Antiretroviral Therapy, Highly ActiveRapIT-NCDNCT02012972
Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
An observational study of Antiretroviral Therapy, Highly Active and Diabetes Mellitus, Type 2, run by Boston University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Antiretroviral Therapy, Highly Active, Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Referral for NCD care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 354 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Referral for NCD care
- Keywords
- Antiretroviral therapy, HIV/AIDS, Non-communicable diseases, South Africa
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Acquired Immunodeficiency Syndrome, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral for NCD careBehavioural
Subjects in the NCD Risks group not already receiving care for the condition will be referred to a primary health clinic for care.
| Study group | Role | What they receive |
|---|---|---|
| NCD Risks | Study subjects with NCD risks or disease at enrollment. Each of these subjects will have a Referral for NCD care Receives: Behavioral: Referral for NCD care | |
| No NCD Risks | Study subjects without NCD risks or disease at enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCDs and NCD risk factors in the study population by time on ART
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.
Measured: Baseline
Secondary outcomes (3)
HIV treatment outcomes
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).
Measured: Baseline
Uptake of NCD care
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
Measured: 6 months
Changes in NCD risks or prevalence
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiretroviral Therapy, Highly ActiveStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, National Institute of Allergy and Infectious Diseases (NIAID), City of Johannesburg
- Responsible party
- Sponsor
- Investigators
- Sydney Rosen, MPA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012972
- Sponsor's protocol ID
- H-32549
- Other IDs
- U01AI100015, M130958
- Acronym
- RapIT-NCD
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2013
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population
- ClinicalTrials.gov ID
- NCT02012972
- Acronym / sponsor ID
- RapIT-NCD / H-32549
- Keywords
- Antiretroviral therapy, HIV/AIDS, Non-communicable diseases, South Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, National Institute of Allergy and Infectious Diseases (NIAID), City of Johannesburg
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCD Risks | – | Behavioral: Referral for NCD careStudy subjects with NCD risks or disease at enrollment. Each of these subjects will have a Referral for NCD care |
| No NCD Risks | – | –Study subjects without NCD risks or disease at enrollment. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral for NCD careSubjects in the NCD Risks group not already receiving care for the condition will be referred to a primary health clinic for care. | Behavioural | NCD Risks |
Primary outcome
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.
3 secondary outcomes
HIV treatment outcomes
Time frame: Baseline
Uptake of NCD care
Time frame: 6 months
Changes in NCD risks or prevalence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Rosen, MPA principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiretroviral Therapy, Highly Active and Diabetes Mellitus, Type 2, run by Boston University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCDs and NCD risk factors in the study population by time on ART (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.