COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.
COHIVE is an observational cohort study nested within four parent open label randomised
clinical trials of first- and second-line antiretroviral therapies (ADVANCE - NCT03122262;
D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE
objective is to study the occurrence and outcomes of COVID-19 in people living with HIV
across a variety of clinical settings. Taken together, these pivotal trials provide an
established population and encompass a range of HIV therapies, HIV populations, and
geographic regions to capture the full spectrum of these global public health emergency as it
pertains to people living with HIV.
The sample will include participants who are possible symptomatic or confirmed COVID-19
cases, and participants who agree to enrol in the SARS-CoV-2 seroprevalence cohort
(regardless of SARS-CoV-2 infection). Approximately 2,500 participants are enrolled in these
4 studies.
Enrolment into COHIVE substudy is voluntary and optional for participants in ADVANCE, D²EFT,
DolPHIN2 and NAMSAL studies. Parameters relevant to COHIVE substudy including demographics,
arm of randomised ART, medical and HIV history, immunological and virological results,
adverse events at required time points will be collected as part of parent studies. Substudy
specific assessments performed at baseline include optional sample collection for SARS-CoV-2
RT-PCR and serology; for the possible symptomatic or confirmed COVID-19 cases, the management
of the patients, diagnostic test results, and outcomes, will be collected.
Inclusion Criteria:
- ≥ 18 years old.
- Either: i) Meet local testing criteria for COVID-19, or present with symptoms that in
the opinion of the investigator are consistent with COVID-19 and do not have an
alternative explanation, or have tested elsewhere and found positive for COVID-19; OR
ii) Agree for serology testing for SARS-CoV2, regardless of history of COVID-19.
- Have signed the informed consent of one of the parent study.
- Give informed consent to the COHIVE substudy.
Exclusion Criteria:
- Refuse to participate in the COHIVE substudy.
- Any condition which would place the participant at risk if they participated.
Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Ciudad De Buenos Aires, Argentina
Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz
Rio de Janeiro, Brazil
Central Hospital of Yaoundé
Yaoundé, Cameroon
Cité Verte Hospital
Yaoundé, Cameroon
Hôpital Militaire de Région N°1
Yaoundé, Cameroon
CART CRS, VHS Hospital
Chennai, Tamil Nadu, India
Univerity of Malaya Medical Centre
Kuala Lumpur, Malaysia
Institute of Human Virology, Nigeria (IHVN)
Abuja, Nigeria
Desmond Tutu HIV Foundation
Cape Town, South Africa
Perinatal HIV Research Unit (PHRU)
Johannesburg, South Africa
Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd
Johannesburg, South Africa
Ezintsha
Parktown, South Africa
HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, Thailand
Infectious Diseases Institute
Kampala, Uganda
University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe