Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study.

INTRODUCTION: In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services. METHODS: We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period-three for the cost-effectiveness analysis (2019-2021) and three for the budget impact analysis (2022-2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients' opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty. RESULTS: After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9-50.2) to 62.5% (95% CI, 60.9-64.1). The mean cost difference comparing DSDMs and conventional care was US$ -6 million (173,391,277 vs. 179,461,668) and -32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care. CONCLUSIONS: DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were estimated to save approximately US$14 million for the health system from 2022 to 2024.

Managers' and providers' perspectives on barriers and facilitators for the implementation of differentiated service delivery models for HIV treatment in Mozambique: a qualitative study.

INTRODUCTION: In 2018, Mozambique's Ministry of Health launched a guideline for a nationwide implementation of eight differentiated service delivery models to optimize HIV service delivery and achieve universal coverage of HIV care and treatment. The models were (1) Fast-track, (2) Three-month Antiretrovirals Dispensing, (3) Community Antiretroviral Therapy Groups, (4) Adherence Clubs, (5) Family-approach, and three one-stop shop models for (6) Tuberculosis, (7) Maternal and Child Health, and (8) Adolescent-friendly Health Services. This study identified drivers of implementation success and failure across these differentiated service delivery models. METHODS: Twenty in-depth individual interviews were conducted with managers and providers from the Ministry of Health and implementing partners from all levels of the health system between July and September 2021. National-level participants were based in the capital city of Maputo, and participants at provincial, district and health facility levels were from Sofala province, a purposively selected setting. The Consolidated Framework for Implementation Research (CFIR) guided data collection and thematic analysis. Deductively selected constructs were assessed while allowing for additional themes to emerge inductively. RESULTS: The CFIR constructs of Relative Advantage, Complexity, Patient Needs and Resources, and Reflecting and Evaluating were identified as drivers of implementation, whereas Available Resources and Access to Knowledge and Information were identified as barriers. Fast-track and Three-month Antiretrovirals Dispensing models were deemed easier to implement and more effective in reducing workload. Adherence Clubs and Community Antiretroviral Therapy Groups were believed to be less preferred by clients in urban settings. COVID-19 (an inductive theme) improved acceptance and uptake of individual differentiated service delivery models that reduced client visits, but it temporarily interrupted the implementation of group models. CONCLUSIONS: This study described important determinants to be addressed or leveraged for the successful implementation of differentiated service delivery models in Mozambique. The models were considered advantageous overall for the health system and clients when compared with the standard of care. However, successful implementation requires resources and ongoing training for frontline providers. COVID-19 expedited individual models by loosening the inclusion criteria; this experience can be leveraged to optimize the design and implementation of differentiated service delivery models in Mozambique and other countries.

Impact of differentiated service delivery models on 12-month retention in HIV treatment in Mozambique: an interrupted time-series analysis.

BACKGROUND: HIV treatment has been available in Mozambique since 2004, but coverage of, and retention in, antiretroviral therapy (ART) remain suboptimal. Therefore, to increase health system efficiency and reduce HIV-associated mortality, in November, 2018, the Ministry of Health launched national guidelines on implementing eight differentiated service delivery models (DSDMs) for HIV treatment. We assessed the effect of this implementation on retention in ART 12 months after initiation, and explored the associated effects of COVID-19. METHODS: In this uncontrolled interrupted time-series analysis, data were extracted from the Mozambique ART database, which contains data on individuals in ART care from 1455 health facilities providing ART in Mozambique. We included individual-level data from facilities that were providing ART at the beginning of the study period (Jan 1, 2016) and at the start of DSDM implementation (Dec 1, 2018). We compared the proportion of individuals retained in ART 12 months after initiation between the periods before (Jan 1, 2017, to Nov 30, 2018) and after (Dec 1, 2019, to June 30, 2021) implementation of the DSDMs, overall and stratified by sex and age. We applied a generalised estimating equation model with a working independence correlation and cluster-robust standard errors to account for clustering at the facility level. In a secondary analysis, we assessed the effect of COVID-19 response measures during the post-intervention period on ART retention. FINDINGS: The study included 613 facilities and 1 131 118 individuals who started ART during the inclusion period up to June 30, 2020, of whom 79 178 (7·0%) were children (age ≤14 years), 226 224 (20·0%) were adolescents and young adults (age 15-24 years), and 825 716 (73·0%) were adults (age ≥25 years). 731 623 (64·7%) were female and 399 495 (35·3%) were male. Introduction of the DSDMs was associated with an estimated increase of 24·5 percentage points (95% CI 21·1 to 28·0) in 12-month ART retention by the end of the study period, compared with the counterfactual scenario without DSDM implementation. By age, the smallest effect was estimated in children (6·1 percentage points, 1·3 to 10·9) and the largest effect in adolescents and young adults (28·8 percentage points, 24·2 to 33·4); by sex, a larger effect was estimated in males (29·7 percentage points, 25·6 to 33·7). Our analysis showed that COVID-19 had an overall negative effect on 12-month retention in ART compared with a counterfactual scenario based on the post-intervention period without COVID-19 (-10·0 percentage points, -18·2 to -1·8). INTERPRETATION: The implementation of eight DSDMs for HIV treatment had a positive impact on 12-month retention in ART. COVID-19 negatively influenced this outcome. FUNDING: None. TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.

Protecting the gains: analysis of HIV treatment and service delivery programme data and interventions implemented in 19 African countries during COVID-19.

INTRODUCTION: The potential disruption in antiretroviral therapy (ART) services in Africa at the start of the COVID-19 pandemic raised concern for increased morbidity and mortality among people living with HIV (PLHIV). We describe HIV treatment trends before and during the pandemic and interventions implemented to mitigate COVID-19 impact among countries supported by the US Centers for Disease Control and Prevention (CDC) through the President's Emergency Plan for AIDS Relief (PEPFAR). METHODS: We analysed quantitative and qualitative data reported by 10,387 PEPFAR-CDC-supported ART sites in 19 African countries between October 2019 and March 2021. Trends in PLHIV on ART, new ART initiations and treatment interruptions were assessed. Viral load coverage (testing of eligible PLHIV) and viral suppression were calculated at select time points. Qualitative data were analysed to summarize facility- and community-based interventions implemented to mitigate COVID-19. RESULTS: The total number of PLHIV on ART increased quarterly from October 2019 (n = 7,540,592) to March 2021 (n = 8,513,572). The adult population (≥15 years) on ART increased by 14.0% (7,005,959-7,983,793), while the paediatric population (<15 years) on ART declined by 2.6% (333,178-324,441). However, the number of new ART initiations dropped between March 2020 and June 2020 by 23.4% for adults and 26.1% for children, with more rapid recovery in adults than children from September 2020 onwards. Viral load coverage increased slightly from April 2020 to March 2021 (75-78%) and viral load suppression increased from October 2019 to March 2021 (91-94%) among adults and children combined. The most reported interventions included multi-month dispensing (MMD) of ART, community service delivery expansion, and technology and virtual platforms use for client engagement and site-level monitoring. MMD of ≥3 months increased from 52% in October 2019 to 78% of PLHIV ≥ age 15 on ART in March 2021. CONCLUSIONS: With an overall increase in the number of people on ART, HIV programmes proved to be resilient, mitigating the impact of COVID-19. However, the decline in the number of children on ART warrants urgent investigation and interventions to prevent further losses experienced during the COVID-19 pandemic and future public health emergencies.

Protocol for active safety monitoring of a cohort of patients using a dolutegravir-based antiretroviral regimen in Mozambique.

INTRODUCTION: Dolutegravir-based antiretroviral therapy (ART) is increasingly being used as the preferred first-line regimen for the treatment of HIV in low-income and middle-income countries. The National Program for the Control of STI/HIV/AIDS in Mozambique has planned a phased introduction of the tenofovir/lamivudine/dolutegravir (TLD) regimen. In 2019, concerns about a potential safety signal identified with dolutegravir identified in the results of the Tsepamo study, conducted in Botswana, led the National Directorate of Pharmacy and the National Program for the Control of STI/HIV/AIDS to establish an active pharmacovigilance surveillance system among newly placed patients on a TLD regimen. This activity aims to establish an active pharmacovigilance system to monitor adverse events in patients on a TLD regimen to support the effectiveness of Mozambique's public health programmes in improving the process of care and treatment outcomes for people with HIV/AIDS. METHODS AND ANALYSIS: This is a prospective, non-interventional, descriptive cohort study to monitor HIV patients managed with TLD at 10 sentinel health centres in Mozambique. The cohort consists of HIV-infected patients commencing treatment with TLD, either as treatment naïve patients or switched from other ART regimens. Patients have monthly routine follow-up visits for the first 3 months after starting HIV treatment with TLD, and subsequently every 3 months for a total period of 1 year. Patients are monitored to identify possible adverse events during the follow-up period. The intended size of the cohort is 3000 patients. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Commission on Bioethics in Health in Mozambique. Written informed consent is obtained from each participant who agrees to participate to have their information collected, analysed and stored. Findings will be reported to the Ministry of Health and participating health centres to inform policy and practice as well as disseminated by peer-review publications.