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NCT Number: NCT02012972

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.

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Key information

Conditions

Antiretroviral Therapy, Highly Active Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Noncommunicable Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thuthukani Health Centre

Johannesburg, Gauteng, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Referral for NCD care

Behavioral

Subjects in the NCD Risks group not already receiving care for the condition will be referred to a primary health clinic for care.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • City of Johannesburg
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Witwatersrand, South Africa

Registry information

Acronym: RapIT-NCD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 17, 2013
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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