HIVNCT04624061

Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY

A study testing Integrated HIV/HTN care model in people with HIV and Hypertension, run by Infectious Diseases Research Collaboration, Uganda at 1 site in Uganda.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV, Hypertension
What is being tested?: Integrated HIV/HTN care model
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,600 participants
Where: 1 siteUganda
Study dates: 16 Nov 2020to 28 Feb 2024
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults 18 years and above with HIV for one category
Adults 18 years and above with HIV and hypertension for the second category
Willing to consent

Who cannot join

Patients who are very sick
Patients not willing to continue seeking care from the study health facility

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Infectious Diseases Research Collaboration
Kampala, Central Region

Other trials in Uganda

About this study

Official title: Leveraging the HIV Platform for Hypertension Control in Uganda

The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.

Read the detailed description

The investigators propose to evaluate a multi-component integrated HIV/HTN care intervention through a cluster randomised controlled trial. A cluster has been defined at the level of the district which is the randomisation unit. A total of 26 districts will be randomised. Selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined HIV and (hypertension) HTN care which includes; 1) Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; 2) the Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics; 3) Health management information system (HMIS) enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the EMR system; and 4) Short messaging system (SMS) and/or WhatsApp for data coordination and communication among providers, DHOs and the study team (who acts as mentors). The 13 control districts will continue implementing the current standard of care as per MoH guidelines.

The investigators will test the hypothesis that a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities.

Specific Objectives are as follows;

To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.
To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.
To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.

Conditions: HIV, Hypertension
Being tested: Integrated HIV/HTN care model
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Integrated HIV/HTN care modelBehavioural
The intervention is a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities

Study groups in NCT04624061
Study group	Role	What they receive
Intervention	Experimental	The integrated HIV/HTN care model with the following components; 1. Training and capacity building on the INTEGRATED HIV/HTN model and NCD care 2. Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics. 3. HMIS enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the (Electronic Medical Record) EMR system. 4. SMS and/or WhatsApp for data coordination and communication among providers, District Health officers (DHOs) and study team (Mentors) to strengthen feedback. Receives: Behavioral: Integrated HIV/HTN care model
Control	No intervention	Standard of care maintained. These are procedures conducted during the routine HIV and Hypertension care visits at the health facilities include;a) Provision of BP machines b)Provision of NCD register and NCD patient card and ; c) Following MOH treatment guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of HIV patients screened for Hypertension(HTN) at Month 24
Proportion of HIV patients Screened for HTN at 24 months months of follow up
Measured: Month 24
Proportion of HTN patients diagnosed and started on treatment
Proportion of HTN patients diagnosed and started on treatment
Measured: Month 24
Proportion of HIV/HTN patients with HTN Control (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.
Proportion of HIV infected patients with with documented history of elevated blood pressure or prior HTN diagnosis on medication who are controlled (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.
Measured: 24 months
Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).
Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).
Measured: 24 months

Secondary outcomes (9)

Lowered blood pressure
Proportion of HTN patients with successfully lowered BP (by at least 10 mmHg systolic and/or diastolic) compared to the time at the first HTN diagnosis
Measured: 24 months
Routine Hypertension care
Proportion of health facilities providing hypertension care as routine practice;
Measured: 12 and 24 months
Adoption of the integrated model
Proportion of HC IIIs and IVs adopting the integrated HIV/HTN care model;
Measured: 12 and 24 months
Knowledge of HTN management and HTN complications among health workers
Knowledge of HTN management and complications among health workers (measured through conducting surveys among health workers working in the HIV clinics using a standardised knowledge test)
Measured: 12 and 24 months
Patient satisfaction
Patient satisfaction outcomes in a sub-sample of facilities (survey)
Measured: 12 and 24 months
Adoption of HMIS tools
Adoption of the integrated HIV/HTN HMIS tools particularly NCD registers and NCD patient card approved by the MoH
Measured: 24 months
Service readiness for delivering hypertension care
Proportion of health facilities (HFs) that demonstrate service readiness for delivering adequate hypertension care for patients with and without HIV-infection
Measured: 24 months
Adherence to national guidelines
Proportion of hypertensive patients (HIV-positive and -negative) registered at HFs that are being managed according to national guidelines.
Measured: 24 months
Cost effectiveness of the integrated HIV/HTN care model
Incremental costs of the intervention (will be measured using micro-costing through interviews with coordinators, site visits and time-and-motion studies with clinic
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 202028 Feb 2024

First posted10 Nov 2020
Study start16 Nov 2020
Primary completion28 Feb 2024 (estimated)
Study completion28 Feb 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIVStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Comparative effectiveness cluster-randomized trial
Masking: None (open label)
Enrolment: 2,600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04624061
Sponsor's protocol ID: 2020-156
Other IDs: 22196
Status last verified: Jul 2022
First submitted: 27 Oct 2020
Last updated: 4 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IDRC will use its proprietary Data Management system to manage and store the data throughout the life of the project. Data is transferred to the system from remote sites via an encrypted link using secure File Transfer Protocol. The system includes a data repository specific to this study which is accessible only to designated study personnel. Study staff will access the repository via a password protected website and the data will be transferred over an encrypted connection via secure Hypertext Transfer Protocol. After the study, clean study datasets will be made shareable in a public certified repository that supports open access. Prior to release, all datasets will be reviewed to ensure they are properly de identified. Any workflows will be exactly described and documented such that it will allow any external groups to precisely reproduce results from the raw data. IDRC will also keep the raw data on the IDRC servers for at least 5 years after the end of the study.

Publications

Byamukama A, Atukunda M, Arinitwe E, Twinamatsiko B, Mutabazi A, Ayebare M, Tindimwembwa W, Asiimwe A, Nangendo J, Okello E, Mutungi G, Kamya MR, Kabami J, Charlebois ED. Partnerships and organizational capacity drive sustainability of integrated hypertension-HIV care in primary health care in Uganda. BMC Health Serv Res. 2026 May 11;26(1):914. doi: 10.1186/s12913-026-14650-8.
PubMed 42116121
Atukunda M, Kabami J, Mutungi G, Twinamatsiko B, Nangendo J, Shade SB, Charlebois E, Grosskurth H, Kamya M, Okello E. Rationale and design of leveraging the HIV platform for hypertension control in Africa: protocol of a cluster-randomised controlled trial in Uganda. BMJ Open. 2022 Dec 8;12(12):e063227. doi: 10.1136/bmjopen-2022-063227.
PubMed 36600388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Leveraging the HIV Platform for Hypertension Control in Uganda
ClinicalTrials.gov ID: NCT04624061
Acronym / sponsor ID: 2020-156
Conditions: HIV, Hypertension
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 2,600 participants (estimated)
Lead sponsor: Infectious Diseases Research Collaboration, UgandaUniversity, hospital or other
Collaborators: Makerere University, Uganda Heart Institute, Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine
Study start: 16 Nov 2020 (actual)
Primary completion: 28 Feb 2024 (estimated)
Study completion: 28 Feb 2024 (estimated)
First posted: 10 Nov 2020 (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.

Detailed description

Specific Objectives are as follows;

To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.
To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.
To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Comparative effectiveness cluster-randomized trial

Arm	Type	Receives
Intervention	Experimental	Behavioral: Integrated HIV/HTN care modelThe integrated HIV/HTN care model with the following components; 1. Training and capacity building on the INTEGRATED HIV/HTN model and NCD care 2. Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics. 3. HMIS enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the (Electronic Medical Record) EMR system. 4. SMS and/or WhatsApp for data coordination and communication among providers, District Health officers (DHOs) and study team (Mentors) to strengthen feedback.
Control	No intervention	–Standard of care maintained. These are procedures conducted during the routine HIV and Hypertension care visits at the health facilities include;a) Provision of BP machines b)Provision of NCD register and NCD patient card and ; c) Following MOH treatment guidelines

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults 18 years and above with HIV for one category
Adults 18 years and above with HIV and hypertension for the second category
Willing to consent

Key exclusion criteria (2 listed)

Patients who are very sick
Patients not willing to continue seeking care from the study health facility

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
Integrated HIV/HTN care modelThe intervention is a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities	Behavioural	Intervention

Primary outcome

Proportion of HIV patients screened for Hypertension(HTN) at Month 24
Time frame: Month 24
Proportion of HIV patients Screened for HTN at 24 months months of follow up
Proportion of HTN patients diagnosed and started on treatment
Time frame: Month 24
Proportion of HTN patients diagnosed and started on treatment
Proportion of HIV/HTN patients with HTN Control (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.
Time frame: 24 months
Proportion of HIV infected patients with with documented history of elevated blood pressure or prior HTN diagnosis on medication who are controlled (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.
Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).
Time frame: 24 months
Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).

9 secondary outcomes

Lowered blood pressure
Time frame: 24 months
Routine Hypertension care
Time frame: 12 and 24 months
Adoption of the integrated model
Time frame: 12 and 24 months
Knowledge of HTN management and HTN complications among health workers
Time frame: 12 and 24 months
Patient satisfaction
Time frame: 12 and 24 months
Adoption of HMIS tools
Time frame: 24 months
Service readiness for delivering hypertension care
Time frame: 24 months
Adherence to national guidelines
Time frame: 24 months
Cost effectiveness of the integrated HIV/HTN care model
Time frame: 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Derived from this study: PubMed 42116121Byamukama A, Atukunda M, Arinitwe E, Twinamatsiko B, Mutabazi A, Ayebare M, Tindimwembwa W, Asiimwe A, Nangendo J, Okello E, Mutungi G, Kamya MR, Kabami J, Charlebois ED. Partnerships and organizational capacity drive sustainability of integrated hypertension-HIV care in primary health care in Uganda. BMC Health Serv Res. 2026 May 11;26(1):914. doi: 10.1186/s12913-026-14650-8.
Derived from this study: PubMed 36600388Atukunda M, Kabami J, Mutungi G, Twinamatsiko B, Nangendo J, Shade SB, Charlebois E, Grosskurth H, Kamya M, Okello E. Rationale and design of leveraging the HIV platform for hypertension control in Africa: protocol of a cluster-randomised controlled trial in Uganda. BMJ Open. 2022 Dec 8;12(12):e063227. doi: 10.1136/bmjopen-2022-063227.
Individual participant dataSharing planned: Yes. IDRC will use its proprietary Data Management system to manage and store the data throughout the life of the project. Data is transferred to the system from remote sites via an encrypted link using secure File Transfer Protocol. The system includes a data repository specific to this study which is accessible only to designated study personnel. Study staff will access the repository via a password protected website and the data will be transferred over an encrypted connection via secure Hypertext Transfer Protocol. After the study, clean study datasets will be made shareable in a public certified repository that supports open access. Prior to release, all datasets will be reviewed to ensure they are properly de identified. Any workflows will be exactly described and documented such that it will allow any external groups to precisely reproduce results from the raw data. IDRC will also keep the raw data on the IDRC servers for at least 5 years after the end of the study.

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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.

Jane Kabami, MPH principal investigator

Infectious Diseases Research Collaboration, Uganda

Moses R Kamya, PhD principal investigator

Infectious Diseases Research Collaboration, Uganda

Heiner Grosskurth, PhD principal investigator

London School of Hygiene and Tropical Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Integrated HIV/HTN care model in people with HIV and Hypertension, run by Infectious Diseases Research Collaboration, Uganda 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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?

Results are not available in the source record.

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?

Proportion of HIV patients screened for Hypertension(HTN) at Month 24 (time frame: Month 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624061, which also lists 2 linked publications.

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 4 Nov 2022.