Evidence map›Paper›PMID 41382078›Full record

Trial reportBMC women's health2025

Bacterial Vaginosis [BV] knowledge, attitudes and behavioural changes after BV diagnosis among women enrolled in a clinical trial in Boston, USA and Vulindlela, South Africa: a qualitative study.

Cecilia Milford, Buyisiwe L Dlamini, Nomfuneko A Mafunda, Timothy S Hardwick, Lara Lewis, Anam A Khan, Makhosazane N Mdladla, Caroline M Mitchell, Disebo Potloane

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC women's health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06135974 (Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06135974 early_phase1completednot on this map

Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product

TypeinterventionalSponsorMassachusetts General HospitalRan2024 to 2025Enrolled24ConditionsBacterial VaginosisArmsLC106, LC115, Placebo, Metronidazole Oral
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. International journal of sexual health : official journal of the World Association for Sexual Health · 2026
    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

9 authors.

Cecilia MilfordCentre for the AIDS Programme of Research in South Africa (CAPRISA), Vulindlela, South Africa. cecilia.milford@gmail.com.ORCID 0000-0002-0026-7560
Buyisiwe L DlaminiCentre for the AIDS Programme of Research in South Africa (CAPRISA), Vulindlela, South Africa.
Nomfuneko A MafundaVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.ORCID 0009-0000-8805-5935
Timothy S HardwickCentre for the AIDS Programme of Research in South Africa (CAPRISA), Vulindlela, South Africa.ORCID 0000-0002-1090-0876
Lara LewisCentre for the AIDS Programme of Research in South Africa (CAPRISA), Vulindlela, South Africa.
Anam A KhanVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Makhosazane N MdladlaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Vulindlela, South Africa.
Caroline M MitchellVincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Disebo PotloaneCentre for the AIDS Programme of Research in South Africa (CAPRISA), Vulindlela, South Africa.

Funding

Bill and Melinda Gates Foundation INV-037901 and INV-037902
6 · The paper itself

Abstract

backgroundBacterial vaginosis (BV), the most common cause of vaginitis among reproductive age women, has high recurrence even after treatment. In addition to the physical risks of BV (e.g. increased HIV risk and adverse pregnancy outcomes such as preterm birth), the symptoms (malodour, itchiness, vaginal discharge) can cause emotional impacts (e.g. shame, embarrassment, self-consciousness). BV knowledge, attitudes, behavioural change(s) after diagnosis and other previous vaginal health concerns were explored among participants in a clinical trial assessing the safety and biologic effects of a vaginal live biotherapeutic product.

methodsIn-depth interviews (IDIs) were conducted with 37 female participants in a clinical trial in Boston, USA (n = 14), and Vulindlela, South Africa (SA) (n = 23). Interviews were audio recorded, transcribed and translated. Transcripts were coded and thematically analysed using NVivo.

resultsIn this study, previous BV diagnosis was lower in SA than USA (2(9%) versus 12(86%)), with 7(19%) overall reporting a previous STI. There were five key themes: (1) Prior BV and other vaginal health experiences: Although BV was not frequently diagnosed in SA, participants reported experiencing symptoms (discharge, itchiness and malodour). Conversely, USA participants had experiences with previous BV diagnoses. (2) Previous vaginal health seeking behaviour and treatments: Almost all participants from both sites had sought treatment from healthcare professionals for vaginal health concerns, with a few from both sites having used self-care practices. (3) BV knowledge, attitudes and reactions to BV diagnosis: BV knowledge in SA was poor compared with the USA, but most participants were relieved to receive help. (4) Behavioural changes because of BV: Vaginal hygiene practices changed and participants washed more frequently/used products to address malodour. Further, BV symptoms resulted in changes in sex acts and/or abstinence. (5) BV diagnosis disclosure patterns: Disclosure varied, with participants commonly disclosing to those who could provide them with support.

conclusionsBV knowledge, attitudes and experiences are related to previous diagnosis and treatment. Symptoms impact individuals' behaviours regardless of previous diagnosis, and can have psychosocial impacts which need to be addressed via appropriate counselling and treatment strategies. Ongoing research for effective BV prevention and treatment options that can be made available and accessible to women with BV globally is needed.

trial registrationSouth African National Clinical Trials Registry (SANCTR DOH-27-102023-8342; October 27, 2023) and ClinicalTrials.gov (NCT06135974; November 02, 2023).

Indexed as

Health Knowledge, Attitudes, PracticeVaginosis, BacterialAdultBostonFemaleHumansInterviews as TopicQualitative ResearchSouth AfricaYoung AdultBacterial vaginosisHealth seeking behaviourKnowledge and attitudesQualitative researchSouth AfricaUSAVaginal hygiene

Identifiers

PMID41382078
PMCPMC12817389

What OpenQuestion holds

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LicenceCC BY
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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.