Treatment of prehypertension among adults with HIV: a randomized clinical trial.

Objective: Elevated blood pressure (BP), even at prehypertensive levels, increases cardiovascular disease risk among people with HIV (PWH); yet international guidelines in low-income countries recommend treatment initiation at BP at least 140/90 mmHg. We determined the efficacy, feasibility, and acceptability of treating prehypertension in PWH in Haiti.

Design: An unblinded randomized clinical trial (enrolled April 2021-March 2022) with 12-month follow-up.

Setting: GHESKIO Centres, Port-au-Prince, Haiti.

Participants: Two hundred fifty adults with HIV with prehypertension (SBP 120-138 or DBP 80-89) not on medication, aged 18-65 years, virally suppressed, and without pregnancy, diabetes, or kidney disease.

Intervention: Participants were randomized to treatment (amlodipine 5 mg) or control (no amlodipine unless two BP ≥140/90 mmHg).

Main Outcome Measure: Primary outcome was mean change in SBP between intervention versus control groups from enrollment to 12 months.

Results: Among 250 adults, median age was 49 years, 40.8% were women. Baseline median BP was 129/78 mmHg intervention versus 128/77 mmHg control. After 12 months, the difference in mean change between study groups for SBP was -5.9 mmHg [95% confidence interval (95% CI) -8.8 to -3.0] and for DBP was -5.5 mmHg (95% CI -7.9 to -3.2). At 12 months, 5.6% intervention and 23.0% control participants developed incident hypertension (hazard ratio 0.18; 95% CI 0.07-0.47). There were no differences in viral load suppression at 12 months or drug-related serious adverse events. Intervention acceptability was high among providers and participants in qualitative interviews.

Conclusion: In PWH in a resource-poor setting, prehypertension treatment was feasible, acceptable, and effective in reducing mean SBP and incident hypertension.

Registration: Clinicaltrials.gov NCT04692467.