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 and van de Wijgert, Janneke HHM ORCID: 0000-0003-2728-4560
(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-.

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<h4>Objectives</h4>To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.<h4>Design</h4>Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.<h4>Setting</h4>Research clinic in Kigali, Rwanda.<h4>Participants</h4>Rwandan women with high sexual risk.<h4>Interventions</h4>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.<h4>Outcome measures</h4>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).<h4>Results</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration number</h4>NCT02459665.

Item Type: Article
Uncontrolled Keywords: bacterial vaginosis, vaginal probiotic, adherence, acceptability, Africa
Depositing User: Symplectic Admin
Date Deposited: 03 Jun 2020 08:45
Last Modified: 18 Jan 2023 23:50
DOI: 10.1136/bmjopen-2019-031819
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