Gender and Drug Use Discrimination Among People Who Inject Drugs: An Intersectional Approach Using the COSINUS Cohort.

Purpose: Injection drug use is strongly associated with stigmatization by loved ones, healthcare providers, and society in general. This stigmatization can have negative consequences on the health of people who inject drugs (PWID) and limit their access to care. Women who inject drugs face greater stigma than men because of gendered social norms and the intersectional effect between gender and drug use identities. For this analysis, we aimed to study discrimination - which is closely linked to stigmatization - experienced by PWID, considering the intersectionality between drug use discrimination and gender discrimination in the French context. Methods: We used data from the COSINUS cohort study, conducted between June 2016 and May 2019 in four French cities. We selected 427 of the 665 PWID who regularly injected drugs enrolled in COSINUS, at three months of follow-up, and performed multivariable logistic regression to identify factors associated with self-reported drug use discrimination. Results: Women comprised 20.6% of the study sample. Sixty-nine percent of the participants declared drug use discrimination and 15% gender discrimination. In the multivariable regression analysis, PWID who had hurried injection out of fear of being seen were almost twice as likely to have experienced drug use discrimination (OR [95% CI]: 1.77 [1.15, 2.74], p = 0.010). Likewise, women experiencing gender discrimination were almost three times as likely to have experienced drug use discrimination (OR [95% CI]: 2.84 [1.07,7.56], p=0.037). Conclusion: Women who inject drugs experienced gender and drug use intersectional discrimination. This could be a reason for the low attendance rates of women in healthcare settings. In addition, discrimination negatively impacted injection drug use practices (eg, hurried injection), particularly for people with unstable housing who injected in public spaces. We recommend introducing adapted services in healthcare facilities for women who inject drugs, and creating a favorable social and physical environment for all PWID in order to improve their health and access to care.

Men Who Have Sex with Both Men and Women in West Africa: Factors Associated with a High Behavioral Risk of Acquiring HIV from Male Partners and Transmission to Women (CohMSM ANRS 12324-Expertise France).

HIV is highly prevalent in men who have sex with men (MSM) in West Africa. Many MSM in the region also have sex with women (MSMW). Accordingly, they are a potential bridge subpopulation for HIV transmission to women. We aimed to evaluate the proportions and characteristics of West African MSMW at high behavioral risk of acquiring HIV from male partners and transmitting it to female partners (HBRMF). The cohort ANRS-12324 CohMSM Study included 630 HIV-negative MSM in Burkina Faso, Cote d'Ivoire, Mali, and Togo. Among MSMW (i.e., with ≥ 1 female partner) in the cohort, HBRMF was identified using trajectory models based on seven at-risk sexual practices with male and female partners, including inconsistent condom use, multiple partnerships, and receptive same-sex anal intercourse. To assess the relevance of using trajectory models, we compared the proportions of participants who seroconverted during the cohort follow-up among those at HBRMF and those not at HBRMF. Factors associated with HBRMF were identified using a generalized estimation equation logistic regression model accounting for longitudinal data. Approximately half (47%) of the 304 MSMW (22% of all CohMSM study participants) were at HBRMF. This group accounted for 75% of the 28 HIV seroconversions observed during follow-up (p = 0.001). HBRMF was positively associated with being aged < 25 years (aOR 95% CI 1.67 [1.23-2.27]), being sexually attracted only to men (1.97 [1.38-2.78]), feelings of loneliness (1.92 [1.38-2.65]), and homonegative violence score (1.22 [1.05-1.41]). HBRMF was negatively associated with having had both stable and casual female partners in the previous 6 months (0.34 [0.20-0.60] vs. only a stable female partner). HBRMF tended to be negatively associated with having ≥ 4 sexual intercourses with female partners in the previous four weeks (0.54 [0.27-1.06] vs. no intercourse). Establishing official relationships with women might be a strategy for young and/or stigmatized MSMW to comply with social pressure to display a heterosexual lifestyle. However, this seems to increase the risk of HIV transmission to female partners. In the present study, almost half of MSMW were at HBRMF. This result stresses the need to adapt HIV research and prevention to MSMW and their female partners.

Drug consumption rooms are effective to reduce at-risk practices associated with HIV/HCV infections among people who inject drugs: Results from the COSINUS cohort study.

AIMS: The primary aim of this study was to evaluate the impact of drug consumption rooms (DCRs) in France on injection equipment-sharing, while the secondary aims focused upon their impact on access to hepatitis C virus (HCV) testing and opioid agonist treatment (OAT). DESIGN: The COhort to identify Structural and INdividual factors associated with drug USe (COSINUS cohort) was a 12-month longitudinal study of 665 people who inject drugs (PWID), conducted in Bordeaux, Marseille, Paris and Strasbourg. We used data from face-to-face interviews at enrolment and at 6-month and 12-month visits. SETTING AND PARTICIPANTS: The participants were recruited in harm reduction programmes in Bordeaux and Marseille and in DCRs in Strasbourg and Paris. Participants were aged more than 18 years, French-speaking and had injected substances the month before enrolment. MEASUREMENTS: We measured the impact of DCR exposure on injection equipment sharing, HCV testing and the use of medications for opioid use disorder, after adjustment for significant correlates. We used a two-step Heckman mixed-effects probit model, which allowed us to take into account the correlation of repeated measures and to control for potential bias due to non-randomization between the two groups (DCR-exposed versus DCR-unexposed participants). FINDINGS: The difference of declared injection equipment sharing between PWID exposed to DCRs versus non-exposed was 10% (1% for those exposed versus 11% for those non-exposed, marginal effect = -0.10; 95% confidence interval = -0.18, -0.03); there was no impact of DCRs on HCV testing and OAT. CONCLUSIONS: In the French context, drug consumption rooms appear to have a positive impact on at-risk practices for infectious diseases such as human immunodeficiency virus (HIV) and hepatitis C virus.

Gradient of vaccine hesitancy among French men having sex with men: An electronic cross-sectional survey in 2022.

In developed countries, vaccinations against hepatitis B (HBV), hepatitis A (HAV), and human papillomavirus (HPV) are often recommended to men who have sex with men (MSM) because of the risky sexual practices in which some engage. Vaccine coverage against these diseases is not optimal in France, probably due in part to vaccine hesitancy (VH). The overall aim of this survey among MSM was to estimate the prevalence of different grades of VH for these vaccines as well as of general VH (toward any vaccine). The specific objectives were to study the sociodemographic correlates of MSM specific and general VH and its association with vaccine uptake. A cross-sectional electronic survey (February-August 2022) collected information from 3,730 French MSM about their perceptions of HBV, HAV, and HPV and their related vaccines, to construct "specific VH" variables. Information about their past vaccination behaviors for any vaccine was used to construct a "general VH" variable, based on the World Health Organization definition. Almost 90% of MSM showed moderate or high specific VH for HBV, HAV, and/or HPV, and 54% general VH. A higher education level and comfortable financial situation were associated with lower grades of specific and general VH. Younger age was associated with less frequent specific VH and more frequent general VH. Specific VH, versus general, was more strongly associated with frequent self-reported non-vaccination against these three disease. Addressing their concerns about vaccines, improving their knowledge of vaccine-preventable sexually transmitted infections, and motivating them to get vaccinated are public health priorities.

Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial).

BACKGROUND: We provide new and comprehensive evidence on the evolution of a wide range of patient-reported outcomes (PROs) in the NAMSAL ANRS 12313 trial in Cameroon (2016-2021)-the first randomized comparison of dolutegravir 50 mg (DTG) and low-dose efavirenz (ie, 400 mg; EFV400) in treatment-naive adults living with HIV-1 in sub-Saharan Africa. METHODS: We first described the evolution of PROs between baseline and week 192. Then, we used random-effects models to measure the effect of time since the initiation of antiretroviral therapy and the differential effect of DTG versus EFV400 on each PRO, adjusting for clinical, demographic, and socioeconomic factors, while accounting for unobserved heterogeneity and missing data. RESULTS: Among the 613 patients randomized (DTG arm, n = 310; EFV400 arm, n = 303), (1) physical and mental health-related quality of life improved by 13.3% and 6.8%, respectively, (2) the percentage of patients with depression, anxiety, and stress decreased from 23.3%, 23.0%, and 7.7% to 3.1%, 3.5%, and 0.4%, respectively, and (3) the mean number of HIV-related symptoms decreased from 7.2 to 3.0 ( P < 0.001). For most PROs, no significant difference was found between both arms, even when accounting for the effect of DTG on weight gain. Nevertheless, our results suggest smaller improvements in mental health outcomes in the DTG arm, with a 5 percentage point higher adjusted probability of having anxiety at week 192 ( P < 0.01). CONCLUSIONS: Although supporting the current World Health Organization guidelines recommending DTG-based and EFV400-based regimens as preferred and alternative first-line antiretroviral therapy, further studies should investigate medium-term mental health outcomes in patients on DTG. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02777229.

A novel community-based therapeutic education program for reducing alcohol-related harms and stigma in people with alcohol use disorders: A quasi-experimental study (ETHER study).

INTRODUCTION: Alcohol use disorder (AUD) is associated with a significant disease burden in France, where alcohol use is deeply rooted in culture. However, the treatment gap is large because of several barriers, including stigmatisation and drinkers' apprehension about total abstinence. However, standardised and evidence-based interventions based on controlled-drinking for people with AUD are lacking. We aimed to assess the effectiveness of a novel community-based French therapeutic patient education (TPE) program for people with AUD named Choizitaconso. METHODS: A before-after non-randomised quasi-experimental study, named ETHER, was designed and implemented with people living with AUD, over a period of 6 months. The primary outcome was percentage change in the number of alcohol-related harms experienced. Secondary outcomes were percentage changes in psycho-social patient-reported and community-validated outcomes. Participants in the intervention group (n = 34) benefited from the 10-week TPE program Choizitaconso, while the comparison group (n = 58) received standard care. The Kruskall-Wallis and chi-squared or Fisher's exact tests were used to compare before-after changes in variables in both groups. Linear regression models were used to test for the effect of study group on each outcome and to test for the effect of alcohol consumption as a confounder. RESULTS: At 6 months, all outcomes but one either remained stable or numerically improved in both groups. Internalised stigma significantly improved in the intervention group (p = 0.026) but not in the comparison group (p = 0.207), with a significant group effect (p = 0.014). DISCUSSION AND CONCLUSIONS: This study demonstrates the effectiveness of the Choizitaconso TPE program on community-validated outcomes, especially internalised stigma.

Missed opportunities for HIV pre-exposure prophylaxis among people with recent HIV infection: The French ANRS 95041 OMaPrEP study.

OBJECTIVES: Our objective was to identify missed opportunities for the use of pre-exposure prophylaxis (PrEP) in people with recently acquired HIV, factors associated with PrEP knowledge, and reasons for not using PrEP. DESIGN: This was a French national cross-sectional multicentre study enrolling people diagnosed with recent HIV (incomplete Western blot or negative HIV test in the previous 6 months) in 28 HIV clinical centres. Data were gathered using a self-administered questionnaire (SAQ). METHOD: We analysed missed opportunities for PrEP use via a retrospective prep cascade. Factors associated with prior knowledge of PrEP and reasons for PrEP non-use among those who knew about PrEP were described using univariate and multivariate logistic regression models. RESULTS: Of the 224 eligible patients, 185 completed the SAQ and 168 (91%) were eligible for PrEP. Of these, 90% reported seeing at least one physician during the previous year, 26% received information about PrEP, and 5% used PrEP. Factors independently associated with a higher probability of knowing about PrEP were being a man who has sex with men, being aged 25-30 years (vs older), undergoing HIV screening at least once every semester (vs less often; odds ratio [OR] 4.11; 95% confidence interval [CI] 2.00-8.45), and practicing chemsex (OR 3.19; 95% CI 1.12-9.10). Fear of side effects and a low perceived risk of HIV infection were the two most common reasons for not using PrEP (N = 40 [33.33%] and N = 34 [28.3%], respectively). CONCLUSIONS: We found two gaps in the retrospective PrEP cascade: insufficient provision of PrEP information by healthcare providers (mainly general practitioners) and low PrEP acceptability by informed, eligible patients. More diverse healthcare providers need to be involved in PrEP prescription, and at-risk people need to be sensitized to the risk of HIV infection.

Loss to Follow-Up from HIV Pre-Exposure Prophylaxis Care in Men Who Have Sex with Men in West Africa.

Loss to follow-up (LTFU) from HIV pre-exposure prophylaxis (PrEP) care compromises the goal of HIV elimination. We investigated the proportion of LTFU and associated risk factors among men who have sex with men (MSM) enrolled in a PrEP demonstration project in Burkina Faso, Côte d'Ivoire, Mali, and Togo. CohMSM-PrEP, a prospective cohort study, was conducted between November 2017 and June 2021 in community-based clinics. MSM aged 18 years or older at substantial risk of HIV infection received a comprehensive prevention package, including PrEP and peer education. LTFU was defined as not returning to the clinic for six months. Associated risk factors were investigated using a time-varying Cox's model. Of 647 participants followed up for a median time of 15 months, 372 were LTFU (57.5%). LTFU was associated with younger age (adjusted hazard ratio [95% Confidence Interval]; 1.50 [1.17-1.94]), unemployment (1.33 [1.03-1.71]), depression (1.63 [1.12-2.38]), and perceiving no HIV risk with stable male partners (1.61 [1.23-2.10]). Contacting peer educators outside of scheduled visits was protective (0.74 [0.56-0.97]). Our findings show that LTFU from PrEP care in West African MSM is a major challenge to achieving HIV elimination, but that the involvement of peer educators in PrEP delivery helps to limit LTFU by providing users with adequate support.

Socio-behavioral correlates of pre-exposure prophylaxis use and correct adherence in men who have sex with men in West Africa.

BACKGROUND: Multiple barriers compromise pre-exposure prophylaxis (PrEP) engagement (i.e., use and adherence) in men who have sex with men (MSM). In low/middle-income countries, little is known about PrEP engagement in this population. In West Africa, the CohMSM-PrEP study was one of the rare interventions providing PrEP to MSM. We estimated PrEP use and correct adherence rates in CohMSM-PrEP, together with associated factors over time.  METHODS: CohMSM-PrEP recruited MSM in four community-based clinics in Mali, Côte d'Ivoire, Burkina Faso, and Togo. Quarterly follow-up included collecting socio-behavioral data, and providing a comprehensive HIV prevention package, PrEP (daily or event-driven), and peer educator (PE)-led counselling. Using repeated measures, multivariate generalized estimating equations models were used to identify factors associated with self-reported i) PrEP use and ii) correct PrEP adherence during participants' most recent anal intercourse (defined as four pills/week for daily users and 2 + 1 + 1 for event-driven users). RESULTS: Five hundred twenty participants were included with a median follow-up time of 12 months (IQR 6-21). Of the 2839 intercourses declared over the follow-up period, PrEP use was self-reported for 1996 (70%), and correct PrEP adherence for 1461 (73%) of the latter. PrEP use was higher in participants who also attended participating clinics outside of scheduled visits (adjusted odds ratio (aOR) [95% Confidence Interval, CI], p-value; 1.32[1.01-1.71], 0.040), and in those who practiced condomless anal sex (1.86[1.54-2.24], < 0.001). Correct adherence was higher in those who often contacted PE outside of scheduled visits (2.16[1.01-4.64], 0.047) and in participants who adopted receptive/versatile sexual positions with stable partners (1.36[1.03-1.81], 0.030). Instead, after an interaction effect between financial situation and regimen was tested, it was lower in event-driven users with a difficult/very difficult financial situation (comfortable/just making ends meet & daily, 4.19[2.56-6.86], < 0.001; difficult/very difficult & daily, 6.47[4.05-10.30], < 0.001; comfortable/just making ends meet & event-driven, 1.63[1.22-2.17], 0.001), and in participants who felt alone (0.76[0.58-0.99], 0.042). CONCLUSIONS: Community-based clinic attendance and PE contact outside of scheduled visits were both associated with higher PrEP engagement, but some socially and economically marginalized participants struggled with adherence. As scale-up continues in West Africa, we recommend implementing community-based interventions and providing extra support for vulnerable users to ensure adequate PrEP engagement.

A Community-Based Therapeutic Education Programme for People with Alcohol Use Disorder in France: A Qualitative Study (ETHER).

Therapeutic patient education (TPE) aims to help people with chronic disease strengthen their empowerment and psychosocial skills to better manage their condition. Although TPE has great potential for addiction medicine, studies on its benefits for reducing alcohol-related harms and increasing empowerment are sparse. We conducted a qualitative study of people with alcohol use disorder (AUD) who participated in the community-based TPE programme Choizitaconso to assess their perceptions and experiences of it. Semi-structured interviews were conducted with 16 participants who had completed the TPE programme at least six months previously. The interviews were transcribed and analysed using a sequential thematic analysis. We identified four general themes: (1) the context of participation: the TPE programme could be a strategy to facilitate engagement in AUD care; (2) representations and experiences: the programme helped to "normalize" participants' relationship with alcohol use by increasing empowerment; (3) TPE strengths: improved knowledge about alcohol use, self-image, weight loss, self-stigma reduction; (4) TPE limitations: difficulty putting learning into practice after the programme ended. The Choizitaconso programme met participants' health and psychosocial expectations, strengthening their empowerment and reducing self-stigma, thereby facilitating engagement in AUD care.

Study protocol for a pragmatic cluster randomized controlled trial to improve dietary diversity and physical fitness among older people who live at home (the "ALAPAGE study").

BACKGROUND: Diet and physical activity are key components of healthy aging. Current interventions that promote healthy eating and physical activity among the elderly have limitations and evidence of French interventions' effectiveness is lacking. We aim to assess (i) the effectiveness of a combined diet/physical activity intervention (the "ALAPAGE" program) on older peoples' eating behaviors, physical activity and fitness levels, quality of life, and feelings of loneliness; (ii) the intervention's process and (iii) its cost effectiveness. METHODS: We performed a pragmatic cluster randomized controlled trial with two parallel arms (2:1 ratio) among people ≥60 years old who live at home in southeastern France. A cluster consists of 10 people participating in a "workshop" (i.e., a collective intervention conducted at a local organization). We aim to include 45 workshops randomized into two groups: the intervention group (including 30 workshops) in the ALAPAGE program; and the waiting-list control group (including 15 workshops). Participants (expected total sample size: 450) will be recruited through both local organizations' usual practices and an innovative active recruitment strategy that targets hard-to-reach people. We developed the ALAPAGE program based on existing workshops, combining a participatory and a theory-based approach. It includes a 7-week period with weekly collective sessions supported by a dietician and/or an adapted physical activity professional, followed by a 12-week period of post-session activities without professional supervision. Primary outcomes are dietary diversity (calculated using two 24-hour diet recalls and one Food Frequency Questionnaire) and lower-limb muscle strength (assessed by the 30-second chair stand test from the Senior Fitness Test battery). Secondary outcomes include consumption frequencies of main food groups and water/hot drinks, other physical fitness measures, overall level of physical activity, quality of life, and feelings of loneliness. Outcomes are assessed before the intervention, at 6 weeks and 3 months later. The process evaluation assesses the fidelity, dose, and reach of the intervention as its causal mechanisms (quantitative and qualitative data). DISCUSSION: This study aims to improve healthy aging while limiting social inequalities. We developed and evaluated the ALAPAGE program in partnership with major healthy aging organizations, providing a unique opportunity to expand its reach. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05140330 , December 1, 2021. PROTOCOL VERSION: Version 3.0 (November 5, 2021).

Rate and Predictors of Ineffective HIV Protection in African Men Who Have Sex with Men Taking Pre-Exposure Prophylaxis.

We investigated the rate and predictors of ineffective HIV protection in men who have sex with men (MSM) taking pre-exposure prophylaxis (PrEP) in a prospective cohort study from November 2017 to November 2020 in Mali, Côte d'Ivoire, Burkina Faso, and Togo. MSM had to be 18 years or older and at high risk of HIV infection to participate. They also received a comprehensive sexual health prevention package, including PrEP, in community-based clinics as part of the cohort study. Using socio-behavioral/clinical data, HIV protection during their most recent anal intercourse with a male partner was categorized as effective or ineffective (i.e., incorrect PrEP adherence and no condom use). Seventeen percent (500/2839) of intercourses were ineffectively protected for the 520 study participants. Predictors of ineffective HIV protection included being an event-driven user with financial difficulties, having a high alcohol misuse score, and not being a member of a community association. PrEP programs in West Africa must be tailored to socially vulnerable MSM who struggle to adopt PrEP.

RESUMEN: En este artículo hemos investigado la proporción y los factores predictivos de la protección ineficaz de VIH en un grupo de hombres, que tienen sexo con hombres (HSH) y que usan la profilaxis pre-exposición (PrEP). Se usaron los datos de un estudio de cohorte prospectivo realizado entre noviembre del 2017 y noviembre del 2020 en Mali, Costa de Marfil, Burkina Faso y Togo. Los participantes son HSH, de 18 años o más, y con alto riesgo de contaminación por el VIH. Estos han recibido un paquete completo de prevención en salud sexual incluyendo la PrEP en clínicas comunitarias como parte del estudio de cohorte. La protección contra el VIH durante la última relación sexual anal con un hombre fue categorizada como eficaz o ineficaz a partir de datos socio-comportamentales/clínicos (i.e. adhesión incorrecta à la PrEP y no utilización del condón). Concerniente a 520 participantes, 17% (500/2839) de las relaciones sexuales fueron protegidas de manera ineficaz. Entre los factores predictivos de la protección ineficaz contra el VIH se encuentran, el uso intermitente de la PrEP asociado a una situación financiera difícil, el consumo de alcohol y no ser miembro de una asociación comunitaria. Los programas de PrEP en África del Oeste, deben adaptarse a los HSH más vulnerables quienes podrían tener más dificultad para adoptar la PrEP.

Individual and healthcare supply-related HIV transmission factors in HIV-positive patients enrolled in the antiretroviral treatment access program in the Centre and Littoral regions in Cameroon (ANRS-12288 EVOLCam survey).

BACKGROUND: Despite great progress in antiretroviral treatment (ART) access in recent decades, HIV incidence remains high in sub-Saharan Africa. We investigated the role of individual and healthcare supply-related factors in HIV transmission risk in HIV-positive adults enrolled in 19 HIV services in the Centre and Littoral regions of Cameroon. METHODS: Factors associated with HIV transmission risk (defined as both unstable aviremia and inconsistent condom use with HIV-negative or unknown status partners) were identified using a multi-level logistic regression model. Besides socio-demographic and behavioral individual variables, the following four HIV-service profiles, identified using cluster analysis, were used in regression analyses as healthcare supply-related variables: 1) district services with large numbers of patients, almost all practicing task-shifting and not experiencing antiretroviral drugs (ARV) stock-outs (n = 4); 2) experienced and well-equipped national reference services, most practicing task-shifting and not experiencing ARV stock-outs (n = 5); 3) small district services with limited resources and activities, almost all experiencing ARV stock-outs (n = 6); 4) small district services with a wide range of activities and half not experiencing ARV stock-outs (n = 4). RESULTS: Of the 1372 patients (women 67%, median age [Interquartile]: 39 [33-44] years) reporting sexual activity in the previous 12 months, 39% [min-max across HIV services: 25%-63%] were at risk of transmitting HIV. The final model showed that being a woman (adjusted Odd Ratio [95% Confidence Interval], p-value: 2.13 [1.60-2.82], p<0.001), not having an economic activity (1.34 [1.05-1.72], p = 0.019), having at least two sexual partners (2.45 [1.83-3.29], p<0.001), reporting disease symptoms at HIV diagnosis (1.38 [1.08-1.75], p = 0.011), delayed ART initiation (1.32 [1.02-1.71], p = 0.034) and not being ART treated (2.28 [1.48-3.49], p<0.001) were all associated with HIV transmission risk. Conversely, longer time since HIV diagnosis was associated with a lower risk of transmitting HIV (0.96 [0.92-0.99] per one-year increase, p = 0.024). Patients followed in the third profile had a higher risk of transmitting HIV (1.71 [1.05-2.79], p = 0.031) than those in the first profile. CONCLUSIONS: Healthcare supply constraints, including limited resources and ARV supply chain deficiency may impact HIV transmission risk. To reduce HIV incidence, HIV services need adequate resources to relieve healthcare supply-related barriers and provide suitable support activities throughout the continuum of care.

Cost-utility analysis of four WHO-recommended sofosbuvir-based regimens for the treatment of chronic hepatitis C in sub-Saharan Africa.

BACKGROUND: Although direct-acting antivirals (DAA) have become standard care for patients with chronic hepatitis C worldwide, there is no evidence for their value for money in sub-Saharan Africa. We assessed the cost-effectiveness of four sofosbuvir-based regimens recommended by the World Health Organization (WHO) in Cameroon, Côte d'Ivoire and Senegal. METHODS: Using modelling, we simulated chronic hepatitis C progression with and without treatment in hypothetical cohorts of patients infected with the country's predominant genotypes (1, 2 and 4) and without other viral coinfections, history of liver complication or hepatocellular carcinoma. Using the status-quo 'no DAA treatment' as a comparator, we assessed four regimens: sofosbuvir-ribavirin, sofosbuvir-ledipasvir (both recommended in WHO 2016 guidelines and assessed in the TAC pilot trial conducted in Cameroon, Côte d'Ivoire and Senegal), sofosbuvir-daclatasvir and sofosbuvir-ledipasvir (two pangenotypic regimens recommended in WHO 2018 guidelines). DAA effectiveness, costs and utilities were mainly estimated using data from the TAC pilot trial. Secondary data from the literature was used to estimate disease progression probabilities with and without treatment. We considered two DAA pricing scenarios: S1) originator prices; S2) generic prices. Uncertainty was addressed using probabilistic and deterministic sensitivity analyses and cost-effectiveness acceptability curves. RESULTS: With slightly higher effectiveness and significantly lower costs, sofosbuvir/velpatasvir was the preferred DAA regimen in S1 with incremental cost-effectiveness ratios (ICERs) ranging from US$526 to US$632/QALY. At the cost-effectiveness threshold (CET) of 0.5 times the 2017 country's per-capita gross domestic product (GDP), sofosbuvir/velpatasvir was only cost-effective in Senegal (probability > 95%). In S2 at generic prices, sofosbuvir/daclatasvir was the preferred regimen due to significantly lower costs. ICERs ranged from US$139 to US$216/QALY according to country i.e. a 95% probability of being cost-effective. Furthermore, this regimen was cost-effective (probability> 95%) for all CET higher than US$281/QALY, US$223/QALY and US$195/QALY in Cameroon, Côte d'Ivoire and Senegal, respectively, corresponding to 0.14 (Côte d'Ivoire and Senegal) and 0.2 (Cameroon) times the country's per-capita GDP. CONCLUSIONS: Generic sofosbuvir/daclatasvir is very cost-effective for treating chronic hepatitis C in sub-Saharan Africa. Large-scale use of generics and an increase in national and international funding for hepatitis C treatment must be priorities for the HCV elimination agenda.

Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER).

BACKGROUND: ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or Therapeutic education for alcohol-related harm reduction) is a multicentre community-based mixed-methods study, which aims to evaluate the effectiveness of the innovative therapeutic patient education (TPE) programme 'Choizitaconso' in a sample of French people with alcohol use disorder (people with AUD). Choizitaconso teaches people with AUD psychosocial skills to help them (re)establish controlled drinking and reduce alcohol-related harms. Recruitment started in October 2019. We present here the protocol of the ETHER study. METHODS: ETHER's quantitative component involves a 6-month controlled intervention study which evaluates Choizitaconso's effectiveness by comparing 30 people with AUD following the programme with a control group of 60 people with AUD not enrolled in it, using a questionnaire co-constructed by the research team and members of the people with AUD community. Thirty-four alcohol-related harms are assessed and summed to provide an individual measure of the 'harm burden' from consuming alcohol (primary outcome). Secondary outcomes are anticipated and internalized stigma, alcohol consumption measures, craving for alcohol, coping strategies, health-related quality of life, self-confidence to control or abstain from drinking, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments, and capabilities (a measure of wellbeing in adults). Data will be collected in face-to-face and phone-based interviews at enrolment and 6 months later. Linear regression models will be used to assess the impact of the TPE programme on changes in the primary and secondary outcomes, while adjusting for other correlates and confounders. The study's qualitative component comprises semi-structured interviews with 16 people with AUD who have already completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis. RESULTS AND CONCLUSIONS: ETHER is the first evaluation study of an innovative TPE programme specifically designed to reduce alcohol-related harms and reach controlled drinking in France. The involvement of the people with AUD community in selecting which experienced and perceived alcohol-related harms to measure ensures that ETHER will provide healthcare staff and researchers with a relevant set of harm reduction criteria for use in future research. Finally, ETHER will provide scientific justification for implementing novel alcohol-related harm reduction approaches and champion controlled drinking as a therapeutic goal. Trial registration ClinicalTrials.gov, NCT03954054. Registered 17 May 2019-Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03954054?cond=alcohol&cntry=FR&city=Marseille&draw=1&rank=1 .

Hepatitis B in Senegal: A Successful Infant Vaccination Program but Urgent Need to Scale Up Screening and Treatment (ANRS 12356 AmBASS survey).

Senegal introduced the infant hepatitis B virus (HBV) vaccination in 2004 and recently committed to eliminating hepatitis B by 2030. Updated epidemiological data are needed to provide information on the progress being made and to develop new interventions. We estimated the prevalence of hepatitis B surface antigen (HBsAg) in children and adults living in rural Senegal and assessed hepatitis B treatment eligibility. A cross-sectional population-based serosurvey of HBsAg was conducted in 2018-2019 in a large sample (n = 3,118) of residents living in the Niakhar area (Fatick region, Senegal). Individuals positive for HBsAg subsequently underwent clinical and biological assessments. Data were weighted for age and sex and calibrated to be representative of the area's population. Among the 3,118 participants, 206 were HBsAg positive (prevalence, 6.9%; 95% confidence interval [CI], 5.6-8.1). Prevalence varied markedly according to age group in individuals aged 0-4, 5-14, 15-34, and ≥35 years as follows: 0.0% (95% CI, 0.00-0.01); 1.5% (95% CI, 0.0-2.3); 12.4% (95% CI, 9.1-15.6); and 8.8% (95% CI, 6.1-11.5), respectively. Of those subsequently assessed, 50.9% (95% CI, 41.8-60.0) had active HBV infection; 4 (2.9%; 95% CI, 0.9-9.4) were eligible for hepatitis B treatment. Conclusion: In this first population-based serosurvey targeting children and adults in rural Senegal, HBsAg prevalence was very low in the former, meeting the World Health Organization's (WHO) < 1% HBsAg 2020 target; however, it was high in young adults (15-34 years old) born before the HBV vaccine was introduced in 2004. To reach national and WHO hepatitis elimination goals, general population testing (particularly for adolescents and young adults), care, and treatment scale-up need to be implemented.

Living conditions, HIV and gender affirmation care pathways of transgender people living with HIV in France: a nationwide, comprehensive, cross-sectional, community-based research protocol (ANRS Trans&HIV).

INTRODUCTION: Transgender identity is poorly accepted in France, and data on living conditions and the daily difficulties transgender people encounter are scarce. This lack of data reinforces their invisibility in social life, contributes to their stigmatisation and probably increases the burden of HIV infection, especially for HIV-positive transgender people (TRHIV). The main objective of the community-based research study ANRS Trans&HIV is to identify personal and social situations of vulnerability in TRHIV, the obstacles they encounter in terms of access to and retention in medical care, and their gender affirmation and HIV care needs. METHODS AND ANALYSIS: ANRS Trans&HIV is a national, comprehensive, cross-sectional survey of all TRHIV currently being followed in HIV care units in France. TRHIV women are exclusively included in the quantitative component, and TRHIV men in the qualitative component. Data are collected by community-based interviewers and will be analysed to explore patient care pathways and living conditions in the TRHIV population with regard to gender affirmation and HIV. Data collection began in October 2020 and should be completed in December 2021. The statistical analyses techniques used will be adapted to each of the study's objectives and to the type of data collected (cross-sectional (questionnaires) and retrospective (biographical trajectory)). The study's results will provide a greater understanding of TRHIV health needs in order to suggest possible national recommendations for comprehensive HIV and gender affirmation medical care. ETHICS AND DISSEMINATION: ANRS Trans&HIV was approved by Inserm's Ethical Evaluation Committee (no 20-694 on 12 May 2020) and is registered with the National Commission on Informatics and Liberty under number 2518030720. Potential participants are informed about the study through an information note provided by their attending HIV physician. All results published in peer-reviewed journals will be disseminated to the HIV transgender community, institutional stakeholders and healthcare providers. TRIAL REGISTRATION NUMBER: NCT04849767.

COVID-19-related attitudes, risk perceptions, preventive behaviours and economic impact in sub-Saharan African countries: implementing a longitudinal phone-based survey protocol in rural Senegalese households.

INTRODUCTION: Rural areas are considered safe havens against the increased spread of COVID-19 and associated restrictive measures, especially in contexts where public authorities are not in a position to systematically and substantially ease COVID-19-induced economic shocks. In the current sub-Saharan Africa context, still marked by uncertainty surrounding the spread of COVID-19, we present the protocol of an ongoing longitudinal study aimed at investigating COVID-19-related attitudes, risks perceptions, preventive behaviours and economic impact in rural areas in Senegal. METHODS AND ANALYSIS: A prospective randomised longitudinal study of 600 households located in three semiurban villages and nine randomly selected rural villages in the Niakhar area (located 135 km East of Dakar). Three ad hoc phone surveys are administered to 600 heads of households, their housewives in charge of managing the household and a relative living temporarily in the household, respectively. In addition to sharing identical sets of questions on several topics (risks perceptions, attitudes to curfew, attitudes to vaccines, beliefs about COVID-19 infection), the three separate survey questionnaires also include other topics (economic impact, local preventive strategies) whose related questions differ between questionnaires. As analysing evolutions is the study's primary focus, data on all the topics covered will be collected in three waves unless the spread of COVID-19 by mid-2021 justifies extending data collection. The present article presents the study protocol and details about the implementation of the first wave of data collection which started in July 2020. The decision to wait before presenting the protocol was based on the unprecedented context the COVID-19 pandemic. ETHICS AND DISSEMINATION: The survey's protocol was approved by the Senegalese National Ethical Committee for Research in Health (131/MSAS/CNERS/Sec) and received authorisation from both the Senegalese Ministry of Health (619/MSAS/DPRS/DR) and the French Commission on Information Technology and Liberties (CNIL 2220771).

Hepatitis B Vaccination in Senegalese Children: Coverage, Timeliness, and Sociodemographic Determinants of Non-Adherence to Immunisation Schedules (ANRS 12356 AmBASS Survey).

Detailed knowledge about hepatitis B virus (HBV) vaccination coverage and timeliness for sub-Saharan Africa is scarce. We used data from a community-based cross-sectional survey conducted in 2018-2019 in the area of Niakhar, Senegal, to estimate coverage, timeliness, and factors associated with non-adherence to the World Health Organisation-recommended vaccination schedules in children born in 2016 (year of the birth dose (BD) introduction in Senegal) and 2017-2018. Vaccination status was assessed from vaccination cards, surveillance data, and healthcare post vaccination records. Among 241 children with available data, for 2016 and 2017-2018, respectively, 31.0% and 66.8% received the BD within 24 h of birth (BD schedule), and 24.3% and 53.7% received the BD plus at least two pentavalent vaccine doses within the recommended timeframes (three-dose schedule). In logistic regression models, home birth, dry season birth, and birth in 2016 were all associated with non-adherence to the recommended BD and three-dose schedules. Living over three kilometres from the nearest healthcare post, being the firstborn, and living in an agriculturally poorer household were only associated with non-adherence to the three-dose schedule. The substantial proportion of children not vaccinated according to recommended schedules highlights the importance of considering vaccination timeliness when evaluating vaccination programme effectiveness. Outreach vaccination activities and incentives to bring children born at home to healthcare facilities within 24 h of birth, must be strengthened to improve timely HBV vaccination.

Heterogeneity in the Prevalence of High-Risk Human Papillomavirus Infection in Human Immunodeficiency Virus-Negative and Human Immunodeficiency Virus-Positive Men Who Have Sex With Men in West Africa.

BACKGROUND: Men who have sex with men (MSM) are at high risk of human papillomavirus (HPV) infection. We assessed (i) the prevalence of high-risk HPV (HR-HPV) infection and associated factors, and (ii) the prevalence of vaccine-preventable HPV infections in MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. METHODS: A cross-sectional study was conducted in 2017-2018 among MSM ≥18 years old followed in community-based clinics. HPV infection was investigated in oral and anal samples using the e-BRID system. Factors associated with HR-HPV infection were identified using multivariate logistic regressions. RESULTS: Among 631 participants, 425 were HIV-negative and 206 HIV-positive. HR-HPV prevalence ranged from 9.2% to 34.8% in the former, and 33.3% to 71.0% in the latter, according to the study country. In multivariate analysis, HIV infection (adjusted odds ratio (aOR) 3.61, 95% confidence interval (CI) 2.48-5.27) and study country (4.73, 2.66-8.43 for Mali; 3.12, 1.68-5.80 for Burkina Faso; 3.51, 1.92-6.42 for Togo) were associated with HR-HPV infection. Other associated factors were low educational level, self-defined homosexual identity, and condomless anal sex. The prevalence of infections which can be prevented with bivalent, quadrivalent, and nonavalent vaccines was 5.9, 27.1, and 34.6% in HIV-negative participants, and 18.9, 43.7, and 54.9% in HIV-positive participants, respectively. CONCLUSIONS: HR-HPV prevalence was very heterogeneous between the study countries in both HIV-negative and HIV-positive MSM. Vaccine-preventable HPV infections predominated. Vaccination should be proposed to young MSM to reduce the burden of HPV infection in this vulnerable population and their female partners in West Africa.