9201793
OpenAlexW4283024490

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.