ART and Inflammatory and Coagulation Biomarkers (ARTIC)
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.
HIV (Human Immunodeficiency Virus)
AIDS (Acquired Immune Deficiency Syndrome)
Non-communicable Diseases (NCD)
|Study Design:||Time Perspective: Prospective|
|Official Title:||Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: Establishment of a Prospective Cohort|
- Change in inflammatory and coagulation markers [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]Blood and urine samples of participants will be analyzed for inflammatory and coagulation biomarkers, including high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6), at four different times during this study to assess the change in marker levels.
- Prevalence of risk factors for noncommunicable diseases (NCDs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]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, e.g. smoking, high BMI, cotinine in blood, family history.
- Prevalence of co-morbid conditions [ Time Frame: 12 months ] [ Designated as safety issue: No ]Using biomarkers, self-report, and other physiological tests (i.e. BP screenings), researchers will assess the prevalence of co-morbid conditions including hypertension, diabetes, cardiovascular disease, overweight /obesity, and tuberculosis.
Biospecimen Retention: Samples With DNA
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.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02027480
|Contact: Wafaa M El-Sadr, MD/MPHemail@example.com|
|Contact: Allison Zerbe, MPHfirstname.lastname@example.org|
|Ahero Sub District Hospital||Recruiting|
|Ahero, Nyanza, Kenya|
|Ambira Sub District Hospital||Recruiting|
|Ambira, Nyanza, Kenya|
|Awasi, Nyanza, Kenya|
|Bondo District Hospital||Recruiting|
|Bondo, Nyanza, Kenya|
|Nyakach District Hospital||Active, not recruiting|
|Kisumu, Nyanza, Kenya|
|Masogo Sub District Hospital||Recruiting|
|Masogo, Nyanza, Kenya|
|Nyangoma, Nyanza, Kenya|
|Sigomere Health Centre||Recruiting|
|Sigomere, Nyanza, Kenya|
|Sondu Health Center||Active, not recruiting|
|Sondu, Nyanza, Kenya|
|Principal Investigator:||Wafaa M El-Sadr, MD/MPH||ICAP-NY, Columbia University|