Blood PressureMAP-ITNCT05031819
Managing Hypertension Among People Living With HIV
A study of Blood Pressure and Human Immunodeficiency Virus I Infection, run by Dr. Dike Ojji at 1 site in Nigeria.
Trial summary
The Managing Hypertension Among People Living with HIV: An InTegrated Model (MAP-IT) a stepped wedge, cluster-randomized controlled trial to evaluate the effect of practice facilitation (PF) on the integration of a Task-Shifting Strategy for hypertension (HTN) control (TASSH) into HIV care for management of HTN in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Human Immunodeficiency Virus I Infection, Acquired Immunodeficiency Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 960 participants
- Where
- 1 siteNigeria
- Study dates
- 26 Oct 2022to 31 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons aged 18 years or older
- Be HIV positive and currently enrolled in HIV treatment services at one of the 30 study PHCs, be receiving HTN treatment services at one of the 30 study PHCs, or can be enrolled at one of the 30 study PHCs to receive HTN services for the entire study duration.
- Have elevated blood pressure between 140-179 mm Hg systolic and/or 90-109 mm Hg diastolic, as determined by the average of the latter two of three separate BP readings during one clinic visit
- Able to provide consent
Who cannot join
- BP ≥180/100 mm Hg
- Known history of kidney disease, heart disease, diabetes mellitus, stroke
- A female who is pregnant or breastfeeding at the time of enrollment
- Inability to provide informed consent
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Hypertension Among People Living With HIV: An Integrated Model (MAP-IT)
The Managing Hypertension Among People Living with HIV: An InTegrated Model (MAP-IT) a stepped wedge, cluster-randomized controlled trial to evaluate the effect of practice facilitation (PF) on the integration of a Task-Shifting Strategy for hypertension (HTN) control (TASSH) into HIV care for management of HTN in people living with HIV (PLWH). The study will recruit 960 PLWH across 30 primary health centers (PHCs) in Akwa Ibom State (32 patients/PHC).
Read the detailed description
People Living with HIV (PLWH) are at increased risk for non-communicable diseases (NCDs) including cardiovascular diseases (CVD) with hypertension (HTN) the most common. Integrating NCD management into HIV chronic care services may be a cost-effective strategy to mitigate the rising burden of NCDs in PLWH. The goal of the study is to evaluate the effectiveness of practice facilitation in the integration of a task-shifting strategy for hypertension control into HIV care service delivered in primary health centers in Akwa Ibom State, Nigeria.
This study will occur in two phases: 1) The first phase is a UG3 Planning Phase during which investigators will use the iPARiHS implementation science framework to explore factors and support systems required for successful implementation and integration of TASSH into existing HIV chronic care platform and development of a context-specific practice facilitation strategy. 2) The second phase, which is the focus of this record, is a UH3 Implementation Phase during which we will use a stepped-wedge, cluster RCT, guided by the RE-AIM implementation science framework, to evaluate the effect of practice facilitation strategy on the level of adoption of TASSH, hypertension control, and level of sustainment of TASSH in management of hypertension among 960 patients enrolled in HIV treatment services across 30 PHCs.
- Conditions
- Blood Pressure, Human Immunodeficiency Virus I Infection, Acquired Immunodeficiency Syndrome, Hypertension
- Being tested
- Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.
- Keywords
- Noncommunicable Diseases, Cardiovascular Diseases, Health Services Accessibility, HIV, Nigeria
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hypertension, Noncommunicable Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.Other
- TASSH includes CVD risk assessment; medication initiation and titration; lifestyle counseling and patient referral to physician care for complex cases.
- Practice Facilitation includes the training of external experts to support the HIV nurses implementing TASSH
| Study group | Role | What they receive |
|---|---|---|
| Practice Facilitation to support TASSH integration (group A). | Experimental | Components of the PF strategy include: (a) establishment of a steering committee of key stakeholders (ministry of health, state primary care agency, AIDS control agency, patient advocates) to provide leadership and guide integration of TASSH into HIV care platform; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the PHC nurses on TASSH implementation. Receives: Other: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation. |
| TASSH only (group B) | Sham comparator | HIV nurses based at Group B facilities will be trained on the 5As counseling approach strategy (Ask, Assess, Advise, Assist, and Arrange) and referral for the participants to the health center. However, they will not receive practice facilitation from the POFs. Participants attending PHC randomized to Group B will receive standard care offered by the facility. Receives: Other: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH).
TASSH is defined as: i identification of patients with uncontrolled hypertension; ii measurement of blood pressure and anthropometrics; iii initiation of lifestyle counselling and blood pressure medications; iv. referral of complicated patients
Measured: 12 months
Secondary outcomes (2)
Level of adoption and implementation fidelity of task sharing and strengthening for hypertension.
We will evaluate the level of adoption and implementation fidelity of TASSH as potential mechanisms that may explain the effect of PF on our primary outcome of BP control and change in systolic BP (SBP) from baseline to 12 months.
Measured: 12 months
Level of sustainment of TASSH
We will evaluate the level of sustainment of TASSH at the end of the 6-month follow- up period.
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 posted2 Sep 2021
- Study start26 Oct 2022
- Primary completion30 Apr 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Step wedge design. One group with a cross over.
- Masking
- None (open label)
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Dike Ojji
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Dr. Dike Ojji, University of Abuja
- Investigators
- Dike Ojji, MBBS, Ph.D, Principal investigator, University of AbujaOlugbenga Ogedegbe, MD, MPH, Principal investigator, NYU Langone HealthJuliet Iwelunmor, Ph.D, Principal investigator, St. Louis UniversityAngela Attah, MBBS, MPH, Principal investigator, FHI 360DANIEL HENRY, Study director, Cardiovascular Research Unit, University of Abuja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031819
- Sponsor's protocol ID
- UATH/HREC/PR/2020-009
- Other IDs
- UH3HL154498
- Acronym
- MAP-IT
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.
PubMed 42370263Aifah AA, Hade EM, Colvin C, Henry D, Mishra S, Rakhra A, Onakomaiya D, Ekanem A, Shedul G, Bansal GP, Lew D, Kanneh N, Osagie S, Udoh E, Okon E, Iwelunmor J, Attah A, Ogedegbe G, Ojji D. Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial. Implement Sci. 2023 May 10;18(1):14. doi: 10.1186/s13012-023-01272-5.
PubMed 37165382Iwelunmor J, Ogedegbe G, Dulli L, Aifah A, Nwaozuru U, Obiezu-Umeh C, Onakomaiya D, Rakhra A, Mishra S, Colvin CL, Adeoti E, Badejo O, Murray K, Uguru H, Shedul G, Hade EM, Henry D, Igbong A, Lew D, Bansal GP, Ojji D. Organizational readiness to implement task-strengthening strategy for hypertension management among people living with HIV in Nigeria. Implement Sci Commun. 2023 May 4;4(1):47. doi: 10.1186/s43058-023-00425-3.
PubMed 37143131
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Hypertension Among People Living With HIV: An Integrated Model (MAP-IT)
- ClinicalTrials.gov ID
- NCT05031819
- Acronym / sponsor ID
- MAP-IT / UATH/HREC/PR/2020-009
- Conditions
- Blood Pressure, Human Immunodeficiency Virus I Infection, Acquired Immunodeficiency Syndrome, Hypertension
- Keywords
- Noncommunicable Diseases, Cardiovascular Diseases, Health Services Accessibility, HIV, Nigeria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Dr. Dike OjjiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 2 Sep 2021 (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.
The Managing Hypertension Among People Living with HIV: An InTegrated Model (MAP-IT) a stepped wedge, cluster-randomized controlled trial to evaluate the effect of practice facilitation (PF) on the integration of a Task-Shifting Strategy for hypertension (HTN) control (TASSH) into HIV care for management of HTN in people living with HIV (PLWH). The study will recruit 960 PLWH across 30 primary health centers (PHCs) in Akwa Ibom State (32 patients/PHC).
Detailed description
People Living with HIV (PLWH) are at increased risk for non-communicable diseases (NCDs) including cardiovascular diseases (CVD) with hypertension (HTN) the most common. Integrating NCD management into HIV chronic care services may be a cost-effective strategy to mitigate the rising burden of NCDs in PLWH. The goal of the study is to evaluate the effectiveness of practice facilitation in the integration of a task-shifting strategy for hypertension control into HIV care service delivered in primary health centers in Akwa Ibom State, Nigeria.
This study will occur in two phases: 1) The first phase is a UG3 Planning Phase during which investigators will use the iPARiHS implementation science framework to explore factors and support systems required for successful implementation and integration of TASSH into existing HIV chronic care platform and development of a context-specific practice facilitation strategy. 2) The second phase, which is the focus of this record, is a UH3 Implementation Phase during which we will use a stepped-wedge, cluster RCT, guided by the RE-AIM implementation science framework, to evaluate the effect of practice facilitation strategy on the level of adoption of TASSH, hypertension control, and level of sustainment of TASSH in management of hypertension among 960 patients enrolled in HIV treatment services across 30 PHCs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step wedge design. One group with a cross over.
| Arm | Type | Receives |
|---|---|---|
| Practice Facilitation to support TASSH integration (group A). | Experimental | Other: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.Components of the PF strategy include: (a) establishment of a steering committee of key stakeholders (ministry of health, state primary care agency, AIDS control agency, patient advocates) to provide leadership and guide integration of TASSH into HIV care platform; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the PHC nurses on TASSH implementation. |
| TASSH only (group B) | Sham comparator | Other: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.HIV nurses based at Group B facilities will be trained on the 5As counseling approach strategy (Ask, Assess, Advise, Assist, and Arrange) and referral for the participants to the health center. However, they will not receive practice facilitation from the POFs. Participants attending PHC randomized to Group B will receive standard care offered by the facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons aged 18 years or older
- Be HIV positive and currently enrolled in HIV treatment services at one of the 30 study PHCs, be receiving HTN treatment services at one of the 30 study PHCs, or can be enrolled at one of the 30 study PHCs to receive HTN services for the entire study duration.
- Have elevated blood pressure between 140-179 mm Hg systolic and/or 90-109 mm Hg diastolic, as determined by the average of the latter two of three separate BP readings during one clinic visit
- Able to provide consent
Key exclusion criteria (5 listed)
- BP ≥180/100 mm Hg
- Known history of kidney disease, heart disease, diabetes mellitus, stroke
- A female who is pregnant or breastfeeding at the time of enrollment
- Inability to provide informed consent
- Refusal 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 |
|---|---|---|
| Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.* TASSH includes CVD risk assessment; medication initiation and titration; lifestyle counseling and patient referral to physician care for complex cases. * Practice Facilitation includes the training of external experts to support the HIV nurses implementing TASSH | Other | Practice Facilitation to support TASSH integration (group A)., TASSH only (group B) |
Primary outcome
The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH).
Time frame: 12 months
TASSH is defined as: i identification of patients with uncontrolled hypertension; ii measurement of blood pressure and anthropometrics; iii initiation of lifestyle counselling and blood pressure medications; iv. referral of complicated patients
2 secondary outcomes
Level of adoption and implementation fidelity of task sharing and strengthening for hypertension.
Time frame: 12 months
Level of sustainment of TASSH
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 21 Nov 2025.
- Derived from this study: PubMed 42370263Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.
- Derived from this study: PubMed 37165382Aifah AA, Hade EM, Colvin C, Henry D, Mishra S, Rakhra A, Onakomaiya D, Ekanem A, Shedul G, Bansal GP, Lew D, Kanneh N, Osagie S, Udoh E, Okon E, Iwelunmor J, Attah A, Ogedegbe G, Ojji D. Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial. Implement Sci. 2023 May 10;18(1):14. doi: 10.1186/s13012-023-01272-5.
- Derived from this study: PubMed 37143131Iwelunmor J, Ogedegbe G, Dulli L, Aifah A, Nwaozuru U, Obiezu-Umeh C, Onakomaiya D, Rakhra A, Mishra S, Colvin CL, Adeoti E, Badejo O, Murray K, Uguru H, Shedul G, Hade EM, Henry D, Igbong A, Lew D, Bansal GP, Ojji D. Organizational readiness to implement task-strengthening strategy for hypertension management among people living with HIV in Nigeria. Implement Sci Commun. 2023 May 4;4(1):47. doi: 10.1186/s43058-023-00425-3.
- 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.
Dike Ojji, MBBS, Ph.D principal investigator
University of Abuja
Olugbenga Ogedegbe, MD, MPH principal investigator
NYU Langone Health
Juliet Iwelunmor, Ph.D principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Blood Pressure and Human Immunodeficiency Virus I Infection, run by Dr. Dike Ojji at 1 site in Nigeria.
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 4 inclusion and 5 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 21 Nov 2025. 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 Nigeria. 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. Some participants in this study may receive a placebo. 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?
The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH). (time frame: 12 months). 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 NCT05031819, which also lists 3 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 21 Nov 2025.