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

Lily D Yan, Vanessa Rouzier, Eliezer Dade, Collette Guiteau, Jean Lookens Pierre, Stephano St-Preux, Miranda Metz, Suzanne Oparil, Jean William Pape, Margaret McNairy, Lily D Yan, Vanessa Rouzier, Eliezer Dade, Collette Guiteau, Jean Lookens Pierre, Stephano St-Preux, Miranda Metz, Suzanne Oparil, Jean William Pape, Margaret McNairy

Abstract

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.

Conflict of interest statement

VR, JWP, MLM report a grant from the Fogarty International Center, grant number R21 TW011693. The remaining authors declare they have no conflicts of interest.

Figures

Fig 1. Study measures and schedule.
Fig 1. Study measures and schedule.
* indicates a study visit in the community.
Fig 2. Study overview.
Fig 2. Study overview.
Study follow-up visits will occur in the GHESKIO Clinic, with community visits to measure BP offered in months 2, 5, and 8.

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