HivCOVIVNCT05022407
COVID-19 and HIV in Health Workers in Mozambique
An observational study of Hiv and Covid19, run by Instituto Nacional de Saúde, Mozambique at 1 site in Mozambique.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Type of treatment
- Vaccines
- How many people
- 3,231 participants
- Where
- 1 siteMozambique
- Study dates
- 15 Jul 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. PLHIV enrolled in HIV care on selected Health facilities. 2. HCWs offering HIV services in selected Health facilities.
Who may be able to join
- 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;
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- 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;
- Does not intend to transfer to another HF during the study period;
- Willing and able to provide contact information.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 Epidemic on Clinical Outcomes and Service Delivery Among People Living With HIV and Health Care Workers in Mozambique
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.
Read the detailed 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
- To determine the incidence and prevalence of SARS-CoV-2 among unvaccinated PLHIV enrolled in care.
- 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.
- To evaluate the effect of COVID-19 pandemic on retention to HIV care.
Secondary Objectives
- To determine the clinical, immunologic, and virological outcomes of SARS-CoV-2 infection in PLHIV and HCWs providing HIV care.
- 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).
- To measure the fidelity of participating health facilities to the implementation of national COVID-19 guidelines.
- To describe COVID-19 breakthrough infection among vaccinated PLHIV and health care workers (HCW) providing HIV care.
- Keywords
- HIV, COVID-19, SARS-COV-2
- Medical subject headings
- Acquired Immunodeficiency Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Severity
Any disease severity considered as any with severe or critical disease, as per WHO definition.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start15 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Saúde, Mozambique
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Edna Viegas, MD, PhD, Principal investigator, INS-CISPOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022407
- Sponsor's protocol ID
- CGH-MOZ-9/24/20-ef1f9
- Acronym
- COVIV
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37280029
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Epidemic on Clinical Outcomes and Service Delivery Among People Living With HIV and Health Care Workers in Mozambique
- ClinicalTrials.gov ID
- NCT05022407
- Acronym / sponsor ID
- COVIV / CGH-MOZ-9/24/20-ef1f9
- Keywords
- HIV, COVID-19, SARS-COV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,231 participants (actual)
- Lead sponsor
- Instituto Nacional de Saúde, MozambiqueOther government
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- To determine the incidence and prevalence of SARS-CoV-2 among unvaccinated PLHIV enrolled in care.
- 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.
- To evaluate the effect of COVID-19 pandemic on retention to HIV care.
Secondary Objectives
- To determine the clinical, immunologic, and virological outcomes of SARS-CoV-2 infection in PLHIV and HCWs providing HIV care.
- 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).
- To measure the fidelity of participating health facilities to the implementation of national COVID-19 guidelines.
- To describe COVID-19 breakthrough infection among vaccinated PLHIV and health care workers (HCW) providing HIV care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. PLHIV enrolled in HIV care on selected Health facilities. 2. HCWs offering HIV services in selected Health facilities.
Key inclusion criteria (17 listed)
- PLHIV enrolled in HIV care
- HCWs offering HIV services
Key exclusion criteria (7 listed)
- PLHIV enrolled in HIV care
- HCWs offering HIV services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Severity
Time frame: month 6
Any disease severity considered as any with severe or critical disease, as per WHO definition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 37280029De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edna Viegas, MD, PhD principal investigator
INS-CISPOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Covid19, run by Instituto Nacional de Saúde, Mozambique at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Severity (time frame: month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.