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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.
BMJ Open. 2020 05 19; 10(5):e031819.BO

Abstract

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.

Authors+Show Affiliations

Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK.Rinda Ubuzima, Kigali, Rwanda.Rinda Ubuzima, Kigali, Rwanda.Rinda Ubuzima, Kigali, Rwanda.Biose, Aurillac, France.Winclove, Amsterdam, The Netherlands.Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK j.vandewijgert@liverpool.ac.uk. Julius Center for Health Sciences and Primary Care, Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32434932

Citation

Verwijs, Marijn C., et al. "Vaginal Probiotic Adherence and Acceptability in Rwandan Women With High Sexual Risk Participating in a Pilot Randomised Controlled Trial: a Mixed-methods Approach." BMJ Open, vol. 10, no. 5, 2020, pp. e031819.
Verwijs MC, Agaba S, Umulisa MM, et al. Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach. BMJ Open. 2020;10(5):e031819.
Verwijs, M. C., Agaba, S., Umulisa, M. M., Uwineza, M., Nivoliez, A., Lievens, E., & van de Wijgert, J. H. H. M. (2020). Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach. BMJ Open, 10(5), e031819. https://doi.org/10.1136/bmjopen-2019-031819
Verwijs MC, et al. Vaginal Probiotic Adherence and Acceptability in Rwandan Women With High Sexual Risk Participating in a Pilot Randomised Controlled Trial: a Mixed-methods Approach. BMJ Open. 2020 05 19;10(5):e031819. PubMed PMID: 32434932.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach. AU - Verwijs,Marijn C, AU - Agaba,Stephen, AU - Umulisa,Marie Michele, AU - Uwineza,Mireille, AU - Nivoliez,Adrien, AU - Lievens,Elke, AU - van de Wijgert,Janneke H H M, Y1 - 2020/05/19/ PY - 2020/5/22/entrez PY - 2020/5/22/pubmed PY - 2020/5/22/medline KW - Africa KW - acceptability KW - adherence KW - bacterial vaginosis KW - vaginal probiotic SP - e031819 EP - e031819 JF - BMJ open JO - BMJ Open VL - 10 IS - 5 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/32434932/Vaginal_probiotic_adherence_and_acceptability_in_Rwandan_women_with_high_sexual_risk_participating_in_a_pilot_randomised_controlled_trial:_a_mixed-methods_approach L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=32434932 DB - PRIME DP - Unbound Medicine ER -
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