Depression and loneliness among Sub-Saharan immigrants living in the greater Paris area: results from the MAKASI empowerment stepped wedge cluster randomised controlled trial.

PURPOSE: The MAKASI intervention aimed to empower Sub-Saharan African immigrants living in precarious situations in the Paris metropolitan area. Because there are factors specifically related to immigration that may increase the risk for common mental disorders, the present study aimed to examine participants' levels of depression and loneliness and analyze the effect of the intervention on depression and loneliness. METHODS: The MAKASI study was designed as a stepped wedge cluster randomized trial. Study participants were recruited through an outreach program led by a nongovernmental organization and randomly assigned to two clusters, with an intervention delay of 3 months between them. Participants were assessed for 6 months after inclusion and the effect of the intervention on depression and loneliness was assessed using generalized linear mixed models. The study was conducted from 2018 to 2021 and took in consideration whether being interviewed during one of the Covid-19 confinement had an effect on the results. RESULTS: Between 2018 and 2021 a total of 821 subjects participated in the Makasi study. High levels of depression and loneliness were found in the study population. We found no effect of the intervention on depression [95% CI 0.77 to 2.40]. Similarly, no effect of the intervention was found on loneliness [95% CI 0.87 to 2.54]. CONCLUSIONS: The intervention tested did not appear to improve the level of depression and loneliness among participants. However, the high prevalence of mental and emotional problems in the study population suggests a public health crisis among immigrants in the greater Paris area. CLINICAL TRIAL REGISTRATION NUMBER:  Trial registration Clinicaltrials.gov, NCT04468724 (July 13, 2020).

Durability of the Efficacy and Safety of Dolutegravir-Based and Low-Dose Efavirenz-Based Regimens for the Initial Treatment of Human Immunodeficiency Virus Type 1 Infection in Cameroon: Week 192 Data of the NAMSAL-ANRS-12313 Study.

Background: A prospective study was extended to the new antiretroviral and monitoring strategies in HIV-infected adults in low-income countries (NAMSAL-ANRS)-12313 trial, a 96-week open-label, multicenter, randomized phase 3 trial comparing dolutegravir (DTG) 50 mg with efavirenz 400 mg (EFV400), both administered with tenofovir disoproxil fumarate and lamivudine (TDF/3TC) as first-line treatment for antiretroviral therapy (ART)-naive people living with human immunodeficiency virus type 1 (HIV). Noninferiority of DTG to EFV400 was demonstrated at 48-week and sustained at 96 weeks. Here, we present results at 192-week. Methods: Previous trial participants were reconsented and followed up on their initial randomization arm (1:1 DTG/TDF/3TC:EFV400/TDF/3TC). Assessments included changes in viral suppression, biological parameters, and new serious adverse events (SAEs). Results: Among the participants enrolled in the trial, 81% (499/613) were analyzed at week 192: 84% (261/310) on DTG/TDF/3TC and 78% (238/303) on EFV400/TDF/3TC. HIV RNA suppression was maintained in 69% (214/310) on DTG/TDF/3TC-based and 62% (187/303) on EFV400/TDF/3TC-based regimens (difference, 7.3% [95% confidence interval, -.20 to 14.83]; P = .057). Five (DTG/TDF/3TC = 2; EFV400/TDF/3TC = 3) new viral failures (World Health Organization definition) without related resistance DTG mutations and 24 new SAEs were observed (DTG/TDF/3TC = 13; EFV400/TDF/3TC = 11). Mean weight gain was +9.4 kg on DTG/TDF/3TC and +5.9 kg on EFV400/TDF/3TC. The percentage of participants with obesity increased from 6.9% to 27.7% on DTG/TDF/3TC (P < .0001) and from 8.3% to 16.7% on EFV400/TDF/3TC (P = .0033). Conclusions: Four-year follow-up of people with HIV on DTG- and EFV400-based regimens showed long-term efficacy and safety of both ARTs, markedly among participants on DTG/TDF/3TC with high baseline viral load. However, unexpected substantial weight gain over time was prominent among participants on DTG/TDF/3TC, which should be closely monitored. Clinical Trials Registration. NCT02777229.

Immigrants' health empowerment and access to health coverage in France: A stepped wedge randomised controlled trial.

Throughout Europe, migration-related health inequalities are mirrored by large inequalities in health coverage. There is a need to develop novel strategies to secure access to health insurance for immigrants in Europe, in order to meet the shared Sustainable Development Goal of universal health coverage. We evaluated the impact of an original health-related empowerment intervention on access to health coverage among vulnerable, mostly undocumented immigrants in France. As part of the MAKASI study, we adopted an outreach approach and developed a community-based intervention with and for immigrants from sub-Saharan Africa living in precarious conditions in the Greater Paris area. This participatory intervention was grounded in the theory of individual empowerment. Using a stepped wedge randomised design, we first conducted a robust evaluation of the effect of the intervention on access to health coverage at three and six months post-intervention. We then investigated whether the intervention effect was mediated by a health empowerment process. Between 2018 and 2021, a total of 821 participants - 77% of whom were men - were recruited in public spaces and followed up for six months. Participants had been living in France for four years on average, 75% of them had no residence permit, and 44% had no health coverage at the time of inclusion. The probability of accessing health coverage increased by 29 percentage points at six months post-intervention (p < 0.01). This improvement was partially mediated by a health empowerment process, namely a reinforcement of participants' knowledge of and capacity to access available social and health resources. A health empowerment intervention largely improved access to health insurance among vulnerable immigrants in France. Our findings may be transferred to other settings where immigrants are entitled to health insurance. This study offers promising perspectives - beyond information provision and direct referral - to reduce migration-related inequalities in health coverage.

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

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

Bridging the knowledge gap of biomedical HIV prevention tools among sub-saharan african immigrants in France. Results from an empowerment-based intervention.

Introduction: Biomedical HIV prevention tools are available in France to prevent new infections. However, evidence suggests a lack of knowledge of these tools among sub-Saharan African immigrants, who are particularly affected by HIV due to social hardship, an indirect factor of HIV acquisition. We analysed the impact of an empowerment-based intervention on the knowledge of treatment as prevention (TasP), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) in a population of precarious sub-Saharan African immigrants. Methods: Data were collected throughout the MAKASI project. Following an outreach approach, participants were recruited in public places based on their precarious situations and followed for six months (0, 3, 6 months) between 2018 and 2021. Participants were randomized into two groups and received an empowerment intervention sequentially (stepped wedge design). We used random-effects logistic regression models to evaluate the intervention effect on the knowledge of biomedical HIV prevention tools. ClinicalTrials.gov Identifier: NCT04468724. Results: The majority of the participants were men (77.5%), and almost half of them had arrived in France within 2 years prior to inclusion (49.3%). At baseline, 56% of participants knew about TasP, 6% knew about PEP and 4% knew about PrEP. Receiving the intervention increased the odds of knowing about PEP (aOR = 2.02 [1.09-3.75]; p < 0.026). Intervention effects were observed for TasP and PrEP only after 6 months. We found significant time effects for PEP (at 3 months, aOR = 4.26 [2.33-7.80]; p < 0.001; at 6 months, aOR = 18.28 [7.39-45.24]; p < 0.001) and PrEP (at 3 months, aOR = 4.02 [2.10-7.72]; p < 0.001; at 6 months, aOR = 28.33 [11.16-71.91]; p < 0.001). Conclusions: We showed that the intervention increased the knowledge of biomedical HIV prevention tools. The effect of the intervention was coupled with an important time effect. This suggested that exposure to the intervention together with other sources of information contributed to increased knowledge of biomedical HIV prevention tools among precarious sub-Saharan African immigrants.

Predicting health services utilization using a score of perceived barriers to medical care: evidence from rural Senegal.

BACKGROUND: Ensuring access to healthcare services is a key element to achieving the Sustainable Development Goal 3 of "promoting healthy lives and well-being for all" through Universal Health Coverage (UHC). However, in the context of low- and middle-income countries, most studies focused on financial protection measured through catastrophic health expenditures (CHE), or on health services utilization among specific populations exhibiting health needs (such as pregnancy or recent sickness). METHODS: This study aims at building an individual score of perceived barriers to medical care (PBMC) in order to predict primary care utilization (or non-utilization). We estimate the score on six items: (1) knowing where to go, (2) getting permission, (3) having money, (4) distance to the facility, (5) finding transport, and (6) not wanting to go alone, using individual data from 1787 adult participants living in rural Senegal. We build the score via a stepwise descendent explanatory factor analysis (EFA), and assess its internal consistency. Finally, we assess the construct validity of the factor-based score by testing its association (univariate regressions) with a wide range of variables on determinants of healthcare-seeking, and evaluate its predictive validity for primary care utilization. RESULTS: EFA yields a one-dimensional score combining four items with a 0.7 Cronbach's alpha indicating good internal consistency. The score is strongly associated-p-values significant at the 5% level-with determinants of healthcare-seeking (including, but not limited to, sex, education, marital status, poverty, and distance to the health facility). Additionally, the score can predict non-utilization of primary care at the household level, utilization and non-utilization of primary care following an individual's episode of illness, and utilization of primary care during pregnancy and birth. These results are robust to the use of a different dataset. CONCLUSION: As a valid, sensitive, and easily documented individual-level indicator, the PBMC score can be a complement to regional or national level health services coverage to measure health services access and predict utilization. At the individual or household level, the PBMC score can also be combined with conventional metrics of financial risk protection such as CHE to comprehensively document deficits in, and progress towards UHC.

Effects of a free health insurance programme for the poor on health service utilisation and financial protection in Senegal.

INTRODUCTION: Implemented in 2013 in Senegal, the Programme National de Bourses de Sécurité Familiale (PNBSF) is a national cash transfer programme for poor households. Besides reducing household poverty and encouraging children's school attendance, an objective of the PNBSF is to expand health coverage by guaranteeing free enrolment in community-based health insurance (CBHI) schemes. In this paper, we provide the first assessment of the PNBSF free health insurance programme on health service utilisation and health-related financial protection. METHODS: We collected household-level and individual-level cross-sectional data on health insurance in 2019-2020 within the Niakhar Population Observatory in rural Senegal. We conducted a series of descriptive analyses to fully describe the application of the PNBSF programme in terms of health coverage. We then used multivariate logistic and Poisson regression models within an inverse probability weighting framework to estimate the effect of being registered in a CBHI through the PNBSF-as compared with having no health insurance or having voluntarily enrolled in a CBHI scheme-on a series of outcomes. RESULTS: With the exception of health facility deliveries, which were favoured by free health insurance, the PNBSF did not reduce the unmet need for healthcare or the health-related financial risk. It did not increase individuals' health service utilisation in case of health problems, did not increase the number of antenatal care visits and did not protect households against the risk of forgoing medical care and of catastrophic health expenditure. CONCLUSION: We found limited effects of the PNBSF free health insurance on health service utilisation and health-related financial protection, although these failures were not necessarily due to the provision of free health insurance per se. Our results point to both implementation failures and limited programme outcomes. Greater commitment from the state is needed, particularly through strategies to reduce barriers to accessing covered healthcare.

Costs and economies of scale in repeated home-based HIV counselling and testing: Evidence from the ANRS 12249 treatment as prevention trial in South Africa.

Universal HIV testing is now recommended in generalised HIV epidemic settings. Although home-based HIV counselling and testing (HB-HCT) has been shown to be effective in achieving high levels of HIV status awareness, little is still known about the cost implications of universal and repeated HB-HCT. We estimated the costs of repeated HB-HCT and the scale economies that can be obtained when increasing the population coverage of the intervention. We used primary data from the ANRS 12249 Treatment as Prevention (TasP) trial in rural South Africa (2012-2016), whose testing component included six-monthly repeated HB-HCT. We relied on the dynamic system generalised method of moments (GMM) approach to produce unbiased short- and long-run estimates of economies of scale, using the number of contacts made by HIV counsellors for HB-HCT as the scale variable. We also estimated the mediating effect of the contact quality - measured as the proportion of HIV tests performed among all contacts eligible for an HIV test - on scale economies. The mean cost (standard deviation) of universal and repeated HB-HCT was $24.2 (13.7) per contact, $1694.3 (1527.8) per new HIV diagnosis, and $269.2 (279.0) per appropriate referral to HIV care. The GMM estimations revealed the presence of economies of scale, with a 1% increase in the number of contacts for HB-HCT leading to a 0.27% decrease in the mean cost. Our results also suggested a significant long-run relationship between mean cost and scale, with a 1% increase in the scale leading to a 0.36% decrease in mean cost in the long run. Overall, we showed that significant cost savings can be made from increasing population coverage. Nevertheless, there is a risk that this gain is made at the expense of quality: the higher the quality of HB-HCT activities, the lower the economies of scale.

Reassessing the demand for community-based health insurance in rural Senegal: Geographic distance and awareness.

Limited access to information is one of the main health insurance market imperfections in developing countries. Differential access to information may determine individuals' awareness of health insurance schemes, thereby influencing their probability of enrollment. Relying on primary data collected in 2019-2020 in rural Senegal, we estimate the uptake of community-based health insurance using a Heckman-type model to correct for awareness-based sample selection bias. Besides showing that health insurance awareness is a precondition for effective enrollment in community-based health insurance schemes, we also bring new evidence on the roles which geographic factors and individual risk preference play in health insurance uptake by rural dwellers. We show that geographic distance prevents individuals from accessing information on health insurance schemes, and discourage those who are informed from enrolling, because of the additional distance they must travel to benefit from covered healthcare services. Results also show that individual risk preference influences health insurance uptake, but only when information barriers are taken into account. Overall, our results could help decision-makers better shape the universal health coverage roadmap, as policies to improve health insurance awareness differ substantially from policies to improve the features of health insurance schemes.

Free access to antiretroviral treatment and protection against the risk of catastrophic health expenditure in people living with HIV: evidence from Cameroon.

BACKGROUND: To foster access to care and reduce the burden of health expenditures on people living with HIV (PLHIV), several sub-Saharan African countries, including Cameroon, have adopted a policy of removing HIV-related fees, especially for antiretroviral treatment (ART). We investigate the impact of Cameroon's free antiretroviral treatment (ART) policy, enacted in May 2007, on catastrophic health expenditure (CHE) risk according to socioeconomic status, in PLHIV enrolled in the country's treatment access program. METHODS: Based on primary data from two cross-sectional surveys of PLHIV outpatients in 2006-2007 and 2014 (i.e., before and after the policy's implementation, respectively), we used inverse propensity score weighting to reduce covariate imbalances between participants in both surveys, combined with probit regressions of CHE incidence. The analysis included participants treated with ART in one of the 11 HIV services common to both surveys (n = 1275). RESULTS: The free ART policy was associated with a significantly lower risk of CHE only in the poorest PLHIV while no significant effect was found in lower-middle or upper socioeconomic status PLHIV. Unexpectedly, the risk of CHE was higher in those with middle socioeconomic status after the policy's implementation. CONCLUSIONS: Our findings suggest that Cameroon's free ART policy is pro-poor. As it only benefitted PLHIV with the lowest socioeconomic status, increased comprehensive HIV care coverage is needed to substantially reduce the risk of CHE and the associated risk of impoverishment for all PLHIV.

Public-private differentials in health care delivery: the case of cesarean deliveries in Algeria.

Akin to other developing countries, Algeria has witnessed an increasing role of the private health sector in the past two decades. Our study sheds light on the public-private overlap and the phenomenon of physician dual practice in the provision of health care services using the particular case of cesarean deliveries in Algeria. Existing studies have reported that, compared to the public sector, delivering in a private health facility increases the risk of enduring a cesarean section. While confirming this result for the case of Algeria, our study also reveals the existence of public-private differentials in the effect of medical variables on the probability of cesarean delivery. After controlling for selection in both sectors, we show that cesarean deliveries in the private sector tend to be less medically justified compared with those taking place in the public sector, thus, potentially leading to maternal and neonatal health problems. As elsewhere, the contribution of the private health sector to the unmet need for health care in Algeria hinges on an appropriate legal framework that better coordinates the activities of the two sectors and reinforces their complementarity.

Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial).

OBJECTIVES: Evidence comparing the economic and patient values of the World Health Organization's preferred (dolutegravir 50 mg [DTG]-based) and alternative (low-dose [400 mg] efavirenz [EFV400]-based) first-line antiretroviral regimens is limited. We compared patient-reported outcomes (PROs), costs, and the cost-utility of DTG- versus EFV400-based regimens in treatment-naive HIV-1 adults in the randomised NAMSAL ANRS 12313 trial in Yaoundé, Cameroon. METHODS: We used clinical data, PROs, and health resource use data collected in the trial's first 96 weeks (2016-2019). Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale. Other PROs included perceived symptoms, depression, anxiety, and stress. In the 96-week base-case analysis, we estimated the unadjusted and multivariate-adjusted (1) mean costs (in US$, 2016 values) and QALYs/patient, (2) incremental costs and QALYs/patient, and (3) net health benefit (NHB). Outcomes were extrapolated over 5 and 10 years. Uncertainty was assessed using the cost-effectiveness acceptability curve and scenario and cost-effective price threshold analyses. RESULTS: In the base-case analysis, the NHB (95% confidence interval) for the DTG-based regimen relative to the EFV400-based regimen was 0.056 (- 0.037 to 0.153), corresponding to an 88% probability of DTG being cost-effective. A 10% decrease in this regimen's price (from $5.2 to $4.7/month) would increase its cost-effectiveness probability to 95%. When extrapolating outcomes over 5 and 10 years, the DTG-based regimen had a 100% probability of being cost-effective for a large range of cost-effectiveness thresholds. CONCLUSIONS: At 2020 antiretroviral drug prices, a DTG-based first-line regimen should be preferred over an EFV400-based regimen in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02777229.

Regional Inequalities in Maternal and Neonatal Health Services in Iraq and Syria From 2000 to 2011.

We analyze regional inequalities in access to maternal and neonatal health services in Iraq and Syria during the period 2000-2011, before the rise of the Islamic State in Iraq and Syria, ISIS. Utilizing nationally representative survey data (Iraq 2000, 2006, 2011; Syria 2006, 2009), we examine changes in the rate of babies weighed at birth and women delivering at home. We calculate 4 regional inequality indicators: (1) extremal quotient, (2) interquartile quotient, (3) coefficient of variation, and (4) systematic component of variation. Despite national improvements in both countries over time, indicators show increasing regional inequalities in access to maternal and neonatal health services, particularly in Syria between 2006 and 2009. Spatial regression results indicate that these inequalities associate with inequalities in maternal education, rurality, and wealth. Regions where women experienced deteriorating access over time, reflecting overall inequalities, are those that fell under the control of ISIS. Inequalities in access to basic services (education and health) deserve more attention in understanding social and political change in the Arab region.

Cost-Effectiveness Analysis of Lopinavir/Ritonavir Monotherapy Versus Standard Combination Antiretroviral Therapy in HIV-1 Infected Patients with Viral Suppression in France (ANRS 140 DREAM).

BACKGROUND: Protease inhibitor monotherapy is a simplified treatment strategy for virally suppressed HIV-positive patients that has the potential for cost savings, as fewer drugs are used than with combination therapy. However, evidence for its economic value is limited. OBJECTIVES: We assessed the cost-effectiveness of lopinavir/ritonavir monotherapy followed by treatment intensification in case of viral load rebound versus combination antiretroviral therapy (cART) with efavirenz/emtricitabine/tenofovir in HIV-1 infected patients with viral suppression in the ANRS 140 DREAM trial. METHODS: DREAM was conducted in 36 French Hospitals between 2009 and 2013. For each treatment strategy, we estimated the unadjusted and multivariate-adjusted mean costs (in €, year 2010 values) and quality-adjusted life-years (QALYs) per patient, as well as incremental costs and QALYs per patient. We then assessed uncertainty using the cost-effectiveness acceptability curve, scenario analyses and cost-effectiveness price-threshold (CEPT) analysis. RESULTS: In the base-case analysis considering 2009-2013 antiretroviral drug (ARV) prices, adjusted incremental costs and QALYs were - €3296 (95% confidence interval [CI] - 5202 to - 1391) and 0.006 (95% CI - 0.021 to 0.033), respectively, over 2 years, suggesting that monotherapy was cost-effective with a probability of 100% at various cost-effectiveness thresholds. In scenario analyses considering 2018 ARV prices, monotherapy remained cost-effective but with a lower probability (94% vs. 100% in the base-case analysis). The current price of cART would have to decrease by 34% to be cost-effective with a probability of 95%. CONCLUSION: Monotherapy appears to be cost-effective compared with cART for virologically suppressed HIV-positive patients in France. CEPT analysis is a useful tool to identify the preferred strategy to adopt given that ARV prices change rapidly. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00946595.

Health differentials between citizens and immigrants in Europe: A heterogeneous convergence.

The literature on immigration and health has provided mixed evidence on the health differentials between immigrants and citizens, while a growing body of evidence alludes to the unhealthy assimilation of immigrants. Relying on five different health measures, the present paper investigates the heterogeneity in health patterns between immigrants and citizens, and also between immigrants depending on their country of origin. We use panel data on more than 100,000 older adults living in nineteen European countries. Our panel data methodology allows for unobserved heterogeneity. We document the existence of a healthy immigrant effect, of an unhealthy convergence, and of a reversal of the health differentials between citizens and immigrants over time. We are able to estimate the time threshold after which immigrants' health becomes worse than that of citizens. We further document some heterogeneity in the convergence of health differentials between immigrants and citizens in Europe. Namely, the unhealthy convergence is more pronounced in terms of chronic conditions for immigrants from low-HDI countries, and in terms of self-assessed health and body-mass index for immigrants from medium- and high-HDI countries.

Medicine and democracy: The importance of institutional quality in the relationship between health expenditure and health outcomes in the MENA region.

Evidence suggests that the effect of health expenditure on health outcomes is highly context-specific and may be driven by other factors. We construct a panel dataset of 18 countries from the Middle East and North Africa region for the period 1995-2012. Panel data models are used to estimate the macro-level determinants of health outcomes. The core finding of the paper is that increasing health expenditure leads to health outcomes improvements only to the extent that the quality of institutions within a country is sufficiently high. The sensitivity of the results is assessed using various measures of health outcomes as well as institutional variables. Overall, it appears that increasing health care expenditure in the MENA region is a necessary but not sufficient condition for health outcomes improvements.