COVID-19 and HIV in Health Workers in Mozambique

NCT05022407 | Completed

• 1 other identifier: CGH-MOZ-9/24/20-ef1f9
• Study Type: observational
• Target: 3,231
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Covid19

Keywords

HIV; COVID-19; SARS-COV-2

Outcome Measures

Primary Outcomes (1)

• Disease Severity

  Any disease severity considered as any with severe or critical disease, as per WHO definition.

  month 6

Study Arms (4)

Cohort 1 (SARS-CoV-2 uninfected)

Participants who test negative on the SARS-CoV-2 rapid test and are not considered at risk of COVID-19 or who have a negative RNA-PCR SARS-CoV-2 test result at baseline.

Cohort 2 (SARS-CoV-2 infected)

Participants who test positive on RNA-PCR SARS-CoV-2.

Cohort 3 (SARS-CoV-2 exposed)

Participants who have a positive SARS-CoV-2 rapid test result and are not considered to be at risk of active COVID-19 infection or have a negative RNA-PCR SARS-CoV-2 test.

Cohort 4 ( Vaccinated)

Participants who declare having received at least one dose of COVID-19 vaccine (verbally or by showing vaccination card) at inclusion (for HCW or PLHIV) or at any follow-up visit (PLHIV) will be followed in this cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. PLHIV enrolled in HIV care on selected Health facilities. 2. HCWs offering HIV services in selected Health facilities.

You may qualify if:

• PLHIV enrolled in HIV care
• Have HIV infection and currently in follow-up care at selected HFs;
• Aged 18 years or older;
• Able and willing to give informed consent;
• Willing to test for exposure to SARS-CoV-2 or COVID-19 infection;
• Willing to be followed and to comply with study visits during the maximum of 15-month study period;
• Does not intend to move from their residence (requiring change of health facility for HIV care) during the study period;
• Willing and able to provide contact information.
• HCWs offering HIV services
• HCWs (medical doctor, medical officer \["técnico de medicina"\], general nurse \["agente de medicina"\], maternal and child health \[MCH\] nurse, pharmacist, laboratory worker, counselor, ancillary worker \[e.g., archivist, receptionist\], and health volunteers based at the health facility) who are employed full-time and offering HIV services at selected HFs;
• ≥18 years of age ;
• Able and willing to give informed consent;
• Be vaccinated with at least one dose against COVID-19 (verbally or vaccination card));
• Willing to test for exposure to SARS-CoV-2/ COVID-19 infection;
• Willing to be followed and available during the maximum of 15-month study period;

You may not qualify if:

• PLHIV enrolled in HIV care
• Any clinical or mental condition that, in the investigator's opinion, would preclude provision of informed consent or make study participation unsafe or unethical;
• Any Differentiated Service Delivery where patients have an ART pick-up scheduled less frequently than four times a year (e.g., Community Adherence Support Group \[CASG\] member);
• Patients whose antiretroviral (ARV) drugs are picked up by a confidant during their scheduled appointment.
• HCWs offering HIV services
• Any clinical or mental conditions that, in the opinion of the investigator or designee, would preclude provision of informed consent or make study participation unsafe or unethical;
• Individuals working in the HF but from the following cadres: drivers, security personnel, and community health workers/volunteers.

Sponsors & Collaborators

• Instituto Nacional de Saúde, Mozambique: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

INSMozambique

Maputo, Mozambique

Location

Related Publications (1)

• De Schacht C, Nhacule E, Belo C, Young PW, Bhatt N, Junior F, Pimentel De Gusmao E, Muquingue H, Muteerwa A, Bila D, Ouenzar MA, Madede T, Cumbane R, Amorim G, Viegas E; COVIV Study Collaborative Group. Measuring the burden of SARS-CoV-2 infection among persons living with HIV and healthcare workers and its impact on service delivery in Mozambique: protocol of a prospective cohort study. BMJ Open. 2023 Jun 6;13(6):e068988. doi: 10.1136/bmjopen-2022-068988.

  PMID: 37280029 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

If participants have a positive rapid test or are considered eligible for RNA-PCR SARS-CoV-2 testing, 10mL (mililliters) of venous blood (6mL EDTA and 4mL serum tubes) will be collected as stored samples for future research related to COVID-19. All participants will have DBS sample collected.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; COVID-19

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Edna Viegas, MD, PhD

  INS-CISPOC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 26, 2021
• Study Start: July 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

MO (1)