HypertensionNCT03605043
Integrated Hypertension and HIV Care Cascades in Uganda
An observational study of Hypertension and HIV, run by Makerere University at 1 site in Uganda.
Trial summary
In this retrospective cohort study, we mapped the care cascades for both Hypertension and HIV within a HIV program in Uganda with the goal of identifying opportunities for developing contextually appropriate integrated care models, . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, HIV
- What is being tested?
- Blood pressure management in the HIV program
- How many people
- 1,649 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jan 2014to 30 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons Living with HIV (PLHIV) 18 years of age and above who were already diagnosed with HIV and enrolled into HIV care at any of the three sites between January 2014 and January 2017.
Who may be able to join
- 18 years of age and above, Having started Antiretroviral therapy between January 2014 and January 2017.
Who cannot join
- PLHIV receiving treatment from clinics other than the 3 selected sites.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Makerere University College of Health Sciences
Kampala, Central Region, +256
About this study
Official title: Integrated Hypertension and HIV Care Cascades in a HIV Treatment Program in Eastern Uganda: a Retrospective Cohort Study
In this retrospective cohort study, we mapped the care cascades for both Hypertension and HIV within a HIV program in Uganda with the goal of identifying opportunities for developing contextually appropriate integrated care models, .
Read the detailed description
Persons living with HIV (PLHIV) and receiving anti-retroviral therapy (ART) are at increased risk of cardiovascular disease (CVD) due to direct effects of ART and HIV infection itself, compounded by traditional CVD risk factors such as increased life expectancy and Westernized diet. Additionally, in sub-Saharan Africa, as is the case globally, hypertension (HTN) is a major risk factor for CVD. The prevalence of HTN in the setting of HIV reported in the literature is variable but may be higher than in the HIV-negative population.
World Health Organization (WHO) and Ugandan national HIV guidelines have recommended the integration of hypertension care into HIV programs since 2014 and 2016, but there has been limited uptake of this recommendation in practice. There have been successful efforts to integrate tuberculosis, malaria, nutrition, maternal-child health, and family planning into HIV programmes in Uganda. In this study, with the goal of identifying opportunities for developing contextually appropriate integrated care models, we mapped the care cascades for both HTN and HIV within a HIV program in Uganda.
- Conditions
- Hypertension, HIV
- Being tested
- Blood pressure management in the HIV program
- Keywords
- Integrated, Care cascade, Uganda
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure management in the HIV programOther
Integrated care for hypertension and HIV in the HIV program
| Study group | Role | What they receive |
|---|---|---|
| Overall cohort | All Persons Living with HIV who enlisted in any one of three high-volume HIV clinics in Tororo District of Eastern Uganda between 2014 and 2017. Receives: Other: Blood pressure management in the HIV program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Blood pressure control among Persons living with both HIV and hypertension. Achieving Blood pressure of <140/90mmHg
Measured: 1 year
Secondary outcomes (1)
HIV control
HIV control among persons living with both HIV and hypertension. Defined as HIV Viral suppression. Viral load of <1000 copies/mL
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605043
- Sponsor's protocol ID
- ss 4583
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Hypertension and HIV Care Cascades in a HIV Treatment Program in Eastern Uganda: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03605043
- Acronym / sponsor ID
- ss 4583
- Conditions
- Hypertension, HIV
- Keywords
- Integrated, Care cascade, Uganda
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,649 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
In this retrospective cohort study, we mapped the care cascades for both Hypertension and HIV within a HIV program in Uganda with the goal of identifying opportunities for developing contextually appropriate integrated care models, .
Detailed description
Persons living with HIV (PLHIV) and receiving anti-retroviral therapy (ART) are at increased risk of cardiovascular disease (CVD) due to direct effects of ART and HIV infection itself, compounded by traditional CVD risk factors such as increased life expectancy and Westernized diet. Additionally, in sub-Saharan Africa, as is the case globally, hypertension (HTN) is a major risk factor for CVD. The prevalence of HTN in the setting of HIV reported in the literature is variable but may be higher than in the HIV-negative population.
World Health Organization (WHO) and Ugandan national HIV guidelines have recommended the integration of hypertension care into HIV programs since 2014 and 2016, but there has been limited uptake of this recommendation in practice. There have been successful efforts to integrate tuberculosis, malaria, nutrition, maternal-child health, and family planning into HIV programmes in Uganda. In this study, with the goal of identifying opportunities for developing contextually appropriate integrated care models, we mapped the care cascades for both HTN and HIV within a HIV program in Uganda.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall cohort | – | Other: Blood pressure management in the HIV programAll Persons Living with HIV who enlisted in any one of three high-volume HIV clinics in Tororo District of Eastern Uganda between 2014 and 2017. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons Living with HIV (PLHIV) 18 years of age and above who were already diagnosed with HIV and enrolled into HIV care at any of the three sites between January 2014 and January 2017.
Key inclusion criteria (1 listed)
- 18 years of age and above, Having started Antiretroviral therapy between January 2014 and January 2017.
Key exclusion criteria (1 listed)
- PLHIV receiving treatment from clinics other than the 3 selected sites.
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 |
|---|---|---|
| Blood pressure management in the HIV programIntegrated care for hypertension and HIV in the HIV program | Other | Overall cohort |
Primary outcome
Blood pressure control
Time frame: 1 year
Blood pressure control among Persons living with both HIV and hypertension. Achieving Blood pressure of <140/90mmHg
1 secondary outcome
HIV control
Time frame: 1 year
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 30 Jul 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and HIV, run by Makerere University at 1 site in Uganda.
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 1 inclusion and 1 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 30 Jul 2018. 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 Uganda. 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?
Blood pressure control (time frame: 1 year). 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 30 Jul 2018.