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Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach

OBJECTIVES: To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence. DESIGN: Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial. SETTING: Research clinic in...

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Autores principales: Verwijs, Marijn C, Agaba, Stephen, Umulisa, Marie Michele, Uwineza, Mireille, Nivoliez, Adrien, Lievens, Elke, van de Wijgert, Janneke H H M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247375/
https://www.ncbi.nlm.nih.gov/pubmed/32434932
http://dx.doi.org/10.1136/bmjopen-2019-031819
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author Verwijs, Marijn C
Agaba, Stephen
Umulisa, Marie Michele
Uwineza, Mireille
Nivoliez, Adrien
Lievens, Elke
van de Wijgert, Janneke H H M
author_facet Verwijs, Marijn C
Agaba, Stephen
Umulisa, Marie Michele
Uwineza, Mireille
Nivoliez, Adrien
Lievens, Elke
van de Wijgert, Janneke H H M
author_sort Verwijs, Marijn C
collection PubMed
description OBJECTIVES: To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence. DESIGN: Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial. SETTING: Research clinic in Kigali, Rwanda. PARTICIPANTS: Rwandan women with high sexual risk. INTERVENTIONS: Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet. OUTCOME MEASURES: Adherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131). RESULTS: Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients. CONCLUSIONS: High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes. TRIAL REGISTRATION NUMBER: NCT02459665.
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spelling pubmed-72473752020-06-03 Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach Verwijs, Marijn C Agaba, Stephen Umulisa, Marie Michele Uwineza, Mireille Nivoliez, Adrien Lievens, Elke van de Wijgert, Janneke H H M BMJ Open Sexual Health OBJECTIVES: To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence. DESIGN: Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial. SETTING: Research clinic in Kigali, Rwanda. PARTICIPANTS: Rwandan women with high sexual risk. INTERVENTIONS: Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet. OUTCOME MEASURES: Adherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131). RESULTS: Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients. CONCLUSIONS: High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes. TRIAL REGISTRATION NUMBER: NCT02459665. BMJ Publishing Group 2020-05-19 /pmc/articles/PMC7247375/ /pubmed/32434932 http://dx.doi.org/10.1136/bmjopen-2019-031819 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Sexual Health
Verwijs, Marijn C
Agaba, Stephen
Umulisa, Marie Michele
Uwineza, Mireille
Nivoliez, Adrien
Lievens, Elke
van de Wijgert, Janneke H H M
Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
title Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
title_full Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
title_fullStr Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
title_full_unstemmed Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
title_short Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
title_sort vaginal probiotic adherence and acceptability in rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach
topic Sexual Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247375/
https://www.ncbi.nlm.nih.gov/pubmed/32434932
http://dx.doi.org/10.1136/bmjopen-2019-031819
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