HypertensionNCT03892265
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
An observational study of Hypertension and Diabetes, run by Weill Medical College of Cornell University at 1 site in Haiti.
Trial summary
Investigators will establish a longitudinal cohort of ~3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes, Obesity
- What is being tested?
- Observational Study
- How many people
- 3,005 participants
- Where
- 1 siteHaiti
- Study dates
- 8 Mar 2019to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include 3,000 adults >=18 years from a population-representative sample. Participants will be selected via multistage random sampling. Investigators will randomly select approximately 2,045 GPS waypoints across census blocks with the number of waypoints per block proportional to the IHSI estimated population size of each block. GPS waypoints will be randomly selected from satellite area maps, using ArcGIS software, and identified with GPS devices.
Who may be able to join
- age > or = 18 years, primary residence in the study area of Port-au-Prince (defined as having slept at the household at least once in the past two weeks and considers the household their primary residence with no plans to move in the next 24 months),
- able to provide consent for study procedures,
- agrees to study procedures, and
- willing to be contacted at a new residence if a move occurs
Who cannot join
- serious medical conditions or cognitive impairment preventing study participation as judged by research physicians,
- unable to speak and understand French or Creole.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators will establish a longitudinal cohort of ~3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Cardiovascular risk factors include hypertension, diabetes, obesity, dyslipidemia, kidney disease, poor diet, cigarette smoking, physical inactivity, and inflammation. Cardiovascular disease include angina and myocardial infarction, heart failure, stroke, and CVD mortality. It is anticipated that hypertension prevalence will be ≥10% in 18-30 year olds, that hypertension incidence will be >10 events/1000 person years. Association of determinants and risk factors with CVD will also be examined. Whole blood, serum, plasma, stool, and urine samples will be biobanked for future studies.
Read the detailed description
Investigators propose a longitudinal observational study which includes establishing a population-based longitudinal cohort to determine the prevalence and incidence of cardiovascular risk factors and diseases in Haiti. Cardiovascular risk factors include hypertension, diabetes, obesity, kidney disease, dyslipidemia, smoking, alcohol use, physical inactivity, poor diet, and inflammation. Cardiovascular diseases include angina and myocardial infarction, heart failure, stroke and cardiac death. The cohort will include ~3,000 adults (>18 years) living in Port-au-Prince who will be followed longitudinally. Participants will be selected via multistage random sampling using census blocks . The GHESKIO Community Advisory Board and GHESKIO community health workers (CHWs) will conduct community sensitization about the study prior to study recruitment. CHWs will introduce the study to selected households and individuals, who will then be referred to the research team at GHESKIO for informed consent and study enrollment procedures. Participants will complete the study enrollment, 12- and 24-month, in addition to subsequent annual study visits at GHESKIO. These study visits include a study questionnaire, measurement of blood pressure and assessment for cardiovascular symptoms and events. Laboratory measures and an electrocardiogram will be done at study enrollment and the 24-month visit, and subsequently every 2 years. Participants will also provide blood, urine and stool samples for biobanking at study enrollment. Blood and urine will be collected at 24, 48 and 72 months, with stool also collected at 72 months. CHWs will perform home visits every 6 months on all participants to update locator information, measure blood pressure, and ask about cardiovascular symptoms and events. CHWs will also call the participant every three months to confirm contact information. Any participant who reports a cardiovascular symptom or event to research staff at any time during the study will be referred to the GHESKIO clinic or to a GHESKIO-affiliate hospital for clinical care. The research team will abstract data from medical records of referred patients on information regarding diagnosis codes, laboratory results, diagnostic imaging and cause of death.
- Conditions
- Hypertension, Diabetes, Obesity, Kidney Diseases, Dyslipidemias, Smoking
- Being tested
- Observational Study
- Medical subject headings
- Hypertension, Diabetes Mellitus, Obesity, Kidney Diseases, Dyslipidemias, Smoking, Alcohol Drinking, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
No intervention is included in this observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adults
The prevalence of CVD risk factors including HTN, diabetes, obesity, cigarette smoking, dyslipidemia, kidney disease, poor diet, physical inactivity, and inflammation will be calculated. Prevalence will be reported for categorical risk factors (e.g., HTN), and mean and standard deviation will be estimated for continuous risk factors (e.g., BP, lipid levels). The research team will also estimate the prevalence of each CVD outcome including MI, HF, and stroke.
Measured: Baseline
Secondary outcomes (1)
Incidence of CVD risk factors and CVD during ~7 years of follow-up and their association with social and environmental determinants
Investigators will calculate the incidence rate of each CVD risk factor per 1000 person years (PY) of follow-up among participants without the respective CVD risk factor at baseline using a Horvitz-Thompson type estimator accounting for unequal sampling weights. Similarly, investigators will calculate the incidence rate of each CVD outcome among participants without the respective CVD at baseline.
Measured: Participants will be followed for ~7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start8 Mar 2019
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 3,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Margaret McNairy, MD, MSc, Principal investigator, Washington University School of MedicineJean W Pape, MD, Principal investigator, Weill Cornell Medical College /Les Centres GHESKIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892265
- Sponsor's protocol ID
- 1803019037
- Other IDs
- R01HL143788
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the individual participant data collected during the trial, after deidentification will be shared.
Publications
Metz M, Pierre JL, Yan LD, Rouzier V, St-Preux S, Exantus S, Preval F, Roberts N, Tymejczyk O, Malebranche R, Deschamps MM, Pape JW, McNairy ML. Hypertension continuum of care: Blood pressure screening, diagnosis, treatment, and control in a population-based cohort in Haiti. J Clin Hypertens (Greenwich). 2022 Mar;24(3):246-254. doi: 10.1111/jch.14399. Epub 2022 Feb 24.
PubMed 35199944Sufra R, Lookens Pierre J, Dade E, Rouzier V, Apollon A, St Preux S, Preval F, Inddy J, Metz M, Tymejczyk O, Nash D, Malebranche R, Deschamps M, Pape JW, Goncalves MD, McNairy ML, Yan LD. Diabetes Epidemiology Among Adults in Port-au-Prince, Haiti: A Cross-Sectional Study. Front Endocrinol (Lausanne). 2022 Feb 24;13:841675. doi: 10.3389/fendo.2022.841675. eCollection 2022.
PubMed 35282460Clermont A, Sufra R, Pierre JL, Mourra MN, Fox EL, Rouzier V, Dade E, St-Preux S, Inddy J, Erline H, Obed FP, Yan LD, Metz M, Lee MH, Fitzgerald DW, Deschamps MM, Pape JW, McNairy ML. Dietary Risk Factors for Cardiovascular Disease among Low-Income Haitian Adults: Findings from a Population-Based Cohort. Nutrients. 2022 Feb 13;14(4):787. doi: 10.3390/nu14040787.
PubMed 35215437Yan LD, Rouzier V, Pierre JL, Lee MH, Muntner P, Parsons PJ, Apollon A, St-Preux S, Malebranche R, Pierre G, Emmanuel E, Nash D, Kingery J, Walsh KF, Smith CE, Metz M, Tymejczyk O, Deschamps M, Pape JW, Fitzgerald DW, McNairy ML. High Lead Exposure Associated With Higher Blood Pressure in Haiti: a Warning Sign for Low-Income Countries. Hypertension. 2022 Jan;79(1):283-290. doi: 10.1161/HYPERTENSIONAHA.121.18250. Epub 2021 Nov 17.
PubMed 34878898Lookens J, Tymejczyk O, Rouzier V, Smith C, Preval F, Joseph I, Baptiste RJ, Victor J, Severe P, Apollon S, Dumont E, Forestal G, St Preux S, Rivera V, Seo G, Charles B, Ariste W, Kingery J, Devieux J, Koenig S, Nash D, Fitzgerald D, Safford M, Deschamps MM, Pape J, McNairy M. The Haiti cardiovascular disease cohort: study protocol for a population-based longitudinal cohort. BMC Public Health. 2020 Nov 1;20(1):1633. doi: 10.1186/s12889-020-09734-x.
PubMed 33131500Yan LD, Lookens Pierre J, Rouzier V, Theard M, Apollon A, St Preux S, Kingery JR, Jamerson KA, Deschamps M, Pape JW, Safford MM, McNairy ML. Comparing six cardiovascular risk prediction models in Haiti: implications for identifying high-risk individuals for primary prevention. BMC Public Health. 2022 Mar 19;22(1):549. doi: 10.1186/s12889-022-12963-x.
PubMed 35305599Smith CE, Metz M, Lookens Pierre J, Rouzier V, Yan LD, Sufra R, Dade E, Preval F, Ariste W, Rivera V, Tymejczyk O, Peck R, Koenig S, Deschamps MM, Pape W, McNairy ML. Comparison of community and clinic-based blood pressure measurements: A cross-sectional study from Haiti. PLOS Glob Public Health. 2022;2(9):e0001064. doi: 10.1371/journal.pgph.0001064. Epub 2022 Sep 30.
PubMed 36285251Yan LD, Devieux JG, Pierre JL, Dade E, Sufra R, St Preux S, Tymejczyk O, Nash D, Metz M, Lee MH, Fitzgerald DW, Deschamps M, Pape JW, McNairy ML, Rouzier V. The relationship between perceived stress and support with blood pressure in urban Haiti: A cross-sectional analysis. PLOS Glob Public Health. 2022;2(5):e0000263. doi: 10.1371/journal.pgph.0000263. Epub 2022 May 2.
PubMed 35785017Dade E, Metz M, Pierre JL, Rouzier V, Sufra R, Fox E, Preval F, St-Preux S, Zephir JR 2nd, Ariste W, Rasul R, Sabwa S, Roberts N, Deschamps MM, Severe P, Fitzgerald D, Pape JW, Yan LD, McNairy ML. High prevalence of obesity among women in urban Haiti: Findings from a population-based cohort. Front Public Health. 2022 Oct 5;10:976909. doi: 10.3389/fpubh.2022.976909. eCollection 2022.
PubMed 36276356Clermont A, Rouzier V, Pierre JL, Sufra R, Dade E, Preval F, St-Preux S, Deschamps MM, Apollon A, Dupnik K, Metz M, Duffus Y, Sabwa S, Yan LD, Lee MH, Palmer LG, Gerber LM, Pecker MS, Mann SJ, Safford MM, Fitzgerald DW, Pape JW, McNairy ML. High Dietary Sodium, Measured Using Spot Urine Samples, is Associated with Higher Blood Pressure among Young Adults in Haiti. Glob Heart. 2023 Feb 14;18(1):5. doi: 10.5334/gh.1187. eCollection 2023.
PubMed 36817226Kingery JR, Roberts NL, Lookens Pierre J, Sufra R, Dade E, Rouzier V, Malebranche R, Theard M, Goyal P, Pirmohamed A, Yan LD, Hee Lee M, Nash D, Metz M, Peck RN, Safford MM, Fitzgerald D, Deschamps MM, Pape JW, McNairy M. Population-Based Epidemiology of Heart Failure in a Low-Income Country: The Haiti Cardiovascular Disease Cohort. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e009093. doi: 10.1161/CIRCOUTCOMES.122.009093. Epub 2022 Dec 6.
PubMed 36472189Rasul R, Rouzier V, Sufra R, Yan LD, Joseph I, Mourra N, Sabwa S, Deschamps MM, Fitzgerald DW, Pape JW, Nash D, McNairy ML. Extreme Food Insecurity and Malnutrition in Haiti: Findings from a Population-Based Cohort in Port-au-Prince, Haiti. Nutrients. 2022 Nov 17;14(22):4854. doi: 10.3390/nu14224854.
PubMed 36432540Yan LD, McNairy ML, Devieux JG, Pierre JL, Dade E, Sufra R, Gerber LM, Roberts N, St Preux S, Malebranche R, Metz M, Tymejczyk O, Nash D, Deschamps M, Safford MM, Pape JW, Rouzier V. Neighborhood cohesion and violence in Port-au-Prince, Haiti, and their relationship to stress, depression, and hypertension: Findings from the Haiti cardiovascular disease cohort study. PLOS Glob Public Health. 2022;2(7):e0000503. doi: 10.1371/journal.pgph.0000503. Epub 2022 Jul 27.
PubMed 36819610Yan LD, Sufra R, St Sauveur R, Jean-Pierre MC, Apollon A, Malebranche R, Theard M, Pierre G, Devieux J, Lau J, Mourra N, Roberts NLS, Rasul R, Nash D, Pirmohamed AM, Devereux RB, Lee MH, Kwan GF, Safford MM, Adrien L, Alfred JP, Deschamps M, Severe P, Fitzgerald DW, Pape JW, Rouzier V, McNairy ML; Haiti Cardiovascular Disease Cohort study team. Spectrum of prevalent cardiovascular diseases in urban Port-au-Prince, Haiti: a population-based cross-sectional study. Lancet Reg Health Am. 2024 Apr 4;33:100729. doi: 10.1016/j.lana.2024.100729. eCollection 2024 May.
PubMed 38590326Roberts NLS, Pierre JL, Rouzier V, Sufra R, St-Preux S, Yan LD, Metz M, Clermont A, Apollon A, Sabwa S, Deschamps MM, Kingery JR, Peck R, Fitzgerald D, Pape JW, Tummalapalli SL, McNairy ML. Prevalence and Severity of Chronic Kidney Disease in Haiti. Clin J Am Soc Nephrol. 2023 Jun 1;18(6):739-747. doi: 10.2215/CJN.0000000000000175. Epub 2023 Apr 18.
PubMed 37081617
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
- ClinicalTrials.gov ID
- NCT03892265
- Acronym / sponsor ID
- 1803019037
- Conditions
- Hypertension, Diabetes, Obesity, Kidney Diseases, Dyslipidemias, Smoking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,005 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 27 Mar 2019 (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.
Investigators will establish a longitudinal cohort of ~3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Cardiovascular risk factors include hypertension, diabetes, obesity, dyslipidemia, kidney disease, poor diet, cigarette smoking, physical inactivity, and inflammation. Cardiovascular disease include angina and myocardial infarction, heart failure, stroke, and CVD mortality. It is anticipated that hypertension prevalence will be ≥10% in 18-30 year olds, that hypertension incidence will be >10 events/1000 person years. Association of determinants and risk factors with CVD will also be examined. Whole blood, serum, plasma, stool, and urine samples will be biobanked for future studies.
Detailed description
Investigators propose a longitudinal observational study which includes establishing a population-based longitudinal cohort to determine the prevalence and incidence of cardiovascular risk factors and diseases in Haiti. Cardiovascular risk factors include hypertension, diabetes, obesity, kidney disease, dyslipidemia, smoking, alcohol use, physical inactivity, poor diet, and inflammation. Cardiovascular diseases include angina and myocardial infarction, heart failure, stroke and cardiac death. The cohort will include ~3,000 adults (>18 years) living in Port-au-Prince who will be followed longitudinally. Participants will be selected via multistage random sampling using census blocks . The GHESKIO Community Advisory Board and GHESKIO community health workers (CHWs) will conduct community sensitization about the study prior to study recruitment. CHWs will introduce the study to selected households and individuals, who will then be referred to the research team at GHESKIO for informed consent and study enrollment procedures. Participants will complete the study enrollment, 12- and 24-month, in addition to subsequent annual study visits at GHESKIO. These study visits include a study questionnaire, measurement of blood pressure and assessment for cardiovascular symptoms and events. Laboratory measures and an electrocardiogram will be done at study enrollment and the 24-month visit, and subsequently every 2 years. Participants will also provide blood, urine and stool samples for biobanking at study enrollment. Blood and urine will be collected at 24, 48 and 72 months, with stool also collected at 72 months. CHWs will perform home visits every 6 months on all participants to update locator information, measure blood pressure, and ask about cardiovascular symptoms and events. CHWs will also call the participant every three months to confirm contact information. Any participant who reports a cardiovascular symptom or event to research staff at any time during the study will be referred to the GHESKIO clinic or to a GHESKIO-affiliate hospital for clinical care. The research team will abstract data from medical records of referred patients on information regarding diagnosis codes, laboratory results, diagnostic imaging and cause of death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 3,000 adults >=18 years from a population-representative sample. Participants will be selected via multistage random sampling. Investigators will randomly select approximately 2,045 GPS waypoints across census blocks with the number of waypoints per block proportional to the IHSI estimated population size of each block. GPS waypoints will be randomly selected from satellite area maps, using ArcGIS software, and identified with GPS devices.
Key inclusion criteria (4 listed)
- age > or = 18 years, primary residence in the study area of Port-au-Prince (defined as having slept at the household at least once in the past two weeks and considers the household their primary residence with no plans to move in the next 24 months),
- able to provide consent for study procedures,
- agrees to study procedures, and
- willing to be contacted at a new residence if a move occurs
Key exclusion criteria (2 listed)
- serious medical conditions or cognitive impairment preventing study participation as judged by research physicians,
- unable to speak and understand French or Creole.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyNo intervention is included in this observational study. | Other | – |
Primary outcome
Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adults
Time frame: Baseline
The prevalence of CVD risk factors including HTN, diabetes, obesity, cigarette smoking, dyslipidemia, kidney disease, poor diet, physical inactivity, and inflammation will be calculated. Prevalence will be reported for categorical risk factors (e.g., HTN), and mean and standard deviation will be estimated for continuous risk factors (e.g., BP, lipid levels). The research team will also estimate the prevalence of each CVD outcome including MI, HF, and stroke.
1 secondary outcome
Incidence of CVD risk factors and CVD during ~7 years of follow-up and their association with social and environmental determinants
Time frame: Participants will be followed for ~7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 35199944Metz M, Pierre JL, Yan LD, Rouzier V, St-Preux S, Exantus S, Preval F, Roberts N, Tymejczyk O, Malebranche R, Deschamps MM, Pape JW, McNairy ML. Hypertension continuum of care: Blood pressure screening, diagnosis, treatment, and control in a population-based cohort in Haiti. J Clin Hypertens (Greenwich). 2022 Mar;24(3):246-254. doi: 10.1111/jch.14399. Epub 2022 Feb 24.
- Background: PubMed 35282460Sufra R, Lookens Pierre J, Dade E, Rouzier V, Apollon A, St Preux S, Preval F, Inddy J, Metz M, Tymejczyk O, Nash D, Malebranche R, Deschamps M, Pape JW, Goncalves MD, McNairy ML, Yan LD. Diabetes Epidemiology Among Adults in Port-au-Prince, Haiti: A Cross-Sectional Study. Front Endocrinol (Lausanne). 2022 Feb 24;13:841675. doi: 10.3389/fendo.2022.841675. eCollection 2022.
- Background: PubMed 35215437Clermont A, Sufra R, Pierre JL, Mourra MN, Fox EL, Rouzier V, Dade E, St-Preux S, Inddy J, Erline H, Obed FP, Yan LD, Metz M, Lee MH, Fitzgerald DW, Deschamps MM, Pape JW, McNairy ML. Dietary Risk Factors for Cardiovascular Disease among Low-Income Haitian Adults: Findings from a Population-Based Cohort. Nutrients. 2022 Feb 13;14(4):787. doi: 10.3390/nu14040787.
- Background: PubMed 34878898Yan LD, Rouzier V, Pierre JL, Lee MH, Muntner P, Parsons PJ, Apollon A, St-Preux S, Malebranche R, Pierre G, Emmanuel E, Nash D, Kingery J, Walsh KF, Smith CE, Metz M, Tymejczyk O, Deschamps M, Pape JW, Fitzgerald DW, McNairy ML. High Lead Exposure Associated With Higher Blood Pressure in Haiti: a Warning Sign for Low-Income Countries. Hypertension. 2022 Jan;79(1):283-290. doi: 10.1161/HYPERTENSIONAHA.121.18250. Epub 2021 Nov 17.
- Background: PubMed 33131500Lookens J, Tymejczyk O, Rouzier V, Smith C, Preval F, Joseph I, Baptiste RJ, Victor J, Severe P, Apollon S, Dumont E, Forestal G, St Preux S, Rivera V, Seo G, Charles B, Ariste W, Kingery J, Devieux J, Koenig S, Nash D, Fitzgerald D, Safford M, Deschamps MM, Pape J, McNairy M. The Haiti cardiovascular disease cohort: study protocol for a population-based longitudinal cohort. BMC Public Health. 2020 Nov 1;20(1):1633. doi: 10.1186/s12889-020-09734-x.
- Background: PubMed 35305599Yan LD, Lookens Pierre J, Rouzier V, Theard M, Apollon A, St Preux S, Kingery JR, Jamerson KA, Deschamps M, Pape JW, Safford MM, McNairy ML. Comparing six cardiovascular risk prediction models in Haiti: implications for identifying high-risk individuals for primary prevention. BMC Public Health. 2022 Mar 19;22(1):549. doi: 10.1186/s12889-022-12963-x.
- Background: PubMed 36285251Smith CE, Metz M, Lookens Pierre J, Rouzier V, Yan LD, Sufra R, Dade E, Preval F, Ariste W, Rivera V, Tymejczyk O, Peck R, Koenig S, Deschamps MM, Pape W, McNairy ML. Comparison of community and clinic-based blood pressure measurements: A cross-sectional study from Haiti. PLOS Glob Public Health. 2022;2(9):e0001064. doi: 10.1371/journal.pgph.0001064. Epub 2022 Sep 30.
- Background: PubMed 35785017Yan LD, Devieux JG, Pierre JL, Dade E, Sufra R, St Preux S, Tymejczyk O, Nash D, Metz M, Lee MH, Fitzgerald DW, Deschamps M, Pape JW, McNairy ML, Rouzier V. The relationship between perceived stress and support with blood pressure in urban Haiti: A cross-sectional analysis. PLOS Glob Public Health. 2022;2(5):e0000263. doi: 10.1371/journal.pgph.0000263. Epub 2022 May 2.
- Background: PubMed 36276356Dade E, Metz M, Pierre JL, Rouzier V, Sufra R, Fox E, Preval F, St-Preux S, Zephir JR 2nd, Ariste W, Rasul R, Sabwa S, Roberts N, Deschamps MM, Severe P, Fitzgerald D, Pape JW, Yan LD, McNairy ML. High prevalence of obesity among women in urban Haiti: Findings from a population-based cohort. Front Public Health. 2022 Oct 5;10:976909. doi: 10.3389/fpubh.2022.976909. eCollection 2022.
- Background: PubMed 36817226Clermont A, Rouzier V, Pierre JL, Sufra R, Dade E, Preval F, St-Preux S, Deschamps MM, Apollon A, Dupnik K, Metz M, Duffus Y, Sabwa S, Yan LD, Lee MH, Palmer LG, Gerber LM, Pecker MS, Mann SJ, Safford MM, Fitzgerald DW, Pape JW, McNairy ML. High Dietary Sodium, Measured Using Spot Urine Samples, is Associated with Higher Blood Pressure among Young Adults in Haiti. Glob Heart. 2023 Feb 14;18(1):5. doi: 10.5334/gh.1187. eCollection 2023.
- Background: PubMed 36472189Kingery JR, Roberts NL, Lookens Pierre J, Sufra R, Dade E, Rouzier V, Malebranche R, Theard M, Goyal P, Pirmohamed A, Yan LD, Hee Lee M, Nash D, Metz M, Peck RN, Safford MM, Fitzgerald D, Deschamps MM, Pape JW, McNairy M. Population-Based Epidemiology of Heart Failure in a Low-Income Country: The Haiti Cardiovascular Disease Cohort. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e009093. doi: 10.1161/CIRCOUTCOMES.122.009093. Epub 2022 Dec 6.
- Background: PubMed 36432540Rasul R, Rouzier V, Sufra R, Yan LD, Joseph I, Mourra N, Sabwa S, Deschamps MM, Fitzgerald DW, Pape JW, Nash D, McNairy ML. Extreme Food Insecurity and Malnutrition in Haiti: Findings from a Population-Based Cohort in Port-au-Prince, Haiti. Nutrients. 2022 Nov 17;14(22):4854. doi: 10.3390/nu14224854.
- Individual participant dataSharing planned: Yes. All the individual participant data collected during the trial, after deidentification will be shared.
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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.
Margaret McNairy, MD, MSc principal investigator
Washington University School of Medicine
Jean W Pape, MD principal investigator
Weill Cornell Medical College /Les Centres GHESKIO
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 Hypertension and Diabetes, run by Weill Medical College of Cornell University at 1 site in Haiti.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. 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 Haiti. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adults (time frame: Baseline). 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 NCT03892265, which also lists 20 linked publications.
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 12 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.