Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population

Diabetes Mellitus, Type 2 Clinical Trial

— RapIT-NCD  

Official title:

Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012972
• Other study ID #: H-32549
• Secondary ID: U01AI100015M1309
• Status: Completed
• Start date: January 2014
• Est. completion date: April 2017

Study information

• Verified date: January 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For national antiretroviral therapy (ART) programs, the most important health system goals in reducing morbidity and mortality among HIV-infection patients are to initiate treatment as early as eligibility criteria allow and to achieve the highest possible long-term retention of patients on ART. In South Africa, cohort data have consistently found high attrition among ART patients, with the combined cumulative outcomes of death and loss to follow up averaging 25-40% over the first five years after ART initiation. Like many other middle income countries, South Africa also faces very high rates of non-communicable diseases (NCDs) and NCD risks. Despite this, there are virtually no studies looking at interactions between ART and NCDs, and none that have considered the effect of NCDs and NCD risk factors on achieving the second health system goal mentioned above: long term retention on ART.

Description:

The main RapIT study focuses on rapid initiation of ART, with short-term (6-month) attrition from treatment and viral suppression as the primary outcomes. In this supplemental study, we will evaluate the role of NCDs and NCD risk factors on long-term retention on ART, with outcomes including mortality, loss to follow up, viral suppression and immunologic improvement, and physical functioning, ability to perform normal daily activities, and economic productivity among patients already on ART. The study will enroll up to 400 adult patients already on ART for ≥ 12 months at the RapIT study site. At enrollment, consented subjects will be screened for elevated levels of several NCD risk factors including body mass index; glucose using HbA1c levels; blood pressure and cholesterol; as well as signs of abnormalities in hepatic, renal, and lung function. A medical history will be taken, and a questionnaire will gather information about chronic pain, alcohol use, smoking, physical functioning, ability to perform normal daily activities, and economic productivity. Referral for further NCD diagnosis and care will be offered as needed. Existing electronic medical records will be accessed to obtain retrospective data since ART initiation and to follow subjects prospectively for up to 24 months after the enrollment screening is completed. Six months after enrollment, subjects with NCDs or at high risk of NCDs will be re-screened at a routine ART medication pickup visit to assess uptake of referral and whether risks, conditions, or outcomes have changed. The study will help identify reasons for poor outcomes on ART and point to interventions that will help achieve the overall goals of the national ART program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Adult ART patients >35 years old.

• Initiated ART at least 12 months prior to study enrollment.

• Presenting at study clinic for a routine ART monitoring visit.

Exclusion Criteria:

• Pregnant or within first six months post-partum.

• Already enrolled in the RapIT study or another research study.

• Stated intention to transfer care to another location during the next 12 months.

• Not physically or emotionally able to participate in the study, in the opinion of the investigators.

• Not willing or able to provide written informed consent to participate in the study.

• Previously enrolled in the same study.

Related Conditions & MeSH terms

• Antiretroviral Therapy, Highly Active
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Noncommunicable Diseases

Intervention

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.

Locations

Country	Name	City	State
South Africa	Thuthukani Health Centre	Johannesburg	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	City of Johannesburg, National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCDs and NCD risk factors in the study population by time on ART	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.	Baseline
Secondary	HIV treatment outcomes	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).	Baseline
Secondary	Uptake of NCD care	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	6 months
Secondary	Changes in NCD risks or prevalence	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	6 months