Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 22196 | Other Identifier | London School of Hygiene and Tropical Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Makerere University | OTHER |
| Uganda Heart Institute | OTHER |
| Ministry of Health, Uganda | OTHER_GOV |
| London School of Hygiene and Tropical Medicine |
Not provided
Not provided
Not provided
Not provided
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.
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;
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The integrated HIV/HTN care model with the following components;
|
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated HIV/HTN care model | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 24 |
| Proportion of HTN patients diagnosed and started on treatment | Proportion of HTN patients diagnosed and started on treatment | 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. | 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). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Routine Hypertension care |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jane Kabami, MPH | Infectious Diseases Research Collaboration, Uganda | Principal Investigator |
| Moses R Kamya, PhD | Infectious Diseases Research Collaboration, Uganda | Principal Investigator |
| Heiner Grosskurth, PhD | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Research Collaboration | Kampala | Central Region | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42116121 | Derived | 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. | |
| 36600388 |
Not provided
Not provided
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.
Not provided
During the study and at least 5 years after the end of the study
All final, clean study datasets will be made shareable in a public certified repository that supports open access.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 14, 2025 | |
| Reset | Sep 2, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2025 | Sep 2, 2025 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| OTHER |
Comparative effectiveness cluster-randomized trial
Not provided
Not provided
Not provided
Not provided
|
Proportion of health facilities providing hypertension care as routine practice;
| 12 and 24 months |
| Adoption of the integrated model | Proportion of HC IIIs and IVs adopting the integrated HIV/HTN care model; | 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) | 12 and 24 months |
| Patient satisfaction | Patient satisfaction outcomes in a sub-sample of facilities (survey) | 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 | 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 | 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. | 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 | 24 months |
| Derived |
| 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. |