Clinical trial NCT02012972: Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
Official title: Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiretroviral Therapy, Highly Active
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: Antiretroviral therapy
HIV/AIDS
Non-communicable diseases
South Africa
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: City of Johannesburg
First posted: 2013-12-17
Enrollment: 354
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: NCDs and NCD risk factors in the study population by time on ART
timeFrame: Baseline
Secondary outcomes:
measure: HIV treatment outcomes
timeFrame: Baseline
measure: Uptake of NCD care
timeFrame: 6 months
measure: Changes in NCD risks or prevalence
timeFrame: 6 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Thuthukani Health Centre
state: Gauteng
Study officials:
affiliation: Boston University
name: Sydney Rosen, MPA
role: PRINCIPAL_INVESTIGATOR
References: