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| ID | Type | Description | Link |
|---|---|---|---|
| UH3HL154498 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation. | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dike Ojji, MBBS, Ph.D | University of Abuja | Principal Investigator |
| Olugbenga Ogedegbe, MD, MPH | NYU Langone Health | Principal Investigator |
| Juliet Iwelunmor, Ph.D | St. Louis University | Principal Investigator |
| Angela Attah, MBBS, MPH | FHI 360 | Principal Investigator |
| DANIEL HENRY | Cardiovascular Research Unit, University of Abuja | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care Facilities | Uyo | Akwa Ibom State | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37165382 | Derived | Aifah 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. | |
| 37143131 | Derived |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006973 | Hypertension |
| D000073296 | Noncommunicable Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Step wedge design. One group with a cross over.
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| Level of sustainment of TASSH |
We will evaluate the level of sustainment of TASSH at the end of the 6-month follow- up period. |
| 6 months |
| Iwelunmor 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |