Clinical trial NCT04704336: Integration of Hypertension Management Into HIV Care in Nigeria
Official title: Integration of Hypertension Management Into HIV Care in Nigeria: A Task Strengthening Strategy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Hypertension
Keywords: Hypertension
Implementation science research
Integrated models
Practice Facilitation
People living with HIV
Human Immunodeficiency Virus
Cluster trial
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-01-11
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.

Detailed description: Although access to antiretroviral therapy has led to increased survival among people living with HIV (PWH) in Africa, this population now has higher cardiovascular disease (CVD) - mortality than the general population largely due to an increased burden of hypertension. In Nigeria, the acute shortage of physicians limits the capacity to control hypertension among PWH at the primary care level where the majority receive treatment. This study proposes the use of practice facilitation (PF) - which will provide external expertise on practice redesign and a tailored approach to delivery of the evidence-based task strengthening strategy - to integrate hypertension into the HIV care model. Using a clinical-effectiveness implementation design, we will evaluate the effect of a PF strategy for integrating an evidence-based intervention for hypertension (HTN) control into HIV care among 960 patients with uncontrolled HTN in 30 primary health centers (PHCs) in Nigeria. Study is in 3 phases: 1) a pre-implementation phase that will develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post- implementation phase to evaluate the effect of PF vs. self-directed condition on the adoption and sustainability of TASSH. The PF intervention comprises: (a) an advisory board to provide leadership support for implementing TASSH in HIV clinics; (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 HIV nurses

Eligibility criteria: Inclusion Criteria:

* Be an adult aged 18 years and older.
* Attends one of the 30 HIV clinics.
* Have a diagnosis of HTN with uncontrolled blood pressure, i.e. BP is 140-179/90-100 mm Hg.
* Ability to provide consent.

Exclusion Criteria:

* BP\>180/110 mm Hg;
* history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
* Inability to provide informed consent.
* Refusal to participate in the study.

Primary outcomes:
measure: Change in systolic Blood Pressure
timeFrame: baseline, 6 months, 12 months, 18 months and 24 months
Secondary outcomes:
measure: The rate of adoption of TASSH across participating primary health centers (PHCs) at 12- and 24 months respectively.
timeFrame: 12 months
measure: The rate of sustainability of TASSH across participating primary health centers (PHCs) at 12- and 24 months respectively.
timeFrame: 24 months
measure: Change in Implementation Climate of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.
timeFrame: 12 months and 24 months
measure: Change in Implementation Leadership of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.
timeFrame: 12 months and 24 months
measure: Change in Proficiency of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.
timeFrame: 12 months and 24 months
measure: Change in Organizational Readiness of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.
timeFrame: 12 months and 24 months
measure: Change in implementation process across the primary health centers (PHCs) at 12 and 24 months.
timeFrame: 12 months and 24 months
measure: Change in Organizational capacity to change across the primary health centers (PHCs) at 12 and 24 months.
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University (SLU)
state: Missouri
city: Yaba
country: Nigeria
facility: Nigerian Institute of Medical Research (NIMR)
state: Lagos
Study officials:
affiliation: NYU Langone Health
name: Olugbenga Ogedegbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iwelunmor J, Ezechi O, Obiezu-Umeh C, Oladele D, Nwaozuru U, Aifah A, Gyamfi J, Gbajabiamila T, Musa AZ, Onakomaiya D, Rakhra A, Jiyuan H, Odubela O, Idigbe I, Engelhart A, Tayo BO, Ogedegbe G. Factors influencing the integration of evidence-based task-strengthening strategies for hypertension control within HIV clinics in Nigeria. Implement Sci Commun. 2022 Apr 15;3(1):43. doi: 10.1186/s43058-022-00289-z.
citation: Aifah AA, Odubela O, Rakhra A, Onakomaiya D, Hu J, Nwaozuru U, Oladele DA, Odusola AO, Idigbe I, Musa AZ, Akere A, Tayo B, Ogedegbe G, Iwelunmor J, Ezechi O. Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol. Implement Sci. 2021 Nov 16;16(1):96. doi: 10.1186/s13012-021-01167-3.