COVID-19 and HIV in Health Workers in Mozambique — COVIV  

Covid19 Clinical Trial

Official title: Impact of COVID-19 Epidemic on Clinical Outcomes and Service Delivery Among People Living With HIV and Health Care Workers in Mozambique

Status Completed

Clinical Trial Summary

While COVID-19 (coronavirus disease 2019) is an important emergent issue for all in the country, there is a significant number of people in the population who are especially vulnerable to the potential impact that the novel coronavirus epidemic may have on their health. The overall purpose of the study is to investigate: (1) the dynamics of COVID-19 infection among people living with HIV and health care workers providing HIV services; (2) the provision of HIV and HIV/TB care and treatment services at health facilities, within the scope of COVID-19 or in the context of COVID-19 and; (3) the perceptions of COVID-19 and access to care among people living with HIV and health care workers providing HIV services.

Clinical Trial Description

The protocol is designed to assess prevalence and incidence of COVID-19 among PLHIV and health care workers. Additionally, we aim to evaluate the effect of the COVID-19 epidemic on clinical and immunological outcomes and health care service delivery among PLHIV and HCWs providing HIV services in Mozambique, as well as monitoring breakthrough infections after vaccination. This will facilitate timely estimates of transmissibility of SARS-CoV-2, and of the severity of COVID-19 infection among PLHIV and HCWs providing HIV services, as well as inform public health responses to these vulnerable populations. In Mozambique, this is particularly important as health systems are operating at capacity, and resources to expand services in the country are limited. It is in this context that a novel respiratory pathogen, SARS-CoV-2, could have a potentially severe impact in Mozambique among its estimated 2.2 million HIV-infected persons and the health care providers caring for them. The study protocol will be implemented at national level in up to 11 provinces of Mozambique. Results will be used primarily for program improvement and strengthening and will support the Ministry of Health in the decision making on strategies for the COVID-19 response.

Goal The overarching goal of this protocol is to determine the incidence, prevalence, and clinical manifestations of SARS-CoV-2 among patients living with HIV and healthcare workers providing HIV services, and to assess the knowledge, attitudes and practices (KAP) and the impact that COVID-19 has on them and on the healthcare system.

Objectives Primary Objectives

1. To determine the incidence and prevalence of SARS-CoV-2 among unvaccinated PLHIV enrolled in care.

2. To describe the knowledge, attitudes, practices and perceived risks (KAP-P) regarding SARS-CoV-2, prevention, transmission, and management among PLHIV and HCWs providing HIV services.

3. To evaluate the effect of COVID-19 pandemic on retention to HIV care.

Secondary Objectives

1. To determine the clinical, immunologic, and virological outcomes of SARS-CoV-2 infection in PLHIV and HCWs providing HIV care.

2. To describe the perceptions of PLHIV and HCWs providing HIV services regarding the influence that the COVID-19 pandemic has on the delivery of essential services (including HIV/TB care).

3. To measure the fidelity of participating health facilities to the implementation of national COVID-19 guidelines.

4. To describe COVID-19 breakthrough infection among vaccinated PLHIV and health care workers (HCW) providing HIV care. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hiv

• NCT number: NCT05022407
• Study type: Observational
• Source: Instituto Nacional de Saúde, Mozambique
• Status: Completed
• Start date: July 15, 2021
• Completion date: September 30, 2023