Effects of the Covid-19 pandemic on ART initiation and access to HIV viral load monitoring in adults living with HIV in West Africa: a regression discontinuity analysis.

OBJECTIVES: Efforts to control the COVID-19 pandemic have potentially compromised the availability and/or quality of HIV services. We aimed to assess the pandemic's impact on ART initiation and HIV viral load (VL) monitoring in three West African countries. METHODS: We used routinely collected data from five clinics contributing to the IeDEA collaboration in Burkina Faso, Côte d'Ivoire and Nigeria. We included ART-naïve adults living with HIV (ALWH) initiating ART from 01/01/2018. We conducted regression discontinuity analysis to estimate changes in the number of ART initiations and VL measures per week, before and during the pandemic period in each country. RESULTS: In clinics in Burkina Faso and Côte d'Ivoire, ART initiations per week remained constant throughout the studied periods (-0.24 points (p) of ART initiations/week 95%CI -5.5, 5.9, -0.9 p 95%CI -8.5,8.6, respectively), whereas in Nigeria's clinic, they decreased significantly (-6.3 p, 95% CI -10.8, -1.7) after the beginning of the pandemic. The volume of VL tests performed decreased significantly in all three countries (-17.0 p 95%CI -25.3, -8.6 in Burkina Faso, -118.4 p 95%CI -171.1, -65.8 in Côte d'Ivoire and -169.1p 95%CI-282.6, -55.6 in Nigeria). CONCLUSIONS: Access to ART was maintained for newly diagnosed ALWH despite pandemic-related physical/social distancing measures. However, VL monitoring was severely disrupted and did not return to pre-pandemic levels approximately one year after the beginning of the pandemic. While HIV services in West Africa appear rather resilient, the impact of disruptions in VL monitoring on virological and clinical outcomes should continue to be monitored.

Time to Treatment Initiation and HIV Viral Suppression in People Diagnosed With HIV-1 During COVID-19 Pandemic in Ex-Aquitaine, France (ANRS CO3 AQUIVIH-NA Cohort-QuAliCOV Study).

OBJECTIVES: The COVID-19 pandemic's impact on initiation and effectiveness of antiretroviral therapy (ART) in people diagnosed with HIV remains unclear. We evaluated critical delays in HIV care in people diagnosed before and during the pandemic in ex-Aquitaine, France. METHODS: We considered adults diagnosed with HIV-1 in 2018-2021 and enrolled in the ANRS CO3 AQUIVIH-NA and followed them until October 10, 2022 for those diagnosed during the pandemic (April 01, 2020-December 31, 2021) and until March 31, 2020 for historical controls. We compared their characteristics at inclusion and the median time between diagnosis and ART initiation, ART initiation and viral suppression, and diagnosis and virologic, suppression (effective management). RESULTS: Eighty-three individuals were diagnosed during the pandemic versus 188 during the prepandemic period. Median follow-up was 549 (interquartile range: 329-713) days. Populations were similar in sex, age, HIV acquisition mode, hospital type, and clinical characteristics at diagnosis; however, fewer were foreign-born during the pandemic (15.7% versus 33.5%, P = 0.003). The probability of ART initiation, therapeutic success, and effective management was higher in people living with HIV (PLWH) diagnosed during the pandemic in adjusted analyses (hazard ratio [HR]: 2.0; 95% CI: 1.5 to 2.7; HR: 1.7; 95% CI: 1.2 to 2.3; HR: 1.8; 95% CI: 1.3 to 2.6, respectively). Those diagnosed during the pandemic were 2.3 (95% CI: 1.2 to 4.1) times more likely to be virologically suppressed within six months of diagnosis compared with historical controls. CONCLUSIONS: Pandemic-related reorganizations may have resulted in newly diagnosed PLWH being prioritized; however, the lower proportion of foreign-born PLWH diagnosed during the pandemic period, likely because of reduced migration and potential delays in diagnosis, may contribute to these preliminary findings.

Factors associated with poorer quality of life in people living with HIV in southwestern France in 2018-2020 (ANRS CO3 AQUIVIH-NA cohort: QuAliV study).

We evaluated people living with Human Immunodeficiency Virus' (PLWH) quality of life (QoL) and assessed whether their demographic, disease-related, socioeconomic, or behavioral characteristics were associated with poorer QoL. ANRS CO3 AQUIVIH-NA cohort participants (Nouvelle Aquitaine, France) were recruited to a cross-sectional study (2018-2020) and their QoL assessed (WHOQOL-BREF). We calculated median (Q1, Q3) QoL domain scores and assessed factors associated with poorer median QoL using bivariable and multivariable quartile regression. Of the 965 PLWH included, 98.4% were on antiretroviral therapy, 94.7% were virally-suppressed, 63.5% reported good/very good QoL. Median scores (0-100) were highest for physical (69;Q1, Q3: 56, 81) and environmental (69; 56, 75) QoL and lowest for social (56; 44, 69) and psychological (56; 44, 69) QoL. PLWH with ≥ 3 comorbidities, HIV-related stigma, or income of < 1500€/month had poorer median adjusted physical, psychological, social, and environmental QoL scores compared to reference groups. While more than half of PLWH reported good/very good QoL, we have not achieved good QoL in 90% of PLWH. Multi-morbidity, HIV-related stigma, and social determinants were consistently and independently associated with poorer QoL. Addressing structural factors in addition to those indirectly related to HIV is required to attain good QoL in all PLWH.

Tobacco, alcohol, cannabis, and illicit drug use and their association with CD4/CD8 cell count ratio in people with controlled HIV: a cross-sectional study (ANRS CO3 AQUIVIH-NA-QuAliV).

BACKGROUND: To evaluate drug use (alcohol, tobacco, cannabis and other drugs) and its association with mean CD4/CD8 T cell count ratio, a marker of chronic inflammation, in virally suppressed people living with HIV-1 (PLWH) in Nouvelle Aquitaine, France. METHODS: A multi-centric, cross-sectional analysis was conducted in 2018-19 in the QuAliV study-ANRS CO3 AQUIVIH-NA cohort. Tobacco, alcohol, cannabis, and other drug use (poppers, cocaine, amphetamines, synthetic cathinones, GHB/GBL) were self-reported. CD4 and CD8 T cell counts and viral load measures, ± 2 years of self-report, and other characteristics were abstracted from medical records. Univariable and multivariable linear regression models, adjusted for age, sex, HIV risk group, time since HIV diagnosis, and other drug use were fit for each drug and most recent CD4/CD8 ratio. RESULTS: 660 PLWH, aged 54.7 ± 11.2, were included. 47.7% [315/660] had a CD4/CD8 ratio of < 1. Their mean CD4/CD8 ratio was 1.1 ± 0.6. 35% smoked; ~ 40% were considered to be hazardous drinkers or have alcohol use disorder; 19.9% used cannabis and 11.9% other drugs. Chemsex-associated drug users' CD4/CD8 ratio was on average 0.226 (95% confidence interval [95% CI] - 0.383, - 0.070) lower than that of non-users in univariable analysis (p = 0.005) and 0.165 lower [95% CI - 0.343, 0.012] in multivariable analysis (p = 0.068). CONCLUSIONS: Mean differences in CD4/CD8 ratio were not significantly different in tobacco, alcohol and cannabis users compared to non-users. However, Chemsex-associated drug users may represent a population at risk of chronic inflammation, the specific determinants of which merit further investigation. TRIAL REGISTRATION NUMBER: NCT03296202.

A comprehensive analysis of excess depressive disorder in women and men living with HIV in France compared to the general population.

We aimed to estimate the prevalence of depressive disorder in people living with HIV (PLWH) and evaluate its association with non-HIV-specific and HIV-specific factors in PLWH and in PLWH compared to the general population (GP). We used cross-sectional data from the QuAliV study, conducted within the ANRS-CO3 Aquitaine-AQUIVIH-NA cohort of PLWH in Nouvelle-Aquitaine (2018-2020), and a nationally-representative survey in the GP (EHIS-ESPS, 2014-2015), we included all participants aged ≥ 18 years old who had completed the Patient Health Questionnaire-8 (PHQ-8). Depressive disorder was defined as Patient Health Questionnaire-8 score greater or equal to 10. Its association with non-HIV-specific (demographic, socio-economic, behavioral, health status), HIV-specific factors (immuno-viral markers, antiretrovirals, level of perceived HIV-stigma), and HIV-status was assessed using Poisson regression models with robust variance in women and men separately. We included 914 PLWH (683 men/231 women). More than one in five PLWH had depressive disorder. It was strongly associated with being younger and experiencing severe pain in both sexes. Unemployment in women, being single, and lack of family ties in men were also associated with depressive disorder. More than 30% of our sample reported HIV-stigma, with a dose-response relationship between level of perceived HIV-stigma and depressive disorder. The crude prevalence of depressive disorder was 2.49 (95%CI 1.92-3.22) and 4.20 (95%CI 3.48-5.05) times higher in women and men living with HIV respectively compared to GP counterparts and 1.46 (95%CI 1.09-1.95) and 2.45 (95%CI 1.93-3.09) times higher after adjustment for non-HIV specific factors. The adjusted prevalence ratio of depressive disorder was not significantly different in HIV-stigma free women, but remained twice as high in HIV-stigma free men. The prevalence of depressive disorder compared to the GP tended to decrease with age in PLWH. Excess depressive disorder remains a major concern in PLWH. Our findings reaffirm the importance of regular screening. Tackling social inequalities and HIV-stigma should be prioritized to ensure that PLWH achieve good mental as well as physical health outcomes.

Preferences for Alternative Care Modalities Among French Adults With Chronic Illness.

Importance: The COVID-19 pandemic led to the implementation of alternative care modalities (eg, teleconsultations and task shifting) that will continue to be implemented in parallel to traditional care after the pandemic. An ideal balance between alternative and traditional care modalities is unknown. Objectives: To quantify the ideal postpandemic balance between alternative and traditional care modalities among patients with chronic illness and to qualify the circumstances in which patients consider it appropriate to replace traditional care with alternative care. Design, Setting, and Participants: This survey study invited 5999 adults with chronic illness in ComPaRe, a French nationwide e-cohort of adults with chronic conditions who volunteer their time to participate in research projects, to participate in this study, which was performed from January 27 to February 23, 2021. Main Outcomes and Measures: Participants rated the ideal proportion at which they would use 3 alternative care modalities instead of the traditional care equivalent on a 0% to 100% scale (with 0% indicating using alternative care modalities for none of one's future care and 100% indicating using alternative care modalities for all of one's future care) of their overall future care: (1) teleconsultations, (2) online symptom-checkers to react to new symptoms, and (3) remote monitoring to adapt treatment outside consultations. The median ideal proportion of alternative care use was calculated. Perceived appropriate circumstances in which each alternative modality could replace traditional care were collected with open-ended questions. Analyses were performed on a weighted data set representative of patients with chronic illness in France. Results: Of the 5999 invited individuals, 1529 (mean [SD] age, 50.3 [14.7] years; 1072 [70.1%] female) agreed to participate (participation rate, 25.5%). Participants would choose teleconsultations for 50.0% of their future consultations (IQR, 11.0%-52.0%), online symptom-checkers over contacting their physician for 22.0% of new symptoms (IQR, 2.0%-50.0%), and remote monitoring instead of consultations for 52.3% of their treatment adaptations (IQR, 25.4%-85.4%). Participants reported 67 circumstances for which replacing traditional with alternative care modalities was considered appropriate, including 31 care activities (eg, prescription renewal and addressing acute or minor complaints), 25 patient characteristics (eg, stable chronic condition and established patient-physician relationship), and 11 required characteristics of the alternative care modalities (eg, quality assurance). Conclusions and Relevance: Results of this survey study suggest that after the pandemic, patients would choose alternative over traditional care for 22% to 52% of the time across different care needs. Participants proposed 67 criteria to guide clinicians in replacing traditional care with alternative care. These findings provide a guide for redesigning care in collaboration with patients after the pandemic.

Withholding Primary Pneumocystis Pneumonia Prophylaxis in Virologically Suppressed Patients With Human Immunodeficiency Virus: An Emulation of a Pragmatic Trial in COHERE.

BACKGROUND: Using data from the COHERE collaboration, we investigated whether primary prophylaxis for pneumocystis pneumonia (PcP) might be withheld in all patients on antiretroviral therapy (ART) with suppressed plasma human immunodeficiency virus (HIV) RNA (≤400 copies/mL), irrespective of CD4 count. METHODS: We implemented an established causal inference approach whereby observational data are used to emulate a randomized trial. Patients taking PcP prophylaxis were eligible for the emulated trial if their CD4 count was ≤200 cells/µL in line with existing recommendations. We compared the following 2 strategies for stopping prophylaxis: (1) when CD4 count was >200 cells/µL for >3 months or (2) when the patient was virologically suppressed (2 consecutive HIV RNA ≤400 copies/mL). Patients were artificially censored if they did not comply with these stopping rules. We estimated the risk of primary PcP in patients on ART, using the hazard ratio (HR) to compare the stopping strategies by fitting a pooled logistic model, including inverse probability weights to adjust for the selection bias introduced by the artificial censoring. RESULTS: A total of 4813 patients (10 324 person-years) complied with eligibility conditions for the emulated trial. With primary PcP diagnosis as an endpoint, the adjusted HR (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared with the existing guidelines (aHR, .8; 95% confidence interval, .6-1.1; P = .2). CONCLUSIONS: This study suggests that primary PcP prophylaxis might be safely withheld in confirmed virologically suppressed patients on ART, regardless of their CD4 count.

Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study.

BACKGROUND: Antiretroviral therapy has prolonged the lives of those with human immunodeficiency virus (HIV), but the effects of chronic infection on their health-related quality of life (HRQoL) remain a concern. Numerous instruments have been developed to measure HRQoL, yet evidence of their cross-cultural equivalence and continued applicability is limited. We adapted the WHOQOL-HIV BREF to French and assessed its psychometric properties in a sample of community-dwelling adults living with HIV who were mostly virally suppressed. METHODS: We conducted a cross-sectional study within the ANRS CO3 Aquitaine cohort from July 2018 to May 2019. Five hundred eighty-six participants were consecutively enrolled at their HIV-consultations and completed either a web-based (n = 406) or paper self-administered assessment (n = 180). The means and standard deviations for items and domains were computed and the presence of floor and ceiling effects assessed. We evaluated internal consistency by calculating Cronbach's alpha coefficients per domain. We assessed construct validity by performing a Confirmatory Factor Analysis (CFA). Concurrent, convergent and discriminant validity were assessed with Pearson's correlations and known-group validity was assessed according to CD4 cell count, viral load, Centers for Disease Control and Prevention clinical categories for HIV, and hospitalization of more than 48 h within 2 years of the most recent consultation using one-way analysis of variance and independent t-tests. RESULTS: Five hundred eighty-six PLWH were included in this analysis. Their median age was 55; 73% were male; 85% were of French descent; 99% were on ART and 93% were virally suppressed. We found floor effects for one and ceiling effects for 11 items. Four of the six domains showed good internal consistency (α range: 0.63-0.79). CFA showed that the WHOQOL-HIV BREF's six-domain structure produced an acceptable fit (SRMR = 0.059; CFI = 0.834; RMSEA = 0.07; 90% CI: 0.06-0.08). It showed good concurrent, convergent and discriminant validity. There was some evidence of known-group validity. The personal beliefs domain had the highest score (15.04 ± 3.35) and the psychological health domain had the lowest (13.70 ± 2.78). CONCLUSIONS: The French WHOQOL-HIV BREF has acceptable measurement properties. Its broad conceptualisation of HRQoL, going beyond physical and mental health, may be of particular value in our older, treatment-experienced and virally suppressed population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps ).

Cervical cancer risk in women living with HIV across four continents: A multicohort study.

We compared invasive cervical cancer (ICC) incidence rates in Europe, South Africa, Latin and North America among women living with HIV who initiated antiretroviral therapy (ART) between 1996 and 2014. We analyzed cohort data from the International Epidemiology Databases to Evaluate AIDS (IeDEA) and the Collaboration of Observational HIV Epidemiological Research in Europe (COHERE) in EuroCoord. We used flexible parametric survival models to determine regional ICC rates and risk factors for incident ICC. We included 64,231 women from 45 countries. During 320,141 person-years (pys), 356 incident ICC cases were diagnosed (Europe 164, South Africa 156, North America 19 and Latin America 17). Raw ICC incidence rates per 100,000 pys were 447 in South Africa (95% confidence interval [CI]: 382-523), 136 in Latin America (95% CI: 85-219), 76 in North America (95% CI: 48-119) and 66 in Europe (95% CI: 57-77). Compared to European women ICC rates at 5 years after ART initiation were more than double in Latin America (adjusted hazard ratio [aHR]: 2.43, 95% CI: 1.27-4.68) and 11 times higher in South Africa (aHR: 10.66, 95% CI: 6.73-16.88), but similar in North America (aHR: 0.79, 95% CI: 0.37-1.71). Overall, ICC rates increased with age (>50 years vs. 16-30 years, aHR: 1.57, 95% CI: 1.03-2.40) and lower CD4 cell counts at ART initiation (per 100 cell/µl decrease, aHR: 1.25, 95% CI: 1.15-1.36). Improving access to early ART initiation and effective cervical cancer screening in women living with HIV should be key parts of global efforts to reduce cancer-related health inequities.

Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation.

BACKGROUND: Patient-reported outcomes (PROs) can be of great value for both research and chronic disease management. We developed a new module of the ANRS CO3 Aquitaine cohort study's Web-based data capture and visualization solution (APPEGE 2.0) for the collection of electronic PROs among people living with HIV cared for in Nouvelle Aquitaine, France. OBJECTIVE: This study aimed to evaluate the usability of 2 successively developed prototypes of ARPEGE 2.0's electronic PROs module before launching a pilot study, owing to the novelty of the proposed data collection method for our setting and specific characteristics of the target population. METHODS: A total of 2 sequential rounds of empirical, task-based usability evaluations were conducted, involving 8 research staff and then 7 people living with HIV. Evaluators provided written feedback during round 1 and oral feedback during round 2. Evaluators who completed the full set of tasks responded to the System Usability Scale (SUS). We assessed changes in SUS scores between rounds and concluded usability testing when SUS scores reached a ceiling effect, defining good usability a priori as a usability score of 70. RESULTS: Insights were generated regarding the visibility of system status and the match between the system and the real world that improved the module's usability. Research staff evaluators reported mean SUS scores of 65 (SD 18.87) and patient evaluators reported mean SUS scores of 85 (SD 5.4; P=.032). CONCLUSIONS: Software modifications, informed by successive rounds of usability testing, resulted in sufficient gains in usability to undertake piloting. Insights generated during evaluations prompted us to find the appropriate balance between optimal security and ease of use. TRIAL REGISTRATION: ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10.2196/resprot.9439.

Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study.

BACKGROUND: Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. OBJECTIVE: We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). METHODS: Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history. RESULTS: The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient's perspective (phase 2). CONCLUSIONS: As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9439.

Commonly Prescribed Antiretroviral Therapy Regimens and Incidence of AIDS-Defining Neurological Conditions.

BACKGROUND: The differential effects of commonly prescribed combined antiretroviral therapy (cART) regimens on AIDS-defining neurological conditions (neuroAIDS) remain unknown. SETTING: Prospective cohort studies of HIV-positive individuals from Europe and the Americas included in the HIV-CAUSAL Collaboration. METHODS: Individuals who initiated a first-line cART regimen in 2004 or later containing a nucleoside reverse transcriptase inhibitor backbone and either atazanavir, lopinavir, darunavir, or efavirenz were followed from cART initiation until death, lost to follow-up, pregnancy, the cohort-specific administrative end of follow-up, or the event of interest, whichever occurred earliest. We evaluated 4 neuroAIDS conditions: HIV dementia and the opportunistic infections toxoplasmosis, cryptococcal meningitis, and progressive multifocal leukoencephalopathy. For each outcome, we estimated hazard ratios for atazanavir, lopinavir, and darunavir compared with efavirenz via a pooled logistic model. Our models were adjusted for baseline demographic and clinical characteristics. RESULTS: Twenty six thousand one hundred seventy-two individuals initiated efavirenz, 5858 initiated atazanavir, 8479 initiated lopinavir, and 4799 initiated darunavir. Compared with efavirenz, the adjusted HIV dementia hazard ratios (95% confidence intervals) were 1.72 (1.00 to 2.96) for atazanavir, 2.21 (1.38 to 3.54) for lopinavir, and 1.41 (0.61 to 3.24) for darunavir. The respective hazard ratios (95% confidence intervals) for the combined end point were 1.18 (0.74 to 1.88) for atazanavir, 1.61 (1.14 to 2.27) for lopinavir, and 1.36 (0.74 to 2.48) for darunavir. The results varied in subsets defined by calendar year, nucleoside reverse transcriptase inhibitor backbone, and age. CONCLUSION: Our results are consistent with an increased risk of neuroAIDS after initiating lopinavir compared with efavirenz, but temporal changes in prescribing trends and confounding by indication could explain our findings.

The acceptability and effectiveness of a questionnaire for the identification of risk factors for HIV and hepatitis B and C: An observational study in general practice.

BACKGROUND: Many people in Europe remain undiagnosed for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV). OBJECTIVES: To evaluate acceptability and effectiveness of a questionnaire designed to facilitate identification of risk factors for these viruses. METHODS: We performed an observational study, in a prospectively enrolled cohort of patients in Paris (France) seen in 2014. Eighteen GPs administered a questionnaire to the first 50 patients, collecting information about risk factors. GPs were randomized into two groups: A (self-administered questionnaire) and B (GP-administered questionnaire). We used the overall response rate to assess the acceptability of the questionnaire. We used the rate of newly identified risk factors and compared the number of tests performed one year before and immediately after the intervention to assess the effectiveness of the questionnaire. RESULTS: 842 patients were randomized: 349 (41.5%) in group A and 493 (58.5%) in group B. Acceptability was 88.5% (95%CI: 86.3-90.6); 93.1% (95%CI: 90.5-95.8) in-group A and 85.2% (95%CI: 82.1-88.3) in group B (P = 0.0004). Prevalence of risk factors was 51.8% (95%CI: 48.2-54.4) and 58.3% were newly identified (95%CI: 52.9-63.7). The number of HIV tests performed during the four weeks after intervention increased by 27% compared to the same period one year before (P = 0.22). It increased by 113% (P = 0.005) and 135% (P = 0.005) for HBV and HCV, respectively. CONCLUSION: The questionnaire proved acceptable and effective in identifying risk factors for HIV, HBV and HCV in general practice.

Bolivia programme evaluation of a package to reach an underserved population: Community-based maternal and newborn care economic analysis.

To address inequitable access to health services of indigenous communities in the Bolivian highlands, the Bolivian Ministry of Health, with the support of Save the Children-Saving Newborn Lives, conducted operational research to identify, implement and test a package of maternal and newborn interventions using locally recruited, volunteer Community Health Workers (vCHW) between 2008 and 2010. The additional annual economic and financial costs of the intervention were estimated from the perspective of the Bolivian Ministry of Health in two municipalities. The cost of intervention-stimulated increases in facility attendance was estimated with national surveillance data using a pre-post comparison, adjusted for secular trends in facility attendance. Three scale-up scenarios were modelled by varying the levels of coverage and the number (per mother and child pair) and frequency of home visits. Average cost per mother and average cost per home visit are presented in constant 2015 US$. Eighteen per cent of expectant mothers in the catchment area were visited at least once. The annualized additional financial cost of the community-based intervention across both municipalities was $43 449 of which 3% ($1324) was intervention design, 20% ($8474) set-up and 77% ($33 651) implementation. Drivers of additional costs were additional paid staff (68%), 81% of which was for management and support by local implementing partner and 19% of which was for vCHW supervision. The annual financial cost per vCHW was $595. Modelled scale-up scenarios highlight potential efficiency gains. Recognizing local imperatives to reduce inequalities by targeting underserved populations, the observed low coverage by vCHWs resulted in a high cost per mother and child pair ($296). This evaluation raises important questions about this model's ability to achieve its ultimate goals of reducing neonatal mortality and inequalities through behaviour change and increased care seeking and has served to inform innovative alternative models, better equipped to tackle stagnant inequitable access to care.

Uganda Newborn Study (UNEST) trial: Community-based maternal and newborn care economic analysis.

The Uganda Newborn Study (UNEST) was a two-arm cluster Randomized Control Trial to study the effect of pregnancy and postnatal home visits by local community health workers called 'Village Health Teams' (VHT) coupled with health systems strengthening. To inform programme planning and decision making, additional economic and financial costs of community and facility components were estimated from the perspective of the provider using the Excel-based Cost of Integrating Newborn Care Tool. Additional costs excluded costs already paid by the government for the routine health system and covered design, set-up, and 1-year implementation phases. Improved efficiency was modelled by reducing the number of VHT per village from two to one and varying the number of home visits/mother, the programme's financial cost at scale was projected (population of 100 000). 92% of expectant mothers (n = 1584) in the intervention area were attended by VHTs who performed an average of three home visits per mother. The annualized additional financial cost of the programme was $83 360 of which 4% ($3266) was for design, 24% ($20 026) for set-up and 72% ($60 068) for implementation. 56% ($47 030) went towards health facility strengthening, whereas 44% ($36 330) was spent at the community level. The average cost/mother for the community programme, excluding one-off design costs, amounted to $22.70 and the average cost per home visit was $7.50. The additional cost of the preventive home visit programme staffed by volunteer VHTs represents $1.04 per capita, 1.8% of Uganda's public health expenditure per capita ($59.00). If VHTs were to spend an average of 6 h a week on the programme, costs per mother would drop to $13.00 and cost per home visit to $3.20, in a population of 100 000 at 95% coverage. Additional resources are needed to rollout the government's VHT strategy nationally, maintaining high quality and linkages to quality facility-based care.

Multi-country analysis of the cost of community health workers kits and commodities for community-based maternal and newborn care.

Community-based maternal and newborn care with home visits by community health workers (CHWs) are recommended by WHO to complement facility-based care. As part of multi-country economic and systems analyses, we aimed to compare the content and financial costs associated with equipping CHWs or 'home visit kits' from seven studies in Bolivia, Ethiopia, Ghana, Malawi, South Africa, Tanzania and Uganda. We estimated the equivalent annual costs (EACs) of home visit kits per CHW in constant 2015 USD. We estimated EAC at scale in a population of 100 000 assuming four home visits per mother during the pregnancy and postnatal period. All seven packages were designed for health promotion; six included clinical assessments and one included curative care. The items used by CHWs differed between countries, even for the same task. The EAC per home visit kit ranged from $15 in Tanzania to $116 in South Africa. For health promotion and preventive care, between 82 and 100% of the cost of CHW commodities did not vary with the number of home visits conducted; however, in Ethiopia, the majority of EAC associated with curative care varied with the number of visits conducted. The EAC of equipping CHWs to meet the needs of 95% of expectant mothers in a catchment area of 100 000 people was highest in Bolivia, $40 260 for 633 CHWs, due to mothers being in hard-to-reach areas with CHW conducting few visits per year per, and lowest in Tanzania ($2693 for 172 CHWs), due to the greater number of CHW visits per week and lower EAC of items. To inform and ensure sustainable implementation at scale, national discussions regarding the cadre of CHWs and their workload should also consider carefully the composition and cost of equipping CHWs to carry out their work effectively and efficiently.

Overview, methods and results of multi-country community-based maternal and newborn care economic analysis.

Home visits for pregnancy and postnatal care were endorsed by the WHO and partners as a complementary strategy to facility-based care to reduce newborn and maternal mortality. This article aims to synthesise findings and implications from the economic analyses of community-based maternal and newborn care (CBMNC) evaluations in seven countries. The evaluations included five cluster randomized trials (Ethiopia, Ghana, South Africa, Tanzania, Uganda) and programmatic before/after assessments (Bolivia, Malawi). The economic analyses were undertaken using a standardized, comparable methodology the 'Cost of Integrated Newborn Care' Tool, developed by the South African Medical Research Council, with Saving Newborn Lives and a network of African economists. The main driver of costs is the number of community health workers (CHWs), determined by their time availability, as fixed costs per CHW (equipment, training, salary/stipend, supervision and management), independent from the level of activity (number of mothers visited) represented over 96% of economic and financial costs in five of the countries. Unpaid volunteers are not necessarily a cheap option. An integrated programme with multi-purpose paid workers usually has lower costs per visit but requires innovative management, including supervision to ensure that coverage, or quality of care are not compromised since these workers have many other responsibilities apart from maternal and newborn health. If CHWs reach 95% of pregnant women in a standardized 100 000 population, the additional financial cost in all cases would be under USD1 per capita. In five of the six countries, the programme would be highly cost-effective (cost per DALY averted < GDP/capita) by WHO threshold even if they only achieved a reduction of 1 neonatal death per 1000 live births. These results contribute useful information for implementation planning and sustainability of CBMNC programmes.

Improving Newborn Survival in Southern Tanzania (INSIST) trial; community-based maternal and newborn care economic analysis.

Despite health systems improvements in Tanzania, gaps in the continuum of care for maternal, newborn and child health persist. Recent improvements have largely benefited those over one month of age, leading to a greater proportion of under-five mortality in newborns. Community health workers providing home-based counselling have been championed as uniquely qualified to reach the poorest. We provide financial and economic costs of a volunteer home-based counselling programme in southern Tanzania. Financial costs of the programme were extracted from project accounts. Ministry of Health and Social Welfare costs associated with programme implementation were collected based on staff and project monthly activity plans. Household costs associated with facility-based delivery were also estimated based on exit interviews with post-natal women. Time spent on the programme by implementers was assessed by interviews conducted with volunteers and health staff. The programme involved substantial design and set-up costs. The main drivers of set-up costs were activities related to volunteer training. Total annualized costs (design, set-up and implementation) amounted to nearly US$300 000 for financial costs and just over US$400 000 for economic costs. Volunteers (n = 842) spent just under 14 hours per month on programme-related activities. When volunteer time was valued under economic costs, this input amounted to just under half of the costs of implementation. The economic consequences of increased service use to households were estimated at US$36 985. The intervention cost per mother-newborn pair visited was between US$12.60 and US$19.50, and the incremental cost per additional facility-based delivery ranged from US$85.50 to US$137.20 for financial and economic costs (with household costs). Three scale-up scenarios were considered, with the financial cost per home visit respectively varying from $1.44 to $3.21 across scenarios. Cost-effectiveness compares well with supply-side initiatives to increase coverage of facility-based deliveries, and the intervention would benefit from substantial economies of scale.