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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Boston University
Sponsor:
Collaborators:
University of the Witwatersrand
City of Johannesburg
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT02012972
First received: December 11, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted

December 11, 2013
December 11, 2013
January 2014
December 2014   (final data collection date for primary outcome measure)
NCDs and NCD risk factors in the study population by time on ART [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • HIV treatment outcomes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population

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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Antiretroviral Therapy, Highly Active
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
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.
  • NCD Risks
    Study subjects with NCD risks or disease at enrollment.
    Intervention: Behavioral: Referral for NCD care
  • No NCD Risks
    Study subjects without NCD risks or disease at enrollment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
May 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact: Mhairi Maskew, MBBCH +27 82 330 9216 mmaskew@heroza.org
South Africa
 
NCT02012972
H-32549, U01AI100015, M130958
No
Boston University
Boston University
  • University of the Witwatersrand
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • City of Johannesburg
Not Provided
Boston University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP