Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population (RapIT-NCD)
|ClinicalTrials.gov Identifier: NCT02012972|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2013
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment|
|Antiretroviral Therapy, Highly Active Diabetes Mellitus, Type 2 Cardiovascular Diseases||Behavioral: Referral for NCD care|
|Study Type :||Observational|
|Actual Enrollment :||354 participants|
|Official Title:||Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||December 2018|
Study subjects with NCD risks or disease at enrollment. Each of these subjects will have a Referral for NCD care
Behavioral: Referral for NCD care
Subjects in the NCD Risks group not already receiving care for the condition will be referred to a primary health clinic for care.
No NCD Risks
Study subjects without NCD risks or disease at enrollment.
- NCDs and NCD risk factors in the study population by time on ART [ Time Frame: Baseline ]The outcomes for primary objective 1 will be NCDs and NCD risk factors in the study population by time on ART, including diabetes, cardiovascular disease, respiratory conditions, hypertension, obesity, and behavioral risks such as smoking and alcohol use.
- HIV treatment outcomes [ Time Frame: Baseline ]The outcomes for primary objective 2 will be HIV treatment outcomes, including all-cause mortality, loss to follow up (defined as having missed a scheduled medical or ART pick up visit by >90 days), attrition from ART care (defined as mortality or loss to follow up), viral suppression (defined as <400 copies/ml), physical functioning (as assessed by questionnaire) and economic productivity (also as assessed by questionnaire).
- Uptake of NCD care [ Time Frame: 6 months ]Uptake of non-communicable disease (NCD) care, defined as a patient newly diagnosed with an NCD or serious risk factor and referred for care who enroll for care at the study site or another clinic
- Changes in NCD risks or prevalence [ Time Frame: 6 months ]Changes in tests results or self-reported risks post-referral for those obtaining NCD care, defined by screening test results or questionnaire responses six months after referral to care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012972
|Thuthukani Health Centre|
|Johannesburg, Gauteng, South Africa|
|Principal Investigator:||Sydney Rosen, MPA||Boston University|