Best practices and lessons learned from implementing a massive Ebola vaccination program: Summarizing UMURINZI team experience.

Background and Aims: The unified Rwandan initiative for national ZEBOVAC immunization (UMURINZI) program's community engagement component was enacted to mobilize and vaccinate high-risk community members. This article describes best practices and lessons learned from the implementation of UMURINZI, a large-scale Ebola vaccination program. Methods: The population deemed to be at risk for EVD consisted of people who frequently cross Rwanda and the Democratic Republic of Congo (DRC) borders including those coming from Kigali City, potential first responders who have not previously been vaccinated against EVD, as well as people who reside in high-risk border-proximate areas of the Rubavu and Rusizi districts in the Western Province of Rwanda. These districts were selected because of their proximity to high-traffic borders linking Rwanda to DRC's cities near an active Ebola outbreak. Volunteers of this program were adults, adolescents, and children aged 2 years or above who resided in the selected communities. Recruitment at the sites was conducted in close collaboration with each health area's Community Health Workers (CHWs). Volunteers were informed that the program involved being fully vaccinated (two doses of Ebola vaccines) within 2 months apart in the allocated vaccination sites. Results: Lessons learned were categorized into four pillars: infrastructure, leadership, myths, and partnership with respect. The best practices that were used during the implementation of the UMURINZI program were the results of a collaboration among CHWs, the involvement of national and local leaders, the use of a comprehensive engagement plan, and training. The study also had limitations. Conclusion: We described best practices and lessons learned during the implementation of the UMURINZI program in Rwanda. These practices and lessons learned represent promising options that could contribute to better community members' participation in mass vaccination programs. Hence, we demonstrated that rigorously designed community awareness and sensitization programs are effective for the implementation of similar programs in resource-limited settings.

Feasibility and acceptability of frequent vaginal self-sampling at home by Rwandan women at high risk of urogenital tract infections.

OBJECTIVES: To establish temporal links between vaginal microbiota (VMB) data and incident clinical events, frequent longitudinal vaginal sampling is required. Self-collection of swabs at the participant's home may be useful to avoid overburdening research clinics and participants. One-off vaginal self-sampling for STI or cervical cancer screening programmes has been shown to be feasible and acceptable to women in multiple studies, including in sub-Saharan Africa, but the feasibility and acceptability of frequent longitudinal vaginal sampling in the context of VMB sequencing studies is unknown. METHODS: Twelve participants of a randomised clinical trial in Kigali, Rwanda, self-collected vaginal swabs three times a week for a month. We studied feasibility by comparing DNA concentrations, proportions of samples with >1000 16S rRNA amplicon sequencing reads and VMB composition outcomes of self-collected swabs with clinician-collected swabs. We evaluated the acceptability of self-collection using structured face-to-face interviews and a focus group discussion. RESULTS: The participants collected vaginal swabs at 131 different time points. One woman stopped self-sampling after one try due to a social harm. All self-sampled swabs generated >1000 rRNA amplicon sequencing reads, and the DNA concentration of self-sampled swabs and clinician-sampled swabs did not differ significantly (Kruskal-Wallis p=0.484). Self-sampled and clinician-sampled swabs generated similar VMB composition data. Participants reported feeling very comfortable during self-sampling (11/12; 91.7%) and that self-sampling had become easier over time (12/12; 100%). They mentioned reduced travel time and travel costs as advantages of self-sampling at home. CONCLUSIONS: Frequent longitudinal vaginal sampling at home is feasible and acceptable to participants, even in the context of a low-resource setting, as long as adequate counselling is provided. TRIAL REGISTRATION NUMBER: NCT02459665.

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 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.

Targeted point-of-care testing compared with syndromic management of urogenital infections in women (WISH): a cross-sectional screening and diagnostic accuracy study.

BACKGROUND: Sexually transmitted and urogenital infections are typically managed by WHO-recommended syndromic algorithms in resource-poor countries, and presumptively in Europe. However, algorithms for vaginal discharge and lower abdominal pain perform poorly in women. The women's improvement of sexual and reproductive health (WISH) study in Kigali, Rwanda, sought to improve case-finding and infection management in women by introducing point-of-care tests. The main aim was to compare the performance of the WISH algorithms and the WHO vaginal discharge and lower abdominal pain algorithms with gold standard testing. METHODS: This cross-sectional screening and diagnostic accuracy study recruited women aged 18 years or older with or without urogenital symptoms at risk of acquiring sexually transmitted infections in Kigali, Rwanda. Recruitment activities were implemented by study staff with the help of community mobilisers at health centres, pharmacies, markets, women's organisations, and at "umuganda" community meetings. At the study visit, participants had a face-to-face interview that included questions about current urogenital symptoms. Participants were first asked without prompting (spontaneous reporting), followed by questions about 14 specific symptoms (structural reporting). Next, the WISH algorithms were implemented. All participants had point-of-care tests for bacterial vaginosis (vaginal pH of 5·0 or above) and Trichomonas vaginalis (immunoassay) regardless of symptom reporting. Women with a positive risk score had point-of-care tests for Chlamydia trachomatis and Neisseria gonorrhoea (nucleic acid amplification tests). Vulvovaginal candidiasis was treated presumptively. Nucleic acid amplification tests for C trachomatis, N gonorrhoeae, T vaginalis, bacterial vaginosis, and vulvovaginal candidiasis were the gold standard, and all patients provided swabs for these. FINDINGS: Participants were recruited between July 5, 2016, and March 14, 2017. 705 participants were enrolled in the study and completed a study visit, and 51 attended 53 additional visits. Prevalence by gold standard testing was 8·5% for C trachomatis, 7·1% for N gonorrhoeae, 16·1% for T vaginalis, 18·1% for bacterial vaginosis, and 8·6% for vulvovaginal candidiasis. The WISH algorithms identified similar numbers of C trachomatis, N gonorrhoeae, and T vaginalis infections, but much higher numbers of bacterial vaginosis and vulvovaginal candidiasis infections. Compared with gold standard testing, the WISH algorithms had a good sensitivity and high specificity for C trachomatis (sensitivity 71·7%, specificity 100%), N gonorrhoeae (sensitivity 76·0%, specificity 100%), and T vaginalis (sensitivity 68·5%, specificity 97·4%), high sensitivity but low specificity for bacterial vaginosis (sensitivity 95·2%, specificity 41·2%), and moderate sensitivity and specificity for vulvovaginal candidiasis (sensitivity 64·4%, specificity 69·4%). The performance of vaginal pH testing for bacterial vaginosis improved by increasing the cutoff to 5·5, followed by confirmatory testing (sensitivity 73·6%, specificity 100%). The WHO algorithms had moderate sensitivity and poor specificity for all infections compared with gold standard testing: C trachomatis sensitivity 58·3%, specificity 44·7%; N gonorrhoeae sensitivity 66·0%, specificity 45·2%; T vaginalis sensitivity 60·4%, specificity 45·6%; bacterial vaginosis sensitivity 61·6%, specificity 46·0%; and vulvovaginal candidiasis sensitivity 74·6%, specificity 50·6%. Two participants attended additional visits because they had a mild allergic reaction to metronidazole. Staff and participants considered point-of-care testing feasible and acceptable. INTERPRETATION: Point-of-care testing for urogenital infections might improve case-finding and infection management and is feasible in resource-poor settings. Point-of-care tests should be further developed, including those targeting multiple conditions. Additional studies in other populations, including populations with low prevalence of sexually transmitted and urogenital infections, are warranted. FUNDING: European and Developing Countries Clinical Trials Partnership.

High burden of prevalent and recently acquired HIV among female sex workers and female HIV voluntary testing center clients in Kigali, Rwanda.

OBJECTIVES: To estimate HIV prevalence and risk factors in population-based samples of female sex workers (FSW) and female voluntary counseling and testing (VCT) clients in Rwanda. METHODS: We conducted a cross-sectional survey of 800 FSW and 1,250 female VCT clients in Rwanda, which included interviewing and testing for HIV-1/2, HSV-2 and pregnancy, and BED-CEIA and Avidity Index (AI) to identify recent infections among HIV-infected women. RESULTS: Prevalence of HIV-1, HSV-2, and pregnancy were 24% (95% CI: 21.0-27.0), 59.8% (56.4-63.2), and 7.6% (5.8-9.5) among FSW, and 12.8% (10.9-14.6), 43.2% (40.4-46.0), and 11.4% (9.7-13.3) among VCT clients, respectively. Thirty-five percent of FSW and 25% of VCT clients had never been HIV tested. Per national guidelines, 33% of newly HIV-diagnosed FSW and 36% of VCT clients were already eligible for ART based on CD4<350 cells/µl. Condom use at last sex was higher among FSW (74%) than VCT clients (12%). In age and district of residence-adjusted models, HIV-1 seropositivity was associated with HSV-2 co-infection; recent treatment for sexually transmitted infection (STI); genital symptoms; forced sex; imprisonment; widowhood; and alcohol consumption. Eleven percent of FSW and 12% of VCT clients had recently acquired HIV-1 per BED-CEIA and AI. HSV-2 infection and recent STI treatment were associated with recent HIV infection in both groups, and being married and vaginal cleansing were associated with recent infection before last sex among VCT clients. CONCLUSIONS: This population-based survey reveals a high HIV prevalence and incidence among FSW and female VCT clients in Kigali, the scale of which is masked by the low general-population HIV prevalence in Rwanda. HIV/STI and family planning services should be strengthened.

HIV diagnosis, linkage to HIV care, and HIV risk behaviors among newly diagnosed HIV-positive female sex workers in Kigali, Rwanda.

OBJECTIVE: To evaluate linkage-to-care, sexual behavior change, and psychosocial experiences among newly HIV-diagnosed female sex workers (FSWs) in Rwanda. METHODS: FSWs (n = 800) with unknown serostatus were screened for HIV during 2007/2008. Women testing HIV positive (n = 192) were referred to care and asked to return for interviews and laboratory testing 12-36 months postdiagnosis. One hundred fourty-one women (73%) returned for the postdiagnosis visit. RESULTS: Median CD4 count at diagnosis was 460 cells per microliter [interquartile range (IQR): 308-628], with 32% eligible for antiretroviral therapy (ART) per national CD4 criteria (median CD4: 235, IQR: 152-303). Postdiagnosis, 92% of women reported having disclosed their HIV status to a friend or relative, 85% reported having enrolled in HIV care (median 30 days after diagnosis, IQR: 7-360), including 89% among ART-eligible women. Among ART-eligible women in care, 87% had initiated ART, with a median follow-up CD4 count of 354 cells per microliter (IQR: 213-456). Women who did not initiate ART experienced a 6-month CD4 count change of -14 cells per microliter (IQR: -41 to 13). Three-quarters of women reported reduced sexual risk behavior postdiagnosis, with only 64% continuing to identify as FSWs. However, 53% reported past month condom use only "sometimes." CONCLUSIONS: Timely linkage to care and ART uptake were high in this group of Rwandan FSWs. However, risky sexual behaviors remained common after enrollment in care. HIV-positive FSWs are an important and receptive group for targeted efforts to increase HIV diagnosis and linkage to care/treatment. Once in care, intensified and sustained HIV prevention education is necessary.