Treatment of early hypertension among persons living with HIV in Haiti: Protocol for a randomized controlled trial

Lily D Yan1,2,3, Vanessa Rouzier2,3, Eliezer Dade3

  • 1Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, United States of America.

Plos One
|August 5, 2021
PubMed

Insights

People living with HIV (PLWH) with prehypertension may benefit from early blood pressure treatment to reduce cardiovascular disease (CVD) risk. This trial investigates initiating antihypertensive medication sooner for PLWH with prehypertension.

Area of Science:

  • Cardiology
  • Infectious Diseases
  • Clinical Trials

Background:

  • People living with HIV (PLWH) face elevated cardiovascular disease (CVD) and mortality risks, particularly in lower-middle income countries.
  • Early intervention for prehypertension in PLWH could prevent hypertension, reduce CVD, and potentially lower mortality.
  • No prior trials have assessed early blood pressure treatment initiation for PLWH with prehypertension.

Purpose of the Study:

  • To evaluate the feasibility, benefits, and risks of initiating antihypertensive treatment in PLWH with prehypertension.
  • To compare early prehypertension treatment against the standard of care based on current WHO guidelines.
  • To assess the impact of early treatment on blood pressure changes and other health outcomes in PLWH.

Main Methods:

  • A randomized controlled trial involving 250 adults (18-65 years) living with HIV and viral suppression.
  • Participants with prehypertension (Systolic Blood Pressure [SBP] 120-139 mmHg or Diastolic Blood Pressure [DBP] 80-89 mmHg) assigned to immediate amlodipine or standard care (treatment upon hypertension diagnosis).
  • Primary outcome: Mean change in SBP at 12 months. Secondary outcomes: Feasibility, acceptability, adverse events, HIV viral suppression, medication adherence, and qualitative interviews.

Main Results:

  • The study is designed to assess the primary outcome of SBP change at 12 months.
  • Secondary outcome analysis will cover feasibility, acceptability, adverse effects, HIV viral suppression, and medication adherence.
  • Qualitative data will explore provider and participant perspectives on early amlodipine initiation and perceived CVD risk.

Conclusions:

  • PLWH exhibit higher CVD risk, suggesting a potential benefit from a lower blood pressure threshold for antihypertensive treatment initiation.
  • This trial aims to provide evidence on the efficacy and safety of early blood pressure management in this population.
  • Findings will inform clinical guidelines for managing hypertension and CVD risk in people living with HIV.
Abstract

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