Trial reportJournal of the International AIDS Society2018
Repeated rectal application of a hyperosmolar lubricant is associated with microbiota shifts but does not affect PrEP drug concentrations: results from a randomized trial in men who have sex with men.
Trial report in Journal of the International AIDS Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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.
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.
Who cites it
18 citing papers in PubMed, 33 citations in OpenAlex.
- Repeated rectal application of a hyperosmolar lubricant is associated with microbiota shifts but does not affect PrEP drug concentrations: results from a randomized trial in men who have sex with men.Journal of the International AIDS Society · 2018Trial
- Review
- Metagenomic analysis reveals rectal microbiota features associated with HIV and behavioral factors in Nigerian men who have sex with men.Scientific reports · 2026Article
- Sexual behavior influences the abundance of Prevotellaceae family in men who have sex with men.AMB Express · 2025Article
- Gut microbiome composition influences immunologic alterations in the blood and gut of HIV-positive and HIV-negative men who have sex with men.Frontiers in immunology · 2025Article
- Rectal mucosal inflammation, microbiome, and wound healing in men who have sex with men who engage in receptive anal intercourse.Scientific reports · 2024Article
- Review
- Pleasurable and problematic receptive anal intercourse and diseases of the colon, rectum and anus.Nature reviews. Gastroenterology & hepatology · 2024Review
- Problematic Cannabis Use Is Associated with Reduced Rectal Microbial Species Richness and Diversity Among a Pilot Sample of Young Sexual and Gender Minorities.AIDS research and human retroviruses · 2024Article
- Gut microbiome dysbiosis in men who have sex with men increases HIV infection risk through immunity homeostasis alteration.Frontiers in cellular and infection microbiology · 2023Article
- A Summary of the Sixth International Workshop on Microbiome in HIV Pathogenesis, Prevention, and Treatment.AIDS research and human retroviruses · 2022Article
- Gut Microbiome Alterations in Men Who Have Sex with Men-A Preliminary Report.Current HIV research · 2022Article
- HIV Pre-exposure Prophylaxis and Its Impact on the Gut Microbiome in Men Having Sex With Men.Frontiers in microbiology · 2022Review
- Condomless receptive anal intercourse is associated with markers of mucosal inflammation in a cohort of men who have sex with men in Atlanta, Georgia.Journal of the International AIDS Society · 2021Article
- The gut microbiome and frailty.Translational research : the journal of laboratory and clinical medicine · 2020Review
- Article
- Can gut microbiota of men who have sex with men influence HIV transmission?Gut microbes · 2020Article
- HIV, Sexual Orientation, and Gut Microbiome Interactions.Digestive diseases and sciences · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
Abstract
introductionOral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is highly effective in preventing HIV infection among men who have sex with men (MSM). The effects of consistent personal lubricant use in the rectum on tissue PrEP drug concentrations and the rectal microbiota are unknown. We investigated rectal PrEP drug concentrations and the microbiota in MSM before and after repeated rectal application of a hyperosmolar lubricant.
methodsWe randomized 60 HIV-negative MSM to apply 4 mL of hyperosmolar rectal lubricant daily (n = 20), take daily oral TDF/FTC (n = 19), or both (n = 21) for seven days. Blood, rectal biopsies and rectal secretions were collected via rigid sigmoidoscopy before and on day 8 after product use. Tenofovir (TFV) and FTC as well as their intracellular metabolites tenofovir-diphosphate (TFV-DP), FTC-triphosphate (FTC-TP) were measured by HPLC-mass spectrometry. Rectal mucosal microbiota was sequenced with 16S rRNA sequencing using Illumina MiSeq.
resultsSeven days of lubricant application was not associated with differences in PrEP drug concentrations in rectal tissue or secretions. Lubricant use was associated with a decrease in the relative abundance of the Bacteroides genus (p = 0.01) and a non-significant increase in the Prevotella genus (p = 0.09) in the rectum. PrEP drug concentrations in rectal tissue and secretions were not associated with microbiota composition or diversity either before or after lubricant use.
conclusionsRepeated rectal application of a hyperosmolar lubricant does not affect mucosal PrEP drug concentrations but is associated with changes in the rectal microbiome.
Indexed as
Identifiers
What OpenQuestion holds
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.