Frequent chlamydia and gonorrhoea but very infrequent syphilis among men who have sex with men using HIV pre-exposure prophylaxis in West Africa.

OBJECTIVES: Although oral pre-exposure prophylaxis (PrEP) for HIV is being rolled out in West Africa, data on sexually transmitted infections (STIs) in PrEP users are scarce. We assessed the prevalence, incidence and determinants of bacterial STIs in men who have sex with men (MSM) taking PrEP in Burkina Faso, Côte d'Ivoire, Mali and Togo. METHODS: A prospective cohort study among MSM initiating PrEP as part of a comprehensive HIV prevention package was conducted between 2017 and 2021 in community-based clinics in the four study countries. Molecular screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) was performed at months 0, 6 and 12. Serological testing for syphilis was performed every 3 months over the first year of follow-up. Determinants of CT and/or NG incidence were identified using Poisson generalised linear mixed models. RESULTS: A total of 598 participants with a median age of 24.7 years were included. Prevalence of CT and/or NG was 24.4% (95% CI 21.0 to 28.1), 22.4% (95% CI 18.4 to 26.8) and 29.0% (95% CI 24.2 to 34.1) at months 0, 6 and 12, respectively. The prevalence of syphilis ranged from 0.2% (95% CI 0.0 to 0.9) at month 0 to 0.8% (95% CI 0.2 to 2.4) at month 12. Ninety incident CT and/or NG infections occurred during a total follow-up time of 280.6 person-years (incidence rate 32.1 per 100 person-years, 95% CI 25.8 to 39.4). Three incident syphilis infections were detected during a total follow-up time of 459.7 person-years (incidence rate 0.7 per 100 person-years, 95% CI 0.1 to 1.9). CT and/or NG incidence was associated with condomless insertive anal sex (adjusted incidence rate ratio 1.96, 95% CI 1.04 to 3.71, p=0.038). CONCLUSIONS: CT and NG were frequent but syphilis was very infrequent in MSM using HIV PrEP in West Africa. HIV programme managers should integrate STI services into PrEP programmes.

Sexual behaviours and risk with women in MSM in sub-Saharan Africa.

In sub-Saharan Africa (SSA), MSM - a high HIV prevalence group - experience strong social stigma and pressure to have female partners. Accordingly, they could constitute a bridging group for HIV transmission to cisgender women. We developed a multilevel summary of MSM sexual behaviors and risk with women in various SSA regions. Following PRISMA guidelines, we conducted a mixed-method systematic review of data of sex with women in MSM in SSA. We performed meta-analyses on quantitative data (i.e. percent of recent sex and condomless sex with women) for each SSA region (when proportions reported in ≥4 studies). Pooled proportions were calculated using random-effects models. Qualitative data were analyzed using the three-step thematic synthesis methodology. The pooled proportion of MSM who had sex with women was 58% (33-83%) in East Africa (in the previous 3 months), and 27% (13-48%) in Southern Africa and 50% (95% CI 39-62%) in West Africa (in the previous 6 months); 23% (16-32%) of MSM in West Africa had condomless sex with a woman (during the most recent encounter). Approximately one quarter of MSM had recent multiple female partners. MSM reported having sex with women because of heteronormative pressure, erotic/romantic attraction, or financial needs leading to transactional sex. MSM may act as a bridging population to women in SSA, as they commonly practice sex with women and risky sexual behaviors with them. HIV programmes and community-based support for MSM should be adapted to this population to reduce this risk.

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.

The Perceived Added Value of Bimonthly Injectable Pre-Exposure Prophylaxis According to West African Men Who Have Sex with Men: A Focus Group Study.

Bimonthly long-acting injectable pre-exposure prophylaxis (LAI-PrEP) can become an important additional tool for HIV prevention among West African men who have sex with men (MSM). The objective was to explore the perceived added value of LAI-PrEP as an HIV prevention tool among MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. We conducted eight focus group discussions among 62 HIV-negative MSM between April and May 2021. Participants were recruited via local community-based clinics. Data collection and analysis were guided by grounded theory and community-based participatory approaches. Participants were generally knowledgeable about HIV, and explained particular barriers for HIV prevention in their communities (e.g., denial of HIV). The added value of LAI-PrEP relative to condoms was similar to oral pre-exposure prophylaxis (PrEP) in terms of perceived advantages (e.g., improved sexual satisfaction) or disadvantages (e.g., no protection against other sexually transmitted infections). Compared with oral PrEP, LAI-PrEP was perceived to provide better protection against HIV and to be more convenient (e.g., no need to be mindful of intake and less risk for stigma). Concerns included fear of needles, doubts about efficacy, potential side effects, and difficulties for ensuring timely injections (e.g., when traveling abroad). The results demonstrate that injectable PrEP can be of particular interest to subgroups of West African MSM, although existing HIV prevention tools such as condoms and oral PrEP will remain valuable alongside of, or instead of, LAI-PrEP. Increasing awareness about HIV and tackling discrimination based on sexual orientation continue to be crucial factors to be addressed for HIV prevention.

TimesUpPRS: A Social Media Movement for Promoting Diversity, Equity, and Inclusion in Plastic Surgery.

OBJECTIVE: Minority representation and promotion in medicine is lacking. Social media can facilitate change by raising awareness of biases, empowering others, and cultivating connections. The TimesUpPRS Instagram account was created in March 2020 to foster diversity, equity, and inclusion (DEI) in plastic surgery by celebrating surgeons of diverse identities and emphasizing the need to create safe, fair, and equitable workplaces. We aim to characterize its content, audience demographics, engagement, and impact. METHODS: All TimesUpPRS posts published until March 2022 were reviewed for content analysis. Audience demographics were assessed through Instagram Insights. Engagement was assessed through likes, comments, and posts tagging @TimesUpPRS. RESULTS: Three hundred fifty-five posts have been published, with 45.9% original content. These posts discuss representation or treatment of women (39.7%), Black (24.2%), Asian and Pacific Islander (14.4%), LGBTQ+ (12.7%), LatinX (6.5%), people of color overall (4.8%), first generation-low income (1.7%), and Native American (1.1%) individuals. 45.1% aimed to raise social awareness, 19.4% spotlighted plastic surgery figures, 16.3% highlighted research, and 5.6% advertised opportunities for community involvement. The mean (SE) number of hashtags utilized was 10.9 (0.6), with #ilooklikeasurgeon used most. There were 2052 followers, but 10,025 accounts reached. Of reached accounts, 66.8% were women, 71.8% were from the U.S., and 55% were aged 25 to 34. The mean (SE) number of likes and comments per post was 62.2 (3.4) and 2.6 (0.2). 85.0% of comments were supportive. Three hundred sixty-six posts tagged @TimesUpPRS. TimesUpPRS has also garnered industry and private sponsorship, inspired DEI programming, and collaborated with multiple other organizations. CONCLUSIONS: In 2 years, TimesUpPRS has generated 350+ posts and reached 10,000+ accounts. Content highlighted figures of diverse identities and cultivated high, positive engagement. Now with 20 content creators, TimesUpPRS will continue increasing content, expanding its audience, and fostering impactful discussion that helps shift the existing culture to one of inclusivity and equity.

Strategies to improve PrEP uptake among West African men who have sex with men: a multi-country qualitative study.

Introduction: West African men who have sex with men (MSM) remain at substantial risk of contracting HIV. Pre-exposure prophylaxis (PrEP) can be an effective game-changer in reducing the number of HIV infections in MSM communities. To optimize the roll-out of PrEP, we need to better understand how we can increase its uptake. The objective of this study was to explore the perceptions of West African MSM toward PrEP and their proposed strategies to overcome barriers to PrEP uptake within their communities. Methods: Between April 2019 and November 2021, we conducted 12 focus group discussions with 97 MSM not taking PrEP, and 64 semi-structured interviews with MSM taking PrEP, in Burkina Faso, Côte d'Ivoire, Mali, and Togo. Data collection and analysis were guided and conducted by local research teams, enabling a community-based participatory approach. A coordinating researcher collaborated with these local teams to analyze the data guided by a grounded theory approach. Results: The results show that participants were generally positive toward PrEP and that MSM communities have become more aware of PrEP for the study. We identified three main strategies for increasing PrEP uptake. First, participants proposed to raise awareness and improve knowledge of HIV as they considered the self-perceived risk of MSM in their communities to be low. Second, because of existing misconceptions and false information, participants proposed to improve the dissemination of PrEP to allow for informed choices, e.g., via peers or PrEP users themselves. Third, as oral PrEP also entails a risk of being associated with HIV or homosexuality, strategies to avoid stigmatization (e.g., hiding pills) were deemed important. Discussion: These findings indicate that the roll-out of oral PrEP and other future PrEP modalities should be accompanied by raising awareness and improving knowledge on HIV, and wide dissemination of information that focuses on the health-promoting aspect of these tools. Tailored delivery and long-acting PrEP modalities will be important to avoid potential stigmatization. Sustained efforts to prevent discrimination and stigmatization based on HIV status or sexual orientation continue to be highly important strategies to address the HIV epidemic in West Africa.

Human Immunodeficiency Virus Seroconversion Among Men Who Have Sex With Men Who Use Event-Driven or Daily Oral Pre-Exposure Prophylaxis (CohMSM-PrEP): A Multi-Country Demonstration Study From West Africa.

BACKGROUND: Data on human immunodeficiency virus (HIV) seroconversion among men who have sex with men (MSM) using pre-exposure prophylaxis (PrEP) in West Africa are needed. This study aimed to document HIV seroconversion and associated determinants, PrEP adherence, plasma drug concentrations, and HIV drug resistance in MSM using event-driven or daily PrEP in Burkina Faso, Côte d'Ivoire, Mali, and Togo. METHODS: A prospective cohort study was conducted in 2017-2021 among HIV-seronegative MSM aged 18 or over who were at high risk of HIV infection. Participants could choose between event-driven and daily PrEP, switch regimens, and discontinue or restart PrEP. The determinants of HIV incidence were investigated using a multivariate mixed-effects Poisson regression analysis. RESULTS: A total of 647 participants were followed for a total time of 1229.3 person-years. Of 5371 visits, event-driven PrEP was chosen in 3873 (72.1%), and daily PrEP in 1400 (26.1%). HIV incidence was 2.4 per 100 person-years (95% confidence interval [CI] 1.5-3.6) for event-driven PrEP, and 0.6 per 100 person-years (95% CI .1-2.3) for daily PrEP (adjusted incidence rate ratio 4.40, 95% CI 1.00-19.36, P = .050). Adequate adherence was lower with event-driven than daily PrEP (44.3% vs 74.9%, P < .001). Plasma drug concentrations were undetectable in 92 (97.9%) of the 94 measures taken for 23 participants who seroconverted. Only 1 participant had resistance to PrEP drugs. CONCLUSIONS: HIV seroconversions mainly occurred in participants who chose event-driven PrEP. The study's data highlighted major difficulties with adherence to this regimen. Improving adherence to event-driven PrEP constitutes a major research and public health priority in this context.

Mycoplasma genitalium and Antimicrobial Resistance Among a Cohort of West African Men Who Have Sex With Men Using Preexposure Prophylaxis (CohMSM-PrEP ANRS 12369-Expertise France Study).

Background: Antimicrobial resistance to macrolides and fluoroquinolones in Mycoplasma genitalium (MG) among men who have sex with men (MSM) is worryingly high in high-resource countries. Data in Africa are lacking. We aimed to assess the burden of MG including the presence of resistance-associated mutations (RAMs) in MG among MSM using human immunodeficiency virus preexposure prophylaxis in Burkina Faso, Côte d'Ivoire, Mali, and Togo. Methods: MSM were included in a prospective cohort study (2017-2021). Molecular detection of MG in urine, anorectal, and pharyngeal samples was performed at baseline and after 6 and 12 months. Detection of RAMs to macrolides and fluoroquinolones was performed by sequencing the 23S ribosomal RNA, parC, and gyrA genes. A sample was found to be possibly resistant to fluoroquinolones if alterations were found in ParC position 83/87. Results: Of 598 participants, 173 (28.9%) were positive at least once for MG and global point-prevalence was 19.4%. Interestingly, 238 of 250 (95.2%) infections were asymptomatic and 72 of 138 MG infections with follow-up data (52.2%) cleared during the study. Only 1 macrolide RAM was found (0.6%). Prevalence of fluoroquinolones RAMs was 11.3% overall, ranging from 2.4% in Burkina Faso to 17.5% in Mali. Conclusions: Although MG was highly prevalent in these MSM, macrolide resistance was almost nonexistent. Nevertheless, >10% of the samples were possibly resistant to fluoroquinolones. Heterogeneity in the prevalence of fluoroquinolone RAMs between countries may be explained by different antimicrobial consumption in humans and animals.

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.

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.

Non-inferiority test for a continuous variable with a flexible margin in an active controlled trial: an application to the "Stratall ANRS 12110 / ESTHER" trial.

BACKGROUND: Non-inferiority trials are becoming increasingly popular in public health and clinical research. The choice of the non-inferiority margin is the cornerstone of such trials. Most of the time, the non-inferiority margin is fixed and constant, determined from historical trials as a fraction of the effect of the reference intervention. But in some circumstances, there may some uncertainty around the reference treatment that one would like to account for when performing the hypothesis testing. In this case, the non-inferiority margin is not fixed in advance and depends on the reference intervention estimate. Hence, the uncertainty surrounding the non-inferiority margin should be accounted for in statistical tests. In this work, we explore how to perform the non-inferiority test for a continuous variable with a flexible margin. METHODS: We have proposed in this study, two procedures for the non-inferiority test with a flexible margin for continuous endpoints. The proposed test procedures are based on a test statistic and confidence interval approaches respectively. Simulations have been used to assess the performances and properties of the proposed test procedures. An application was done on a real-world clinical data, to assess the efficacy of clinical monitoring alone versus laboratory and clinical monitoring in HIV-infected adult patients. RESULTS: Basically, for both proposed methods, the type I error estimate was not dependent on the values of the reference treatment. In the test statistic approach, the type 1 error rate estimate was approximatively equal to the nominal value. It has been found that the confidence interval level determined approximatively the level of significance. For a given nominal type I error α, the appropriate one- and two-sided confidence intervals should be with levels 1-α and 1-2α, respectively. CONCLUSIONS: Based on the type I error rate and power estimates, the proposed non-inferiority hypothesis test procedures had good performances and were applicable in practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT00301561. Registered on March 13, 2006, url: https://clinicaltrials.gov/ct2/show/NCT00301561 .

Examining educational attainment and allostatic load in non-Hispanic Black women.

BACKGROUND: Research suggests that non-Hispanic Black (henceforth, Black) women and people with lower educational attainment have higher levels of allostatic load (AL). This study sought to determine the association between educational attainment and AL among a large sample of Black women. METHODS: We analyzed data among 4177 Black women from the National Health and Nutrition Examination Survey years 1999-2018. AL score was defined as the total for abnormal measures of eight biomarkers. We further categorized participants with AL score greater than or equal to 4 as having high AL. We calculated mean estimates of total allostatic load scores using generalized linear models. We performed modified Poisson Regression models with robust variance estimation to estimate prevalence ratios (PRs) of high allostatic load and their associated 95% confidence intervals (CIs) by educational attainment. RESULTS: Black women with a college degree or higher had the lowest prevalence of high allostatic load (31.8% vs. 42.7%, 36.3%, 36.6%), and age adjusted mean allostatic load scores (mean = 1.90 vs. mean = 2.34, mean = 1.99, mean = 2.05) when compared to Black women with less than a high school diploma, high school diploma or GED, and some college or associates degree respectively. Even after accounting for age, poverty-to-income ratio, smoking, congestive heart failure, and heart attack, Black college graduates had an 14.3% lower prevalence of high allostatic load (PR = 0.857, 95% CI 0.839-0.876) when compared to Black women with lower educational attainment. CONCLUSIONS: Black women with a baccalaureate degree or higher educational attainment had lower allostatic load compared to Black women with less than a high school education. This finding further confirms higher education is a social determinant of health. Future research should explore differences in AL by more granular degree types.

Decrease in incidence of sexually transmitted infections symptoms in men who have sex with men enrolled in a quarterly HIV prevention and care programme in West Africa (CohMSM ANRS 12324-Expertise France).

OBJECTIVE: Although men who have sex with men (MSM) are at high risk of STI, their access to tailored healthcare services remains limited in West Africa. We assessed the change in STI symptoms incidence over time among MSM enrolled in a quarterly HIV prevention and care programme in four cities in Burkina Faso, Côte d'Ivoire, Mali and Togo. METHODS: We performed a prospective cohort study in MSM followed up between 2015 and 2019. Men aged over 18 who reported anal sex with another man within the previous 3 months were offered quarterly syndromic diagnosis and treatment for STI, as well as HIV testing, peer-led counselling and support. Condoms and lubricants were also provided. The change in STI symptoms incidence during follow-up was investigated using a non-parametric trend test and mixed-effect Poisson regression models. RESULTS: 816 participants were followed for a total duration of 1479 person-years. 198 participants (24.3%) had at least one STI symptom during follow-up. Overall, STI symptoms incidence was 20.4 per 100 person-years (95% CI 18.4 to 22.6), ranging from 15.3 in Abidjan to 33.1 in Ouagadougou (adjusted incidence rate ratio (aIRR) 2.39, 95% CI 1.55 to 3.69, p<0.001). STI symptoms incidence was 16.8 and 23.0 per 100 person-years in HIV-positive and HIV-negative participants, respectively (aIRR 0.77, 95% CI 0.57 to 1.04, p=0.087). STI symptoms incidence decreased significantly from 29.9 per 100 person-years in the first 6 months to 8.6 at 30-35 months of follow-up (aIRR per 6-month increase 0.84, 95% CI 0.77 to 0.92, p<0.001). CONCLUSION: STI symptoms incidence decreased over time but the overall burden of STI appeared to be very high in MSM followed up in West Africa. STI services including counselling, diagnosis and treatment should be reinforced. Laboratory tests that allow accurate diagnosis of STI are required. Strengthening STI services will be critical for controlling the HIV and STI epidemics in this vulnerable population and in the general population. TRIAL REGISTRATION NUMBER: NCT02626286.

Correlates of COVID-19 Vaccine Hesitancy among a Community Sample of African Americans Living in the Southern United States.

In the United States, African Americans (AAs) have been disproportionately affected by COVID-19 mortality. However, AAs are more likely to be hesitant in receiving COVID-19 vaccinations when compared to non-Hispanic Whites. We examined factors associated with vaccine hesitancy among a predominant AA community sample. We performed a cross-sectional analysis on data collected from a convenience sample of 257 community-dwelling participants in the Central Savannah River Area from 5 December 2020, through 17 April 2021. Vaccine hesitancy was categorized as resistant, hesitant, and acceptant. We estimated relative odds of vaccine resistance and vaccine hesitancy using polytomous logistic regression models. Nearly one-third of the participants were either hesitant (n = 40, 15.6%) or resistant (n = 42, 16.3%) to receiving a COVID-19 vaccination. Vaccine-resistant participants were more likely to be younger and were more likely to have experienced housing insecurity due to COVID-19 when compared to both acceptant and hesitant participants, respectively. Age accounted for nearly 25% of the variation in vaccine resistance, with 21-fold increased odds (OR: 21.93, 95% CI: 8.97-5.26-91.43) of vaccine resistance in participants aged 18 to 29 compared to 50 and older adults. Housing insecurity accounted for 8% of the variation in vaccine resistance and was associated with 7-fold increased odds of vaccine resistance (AOR: 7.35, 95% CI: 1.99-27.10). In this sample, AAs under the age of 30 and those experiencing housing insecurity because of the COVID-19 pandemic were more likely to be resistant to receiving a free COVID-19 vaccination.

Rapid antiretroviral therapy initiation and its effect on treatment response in MSM in West Africa.

OBJECTIVE: To assess the time from HIV diagnosis to ART initiation and the effect of rapid ART initiation (i.e. within 7 days of HIV diagnosis) on attrition and virologic and immunologic responses among MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. DESIGN: Prospective cohort study between 2015 and 2019. METHODS: MSM aged 18 years or older newly diagnosed with HIV infection were eligible to participate. ART was proposed to participants upon HIV diagnosis, irrespective of clinical stage and CD4+ cell count, and was initiated as soon as possible, with no specific time frame. Determinants of rapid ART initiation and its effect on treatment outcomes were assessed using multivariate analyses. RESULTS: Of 350 MSM, 335 (95.7%) initiated ART after a median time of 5 days. Of the latter, 216 (64.5%) had rapid ART initiation. The 335 participants were followed up for a median time of 24.1 months. One hundred and eleven (33.1%) were not retained in care. Rapid ART initiation was less likely in participants with a CD4+ cell count at least 200 cells/µl [adjusted odds ratio (aOR) 0.37, 95% confidence interval (CI) 0.15-0.88]. It improved viral load suppression (aOR 6.96, 95% CI 1.98-24.46) but had no effect on attrition (aOR 0.87, 95% CI 0.57-1.33) or CD4+ cell count increase (adjusted coefficient 28.23, 95% CI -17.00 to 73.45). CONCLUSION: These results in MSM in West Africa support the WHO recommendation for rapid ART initiation. Clinics need to develop context-specific strategies for rapid ART initiation and for retaining MSM in HIV care.ClinicalTrials.gov, number NCT02626286.

The Performance of Immunoassays to Measure Antibodies to the Chlamydia trachomatis Antigen Pgp3 in Different Epidemiological Settings for Trachoma.

Programs to eliminate trachoma as a public health problem use prevalence of the clinical sign trachomatous inflammation-follicular (TF) in 1- to 9-year-olds in endemic districts to make decisions to begin or end mass drug administration with azithromycin. Trachomatous inflammation-follicular is used as a proxy for transmission of ocular Chlamydia trachomatis infection. Long-term monitoring of previously endemic districts for recrudescence of ocular C. trachomatis infection would benefit from a simple blood test that could be integrated with other public health programs. In this study, we evaluated multiple tests to measure antibodies against the C. trachomatis antigen Pgp3-a multiplex bead assay (MBA), an ELISA, and two versions of a lateral flow assay (LFA)-in four districts of the Amhara region of Ethiopia with varying levels of TF. Seroprevalence and seroconversion rate (SCR) results were proportional to TF prevalence by district for most tests, with the notable exception of the LFA using colloidal gold as the developing reagent. Changing the test developing reagent to black latex improved agreement between serological measures and TF prevalence and in inter-rater agreement. Seroconversion rate estimates using data derived from the LFA-gold assay were inconsistent with the shape of the age-seroprevalence curve, which did not increase in older ages. These data revealed potential complications with using SCR that will need further evaluation. Data from MBA, ELISA, and LFA with the black test line showed good agreement with each other and proportionality to TF estimates, providing further data that serology has potential utility for trachoma surveillance.

HIV pre-exposure prophylaxis for men who have sex with men in west Africa: a multicountry demonstration study.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) data in men who have sex with men (MSM) in west Africa are essential to guide its large-scale implementation. We assessed the uptake of event-driven and daily PrEP, HIV incidence, and changes over time in sexual behaviours and prevalence of bacterial sexually transmitted infections (STIs) in MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. METHODS: We did a prospective cohort study from Nov 20, 2017, to April 14, 2020, in four community-based clinics in Abidjan (Côte d'Ivoire), Bamako (Mali), Lomé (Togo), and Ouagadougou (Burkina Faso). Participants were MSM aged 18 years or older at substantial risk of HIV infection. Participants could choose between event-driven (2+1+1 dosing) and daily oral PrEP (tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg), switch regimen, and discontinue or restart PrEP. We compared HIV incidence in this study with that of the same cohort before the availability of PrEP (CohMSM). Statistical analysis included the Kaplan-Meier method and mixed-effects regression models. This study is registered with ClinicalTrials.gov, NCT03459157. FINDINGS: We followed up 598 participants for a total of 743·6 person-years. At enrolment, 445 (74%) of 598 participants chose event-driven PrEP and 153 (26%) of 598 chose daily PrEP. 60 (13%) of 445 and 65 (42%) of 153 participants switched PrEP regimen at least once (p<0·0001). 159 participants (27%) were lost to follow-up. Overall HIV incidence was 2·3 per 100 person-years (95% CI 1·3-3·7; adjusted incidence rate ratio 0·21, 95% CI 0·12-0·36 compared with CohMSM). Adherence was optimal in 802 (41%) of 1946 measures with event-driven PrEP and in 394 (71%) of 554 measures with daily PrEP (p<0·0001). Coverage of sex acts with PrEP only and PrEP and condom decreased during follow-up (p=0·039 if PrEP only; p=0·0025 if PrEP and condom). The frequency of condomless anal sex remained stable (p=0·96). The number of male sexual partners (p<0·0001) and number of sex acts with casual male partners (p=0·0014 for 1-4 sex acts in previous 4 weeks; p=0·030 for ≥5 sex acts) decreased. The prevalence of gonorrhoea, chlamydia, and syphilis remained stable. INTERPRETATION: PrEP availability helped prevent HIV infection and did not lead to an increase in risky sexual behaviours or other STIs. PrEP should be urgently implemented in west Africa. Retention in care and PrEP adherence require special attention to ensure PrEP reaches its full prevention potential. FUNDING: ANRS and Expertise France. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.