Evidence map›Paper›PMID 31324206›Full record

ArticleTrials2019

Protocol for a randomized clinical trial exploring the effect of antimicrobial agents on the penile microbiota, immunology and HIV susceptibility of Ugandan men.

Ronald M Galiwango, Bernard Bagaya, Juliet Mpendo, Vineet Joag, Brenda Okech, Annet Nanvubya, Ali Ssetaala, Moses Muwanga, Rupert Kaul

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03412071 (Testing the Ability of a Microbiome - Focused Intervention to Reduce HIV Susceptibility in Ugandan Men), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT03412071 naunknown statusnot on this map

Testing the Ability of a Microbiome - Focused Intervention to Reduce HIV Susceptibility in Ugandan Men

TypeinterventionalSponsorUniversity of TorontoRan2017 to 2019Enrolled125ConditionsForeskin HIV SusceptibilityArmsOral Tinidazole, Topical metronidazole, Topical Clindamycin, Topical Hydrogen Peroxide
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Impact ofVaccines · 2025
    Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. 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

9 authors at 4 institutions in 3 countries.

Ronald M GaliwangoDepartment of Immunology, University of Toronto, St. George Campus Medical Sciences Building #6356 1 King's College Circle, Toronto, ON, M5S 1A8, Canada.ORCID http://orcid.org/0000-0003-3702-5722
Bernard BagayaHIV Vaccine Program, Uganda Virus Research Institute-International AIDS Vaccine Initiative, Entebbe, Uganda.
Juliet MpendoHIV Vaccine Program, Uganda Virus Research Institute-International AIDS Vaccine Initiative, Entebbe, Uganda.
Vineet JoagDepartment of Immunology, University of Toronto, St. George Campus Medical Sciences Building #6356 1 King's College Circle, Toronto, ON, M5S 1A8, Canada.
Brenda OkechHIV Vaccine Program, Uganda Virus Research Institute-International AIDS Vaccine Initiative, Entebbe, Uganda.
Annet NanvubyaHIV Vaccine Program, Uganda Virus Research Institute-International AIDS Vaccine Initiative, Entebbe, Uganda.
Ali SsetaalaHIV Vaccine Program, Uganda Virus Research Institute-International AIDS Vaccine Initiative, Entebbe, Uganda.
Moses MuwangaEntebbe General Hospital, Entebbe, Uganda.
Rupert KaulDepartment of Immunology, University of Toronto, St. George Campus Medical Sciences Building #6356 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. rupert.kaul@utoronto.ca.
International AIDS Vaccine Initiative · USUniversity of Toronto · CAMinistry of Agriculture, Animal Industry and Fisheries · UGUniversity Health Network · CA

Funding

Male Circumcision and Use of Foreskin Tissues for HIV Prevention in UgandaD43TW009578 · FIC · JOHNS HOPKINS UNIVERSITY · PI GRAY, RONALD H · 2013 to 2017
$1.3M
FIC NIH HHS D43 TW009578Fogarty International Center (US) 4D43TW009578-04Institute of Infection and Immunity TMI-138656Ontario HIV Treatment Network Endowed Chair in HIV Research
6 · The paper itself

Abstract

backgroundThe foreskin is the main site of HIV acquisition in a heterosexual uncircumcised man, but many men in endemic countries are reluctant to undergo penile circumcision (PC). Observational studies suggest that proinflammatory anaerobic bacteria are enriched on the uncircumcised penis, where they may enhance HIV susceptibility through increased foreskin inflammatory cytokines and the recruitment of HIV-susceptible CD4 METHODS/

designThis randomized, open-label clinical trial will randomize 125 HIV-negative Ugandan men requesting voluntary PC to one of five arms (n = 25 each). The control group will receive immediate PC, while the four intervention groups will defer PC for 1 month and be provided in the interim with either oral tinidazole, penile topical metronidazole, topical clindamycin, or topical hydrogen peroxide. The impact of these interventions on HIV entry into foreskin-derived CD4 DISCUSSION: There is a critical need to develop acceptable, simple, and effective means of HIV prevention in men unwilling to undergo PC. This trial will provide insight into the causative role of the foreskin microbiota on HIV susceptibility, and the impact of simple microbiota-focused clinical interventions. This may pave the way for future clinical trials using low-cost, nonsurgical intervention(s) to reduce HIV risk in uncircumcised heterosexual men.

trial registrationClinicalTrials.gov, NCT03412071 . Retrospectively registered on 26 January 2018.

Indexed as

Administration, CutaneousAdministration, OralAnti-Infective AgentsBacteriaCD4-Positive T-LymphocytesCircumcision, MaleClindamycinFemaleForeskinHeterosexualityHIV InfectionsHost-Pathogen InteractionsHumansHydrogen PeroxideMaleMetronidazoleAnti-Infective AgentsClindamycinHydrogen PeroxideMetronidazoleTinidazoleAntimicrobialsClinical trialHIV transmissionPenile microbiomeUganda

Identifiers

PMID31324206
PMCPMC6642556
OpenAlexW2963961837

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.