Community Health Worker Optimization of Antihypertensive Care in HIV (COACH): Study protocol for a pilot trial of an intervention to improve hypertension care among Tanzanians with HIV

by Wai Yan Min Htike, Preeti Manavalan, Lisa Wanda, Kelvin Haukila, Blandina T. Mmbaga, Francis M. Sakita, Rennyda Zebedayo, Francis Gwasma, Tazeen Jafar, Hayden B. Bosworth, Nathan M. Thielman, Julian T. Hertz

Objective

This study will evaluate the feasibility and preliminary effectiveness of the COACH (Community Health Worker Optimization of Antihypertensive Care in HIV) intervention, which integrates hypertension management into existing HIV care for people living with HIV (PLWH) in Tanzania.

Methods

The study will be conducted at two HIV Care and Treatment Centers (CTCs) in Tanzania. In a single-arm pre-post feasibility trial, 100 PLWH with hypertension will be enrolled and will receive the six-month intervention. The COACH intervention includes six monthly hypertension educational sessions delivered by community health workers (CHWs) and integrated within HIV CTC visits, monthly blood pressure monitoring, follow up care coordination, fully subsidized antihypertensive medications, a standardized antihypertensive treatment algorithm, and training for providers. The intervention’s implementation outcomes will be evaluated using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, and the primary study outcome (reach of the intervention) will be the proportion of all scheduled intervention sessions attended by participants, a measure of feasibility. Secondary clinical effectiveness outcomes will include adherence to antihypertensive medication, blood pressure control, body mass index, cardiovascular risk, and hypertension knowledge.

Significance

The COACH intervention has the potential to significantly improve hypertension management among PLWH in Tanzania by leveraging the existing HIV care infrastructure and CHWs. This study will provide crucial insights into the feasibility and potential effectiveness of the intervention in integrating hypertension care into HIV services, informing larger-scale implementation and policy changes in Tanzania and other resource-limitted settings.

Trial registration

Clinical trials.gov Identifer: NCT06503991.