Trading HIV for sheep: Risky sexual behavior and the response of female sex workers to Tabaski in Senegal.

We use a cohort of female sex workers (FSWs) in Senegal to show how large anticipated economic shocks lead to increased risky sexual behavior. Exploiting the exogenous timing of interviews, we study the effect of Tabaski, the most important Islamic festival celebrated in Senegal, in which most households purchase an expensive animal for sacrifice. Condom use, measured robustly via the list experiment, falls by between 27.3 percentage points (pp) (65.5%) and 43.1 pp (22.7%) in the 9 days before Tabaski, or a maximum of 49.5 pp (76%) in the 7 day period preceding Tabaski. The evidence suggests the economic pressures from Tabaski are key to driving the behavior change observed through the price premium for condomless sex. Those most exposed to the economic pressure from Tabaski were unlikely to be using condoms at all in the week before the festival. Our findings show that Tabaski leads to increased risky behaviors for FSWs, a key population at high risk of HIV infection, for at least 1 week every year and has implications for FSWs in all countries celebrating Tabaski or similar festivals. Because of the scale, frequency, and size of the behavioral response to shocks of this type, policy should be carefully designed to protect vulnerable women against anticipated shocks.

m-PIMA™ HIV1/2 VL: A suitable tool for HIV-1 and HIV-2 viral load quantification in West Africa.

Point-of-Care for HIV viral RNA quantification seems to be a complementary strategy to the existing conventional systems. This study evaluated the performance of the m-PIMA™ HIV1/2 Viral Load for the quantification of both HIV-1 and HIV-2 RNA viral load. A total of 555 HIV-1 and 90 HIV-2 samples previously tested by Abbott RealTime HIV-1 (Abbott, Chicago, USA) and Generic HIV-2® Charge virale (Biocentric, France) were tested using the m-PIMA™ HIV1/2 Viral Load at the HIV National Reference lab in Senegal. For HIV-1, Pearson correlation and Bland-Altman plots showed a coefficient r = 0.97 and a bias of -0.11 log10 copies/ml (95% confidence interval [CI]: -0.086 to -0.133 log10 copies/ml) for the m-PIMA™ HIV1/2 Viral Load, respectively. Sensitivity and specificity at 3 log10 copies/ml (threshold of virological failure) were 93.6% (95%[CI]: 91.5% to 95.6%) and 99.1% (95%[CI]: 98.3% to 99.9%), respectively. For HIV-2, a correlation of r = 0.95 was also noted with a bias of - 0.229 log10 copies/ml (95%[CI]: -0.161 to -0.297 log10 copies/ml). Sensitivity and specificity at 3 log10 copies/ml were 97.6% (95%[CI]: 94.3% to 100%) and 93.9% (95%[CI]: 88.9% to 98.8%), respectively. These results confirmed that m-PIMA™ HIV1/2 VL could be a good alternative for HIV-1 and HIV-2 viral load testing in decentralized settings in Senegal.

Reforming the registration policy of female sex workers in Senegal? Evidence from a discrete choice experiment.

Evidence suggests that treating sexually transmitted infections (STIs) amongst female sex workers (FSWs) is a cost-effective strategy to reduce the spread of HIV/AIDS. Senegal is the only African country where sex work is regulated by a public health policy which aims to monitor and routinely treat STIs. The law requires FSWs to be at least 21 years old, register with a health centre and the police, carry an up-to-date registration booklet, attend monthly health check-ups, and test negative for STIs. Despite health and legal benefits of registration, 80% of FSWs in Senegal are not registered. Hence, the potential health benefits of the policy have not materialised. To understand why FSWs do not want to register and to define policy changes that would increase the registration rate of FSWs in Senegal, we designed and implemented a discrete choice experiment (DCE) completed by 241 registered and 273 non-registered FSWs. Participants made choices between a series of hypothetical but realistic registration policy changes. Conditional logit models were used to analyse the DCE data. The results highlighted that confidentiality at the health facility was an important element, registered and non-registered FWs were respectively 26.0 percentage points (pp) and 22.1 pp more likely to prefer a policy that guaranteed confidentiality at the health centre. Similarly, both groups preferred a policy where their health record was only held at the health centre and not with the police. Several interventions to increase FSW registration rate and improve their wellbeing may be implemented without modifying the law. For example, the introduction of psychosocial support in the registration policy package, replacing the registration booklet by a QR code, the use of electronic medical files and the integration of FSWs routine visits with maternal health appointments to increase confidentiality have the potential to encourage registration of FSWs.

Validation of the point-of-care (POC) technologies Xpert HIV-1 Qual and m-PIMA HIV 1/2 detect for early diagnosis of HIV-1 and HIV-2 in Senegal.

Introduction: early infant diagnosis (EID) is crucial in the prevention of mother to child transmission (PMTCT) of human immunodeficiency virus (HIV) and is an essential component for the elimination of HIV. EID can be strengthened in resource-limited countries by the introduction and the roll out of real-time polymerase chain reaction (PCR) technologies via point-of-care (POC) devices which improves treatment in remote areas and reduces turnaround time for clinicians and patients to receive results and linkage to care. The objective of this study was to evaluate the performance of Xpert® HIV-1 Qual Assay (Cepheid) and m-PIMA™ HIV 1/2 Detect (ABBOTT) for EID of HIV-1 and HIV-2. Methods: the performance of the Xpert® HIV-1 qual device was evaluated with 192 samples including 100 dried blood spot (DBS) samples from the National Reference Laboratory biobank (71 negative and 29 positive samples) and an additional 92 whole blood samples collected from infants from neonatal departments. These infants from seven treatment centers in the Dakar region were born to mothers infected with HIV-1 (n=91), HIV-2 (n= 8) or HIV-1/2 (n=1). The m-PIMA™ HIV 1/2 detect assay was evaluated on whole blood samples (n=100) with 92 HIV-1 samples and 8 HIV-2 samples from children born to HIV-infected mothers. The Cobas AmpliPreP/Cobas TaqMan (CAP/CTM) platform from Roche Diagnostic Laboratories was used as a reference for HIV-1 diagnosis and the Generic HIV-2 Viral Load Assay (Biocentric) was used as a reference for HIV-2 diagnosis. Performance was evaluated by calculating sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and Cohen's kappa coefficient. Results: for HIV-1 detection on GeneXpert and m-PIMA, no discordance was found on the samples tested, i.e. a sensitivity of 100% (95% CI: 93.9-100%), a specificity of 100% (95% CI: 97.5-100%), a positive predictive value (PPV) of 100% (95% CI: 93.9-100%) and a negative predictive value (NPV) of 100% (95% CI: 97.5-100%). Agreement with Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) was 100% with a Kappa coefficient of 1 (p<0.001, 95% CI) for both techniques. Similarly, the comparison between m-PIMA and generic biocentric for the detection of HIV-2 on the 8 samples tested showed perfect agreement. Conclusion: these results confirm the excellent performance of the Xpert® HIV-1 qual and m-PIMA™ HIV1/2 detect tests for the detection of HIV-1 and HIV-2 and encourage the extension of POC tests to improve access to EID in Senegal.

Performance of Xpert HIV-1 viral load test in Senegal: a country of high circulation of CRF02_AG.

Introduction: the introduction of the point-of-care in HIV-1 viral load quantification appears to be a complementary strategy to the existing conventional system of the acceleration plan for the achievement of the three 90s in Senegal. The objective of this study was to evaluate the performance of the Xpert® HIV-1 viral load in the context of circulation of non-B, non-C subtypes. Methods: two hundred samples, were tested on Xpert® HIV-1 Viral Load using 1 ml of plasma in comparison to 600 µl on Abbott Real-time HIV-1 assay. The difference between viral load values was considered significant for Dlog <0.5 log copies/ml. Results: a good correlation (r=0.985) was noted and confirmed using passing-bablok regression (slope 1.048; 95% CI: 1.036 to 1.069) for 188 samples with samples. A mean difference of 0.0075 log10 copies/ml for a 95% confidence interval (CI) of 0.002 log10 copies/ml to 0.013 log10 copies/ml was obtained. Sensitivity and specificity were respectively 93.6% and 93.5% at the threshold of 1.6 log10 copies/ml and 100% and 99% at the threshold of 3.0 log10 copies/ml. Conclusion: these results show that Xpert® HIV-1 Viral Load has excellent performance. In Senegal, and can be used for HIV viral load monitoring.

They call us goor-jigeen: a qualitative exploration of the experiences of Senegalese Muslim men who have sex with men living with HIV.

Men who have sex with men living with HIV in majority Muslim communities face discrimination based on multiple forms of stigma at socio-cultural and legislative levels. This study aimed to explore qualitatively the experiences of men who have sex with men living with HIV in Dakar, Senegal. In-depth individual interviews were conducted with 30 Senegalese men aged 18 to 55 years, who self-reported as same-sex practising, Muslim, and receiving HIV treatment at health centres in Dakar. Interview data were analysed using an ethnographic phenomenological approach to explore their life experiences. Primary themes included: the self-discovery process; the social, religious and health ramifications of being same-sex practising; and stigma. Within the theme of stigma issues described included shame, blame (of self and others), and violence resulting from being a man who has sex with other men and/or being HIV seropositive. Those with undetectable viral load reported how HIV related stigma and burden diminished as their health improved. Disclosure of being men who have sex with men and/or HIV status, whether voluntary or not, affected experiences of violence and/or isolation. Addressing stigma at healthcare institutions and improving access to HIV treatment can help mitigate the burden of stigma affecting such men. Interventions to address their physical and psychosocial wellbeing require the engagement of multiple stakeholders, including religious and political leaders.

Stigma and healthcare access among men who have sex with men and transgender women who have sex with men in Senegal.

Objectives: Cisgender gay, bisexual, and other men who have sex with men and transgender women experience HIV incidence disparities in Senegal. These analyses determined how depression and different stigma mechanisms related to sexual behavior are associated with healthcare access, sexually transmitted infection testing, and HIV testing among cisgender gay, bisexual, and other men who have sex with men and transgender women across three cities in western Senegal. Methods: Logistic regression assessed the relationship of three stigma scales (stigma from family and friends, anticipated healthcare stigma, and general social stigma) and depression with these outcomes. Results: Depression and stigma were not associated with healthcare access, sexually transmitted infection testing, or HIV testing. However, individuals who had disclosed their sexual identity to a medical provider were more likely to test for HIV. Conclusions: Sexual behavior stigma experienced by cisgender gay, bisexual, and other men who have sex with men and trans women in Senegal may not limit access to routine healthcare, but may limit disclosure of sexual orientation and practices, limiting access to appropriate HIV prevention services.

Modeling COVID-19 daily cases in Senegal using a generalized Waring regression model.

The rapid spread of the COVID-19 pandemic has triggered substantial economic and social disruptions worldwide. The number of infection-induced deaths in Senegal in particular and West Africa in general are minimal when compared with the rest of the world. We use count regression (statistical) models such as the generalized Waring regression model to forecast the daily confirmed COVID-19 cases in Senegal. The generalized Waring regression model has an advantage over other models such as the negative binomial regression model because it considers factors that cannot be observed or measured, but that are known to affect the number of daily COVID-19 cases. Results from this study reveal that the generalized Waring regression model fits the data better than most of the usual count regression models, and could better explain some of the intrinsic characteristics of the disease dynamics.

Sexuality-based stigma and access to care: intersecting perspectives between healthcare providers and men who have sex with men in HIV care centres in Senegal.

Men who have sex with men (MSM) in Senegal face a challenging socio-legal context, marked by homophobia and the illegality of homosexuality. In addition, human immunodeficiency virus (HIV) prevalence among MSM is 27.6%, 46 times greater than the one in the general population (0.5%). Nevertheless, access to healthcare by MSM may be hampered by stigmatizing attitudes from health facility staff (medical and non-medical). This article describes the health facility staff/MSM relationship and analyses its effects on access to healthcare by MSM. The data used were collected through a field survey based on observations and qualitative interviews conducted in 2019 and 2020 with 16 MSM, 1 non-governmental organization (NGO) staff and 9 healthcare providers in Dakar (the capital city) and Mbour (secondary city on the West Coast) hospitals. The data were subject to a thematic analysis assisted by the ATLAS software. The relationship between MSM and healthcare providers is ambiguous. On the one hand, healthcare providers are torn between their professional duty to treat MSM and the cost of being stigmatized by other colleagues. Therefore, they often limit their empathy with MSM within the hospital context. On the other hand, MSM, trusting in the confidentiality of healthcare providers, feel safe in the care pathway. However, we identify the following stigmatizing factors limiting access to care include (1) fear of meeting a relative, (2) difficult relationships with non-medical support staff (mainly security guards), (3) HIV status disclosure and (4) potential conflicts with other MSM. This study is unique as it includes non-medical staff in its respondents. It shows that hospitals are divided into several areas, based on the stigma perceived by MSM. It is important to map out MSM's care trajectories and spaces and to identify all types of staff working within them, including non-medical staff, and enrol them in stigma reduction interventions.

Food insecurity predicts loss to follow-up among people living with HIV in Senegal, West Africa.

The goals of this study were to assess retention on antiretroviral therapy (ART) and to identify predictors of loss to follow-up (LTFU) among people living with HIV (PLHIV) in Senegal. HIV-positive individuals presenting for initiation of ART in Dakar and Ziguinchor were enrolled and followed for 12 months. Data were collected using interviews, clinical evaluations, laboratory analyses, chart review, and active patient tracing. Of the 207 individuals enrolled, 70% were female, 32% had no formal education, and 28% were severely food insecure. At the end of the follow-up period, 58% were retained on ART, 15% were deceased, 4% had transferred care, 5% had migrated, and 16% were lost to follow-up. Enrollment in Ziguinchor (OR 2.71 [1.01-7.22]) and severe food insecurity (OR 2.55 [1.09-5.96]) were predictive of LTFU. Sex, age, CD4 count, BMI <18.5, country of birth, marital status, number of children, household size, education, consultation with traditional healers, transportation time, and transportation cost were not associated with LTFU. The strongest predictor of severe food insecurity was lack of formal education (OR 2.75 [1.30-5.80]). Addressing the upstream drivers of food insecurity and implementing strategies to enhance food security for PLHIV may be effective approaches to reduce LTFU and strengthen the HIV care cascade in the region.

Impact of Traditional Healers on the HIV Care Cascade in Senegal, West Africa: A Longitudinal Study.

Consultation with traditional healers (THs) is common among people living with HIV in sub-Saharan Africa. We conducted a prospective longitudinal study to determine the association between consultation with THs and HIV outcomes following 12 months of antiretroviral therapy (ART). HIV-infected individuals presenting for care and initiation of ART in Dakar and Ziguinchor, Senegal were eligible for enrollment. Data were collected using interviews, clinical evaluations, laboratory analyses, and chart reviews at enrollment, 6 months after ART initiation, and 12 months after ART initiation. Among the 186 participants, 35.5% consulted a TH. The most common reason for consulting a TH was "mystical" concerns (18%). Those who consulted a TH before ART initiation were more likely to present with a CD4 count < 200 cells/mm3 (44% versus 28%; P = 0.04) and WHO stage 3 or 4 disease (64% versus 46%; P = 0.03), and they were less likely to disclose their HIV status (44% versus 65%; P = 0.04). Those who consulted a TH more than 6 months after ART initiation were more likely to report poor adherence to ART (57% versus 4%; P < 0.01). The strongest predictor of virologic failure was consulting a TH more than 6 months after ART initiation (odd ratio [OR], 7.43; 95% CI, 1.22-45.24). The strongest predictors of mortality were consulting a TH before ART initiation (OR, 3.53; 95% CI, 1.25-9.94) and baseline CD4 count < 200 cells/mm3 (OR, 3.15; 95% CI, 1.12-8.89). Our findings reveal multiple opportunities to strengthen the HIV care cascade through partnerships between THs and biomedical providers. Future studies to evaluate the impact of these strategies on HIV outcomes are warranted.

The impact of food insecurity on HIV outcomes in Senegal, West Africa: a prospective longitudinal study.

BACKGROUND: Understanding the impact of food insecurity on HIV outcomes is critical for the development and implementation of effective, evidence-based interventions to address food insecurity and improve the HIV care cascade. We conducted a prospective, longitudinal study to determine the impact of food insecurity on HIV outcomes in Senegal, West Africa. METHODS: HIV-infected individuals presenting for care and initiation of ART through the Senegalese National AIDS program in Dakar and Ziguinchor were eligible for enrollment. Data were collected using interviews, clinical evaluations, laboratory analyses, and chart review at enrollment, month 6, and month 12. Logistic regression was used to determine the association between food insecurity and HIV outcomes. RESULTS: Among the 207 participants in this study, 70% were female and the median age was 37 years. The majority (69%) were food insecure at enrollment, 29% were severely food insecure, and 38% were undernourished. Nearly a third (32%) had no formal education, 23% practiced agriculture, and 40% owned livestock. The median daily food expenditure per person was $0.58. The median round trip transportation time to clinic was 90 min (IQR 30-240). The median cost of transportation to clinic was $1.74. At month 12, 69% were food insecure, 23% were severely food insecure, and 14% were undernourished. At month 12, 43% had not disclosed their HIV status; food insecurity was associated with non-disclosure of HIV-status due to fear of stigmatization and feelings of shame. Severe food insecurity was a strong predictor of loss to follow-up (OR 3.13 [1.08-9.06]) and persistent severe food insecurity was associated with virologic failure (OR 5.14 [1.01-26.29]) and poor adherence to ART 8.00 [1.11-57.57]. Poor nutritional status was associated with poor immunologic recovery (OR 4.24 [1.56-11.47]), virologic failure (OR 3.39 [1.13-10.21]), and death (OR 3.35 [1.40-8.03]). CONCLUSION: Severity and duration of food insecurity are important factors in understanding the relationship between food insecurity and HIV outcomes. Our findings highlight the importance of nutritional status, socioeconomic opportunity, and self-stigmatization in the complex pathway between food insecurity and HIV outcomes. Interdisciplinary, multisectoral efforts are needed to develop and implement effective interventions to address food insecurity among people living with HIV.

Long-term Experience and Outcomes of Programmatic Antiretroviral Therapy for Human Immunodeficiency Virus Type 2 Infection in Senegal, West Africa.

BACKGROUND: Programmatic treatment outcome data for people living with human immunodeficiency virus type 2 (HIV-2) in West Africa, where the virus is most prevalent, are scarce. METHODS: Adults with HIV-2 initiating or receiving antiretroviral therapy (ART) through the Senegalese national AIDS program were invited to participate in this prospective, longitudinal observational cohort study. We analyzed HIV-2 viral loads, CD4 cell counts, antiretroviral drug resistance, loss to follow-up, and mortality. We also examined changes in treatment guidelines over time and assessed progress toward the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets for HIV-2. RESULTS: We enrolled 291 participants at 2 sites for 926.0 person-years of follow-up over 13 years. Median follow-up time was 2.2 years per participant. There were 21 deaths reported (7.2%), and 117 individuals (40.2%) were lost to follow-up, including 43 (14.7%) who had an initial visit but never returned for follow-up. CD4 counts and HIV-2 viral suppression (< 50 copies/mL) at enrollment increased over calendar time. Over the study period, 76.7% of plasma viral loads for participants receiving ART were suppressed, and median CD4 gain was 84 cells/µL in participants' first 2 years on study. Since the UNAIDS 90-90-90 strategy was published, 88.1% of viral loads were suppressed. Fifteen percent of patients experienced virologic failure with no known resistance mutations, while 56% had evidence of multiclass drug resistance. CONCLUSIONS: Participants in the Senegalese national AIDS program are initiating ART earlier in the course of disease, and more modern therapeutic regimens have improved outcomes among those receiving therapy. Despite these achievements, HIV-2 treatment remains suboptimal, and significant challenges to improving care remain.

Describing, analysing and understanding the effects of the introduction of HIV self-testing in West Africa through the ATLAS programme in Côte d'Ivoire, Mali and Senegal.

BACKGROUND: The ATLAS programme aims to promote and implement HIV self-testing (HIVST) in three West African countries: Côte d'Ivoire, Mali, and Senegal. During 2019-2021, in close collaboration with the national AIDS implementing partners and communities, ATLAS plans to distribute 500,000 HIVST kits through eight delivery channels, combining facility-based, community-based strategies, primary and secondary distribution of HIVST. Considering the characteristics of West African HIV epidemics, the targets of the ATLAS programme are hard-to-reach populations: key populations (female sex workers, men who have sex with men, and drug users), their clients or sexual partners, partners of people living with HIV and patients diagnosed with sexually transmitted infections and their partners. The ATLAS programme includes research support implementation to generate evidence for HIVST scale-up in West Africa. The main objective is to describe, analyse and understand the social, health, epidemiological effects and cost-effectiveness of HIVST introduction in Côte d'Ivoire, Mali and Senegal to improve the overall HIV testing strategy (accessibility, efficacy, ethics). METHODS: ATLAS research is organised into five multidisciplinary workpackages (WPs): Key Populations WP: qualitative surveys (individual in-depth interviews, focus group discussions) conducted with key actors, key populations, and HIVST users. Index testing WP: ethnographic observation of three HIV care services introducing HIVST for partner testing. Coupons survey WP: an anonymous telephone survey of HIVST users. Cost study WP: incremental economic cost analysis of each delivery model using a top-down costing with programmatic data, complemented by a bottom-up costing of a representative sample of HIVST distribution sites, and a time-motion study for health professionals providing HIVST. Modelling WP: Adaptation, parameterisation and calibration of a dynamic compartmental model that considers the varied populations targeted by the ATLAS programme and the different testing modalities and strategies. DISCUSSION: ATLAS is the first comprehensive study on HIV self-testing in West Africa. The ATLAS programme focuses particularly on the secondary distribution of HIVST. This protocol was approved by three national ethic committees and the WHO's Ethical Research Committee.

Intersectional stigmas and HIV-related outcomes among a cohort of key populations enrolled in stigma mitigation interventions in Senegal.

OBJECTIVES: The current study aims to assess longitudinal differences in stigma and HIV outcomes among key populations at risk for and living with HIV. DESIGN: Key populations enrolled into two parallel prospective cohorts; one for female sex workers and one for sexual and gender minorities (SGMs). Participants were recruited from three urban areas in Senegal; were followed for 24 months; and had the option to participate in an integrated stigma mitigation intervention. METHODS: Participants included individuals both at risk for and living with HIV. Sociobehavioral questionnaires and biological HIV testing were administered every 3-4 months. Longitudinal analyses used nonparametric Chi-squared test for trends and multivariable logistic regression with generalized estimating equations. RESULTS: 183 SGM and 192 sex workers were enrolled. Among SGM participants, 39.9% were living with HIV at baseline and incidence over 24 months was 3.21/100 person-years. Among sex workers, 36.6% were living with HIV at baseline and incidence was 1.32/100 person-years. Among SGM, perceived healthcare stigma (P < 0.001), anticipated healthcare stigma (P < 0.001), and perceived friend stigma (P = 0.047) reduced, but differed by HIV status for perceived [adjusted odds ratio (aOR): 3.51; 95% confidence interval (CI): 1.75, 7.06] and anticipated healthcare stigmas (aOR: 2.85; 95% CI: 1.06-7.67). Among sex workers perceived healthcare stigma (P = 0.043) and perceived friend stigma (P = 0.006) reduced. Viral suppression increased among SGM (P = 0.028) and was associated with perceived (aOR: 2.87; 95% CI: 1.39-5.55) and enacted healthcare stigma (aOR: 0.42; 95% CI: 0.18-0.99). CONCLUSION: Overall, there were decreases in stigmas observed but clear differences in stigma patterns by HIV status. These data highlight the need to consider specific strategies to address multiple intersecting stigmas as a means of improving HIV-related prevention and treatment outcomes among key populations with diverse identities.

Uptake, retention, and outcomes in a demonstration project of pre-exposure prophylaxis among female sex workers in public health centers in Senegal.

The Senegal pre-exposure prophylaxis (PrEP) Demonstration Project was an open-label cohort study assessing the delivery of daily oral PrEP to HIV-negative female sex workers (FSWs) in four Ministry of Health (MoH)-run clinics in Dakar, Senegal. We assessed uptake, retention in care, and adherence over up to 12 months of follow-up as well as HIV infection rates. Between July and November 2015, 350 individuals were approached and 324 (92.6%) were preliminarily eligible. Uptake was high, with 82.4% of eligible participants choosing to enroll and take PrEP. The mean age of those enrolled was 37.7 years (SD = 8.7), and approximately half had not attended school (41.2%). Among the 267 participants who were prescribed PrEP, 79.9 and 73.4% were retained in PrEP care at 6 and 12 months, respectively. Older age among FSWs was found to be the only significant predictor of lower discontinuation. We did not find significant differences in retention by site, education, condom use, or HIV risk perception. There were no new HIV infections at follow-up. Our results showed evidence of high interest in PrEP and very good PrEP retention rates among FSWs at 12-month follow-up when offered in MoH-run clinics, with older age as the only significant predictor of higher PrEP retention. This highlights the role that these clinics can play in expanding PrEP access nationwide.

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.

BACKGROUND: The 2014 Zaire Ebola virus disease epidemic accelerated vaccine development for the virus. We aimed to assess the safety, reactogenicity, and immunogenicity of one dose of monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in adults. METHODS: This phase 2, randomised, observer-blind, controlled trial was done in study centres in Cameroon, Mali, Nigeria, and Senegal. Healthy adults (≥18 years) were randomly assigned with a web-based system (1:1; minimisation procedure accounting for age, gender, centre) to receive ChAd3-EBO-Z (day 0), or saline placebo (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind until planned interim day 30 analysis, single-blind until month 6, and open-label after month 6 vaccination. Primary outcomes assessed in the total vaccinated cohort, which comprised all participants with at least one study dose administration documented, were serious adverse events (up to study end, month 12); and for a subcohort were solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02485301. FINDINGS: Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504 [49·9%] in the placebo/ChAd3-EBO-Z group), 17 were excluded because no vaccine was administered. The most common solicited injection site symptom was pain (356 [48%] of 748 in the ChAd3-EBO-Z group vs 57 [8%] of 751 in the placebo/ChAd3-EBO-Z group); the most common solicited general adverse event was headache (345 [46%] in the ChAd3-EBO-Z group vs 136 [18%] in the placebo/ChAd3-EBO-Z group). Unsolicited adverse events were reported by 123 (16%) of 749 in the ChAd3-EBO-Z group and 119 (16%) of 751 in the placebo/ChAd3-EBO-Z group. Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group; none were considered vaccination-related. No clinically meaningful thrombocytopenia was reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentration was 900 (95% CI 824-983) in the ChAd3-EBO-Z group. There were no treatment-related deaths. INTERPRETATION: ChAd3-EBO-Z was immunogenic and well tolerated in adults. Our findings provide a strong basis for future development steps, which should concentrate on multivalent approaches (including Sudan and Marburg strains). Additionally, prime-boost approaches should be a focus with a ChAd3-based vaccine for priming and boosted by a modified vaccinia Ankara-based vaccine. FUNDING: EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.

BACKGROUND: During the large 2013-16 Ebola virus outbreak caused by the Zaire Ebola virus, about 20% of cases were reported in children. This study is the first, to our knowledge, to evaluate an Ebola vaccine in children younger than 6 years. We aimed to evaluate the safety, reactogenicity, and immunogenicity of a monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in a paediatric population. METHODS: This phase 2, randomised, observer-blind, controlled trial was done in a vaccine centre in Mali and a university hospital centre in Senegal. Healthy children were randomly assigned through a web-based system (1:1; stratified by age group, gender, and centre) to receive ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind from study start until interim day 30 analysis and became single-blind as of interim analysis. Primary outcomes assessed were serious adverse events (up to study end, month 12), solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). As secondary endpoints, we evaluated anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02548078. FINDINGS: From Nov 11, 2015, to May 9, 2016, of 776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the ChAd3-EBO-Z/MenACWY-TT group and 300 (50%) to the MenACWY-TT/ChAd3-EBO-Z group; all were included in the total vaccinated cohort. Post-day 0 vaccination, the most common solicited injection site symptom was pain (127 [42%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 60 [20%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group); the most common solicited general adverse event was fever (95 [32%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 28 [9%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group). Unsolicited adverse events post-day 0 vaccination were reported by 41 (14%) of 300 participants in the ChAd3-EBO-Z/MenACWY-TT group and 24 (8%) of 300 MenACWY-TT/ChAd3-EBO-Z recipients. Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related. No clinical symptoms of thrombocytopenia were reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentrations (GMC) in the ChAd3-EBO-Z/MenACWY-TT group were 1564 (95% CI 1340-1826) for those aged 13-17 years, 1395 (1175-1655) for 6-12 years, and 2406 (1942-2979) for 1-5 years. Anti-glycoprotein Ebola virus IgG antibody responses persisted up to 12 months post-vaccination, with a GMC of 716 (95% CI 619-828) for those aged 13-17 years, 752 (645-876) for 6-12 years, and 1424 (1119-1814) for 1-5 years. INTERPRETATION: ChAd3-EBO-Z was immunogenic and well tolerated in children aged 1-17 years. This study provides the first ChAd3-EBO-Z data in a paediatric population. Further development should focus on multivalent approaches including Sudan and Marburg strains, and heterologous prime-boost strategies, for instance using modified vaccinia Ankara-based vaccine to boost the immune response. FUNDING: EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.

HIV infection risk and condom use among sex workers in Senegal: evidence from the list experiment method.

Social desirability bias, which is the tendency to under-report socially undesirable health behaviours, significantly distorts information on sensitive behaviours that is gained from self-reports. As a result, self-reported condom use among high-risk populations is thought to be systematically over-reported, and it is impossible to identify the determinants of condom use. The main objective of the article is to elicit unbiased information on condom use among female sex workers (FSWs) using the double list experiment method to analyse the role of HIV infection and exposure to HIV prevention methods in condom use. More specifically, the difference in levels of condom use between HIV-positive and HIV-negative FSWs is estimated. In addition, the role of FSWs' registration and participation in a pre-exposure prophylaxis (PrEP) demonstration project in condom use is considered. A list experiment was designed to elicit condom use information from 786 FSWs in Senegal who were surveyed in 2015 and 2017. Using the list experiment method, participants were randomly assigned to one of two groups (treatment or control) and were asked to report the number of statements they agreed with. Respondents assigned to the control group were presented with three non-sensitive items, whereas those allocated to the treatment group were presented with the same three statements plus the sensitive item (e.g. 'I used a condom during my last intercourse with a client'). Comparing the average number of sentences that were agreed with in both groups provides an estimation of the condom use rate in the treatment group and estimating such prevalence for several sub-groups allows the role of HIV infection risk in condom use to be identified. The percentage of FSWs using condoms in their last sexual intercourse with a client was 80% in 2015 and 78% in 2017, which was significantly lower than the 97% obtained in the face-to-face surveys in both waves. When estimating condom use among sub-groups with the list experiment method, we found that condom use among HIV-positive FSWs was only 34%, which was 47 percentage points lower than condom use among HIV-negative FSWs. We also found that registered FSWs are more likely to use condoms than clandestine FSWs. However, we did not find any difference in condom use between FSWs who were enrolled in the PrEP demonstration project and those who were not enrolled. Health policies should therefore aim to increase condom use among HIV-positive FSWs.

[Low Body Mass Index and impact of antiretroviral therapy on nephrotoxicity, chronic renal disease among HIV-infected patients in Brazzaville, Congo]. / Faible indice de masse corporelle et impact des antirétroviraux sur la néphrotoxicité, la maladie rénale chronique chez les patients infectés par le VIH à Brazzaville, Congo.

OBJECTIVE: To describe the incidence and risks factors of ART induced nephrotoxicity and chronic kidney disease in HIV-1-infected adults with low body mass index (<18.5kg/m2). METHODS: A retrospective cohort study at the Ambulatory Treatment Center in Brazzaville, Congo. Patients with estimated glomerular filtration rate decrease by 25% compared to baseline or a 0.5mg/dL increase in serum creatinine above baseline were classified as having nephrotoxicity, and chronic kidney disease was defined as a value less than 60mL/min/1.73m2. We used Cox proportional hazards regression models to determine factors associated with nephrotoxicity and chronic kidney disease. RESULTS: Of 325 patients, 73.23% were women. Median values were an age 37.55 years (IQR: 33.51-44.96), weight 45kg (IQR: 41-49), CD4 count 137.5 cells/µL (42-245). In the first 24-months, follow-up on ART incidence rate of nephrotoxicity and chronic kidney disease was 27.95 and 7.44 per 100 persons-year respectively. Multivariate analysis identified as a risk factor of nephrotoxicity, baseline haemoglobin below or equal 8g/dL (aHR=2.25; 95%CI 1.28-3.98; P=0.005) and the use of tenofovir (aHR=1.51; 95%CI 1.01-2.27; P=0.04). DFG between 60-80 mL/min/1.73 m2 (aHR=0.35; 95%CI 0.21-0.59; P<0.001) and 45-59mL/min/1.73 m2 (aHR=0.10; 95%CI 0.01-0.72; P=0.02) was not a contraindication for initiating antiretroviral therapy. Each 10-year older age was associated with an increased risk of developing chronic kidney disease (aHR=1.95; 95%CI 1.2-3.17; P=0.007). CONCLUSION: Incidence of nephrotoxicity and chronic kidney disease were high. African HIV-positive patient with low body mass index at baseline need close monitoring of their renal function when treated with tenofovir.