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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 20, 2014
Last verified: October 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non‐Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NCD Risks
Study subjects with NCD risks or disease at enrollment.
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012972

Contacts
Contact: Mhairi Maskew, MBBCH +27 82 330 9216 mmaskew@heroza.org

Locations
South Africa
Thuthukani Health Centre Recruiting
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
Boston University
University of the Witwatersrand
City of Johannesburg
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02012972     History of Changes
Other Study ID Numbers: H-32549, U01AI100015, M130958
Study First Received: December 11, 2013
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board
South Africa: Human Research Ethics Committee (Medical)

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

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

ClinicalTrials.gov processed this record on October 21, 2014