R21TW012650

Adapting and piloting an evidence-based intervention to improve hypertension care among Tanzanians living with HIV - Abstract

In sub-Saharan Africa (SSA), people living with HIV (PLWH) face a new epidemic of uncontrolled hypertension, the leading risk factor for death worldwide. Current care models in SSA are inadequate to address the growing burden of hypertension in PLWH, yet few interventions targeting this population exist.

We previously piloted Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP), a clinic-based hypertension educational intervention delivered by a CHW situated within a Tanzanian HIV clinic, and found it to be highly feasible and acceptable. However, the efficacy and sustainability of CHAMP remains unproven.

In contrast, Control of Blood Pressure and Risk Attenuation (COBRA), a multi-component intervention consisting of community-based CHW-delivered education and blood pressure monitoring and protocolized referrals to physicians, demonstrated efficacy in improving hypertension control and reducing all-cause mortality in a cluster-randomized trial across 3 countries in Asia.

Evidence-based interventions like COBRA hold considerable promise in achieving hypertension control among PLWH in SSA, but have not been studied in this population. In this 2-year study, we will integrate an evidence-based, multi-component, CHW-delivered hypertension intervention (COBRA) with our early experience deriving CHAMP to improve hypertension care and reduce blood pressure among PLWH in Tanzania.

Using implementation science methods, we will adapt COBRA for delivery within the Tanzanian HIV clinic, examine implementation outcomes, and estimate effect size in preparation for a subsequent large-scale, hybrid effectiveness-implementation trial across Tanzania.

In Aim 1, we will assemble a design consultation team of key stakeholders to assist in intervention adaption. Adaptation and integration of COBRA and CHAMP will occur iteratively over 8 months, guided by the ADAPT-ITT model, and informed by our previously collected qualitative data describing barriers and facilitators to hypertension care for PLWH.

In Aim 2, we will pilot the adapted intervention with a single-arm pre-post feasibility trial in two HIV clinics and assess implementation (reach, adoptability, implementation, maintenance) and preliminary effectiveness outcomes (hypertension control, systolic and diastolic blood pressure, antihypertensive adherence, cardiovascular disease risk score, and hypertension knowledge).

Our research team, comprised of experts in hypertension, HIV, and implementation science, and our robust relationships with community agencies and health systems make us well-suited to conduct this work.

The proposed program will lay the groundwork for an R01 application to evaluate implementation, effectiveness, and scalability of the adapted intervention in a fully powered trial across Tanzania and help stem the rising tide of cardiovascular comorbidities among PLWH in SSA.

Duke University

NOT APPLICABLE

93.989 - International Research and Research Training

Fogarty International Center (FIC) [HHS - NIH]

Durham, North Carolina 277080519 United States

Single Zip Code

HIV-associated Non-Communicable Diseases Research at Low- and Middle-Income Country Institutions (R21 Clinical Trial Optional) (PAR-21-246)

Amendment Since initial award the total obligations have increased 69% from $231,687 to $392,285.