An observational study in HIV (Human Immunodeficiency Virus), AIDS (Acquired Immune Deficiency Syndrome) and Tuberculosis, sponsored by Columbia University. Completed at 9 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by Columbia University · Observational
The aim of this study is to develop and follow a cohort of human immunodeficiency virus (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and urine samples will be collected from all participants in order to establish a sample bank of samples in order to further the understanding of the levels of inflammatory biomarkers and coagulation biomarkers in African patients and the effect of taking HIV drugs on these biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs and collect blood and urine specimens from them at 4 study visits. These samples will be frozen and stored for future testing related to inflammatory and coagulation biomarkers.
Biomarkers have been investigated as predictors of HIV disease progression, i.e. development of acquired immunodeficiency syndrome (AIDS) defining diagnoses or death. There are limited data on the levels of these biomarkers among HIV-infected individuals in sub Saharan Africa and on the effect of antiretroviral therapy (ART) initiation on these levels. In addition, further work is needed to examine the association between such markers and various complications associated with HIV as well as mortality in sub Saharan Africa. The overall aim of this study is to develop a cohort of HIV-infected adults who are initiating ART at health facilities in Kenya and to establish a sample bank of plasma and urine samples in order to further the understanding of the levels of inflammatory biomarkers (IBM) and coagulation biomarkers (CBM) in African patients and the effect of ART initiation on these biomarkers. The study objectives are as follows:
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 685 is above the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cohort participants will be consenting HIV-infected men and women initiating ART at four to eight study sites.
Exclusion Criteria:
The study will be a prospective cohort study of HIV-infected adults initiating ART at 4-8 health facilities in Nyanza Province, Kenya. Participants will be asked to take part in four visits over a 12 month period. At each study visit, participants will be asked questions related to demographic characteristics, medical history, including history of/recent medical conditions, family medical history, TB history and smoking status. Participants will also have their height (at baseline visit only) and weight measured for calculation of BMI and blood pressure reading. Blood and urine specimens will be collected and stored at each study visit for future testing.
Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L
Blood and urine samples of participants will be analyzed for inflammatory and coagulation biomarkers at four different times during this study to assess the change in marker levels.
Time frame: Baseline to 12 months
Change in mean interleukin-6 (IL-6) levels measured in ng/mL
Blood and urine samples of participants will be analyzed for inflammatory and coagulation biomarkers at four different times during this study to assess the change in marker levels.
Time frame: Baseline to 12 months
Prevalence (% of participants) of smoking in the study population
Using baseline surveys, human specimens, and other physiological measures (i.e. BP screenings), the prevalence of risk factors for non-communicable diseases will be assessed.
Time frame: 12 months
Prevalence (% of participants) of high BMI in the study population
Using baseline surveys, human specimens, and other physiological measures (i.e. BP screenings), the prevalence of risk factors for non-communicable diseases will be assessed.
Time frame: 12 months
Prevalence (% of participants) of cotinine in blood in the study population.
Using baseline surveys, human specimens, and other physiological measures (i.e. BP screenings), the prevalence of risk factors for non-communicable diseases will be assessed.
Time frame: 12 months
Prevalence (% of participants) of hypertension in the study population.
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
Time frame: 12 months
Prevalence (% of participants) of diabetes in the study population.
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
Time frame: 12 months
Prevalence (% of participants) of overweight/obesity in the study population.
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
Time frame: 12 months
Prevalence (% of participants) of tuberculosis in the study population.
Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions.
Time frame: 12 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Columbia University