HIV Pre-exposure Prophylaxis (PrEP) Care in Belgium: A mixed-methods Study on PrEP Users' Experiences and Service Delivery Preferences.

In Belgium, HIV pre-exposure prophylaxis (PrEP) services are mainly provided through specialised HIV clinics. To optimise PrEP uptake and retention in care, we require insights into users' perspectives on PrEP care. We aimed to elicit experiences with, and preferences for, PrEP service delivery among PrEP users in Belgium, including willingness to involve their family physician (FP) in PrEP care. We adopted a sequential mixed-methods design. We used a web-based longitudinal study among 326 PrEP users that consisted of two questionnaires at six-month intervals, and complemented this with 21 semi-structured interviews (September 2020-January 2022). We conducted descriptive analyses and logistic regression to examine factors associated with willingness to involve their FP in PrEP care. Interviews were analysed using thematic analysis. Survey respondents reported high satisfaction with care received in HIV clinics [median score 9 (IQR 8-10), 10='very satisfied']. Interviews revealed the importance of regular HIV/STI screening, and the expertise and stigma-free environment of HIV clinics. Yet, they also contextualised service delivery barriers reported in the questionnaire, including the burden of cost and challenges integrating PrEP visits into their private and professional lives. Although 63.8% (n = 208/326) of baseline respondents preferred attending an HIV clinic for PrEP follow-up, 51.9% (n = 108/208) of participants in the follow-up questionnaire reported to be willing to have their FP involved in PrEP care. Participants reporting trust in FPs' PrEP and sexual health expertise, or who didn't feel judged by their FP, were more likely to be willing to involve them in PrEP care. Therefore, we recommend a differentiated PrEP service delivery approach, including involving FPs, to make PrEP care more client-centred.

Putting 2-1-1 into Practice: PrEP Users' Knowledge of Effectively Starting and Stopping Oral PrEP Use.

Starting and stopping oral HIV pre-exposure prophylaxis (PrEP) in a way that compromises its effectiveness should be avoided. Between September 2020 and June 2021, we assessed self-perceived and actual knowledge of effectively starting and stopping oral PrEP through an online survey among 206 PrEP users assigned male at birth in Belgium. We examined associations between incorrect start-and-stop knowledge and socio-demographics, sexual behaviour and PrEP use, using bi- and multi-variable logistic regression. The majority of men (84.9%) perceived their start-and-stop knowledge as 'very good', but only 62.1% of all men correctly indicated how to effectively start and stop with PrEP. Using PrEP daily [adjusted OR 2.12, 95% CI (1.06-4.28), p = 0.034] was significantly associated with incorrect start-and-stop knowledge. To enable PrEP users to effectively use PrEP, they need to be better informed about how to start and stop use, irrespective of the dosing regimen.

Patterns of PrEP and condom use among PrEP users in Belgium: a web-based longitudinal study.

BACKGROUND: Tailoring pre-exposure prophylaxis (PrEP) service delivery is key to scaling-up PrEP uptake. Optimal implementation of tailored services requires, among other things, insights into patterns of PrEP use, sexual behaviours and condom use over time. METHODS: Between September 2020 and January 2022, we conducted a web-based, longitudinal study among PrEP users in Belgium. In three questionnaire rounds every six-months, we assessed PrEP and condom use, and sex with steady, casual and anonymous partners in the preceding three months. Based on the patterns of PrEP use in the preceding three months, we identified distinct PrEP use categories. We investigated differences in baseline socio-demographics and sexual behaviours by PrEP use category using Fisher's exact and one-way ANOVA tests. Patterns in PrEP and condom use over time were examined using descriptive analyses and visualised in alluvial diagrams. RESULTS: In total, 326 participants completed the baseline questionnaire, and 173 completed all three questionnaires. We identified five distinct PrEP use categories: daily (≥ 90 pills), almost daily (75-89 pills), long period (> 7 consecutive days and < 75 pills) with or without additional short period use, short period (1-7 consecutive days and < 75 pills) and no PrEP use (0 pills). During the study, percentages of individuals in each PrEP use category varied, but did not change significantly over time. At baseline, daily and almost daily users were more likely to report five or more casual sex partners, ten or more anonymous sex partners and anal sex on a weekly basis with casual or anonymous partners compared to those using PrEP for long or short periods. Up to 12.6% (n = 16/127) of participants reporting anal sex with casual or anonymous partners, indicated always using condoms and PrEP with these partners. One in three (n = 23/69) participants who reported anal sex with steady partners had condomless anal sex and did not use PrEP with these partners; with casual or anonymous partners less than 3% reported this. CONCLUSIONS: Our findings show that there is little variation in PrEP use over time and that PrEP use was associated with sexual behaviours, which could be taken into account when designing tailored PrEP care.

Insights into barriers and facilitators in PrEP uptake and use among migrant men and transwomen who have sex with men in Belgium.

BACKGROUND: PrEP uptake is low among non-Belgian men and transwomen who have sex with men, although the HIV epidemic among men who have sex with men in Belgium is diversifying in terms of nationalities and ethnicity. We lack an in-depth understanding of this gap. METHODS: We conducted a qualitative study using a grounded theory approach. The data consists of key informants interviews and in-depth interviews with migrant men or transwomen who have sex with men. RESULTS: We identified four underlying determinants which shape our participants' experiences and contextualize the barriers to PrEP use. These include (1) the intersectional identities of being migrant and men and transwomen who have sex with men, (2) migration related stressors, (3) mental health and (4) socio-economic vulnerability. Identified barriers include: the accessibility of services; availability of information, social resources and providers' attitudes. These barriers influence PrEP acceptance and mediated by individual agency this influences their PrEP uptake. CONCLUSION: An interplay of several underlying determinants and barriers impacts on PrEP uptake among migrant men and transwomen who have sex with men, illustrating a social gradient in access to PrEP. We need equitable access to the full spectrum of HIV prevention and care for all priority populations, including undocumented migrants. We recommend social and structural conditions that foster exercising these rights, including adapting PrEP service delivery, mental health and social support.

Did you hear about HIV self-testing? HIV self-testing awareness after community-based HIVST distribution in rural Zimbabwe.

BACKGROUND: Several trials of community-based HIV self-testing (HIVST) provide evidence on the acceptability and feasibility of campaign-style distribution to reach first-time testers, men and adolescents. However, we do not know how many remain unaware of HIVST after distribution campaigns, and who these individuals are. Here we look at factors associated with never having heard of HIVST after community-based campaign-style HIVST distribution in rural Zimbabwe between September 2016 and July 2017. METHODS: Analysis of representative population-based trial survey data collected from 7146 individuals following community-based HIVST distribution to households was conducted. Factors associated with having never heard of HIVST were determined using multivariable mixed-effects logistic regression adjusted for clustered design. RESULTS: Among survey participants, 1308 (18.3%) self-reported having never heard of HIVST. Individuals who were between 20 and 60 years old {20-29 years: [aOR = 0.74, 95% CI (0.58-0.95)], 30-39 years: [aOR = 0.56, 95% CI (0.42-0.74)], 40-49 years: [aOR = 0.50, 95% CI (0.36-0.68)], 50-59 years [aOR = 0.58, 95% CI (0.42-0.82)]}, who had attained at least ordinary level education [aOR = 0.51, 95% CI (0.34-0.76)], and who had an HIV test before [aOR = 0.30, 95% CI (0.25-0.37)] were less likely to have never heard of HIVST compared with individuals who were between 16 and 19 years old, who had a lower educational level and who had never tested for HIV before, respectively. In addition, non-household heads or household head representatives [aOR = 1.21, 95% CI (1.01-1.45)] were more likely to report never having heard of HIVST compared to household head and representatives. CONCLUSIONS: Around one fifth of survey participants remain unaware of HIVST even after an intensive community-based door-to-door HIVST distribution. Of note, those least likely to have heard of self-testing were younger, less educated and less likely to have tested previously. Household heads appear to play an important role in granting or denying access to self-testing to other household members during door-to-door distribution. Differentiated distribution models are needed to ensure access to all. Trial registration PACTR, PACTR201607001701788. Registered 29 June 2016, https://pactr.samrc.ac.za/ PACTR201607001701788.

COVID-19 as a social disease: qualitative analysis of COVID-19 prevention needs, impact of control measures and community responses among racialized/ethnic minorities in Antwerp, Belgium.

BACKGROUND: In high income countries, racialized/ethnic minorities are disproportionally affected by COVID-19. Despite the established importance of community involvement in epidemic preparedness, we lack in-depth understanding of these communities' experiences with and responses to COVID-19. We explored information and prevention needs, coping mechanisms with COVID-19 control measures and their impact on lived experiences among selected racialized/ethnic minority communities. METHODS: This qualitative rapid assessment conducted in Antwerp/Belgium used an interpretative and participatory approach. We included migrant communities with geographic origins ranging from Sub-Saharan Africa, North-Africa to the Middle East, Orthodox Jewish communities and professional community workers. Data were collected between May 2020-May 2021 through key informant-, in-depth interviews and group discussions (N = 71). Transcripts were analyzed inductively, adopting a reflexive thematic approach. A community advisory board provided feedback throughout the research process. RESULTS: Participants indicated the need for tailored information in terms of language and timing. At the start of the epidemic, they perceived official public health messages as insufficient to reach all community members. Information sources included non-mainstream (social) media and media from home countries, hampering a nuanced understanding of virus transmission mechanisms and local and national protection measures. Participants felt the measures' most negative impact on their livelihoods (e.g. loss of income, disruption of social and immigration support). Economic insecurity triggered chronic stress and fears at individual and family level. High degrees of distrust in authorities and anticipated stigma were grounded in previously experienced racial and ethnic discrimination. Community-based initiatives mitigated this impact, ranging from disseminating translated and tailored information, providing individual support, and successfully reaching community members with complex needs (e.g. the elderly, digitally illiterate people, those with small social networks or irregular legal status). CONCLUSION: Study participants' narratives showed how coping with and responding to COVID-19 was strongly intertwined with socio-economic and ethnic/racial characteristics. This justifies conceptualizing COVID-19 a social disease. At the same time, communities demonstrated resilience in responding to these structural vulnerabilities. From a health equity perspective, we provide concrete policy recommendations grounded in insights into communities' structural vulnerabilities and resilience.

Reduced sexual contacts with non-steady partners and less PrEP use among MSM in Belgium during the first weeks of the COVID-19 lockdown: results of an online survey.

OBJECTIVES: To examine changes in the occurrence of physical sex with non-steady partners among men who have sex with men (MSM) in Belgium during the first weeks of the COVID-19 lockdown and associations with sociodemographic factors, sexual practices, drug, alcohol and pre-exposure prophylaxis (PrEP) use. A secondary objective was to explore changes in PrEP use and the need for PrEP follow-up. METHODS: A cross-sectional online survey. The questionnaire was available in Dutch, French and English, between April 10 and 27 (2020), and disseminated via sexual health and lesbian, gay, bisexual, trans, queer or intersex organisations throughout Belgium. Eligibility criteria included being 18 years or older, not being exclusively heterosexual and living or being born in Belgium. RESULTS: The sample included 694 MSM. Physical sex with non-steady partners decreased from 59.1% to 8.9% during the first weeks of the lockdown. Those who had sex with non-steady partners were significantly more likely to be HIV positive, to use PrEP or to have engaged in sexual practices such as group sex, chemsex and sex work before the lockdown, compared with their counterparts. Among those who used PrEP before the lockdown, 47.0% stopped using PrEP, 19.7% used event-driven PrEP and 33.3% used daily PrEP during the lockdown. Almost two-thirds of PrEP users had a PrEP care appointment in the weeks before the lockdown and a minority received follow-up elsewhere or online. Some PrEP users had concerns regarding their follow-up. CONCLUSIONS: MSM in our survey substantially reduced sexual contact with non-steady partners during the first weeks of the COVID-19 lockdown, suggesting that the risk for HIV and STI transmission in this period was low. We recommend ensuring access to sexual health services, such as HIV testing and follow-up for PrEP for the small group having multiple sex partners and engaging in sexual practices such as chemsex, or group sex, even in times of a pandemic threat.

Understanding how communities respond to COVID-19: experiences from the Orthodox Jewish communities of Antwerp city.

BACKGROUND: The importance of community involvement in the response against disease outbreaks has been well established. However, we lack insights into local communities' experiences in coping with the current COVID-19 pandemic. This study explored both the impact of, and response to, COVID-19 within the Orthodox Jewish communities of Antwerp (Belgium) during the first lockdown period (March 2020 - May 2020). METHODS: We conducted an explorative qualitative study using a participatory approach. First, we performed a community mapping to identify relevant stakeholders. Through the active involvement of a community advisory board and based on qualitative interviews with key-informants and community members, we elicited lived experiences, attitudes, and perceptions towards COVID-19. Interviews were conducted both face-to-face and using online web conferencing technology. Data were analyzed inductively according to the principles of thematic analysis. RESULTS: Government-issued outbreak control measures presented context-specific challenges to the Orthodox Jewish communities in Antwerp. They related mainly to the remote organization of religious life, and practicing physical distancing in socially and culturally strongly connected communities. Existing community resources were rapidly mobilized to adapt to the outbreak and to self-organize response initiatives within communities. The active involvement of community and religious leaders in risk communication proved to be of great importance to facilitate the coverage and uptake of pandemic control measures while protecting essential community values and traditions. Creating bottom-up and community-adapted communication strategies, including addressing language barriers and involving Rabbis in the dissemination of prevention messages, fostered a feeling of trust in government's response measures. However, unmet information and prevention needs were also identified, such as the need for inclusive communication by public authorities and the need to mitigate the negative effects of stigmatization. CONCLUSION: The experiences of Orthodox Jewish communities in Antwerp demonstrate a valuable example of a feasible community-centered approach to health emergencies. Increasing the engagement of communities in local decision-making and governance structures remains a key strategy to respond to unmet information and prevention needs.

The current landscape of pre-exposure prophylaxis service delivery models for HIV prevention: a scoping review.

BACKGROUND: Strengthening HIV prevention is imperative given the continued high HIV incidence worldwide. The introduction of oral PrEP as a new biomedical HIV prevention tool can be a potential game changer because of its high clinical efficacy and the feasibility of its provision to different key populations. Documenting the existing experience with PrEP service delivery in a variety of real-world settings will inform how its uptake and usage can be maximised. METHODS: We conducted a scoping review using the five-step framework provided by Arksey and O'Malley. We systematically searched the existing peer-reviewed international and grey literature describing the implementation of real-world PrEP service delivery models reporting on four key components: the target population of PrEP services, the setting where PrEP was delivered, PrEP providers' professionalisation and PrEP delivery channels. We restricted our search to English language articles. No geographical or time restrictions were set. RESULTS: This review included 33 articles for charting and analysing of the results. The identified service delivery models showed that PrEP services mainly targeted people at high risk of HIV acquisition, with some models targeting specific key populations, mainly men who have sex with men. PrEP was often delivered centralised and in a clinical or hospital setting. Yet also community-based as well as home-based PrEP delivery models were reported. Providers of PrEP were mainly clinically trained health professionals, but in some rare cases community workers and lay providers also delivered PrEP. In general, in-person visits were used to deliver PrEP. More innovative digital options using mHealth and telemedicine approaches to deliver specific parts of PrEP services are currently being applied in a minority of the service delivery models in mainly high-resource settings. CONCLUSIONS: A range of possible combinations was found between all four components of PrEP service delivery models. This reflects differentiation of care according to different contextual settings. More research is needed on how integration of services in these contexts could be expanded and optimised to respond to key populations with unmet HIV prevention needs in different settings.

Understanding adaptive responses in PrEP service delivery in Belgian HIV clinics: a multiple case study using an implementation science framework.

INTRODUCTION: In Belgium, oral HIV pre-exposure prophylaxis (PrEP) is primarily provided in specialized clinical settings. Optimal implementation of PrEP services can help to substantially reduce HIV transmission. However, insights into implementation processes, and their complex interactions with local context, are limited. This study examined factors that influence providers' adaptive responses in the implementation of PrEP services in Belgian HIV clinics. METHODS: We conducted a qualitative multiple case study on PrEP care implementation in eight HIV clinics. Thirty-six semi-structured interviews were conducted between January 2021 and May 2022 with a purposive sample of PrEP care providers (e.g. physicians, nurses, psychologists), supplemented by 50 hours of observations of healthcare settings and clinical interactions. Field notes from observations and verbatim interview transcripts were thematically analysed guided by a refined iteration of extended Normalisation Process Theory. RESULTS: Implementing PrEP care in a centralized service delivery system required considerable adaptive capacity of providers to balance the increasing workload with an adequate response to PrEP users' individual care needs. As a result, clinic structures were re-organized to allow for more efficient PrEP care processes, compatible with other clinic-level priorities. Providers adapted clinical and policy norms on PrEP care (e.g. related to PrEP prescribing practices and which providers can deliver PrEP services), to flexibly tailor care to individual clients' situations. Interprofessional relationships were reconfigured in line with organizational and clinical adaptations; these included task-shifting from physicians to nurses, leading them to become increasingly trained and specialized in PrEP care. As nurse involvement grew, they adopted a crucial role in responding to PrEP users' non-medical needs (e.g. providing psychosocial support). Moreover, clinicians' growing collaboration with sexologists and psychologists, and interactions with PrEP users' family physician, became crucial in addressing complex psychosocial needs of PrEP clients, while also alleviating the burden of care on busy HIV clinics. CONCLUSIONS: Our study in Belgian HIV clinics reveals that the implementation of PrEP care presents a complex-multifaceted-undertaking that requires substantial adaptive work to ensure seamless integration within existing health services. To optimize integration in different settings, policies and guidelines governing PrEP care implementation should allow for sufficient flexibility and tailoring according to respective local health systems.

Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial.

BACKGROUND: Guidelines recommend screening for Neisseria gonorrhoeae and Chlamydia trachomatis at three anatomical sites (urethra, anus, and pharynx) every 3 months (3 × 3) in men who have sex with men (MSM) and transgender women taking HIV pre-exposure prophylaxis (PrEP). We present the first randomised controlled trial to compare the effect of screening versus non-screening for N gonorrhoeae and C trachomatis on the incidence of these infections in MSM and transgender women taking PrEP. METHODS: A multicentre, randomised, controlled trial of 3 × 3 screening for N gonorrhoeae and C trachomatis versus non-screening was done among MSM and transgender women taking PrEP in five HIV reference centers in Belgium. Participants attended the PrEP clinics quarterly for 12 months. N gonorrhoeae and C trachomatis was tested at each visit in both arms, but results were not provided to the non-screening arm, if asymptomatic. The primary outcome was incidence rate of N gonorrhoeae and C trachomatis infections in each arm, assessed in the per-protocol population. Non-inferiority of the non-screening arm was proven if the upper limit of the 95% CI of the incidence rate ratio (IRR) was lower than 1·25. This trial is registered with ClinicalTrials.gov, NCT04269434, and is completed. FINDINGS: Between Sept 21, 2020, and June 4, 2021, 506 participants were randomly assigned to the 3 × 3 screening arm and 508 to the non-screening arm. The overall incidence rate of N gonorrhoeae and C trachomatis was 0·155 cases per 100 person-days (95% CI 0·128-0·186) in the 3 × 3 screening arm and 0·205 (95% CI 0·171-0·246) in the non-screening arm. The incidence rate was significantly higher in the non-screening arm (IRR 1·318, 95% CI 1·068-1·627). Participants in the non-screening arm had a higher incidence of C trachomatis infections and symptomatic C trachomatis infections. There were no significant differences in N gonorrhoeae infections. Participants in the non-screening arm consumed significantly fewer antimicrobial drugs. No serious adverse events were reported. INTERPRETATION: We failed to show that non-screening for N gonorrhoeae and C trachomatis is non-inferior to 3 × 3 screening in MSM and transgender women taking PrEP in Belgium. However, screening was associated with higher antibiotic consumption and had no effect on the incidence of N gonorrhoeae. Further research is needed to assess the benefits and harms of N gonorrhoeae and C trachomatis screening in this population. FUNDING: Belgian Health Care Knowledge Centre.

Acceptability of a new 4-in-1 Abacavir/Lamivudine/Lopinavir/Ritonavir paediatric fixed-dose combination: the caregiver-child dyads' perspective.

Background: Worldwide, 1.7 million children younger than 15 years were living with HIV in 2021. Only 52% of them had access to antiretrovirals (ARVs). Lack of age-appropriate ARV formulations (i.e. easy to swallow for young infants, acceptable taste) remains the main obstacle to the access to ARVs. Therefore, a strawberry-flavoured Abacavir/Lamivudine/Lopinavir/Ritonavir (30/15/40/10 mg) fixed-dose combination of granules in a capsule (4-in-1) for children living with HIV weighing 3-25 kg was developed. Objective: We assessed caregivers' perceived acceptability of the 4-in-1 compared with previous paediatric ARV formulations and factors influencing acceptability. Methods: This exploratory qualitative case study embedded in a phase I/II, open-label, randomized cross-over pharmacokinetic, safety and acceptability study (LOLIPOP) was conducted in three sites in Uganda (May 2019-October 2020). Thirty-six children weighing between 3 and 19.9 kg participated in the main study. We purposively sampled caregiver-child dyads according to weight bands, and conducted 20 semi-structured interviews with caregivers and 5 with healthcare providers. We triangulated these results with a quantitative acceptability questionnaire. We analysed interviews inductively using NVivo12 adopting a thematic analysis approach and acceptability questionnaires descriptively to assess concordance between them. Results: All caregivers found the 4-in-1 formulation highly acceptable and easier to use than previous formulations (i.e. pellets/tables/syrup). Appealing taste, ease of administration, easy storage and children's acceptance contributed to acceptability despite structural challenges of food shortage and HIV stigma. Visible improvements in children's health and comprehensive and tailored healthcare provider support to overcome initial difficulties such as vomiting increased caregivers' acceptance. Concordant results from questionnaire- and interview-data confirmed high acceptability. Conclusion: Caregivers of children in all weight bands in this sample found the 4-in-1 granules highly acceptable compared with the pellets/tablets combination. Healthcare providers' support to caregivers allowed for individual tailoring of drug administration despite challenges such as food shortage. This enabled short-term adherence. These findings informed further practical recommendations. Registration: Clinical trial number: NCT03836833.

Why Do HIV Pre-Exposure Prophylaxis Users Discontinue Pre-Exposure Prophylaxis Care? A Mixed Methods Survey in a Pre-Exposure Prophylaxis Clinic in Belgium.

It remains unclear why patients discontinue HIV pre-exposure prophylaxis (PrEP) care and to what extent they remain at risk for HIV when they do. We reviewed routinely collected medical records and patient questionnaires and performed an e-mail/telephone survey to assess reasons for discontinuing PrEP care, ongoing risks for HIV infection, and associated factors. Patients with more than two registered PrEP visits from a PrEP clinic in Antwerp, Belgium between June 2017 and February 2020 were included in this study. Patients who did not return for a visit after October 30, 2019 and who were not transferred out were considered as having discontinued PrEP care. A total of 143/1073 patients were considered as having discontinued PrEP care. Patients who discontinued PrEP care were more likely to be younger than those who remained in care (35 vs. 38 years old, p < 0.01). The most common reasons for discontinuation were having stopped using PrEP (62/101, 61.4%) and "COVID-19" (n = 35, 34.7%). The most common reasons for stopping PrEP use was a decreased sexual activity due to coronavirus disease 2019 (COVID-19; 21/62, 33.9%) or not COVID-19 related (10/62, 16.1%), a monogamous relationship (20/62, 32.3%) and consistent condom use (7/62, 11.3%). Among respondents who reported about current HIV risk the majority reported being at low risk either by still taking PrEP (32/91, 35.2%), consistently using condoms, or limiting number of sex acts or partners (58/91, 52.7%). No HIV seroconversion was reported.

PrEP user profiles, dynamics of PrEP use and follow-up: a cohort analysis at a Belgian HIV centre (2017-2020).

INTRODUCTION: The number of individuals initiating antiretroviral pre-exposure prophylaxis (PrEP) is increasing, but we do not fully understand who is coming forward for PrEP, how they use it and how they are followed-up. The objective of this study was to examine PrEP user profiles, dynamics in PrEP use and follow-up over time. METHODS: We conducted a cohort analysis of longitudinally collected clinical record and questionnaire data among PrEP users at an HIV centre in Antwerp, Belgium, between June 2017 and March 2020. PrEP follow-up and user profiles were examined using descriptive analyses and bivariate logistic regression. We compared early adopting PrEP users (started before June 2018) with late users. We also calculated the probabilities of switching between daily and on-demand PrEP, and interruption, using a naïve estimator. RESULTS AND DISCUSSION: We included 1347 PrEP users in the analysis. After 12 months, retention in care was 72.3%. Median time between PrEP visits was 98 days (IQR 85-119 days). At screening visit, early adopting PrEP users (starting June 2017-May 2018) were significantly more likely to report one or more sexually transmitted infection in the prior 12 months, having used drugs during sex, a higher number of sexual partners and a history of paid sex and PrEP use prior to initiation, compared with PrEP users who initiated later (starting June 2018-February 2020). When taking PrEP daily, the probability of staying on daily PrEP at the next visit was 76%, while this was 73% when taking PrEP on-demand. Those using on-demand PrEP had a higher probability (13%) of interrupting PrEP care than daily PrEP users (7%), whereas those returning to PrEP care would mostly re-start with on-demand (35% vs. 13% for daily). CONCLUSIONS: The majority of PrEP users in this sample remained in care after 12 months. The probability of remaining on the same PrEP regimen at the subsequent visit was high. Though, we observed a diversity of transitions between regimens and interruptions in between visits. Our findings reaffirm the need to provide tailored PrEP services, counselling PrEP users across their life course.

How Do Family Physicians Perceive Their Role in Providing Pre-exposure Prophylaxis for HIV Prevention?-An Online Qualitative Study in Flanders, Belgium.

Introduction: In Belgium, the provision of pre-exposure prophylaxis (PrEP) for HIV prevention is centralized in specialized HIV clinics. Engaging family physicians in PrEP care could help scale-up its delivery and reach underserved populations. The objective of this study was to gain insight into family physicians' self-perceived roles in providing PrEP. Methods: We conducted 16 online group discussions with a total of 105 Flemish family physicians, between November 2020 and February 2021. A brief online questionnaire assessed their socio-demographics and experience with sexual health. We analyzed verbatim transcribed data using a grounded theory approach. Results: Despite limited awareness and experience, participants reported a high willingness to be more actively involved in PrEP care. Four potential roles for the family physician in PrEP care were identified: acting as low-threshold entry point for advice; opportunistic case finding of PrEP candidates; initiating appropriate care for PrEP-eligible clients; and ensuring high-quality follow-up care for PrEP users. Participants framed each of these roles within their current activities and responsibilities as primary care providers. Yet, participants differed in their views on the concrete operationalization of these roles, and in the extent of their involvement in PrEP. Particular challenges were a lack of experience with antiretrovirals, perceived limited exposure to clients at high HIV risk, and a lack of expertise and resources to conduct time-intensive risk assessments and counseling related to PrEP. Conclusion: Belgian family physicians demonstrated a keen willingness to be involved in PrEP care, but had differing views on the practical implementation into their practices. Providing tailored training on sexual health and PrEP, and investing in collaboration between primary and secondary care, could optimize the integration of PrEP in the primary care practice.

Pre-Exposure Prophylaxis Users' Attitudes About Sexually Transmitted Infections and Its Influence on Condom Use: A Mixed-Method Study in Belgium.

Incidence rates of sexually transmitted infections (STIs) are rising among men who have sex with men (MSM). Since the rollout of HIV pre-exposure prophylaxis (PrEP), promoting condom use to prevent the spread of STIs has become more challenging. Using a mixed-method design, we explored MSM PrEP users' attitudes toward STIs, condoms, and condom use with nonsteady partners to prevent STIs. We triangulated data from 22 in-depth interviews conducted at a large HIV/STI clinic between August 2021 and January 2022 and an online survey among 326 PrEP users between September 2020 and January 2022. Interviews were analyzed iteratively using a thematic analysis approach. We used bivariate and multi-variate ordered logistic regression to analyze the online survey data. Themes identified in the qualitative data influencing condom use decisions to prevent STIs were as follows: (1) awareness (i.e., perceived severity of and susceptibility to STIs, condom counseling), (2) motivation (i.e., concerns about STIs, sexual pleasure and protection of own health), and (3) perceived social norms and practices (e.g., reduced condom use at community level). Overall, 10.7% of survey respondents consistently used condoms with nonsteady partners. Survey respondents who reported high or moderate levels of willingness to use condoms to prevent acquiring STIs were significantly more likely to use condoms for anal sex with nonsteady partners; those who initiated PrEP 6-12 months ago were less likely to use condoms. We found a wide variation in attitudes toward condom use for the prevention of STIs among MSM using PrEP. We recommend client-centered approaches, taking into account PrEP users' values and priorities toward STI prevention to help reduce the spread of STIs.

Antibacterial mouthwash to prevent sexually transmitted infections in men who have sex with men taking HIV pre-exposure prophylaxis (PReGo): a randomised, placebo-controlled, crossover trial.

BACKGROUND: Bacterial sexually transmitted infections (STIs) are highly prevalent among men who have sex with men who use HIV pre-exposure prophylaxis (PrEP), which leads to antimicrobial consumption linked to the emergence of antimicrobial resistance. We aimed to assess use of an antiseptic mouthwash as an antibiotic sparing approach to prevent STIs. METHODS: We invited people using PrEP who had an STI in the past 24 months to participate in this single-centre, randomised, double-blind, placebo-controlled, AB/BA crossover superiority trial at the Institute of Tropical Medicine in Antwerp, Belgium. Using block randomisation (block size eight), participants were assigned (1:1) to first receive Listerine Cool Mint or a placebo mouthwash. They were required to use the study mouthwashes daily and before and after sex for 3 months each and to ask their sexual partners to use the mouthwash before and after sex. Participants were screened every 3 months for syphilis, chlamydia, and gonorrhoea at the oropharynx, anorectum, and urethra. The primary outcome was combined incidence of these STIs during each 3-month period, assessed in the intention-to-treat population, which included all participants who completed at least the first 3-month period. Safety was assessed as a secondary outcome. This trial is registered with Clinicaltrials.gov, NCT03881007. FINDINGS: Between April 2, 2019, and March 13, 2020, 343 participants were enrolled: 172 in the Listerine followed by placebo (Listerine-placebo) group and 171 in the placebo followed by Listerine (placebo-Listerine) group. The trial was terminated prematurely because of the COVID-19 pandemic. 151 participants completed the entire study, and 89 completed only the first 3-month period. 31 participants withdrew consent, ten were lost to follow-up, and one acquired HIV. In the Listerine-placebo group, the STI incidence rate was 140·4 per 100 person-years during the Listerine period, and 102·6 per 100 person-years during the placebo period. In the placebo-Listerine arm, the STI incidence rate was 133·9 per 100 person-years during the placebo period, and 147·5 per 100 person-years during the Listerine period. We did not find that Listerine significantly reduced STI incidence (IRR 1·17, 95% CI 0·84-1·64). Numbers of adverse events were not significantly higher than at baseline and were similar while using Listerine and placebo. Four serious adverse events (one HIV-infection, one severe depression, one Ludwig's angina, and one testicular carcinoma) were not considered to be related to use of mouthwash. INTERPRETATION: Our findings do not support the use of Listerine Cool Mint as a way to prevent STI acquisition among high-risk populations. FUNDING: Belgian Research Foundation - Flanders (FWO 121·00).

High prevalence of epilepsy in an onchocerciasis endemic health zone in the Democratic Republic of the Congo, despite 14 years of community-directed treatment with ivermectin: A mixed-method assessment.

OBJECTIVES: To investigate the reasons for the high prevalence of epilepsy (>6%) discovered in 2015 in the Aketi health zone in the north of the Democratic Republic of the Congo. METHODS: Persons with epilepsy (PWE) diagnosed in a door-to-door survey in 2015 were traced and re-examined in 2017 by a neurologist. Confirmed PWE were paired with matched controls. For onchocerciasis assessment, children 7-10 years old were tested for IgG4 Onchocerca volvulus (OV16) antibodies, a rapid epidemiological mapping of onchocerciasis (REMO) study was performed, and ivermectin coverage was investigated. RESULTS: Forty-three (61.4%) previously diagnosed PWE were traced; the neurologist confirmed the epilepsy diagnosis in all of them. The overall OV16 positivity rate was 64.5%. Poor ivermectin coverage (55.9%) and a high prevalence of onchocercal nodules (>70%) were observed. The prevalence of epilepsy was 5.7% in Aketi rural town, with nine PWE (13.8%) experiencing head nodding seizures. A case-control study showed that PWE had lower body weight and higher ivermectin coverage in 2017 than healthy controls. CONCLUSIONS: The high prevalence of epilepsy in the Aketi health zone, despite 14 years of community-directed treatment with ivermectin (CDTI), was found to be associated with high onchocerciasis transmission and low ivermectin use. An awareness programme to increase ivermectin coverage and the introduction of a bi-annual CDTI programme should be considered.

From river blindness control to elimination: bridge over troubled water.

BACKGROUND: An estimated 25 million people are currently infected with onchocerciasis (a parasitic infection caused by the filarial nematode Onchocerca volvulus and transmitted by Simulium vectors), and 99% of these are in sub-Saharan Africa. The African Programme for Onchocerciasis Control closed in December 2015 and the World Health Organization has established a new structure, the Expanded Special Project for the Elimination of Neglected Tropical Diseases for the coordination of technical support for activities focused on five neglected tropical diseases in Africa, including onchocerciasis elimination. AIMS: In this paper we argue that despite the delineation of a reasonably well-defined elimination strategy, its implementation will present particular difficulties in practice. We aim to highlight these in an attempt to ensure that they are well understood and that effective plans can be laid to solve them by the countries concerned and their international partners. CONCLUSIONS: A specific concern is the burden of disease caused by onchocerciasis-associated epilepsy in hyperendemic zones situated in countries experiencing difficulties in strengthening their onchocerciasis control programmes. These difficulties should be identified and programmes supported during the transition from morbidity control to interruption of transmission and elimination.