AIDS (Acquired Immune Deficiency Syndrome), HIV (Human Immunodeficiency Virus), Non-communicable Diseases (NCD), Tuberculosis
Conditions
Keywords
Antiretroviral Therapy (ART), Biomarkers, Nyanza Province, Kenya
Brief summary
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.
Detailed description
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: * To recruit, establish and follow a cohort of HIV-infected individuals who are eligible for initiation of ART through 12 months * To obtain blood and urine samples on all cohort participants at baseline, months 2, 6, and 12 for future HIV and related research * To describe the demographic and disease characteristics of cohort participants and associations with various biomarkers
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
Columbia University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women at least 18 years of age * Known to be HIV positive * ART-naïve (with exception of prior exposure to single dose nevirapine in women) * Documented ART eligibility based on CD4+ cell count and/or WHO staging * Willing to provide locator information and to adhere to study procedures. * No intention of permanently moving away from area for coming 12 months
Exclusion criteria
* Individuals who do not meet the inclusion criteria outlined above * Women who are currently pregnant * Any condition which in the opinion of the investigators would interfere with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean high-sensitivity C-reactive protein (hsCRP) levels measured in mg/L | Baseline to 12 months | 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. |
| Change in mean interleukin-6 (IL-6) levels measured in ng/mL | Baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence (% of participants) of cotinine in blood in the study population. | 12 months | 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. |
| Prevalence (% of participants) of hypertension in the study population. | 12 months | Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions. |
| Prevalence (% of participants) of smoking in the study population | 12 months | 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. |
| Prevalence (% of participants) of overweight/obesity in the study population. | 12 months | Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions. |
| Prevalence (% of participants) of tuberculosis in the study population. | 12 months | Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions. |
| Prevalence (% of participants) of diabetes in the study population. | 12 months | Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions. |
| Prevalence (% of participants) of high BMI in the study population | 12 months | 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. |
Countries
Kenya
Outcome results
None listed