Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial.

BACKGROUND: Due to the low number of individuals with HIV-2, no randomised trials of HIV-2 treatment have ever been done. We hypothesised that a non-comparative study describing the outcomes of several antiretroviral therapy (ART) regimens in parallel groups would improve understanding of how differences between HIV-1 and HIV-2 might lead to different therapeutic approaches. METHODS: This pilot, phase 2, non-comparative, open-label, randomised controlled trial was done in Burkina Faso, Côte d'Ivoire, Senegal, and Togo. Adults with HIV-2 who were ART naive with CD4 counts of 200 cells per µL or greater were randomly assigned 1:1:1 to one of three treatment groups. A computer-generated sequentially numbered block randomisation list stratified by country was used for online allocation to the next available treatment group. In all groups, tenofovir disoproxil fumarate (henceforth tenofovir) was dosed at 245 mg once daily with either emtricitabine at 200 mg once daily or lamivudine at 300 mg once daily. The triple nucleoside reverse transcriptase inhibitor (NRTI) group received zidovudine at 250 mg twice daily. The ritonavir-boosted lopinavir group received lopinavir at 400 mg twice daily boosted with ritonavir at 100 mg twice daily. The raltegravir group received raltegravir at 400 mg twice daily. The primary outcome was the rate of treatment success at week 96, defined as an absence of serious morbidity event during follow-up, plasma HIV-2 RNA less than 50 copies per mL at week 96, and a substantial increase in CD4 cells between baseline and week 96. This trial is registered at ClinicalTrials.gov, NCT02150993, and is closed to new participants. FINDINGS: Between Jan 26, 2016, and June 29, 2017, 210 participants were randomly assigned to treatment groups. Five participants died during the 96 weeks of follow-up (triple NRTI group, n=2; ritonavir-boosted lopinavir group, n=2; and raltegravir group, n=1), eight had a serious morbidity event (triple NRTI group, n=4; ritonavir-boosted lopinavir group, n=3; and raltegravir group, n=1), 17 had plasma HIV-2 RNA of 50 copies per mL or greater at least once (triple NRTI group, n=11; ritonavir-boosted lopinavir group, n=4; and raltegravir group, n=2), 32 (all in the triple NRTI group) switched to another ART regimen, and 18 permanently discontinued ART (triple NRTI group, n=5; ritonavir-boosted lopinavir group, n=7; and raltegravir group, n=6). The Data Safety Monitoring Board recommended premature termination of the triple NRTI regimen for safety reasons. The overall treatment success rate was 57% (95% CI 47-66) in the ritonavir-boosted lopinavir group and 59% (49-68) in the raltegravir group. INTERPRETATION: The raltegravir and ritonavir-boosted lopinavir regimens were efficient and safe in adults with HIV-2. Both regimens could be compared in future phase 3 trials. The results of this pilot study suggest a trend towards better virological and immunological efficacy in the raltegravir-based regimen. FUNDING: ANRS MIE.

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.

Metabolic causes of liver disease among adults living with HIV from low- and middle-income countries: a cross-sectional study.

INTRODUCTION: Liver disease is a leading cause of morbidity and mortality among persons living with HIV (PLHIV). While chronic viral hepatitis has been extensively studied in low- and middle-income countries (LMICs), there is limited information about the burden of metabolic disorders on liver disease in PLHIV. METHODS: We conducted a cross-sectional analysis of baseline data collected between October 2020 and July 2022 from the IeDEA-Sentinel Research Network, a prospective cohort enrolling PLHIV ≥40 years on antiretroviral treatment (ART) for ≥6 months from eight clinics in Asia, Americas, and central, East, southern and West Africa. Clinical assessments, laboratory testing on fasting blood samples and liver stiffness measurement (LSM)/controlled attenuation parameter (CAP) by vibration-controlled transient elastography were performed. Multivariable logistic regression models assessed factors associated with liver fibrosis (LSM ≥7.1 kPa) and steatosis (CAP ≥248 dB/m). Population attributable fraction (PAF) of each variable associated with significant liver fibrosis was estimated using Levin's formula. RESULTS: Overall, 2120 PLHIV (56% female, median age 50 [interquartile range: 45-56] years) were included. The prevalence of obesity was 19%, 12% had type 2 diabetes mellitus (T2DM), 29% had hypertension and 53% had dyslipidaemia. The overall prevalence of liver fibrosis and steatosis was 7.6% (95% confidence interval [CI] 6.1-8.4) and 28.4% (95% CI 26.5-30.7), respectively, with regional variability. Male sex at birth (odds ratio [OR] 1.62, CI 1.10-2.40), overweight/obesity (OR = 2.50, 95% CI 1.69-3.75), T2DM (OR 2.26, 95% CI 1.46-3.47) and prolonged exposure to didanosine (OR 3.13, 95% CI 1.46-6.49) were associated with liver fibrosis. Overweight/obesity and T2DM accounted for 42% and 11% of the PAF for liver fibrosis, while HBsAg and anti-HCV accounted for 3% and 1%, respectively. Factors associated with steatosis included overweight/obesity (OR 4.25, 95% CI 3.29-5.51), T2DM (OR 2.06, 95% CI 1.47-2.88), prolonged exposure to stavudine (OR 1.69, 95% CI 1.27-2.26) and dyslipidaemia (OR 1.68, 95% CI 1.31-2.16). CONCLUSIONS: Metabolic disorders were significant risk factors for liver disease among PLHIV in LMICs. Early recognition of metabolic disorders risk factors might be helpful to guide clinical and lifestyle interventions. Further prospective studies are needed to determine the causative natures of these findings.

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.

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.

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.

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.

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.

Adherence to quarterly HIV prevention services and its impact on HIV incidence in men who have sex with men in West Africa (CohMSM ANRS 12324 - Expertise France).

BACKGROUND: Access to tailored HIV prevention services remains limited for West African MSM. We assessed adherence to quarterly HIV prevention services and its impact on HIV incidence in MSM followed up in four cities in Burkina Faso, Côte d'Ivoire, Mali, and Togo. METHODS: We performed a prospective cohort study between 2015 and 2018. HIV-negative MSM aged over 18 benefited from quarterly medical visits which included a clinical examination, HIV testing, screening and treatment for other sexually transmitted infections, peer-led counselling and support, and the provision of condoms and lubricants. Determinants of adherence to quarterly follow-up visits and incident HIV infections were identified using generalized estimating equation models and Cox proportional hazard models, respectively. RESULTS: 618 MSM were followed up for a median time of 20.0 months (interquartile range 15.2-26.3). Overall adherence to quarterly follow-up visits was 76.5% (95% confidence interval [CI] 75.1-77.8), ranging from 66.8% in Abidjan to 87.3% in Lomé (p < 0.001). 78 incident HIV infections occurred during a total follow-up time of 780.8 person-years, giving an overall incidence of 10.0 per 100 person-years (95% CI 8.0-12.5). Adherence to quarterly follow-up visits was not associated with the risk of incident HIV infection (adjusted hazard ratio 0.80, 95% CI 0.44-1.44, p = 0.545). CONCLUSIONS: Strengthening HIV prevention services among MSM in West Africa, including the use of PrEP, will be critical for controlling the epidemic, not only in this key population but also in the general population. Quarterly follow-up of MSM, which is essential for PrEP delivery, appears feasible. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02626286 (December 10, 2015).

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.

Homonegativity, sexual violence and condom use with women in men who have sex with men and women in West Africa.

OBJECTIVE: The study aimed to explore longitudinal interactions between homonegativity and sexual behaviors with female partners among HIV-negative West African men who have sex with men and women (MSMW). DESIGN AND METHOD: The community-based cohort CohMSM ANRS 12324 - Expertise France enrolled MSM in Togo, Burkina Faso, Côte d'Ivoire and Mali. Sociobehavioral data were collected every 6 months. Using 30-month follow-up data, a multiprobit analysis was performed to investigate the relationship between psychosocial and behavioral variables ex-ante (t - 1) and ex-post (t). RESULTS: MSMW (n = 326) accounted for half of all participants in CohMSM. They reported inconsistent condom use with women in 39% of visits. Perceived and internalized homonegativity at t - 1 tended to lead to sexual violence toward women at t (P < 0.1), which was associated with inconsistent condom use with them at t (P < 0.05). CONCLUSION: Given the high HIV prevalence in West African MSM, widespread condom-less sex with women in MSMW, and the aggravating effect of social and internalized homonegativity, more research in the MSMW subpopulation is needed to assess the risk of HIV bridging to women and to design support activities.

[Acceptability of the use of mobile phones for HIV management in Togo]. / Acceptabilité de l'utilisation de la téléphonie mobile dans la prise en charge du VIH au Togo.

OBJECTIVE: To describe the acceptability and factors associated with the use of mobile telephones in the care of people living with HIV (PLHIV) in Lomé, Togo. METHOD: A cross-sectional study was conducted from January 5th to March 31st, 2018 in Lomé. PLHIV were recruited from the Department of Infectious and Tropical Diseases of the teaching hospital “CHU Sylvanus Olympio” and the NGO “Espoir Vie Togo”. Socio-demographic and clinical data, mobile phone possession and acceptability of communication with health professionals using a mobile phone were collected with a standardized questionnaire during a face-to-face interview. RESULTS: A total of 259 PLHIV (79.6% women) were recruited. The mean age (± standard deviation) of PLHIV was 43.7 ± 9.8 years and the majority (95.4%) had a mobile phone. Almost all (98.1%) of respondents declared that mobile phone could be a means to maintain contact with a health professional. Phone calls (43.0%), text messages (SMS) (35.1%), and voice messages (20.0%) were the preferred means of communication with health professionals. Factors associated with the acceptability of receiving SMS from a health professional were age < 44 years and having at least a secondary level of education. CONCLUSION: PLHIV are receptive to the integration of mobile technology into the management of their condition. M-health could be an opportunity to improve the management of HIV infection in Togo.

[Acceptability of the use of mobile phones for HIV management in Togo] / Acceptabilité de l'utilisation de la téléphonie mobile dans la prise en charge du VIH au Togo.

OBJECTIVE: To describe the acceptability and factors associated with the use of mobile telephones in the care of people living with HIV (PLHIV) in Lomé, Togo. METHOD: A cross-sectional study was conducted from January 5th to March 31st, 2018 in Lomé. PLHIV were recruited from the Department of Infectious and Tropical Diseases of the teaching hospital “CHU Sylvanus Olympio” and the NGO “Espoir Vie Togo”. Socio-demographic and clinical data, mobile phone possession and acceptability of communication with health professionals using a mobile phone were collected with a standardized questionnaire during a face-to-face interview. RESULTS: A total of 259 PLHIV (79.6% women) were recruited. The mean age (± standard deviation) of PLHIV was 43.7 ± 9.8 years and the majority (95.4%) had a mobile phone. Almost all (98.1%) of respondents declared that mobile phone could be a means to maintain contact with a health professional. Phone calls (43.0%), text messages (SMS) (35.1%), and voice messages (20.0%) were the preferred means of communication with health professionals. Factors associated with the acceptability of receiving SMS from a health professional were age < 44 years and having at least a secondary level of education. CONCLUSION: PLHIV are receptive to the integration of mobile technology into the management of their condition. M-health could be an opportunity to improve the management of HIV infection in Togo.