Treatment of early hypertension among persons living with HIV in Haiti: Protocol for a randomized controlled trial
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Updated: Oct 25, 2025

An Affordable HIV-1 Drug Resistance Monitoring Method for Resource Limited Settings
Published on: March 30, 2014
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.
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.
Background:
People living with HIV (PLWH) are at increased risk of cardiovascular disease (CVD) and death, with greater burdens of both HIV and CVD in lower-middle income countries. Treating prehypertension in PLWH may reduce progression to hypertension, CVD risk and potentially mortality. However, no trial has evaluated earlier blood pressure treatment for PLWH. We propose a randomized controlled trial to assess the feasibility, benefits, and risks of initiating antihypertensive treatment among PLWH with prehypertension, comparing prehypertension treatment to standard of care following current WHO guidelines.
Methods:
A total of 250 adults 18-65 years and living with HIV (PLWH) with viral suppression in the past 12 months, who have prehypertension will be randomized to prehypertension treatment versus standard of care. Prehypertension is defined as having a systolic blood pressure (SBP) 120-139 mmHg or diastolic blood pressure (DBP) 80-89 mmHg. In the prehypertension treatment arm, participants will initiate amlodipine 5 mg daily immediately. In the standard of care arm, participants will initiate amlodipine only if they develop hypertension defined as SBP ≥ 140 mmHg or DBP ≥ 90 mmHg. The primary outcome is the difference in mean change of SBP from enrollment to 12 months. Secondary outcomes include feasibility, acceptability, adverse effects, HIV viral suppression, and medication adherence. Qualitative in-depth interviews with providers and participants will explore attitudes about initiating amlodipine, satisfaction, perceived CVD risk, and implementation challenges.
Discussion:
PLWH have a higher CVD risk and may benefit from a lower BP threshold for initiation of antihypertensive treatment.
Trial Registration:
Clinicaltrials.gov registration number NCT04692467, registration date December 15, 2020, protocol ID 20-03021735.
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