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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Prevalence (% of participants) of high BMI in the study population |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort participants will be consenting HIV-infected men and women initiating ART at four to eight study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Wafaa M El-Sadr, MD/MPH | ICAP-NY, Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahero Sub District Hospital | Ahero | Nyanza | Kenya | |||
| Ambira Sub District Hospital |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D014376 | Tuberculosis |
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Blood and urine samples will be collected from study participants at 4 different points during their 12 months of participation. 15 mL of blood and 10 mL of urine will collected via venipuncture at baseline, 2 months, 6 months, and 12 months. Specimens will be retained for 10 years.
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. |
| 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. | 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. | 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. | 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. | 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. | 12 months |
| Ambira |
| Nyanza |
| Kenya |
| Awasi Mission | Awasi | Nyanza | Kenya |
| Bondo District Hospital | Bondo | Nyanza | Kenya |
| Nyakach District Hospital | Kisumu | Nyanza | Kenya |
| Masogo Sub District Hospital | Masogo | Nyanza | Kenya |
| Nyangoma Dispensary | Nyangoma | Nyanza | Kenya |
| Sigomere Health Centre | Sigomere | Nyanza | Kenya |
| Sondu Health Center | Sondu | Nyanza | Kenya |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |