Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: general and demographic criteria 1. age ≥ 18 years if participant self-reports living with hiv or another comorbidity known to be associated with severe covid-19, for example (cdc.gov for exhaustive list): * hypertension * type 2 diabetes mellitus * overweight, obese, or severely obese (ie, body mass index \[bmi\] ≥ 25 kg/m2) * heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies * chronic kidney disease * copd (chronic obstructive pulmonary disease) * cancer * non-hiv immunocompromised state (weakened immune system) or solid organ transplant * pregnancy * sickle cell disease * smoking 2. willingness to be followed and remain in the catchment area for the planned duration of the study. 3. ability and willingness to provide informed consent. 4. willingness to discuss hiv infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize hiv acquisition/improve hiv care as appropriate based on their infection status. 5. assessment of understanding (aou): participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. 6. agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. enrollment in studies of investigational research agents for the treatment of covid-19 is allowed for participants who develop covid-19 disease.

inclusion criteria: general and demographic criteria 1. age ≥ 18 years if participant self-reports living with hiv or another comorbidity known to be associated with severe covid-19, for example (cdc.gov for exhaustive list): * hypertension * type 2 diabetes mellitus * overweight, obese, or severely obese (ie, body mass index \[bmi\] ≥ 25 kg/m2) * heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies * chronic kidney disease * copd (chronic obstructive pulmonary disease) * cancer * non-hiv immunocompromised state (weakened immune system) or solid organ transplant * pregnancy * sickle cell disease * smoking 2. willingness to be followed and remain in the catchment area for the planned duration of the study. 3. ability and willingness to provide informed consent. 4. willingness to discuss hiv infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize hiv acquisition/improve hiv care as appropriate based on their infection status. 5. assessment of understanding (aou): participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. 6. agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. enrollment in studies of investigational research agents for the treatment of covid-19 is allowed for participants who develop covid-19 disease.

April 6, 2022, 9 p.m. usa

inclusion criteria: general and demographic criteria age ≥ 18 years if participant self-reports living with hiv or another comorbidity known to be associated with severe covid-19, for example (cdc.gov for exhaustive list): hypertension type 2 diabetes mellitus overweight, obese, or severely obese (ie, body mass index [bmi] ≥ 25 kg/m2) heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies chronic kidney disease copd (chronic obstructive pulmonary disease) cancer non-hiv immunocompromised state (weakened immune system) or solid organ transplant pregnancy sickle cell disease smoking willingness to be followed and remain in the catchment area for the planned duration of the study. ability and willingness to provide informed consent. willingness to discuss hiv infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize hiv acquisition/improve hiv care as appropriate based on their infection status. assessment of understanding (aou): participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. enrollment in studies of investigational research agents for the treatment of covid-19 is allowed for participants who develop covid-19 disease.

inclusion criteria: general and demographic criteria age ≥ 18 years if participant self-reports living with hiv or another comorbidity known to be associated with severe covid-19, for example (cdc.gov for exhaustive list): hypertension type 2 diabetes mellitus overweight, obese, or severely obese (ie, body mass index [bmi] ≥ 25 kg/m2) heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies chronic kidney disease copd (chronic obstructive pulmonary disease) cancer non-hiv immunocompromised state (weakened immune system) or solid organ transplant pregnancy sickle cell disease smoking willingness to be followed and remain in the catchment area for the planned duration of the study. ability and willingness to provide informed consent. willingness to discuss hiv infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize hiv acquisition/improve hiv care as appropriate based on their infection status. assessment of understanding (aou): participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. enrollment in studies of investigational research agents for the treatment of covid-19 is allowed for participants who develop covid-19 disease.

Dec. 30, 2021, 4:30 a.m. usa

inclusion criteria: age ≥ 18 years if volunteer self-reports they are living with hiv and/or have at least one comorbidity known to be associated with severe covid-19, for example (cdc.gov for exhaustive list): hypertension type 2 diabetes mellitus obesity (body mass index [bmi] of 30 kg/m2 or higher but < 40 kg/m2) severe obesity (bmi ≥ 40 kg/m2) heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies chronic kidney disease copd (chronic obstructive pulmonary disease) cancer non-hiv immunocompromised state (weakened immune system) or solid organ transplant pregnancy sickle cell disease smoking willingness to be followed and remain in the catchment area for the planned duration of the study. ability and willingness to provide informed consent. willingness to discuss hiv infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize hiv acquisition/improve hiv care, as appropriate based on their infection status. assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. agrees not to enroll in another study of an investigational research agent until the end of the study. enrollment in studies of investigational research agents for the treatment of covid-19 is allowed for participants who develop covid-19 disease.

inclusion criteria: age ≥ 18 years if volunteer self-reports they are living with hiv and/or have at least one comorbidity known to be associated with severe covid-19, for example (cdc.gov for exhaustive list): hypertension type 2 diabetes mellitus obesity (body mass index [bmi] of 30 kg/m2 or higher but < 40 kg/m2) severe obesity (bmi ≥ 40 kg/m2) heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies chronic kidney disease copd (chronic obstructive pulmonary disease) cancer non-hiv immunocompromised state (weakened immune system) or solid organ transplant pregnancy sickle cell disease smoking willingness to be followed and remain in the catchment area for the planned duration of the study. ability and willingness to provide informed consent. willingness to discuss hiv infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize hiv acquisition/improve hiv care, as appropriate based on their infection status. assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. agrees not to enroll in another study of an investigational research agent until the end of the study. enrollment in studies of investigational research agents for the treatment of covid-19 is allowed for participants who develop covid-19 disease.