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Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population (RapIT-NCD)

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ClinicalTrials.gov Identifier: NCT02012972
Recruitment Status : Active, not recruiting
First Posted : December 17, 2013
Last Update Posted : October 9, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Antiretroviral Therapy, Highly Active Diabetes Mellitus, Type 2 Cardiovascular Diseases Behavioral: Referral for NCD care

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 354 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
Actual Study Start Date : January 2014
Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018
Groups and Cohorts

Group/Cohort Intervention/treatment
NCD Risks
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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

Eligibility Criteria

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be non-pregnant adults who initiated antiretroviral therapy (ART) for HIV at least 12 months prior to study enrollment and are at least 35 years old. The age restriction will allow the study to focus on older patients who are at greater risk of NCDs. Pregnant women will be excluded because they face a different set of NCD risks directly related to pregnancy; women less than 6 months post-partum are also excluded to allow for the remaining effects of pregnancy.

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.
Contacts and Locations

Information from the National Library of Medicine

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

South Africa
Thuthukani Health Centre
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
Boston University
University of Witwatersrand, South Africa
National Institute of Allergy and Infectious Diseases (NIAID)
City of Johannesburg
Principal Investigator: Sydney Rosen, MPA Boston University
More Information

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02012972     History of Changes
Other Study ID Numbers: H-32549
U01AI100015 ( U.S. NIH Grant/Contract )
M130958 ( Other Identifier: Wits University HREC (Medical) )
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston University:
Antiretroviral therapy
Non-communicable diseases
South Africa

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases