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

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.

Keywords: Africa; acceptability; adherence; bacterial vaginosis; vaginal probiotic.

Conflict of interest statement

Competing interests: AN is employed by Biose (owner of trial product GynLP) and EL by Winclove Probiotics BV (owner of trial product EF+). AN has financial and/or intellectual investments in competing products.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Flowchart of the study. *Totals to 110 reasons among 102 women because there could be more than one reason per woman. †Reasons: outside of metronidazole treatment window (n=5), enrolment target already met (n=4), has a mental disorder (n=1), did not complete screening procedures and was subsequently lost to follow=up (n=1), withdrew consent during the screening visit because she thought the reimbursement was too low (n=1). ‡Reasons: moved away from Kigali (n=2), lost interest because symptoms resolved (n=1), and was verbally harassed by partner and sister about study participation (n=1). Acceptability assessments were made at enrolment and at the M2 visit. Adherence assessments were made using self-rated assessments, pictorial diary cards, and returned packaging at the D7, M1 and M2 visits (after which product use was ceased). The vaginal infection knowledge survey was held at recruitment sessions in the community and at the enrolment visit. Changes in sexual risk-taking and vaginal practices were assessed at each follow-up visit and compared with answers given during the enrolment visit. All of these themes were discussed during the eight FGDs and IDIs. BV, bacterial vaginosis; D7, day 7 visit; FGD, focus group discussion; IDI, in-depth interview; M1/2/6, month 1/2/6 visit; RU, Rinda Ubuzima; TV, Trichomonas vaginalis.