A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial

Figures & data

Table 1. Inclusion and exclusion criteria for V-EXTRA CVD trial.

Inclusion criteria

Exclusion criteria

Age ≥ 18 years Confirmed HIV + diagnosis Undetectable HIV viral load: defined as the most recent HIV viral load < 200 copies/mL, checked within the past 18 months (assessed via chart abstraction) Hypertension: Defined as being prescribed an anti-hypertensive medication OR 2 recent outpatient BP measurements in the last 18 months to show systolic BP ≥ 130 and/or diastolic ≥ 90 mmHg Veteran at one of the sites participating in the study Regular access to a computer, tablet, or smartphone device with internet

Severely hearing or speech impaired, or other disability that would limit participation In a nursing home at baseline and/or any long-term care facility (participants will be censored at the point of entering nursing home care) In-patient psychiatric care Diagnosis of dementia or active psychosis Terminal illness with life expectancy < 4 months (e.g. metastatic cancer, hospice care) Recent (<90 days) hospitalization for CABG, MI, stroke Pregnant, breast-feeding, or planning a pregnancy during the study period Planning to move out of the area in the next 12 months No reliable access to telephone services Currently enrolled in a competing research study (e.g. an intervention that may impact BP management)

Figure 1. Intervention components employed in the study.

Figure 2. Blood pressure management algorithm employed by the interventionist adapted Department of Defense Hypertension treatment algorithm.

Figure 3. Lipid treatment algorithm employed by the interventionist for lipid management.

Figure 4. Examples of frequency and mode of participant contacts. (A) Minimum contact by the interventionist and study team. (B) Example of a participant in the intervention arm requiring additional contacts for BP or lipid management during the study. (C) Contacts made with participants in the education control arm. Circles represent in-person visits and outcome assessments conducted by research team members, triangles represent virtual visits and crosses represent telephone contacts made by interventionists.

Table 2. Antihypertensive regimens used in the intervention arm.

Class	Select medication	Dosage range	Comments
First line agents
Thiazide type diuretics	Chlorthalidone Hydrochlorothiazide (HCTZ)	12.5 mg→25 mg once daily 25 mg→50 mg once daily	May cause hyperuricemia/gout Monitor serum potassium Avoid estimated creatinine clearance (CrCl) <30 mL/min
Angiotensin-converting enzyme inhibitors (ACEIs)	Lisinopril	2.5→5 mg→10 mg→20 mg→40 mg once daily Max 40 mg per day CrCl 10–30: Start at 5 mg per day CrCl <10: Start 2.5 mg per day	Avoid in pregnancy Avoid in acute decline in CrCl May cause new cough or angioedema
Angiotensin II receptor blockers (ARBs)	Losartan Valsartan	25 mg→50 mg→100 mg (once daily or twice daily; Max 100 mg/24 h) 40 mg→80 mg→160 mg→240 mg→320 mg OD	Avoid in pregnancy Avoid in acute decline in CrCl Monitor K + in chronic kidney disease
Fixed-dose combinations	Lisinopril/HCTZ HCTZ/Losartan	10 mg/12.5 mg→20 mg/12.5 mg→20 mg/12.5 mg (once daily) 12.5 mg/50 mg→12.5 mg/100 mg→25 mg/100 mg (once daily)	*See comments above
Second line agents
Long-acting calcium channel blockers (CCBs): dihydropyridines	Amlodipine	2.5 mg→5 mg→10 mg once daily	May cause ankle edema, dizziness, flushing, headache, constipation
Combined alpha and beta blockers	Carvedilol	6.25 mg→12.5 mg→25 mg twice daily	Monitor for bradycardia Asthma and chronic obstructive pulmonary disease Avoid using with non DHP CCB
Long acting CCBs: non-dihydropyridines	Diltiazem (SR) Verapamil (SR)	120 mg→180 mg→240 mg→300 mg→360→420 mg (once daily) 120 mg→180 mg→240 mg (once daily or twice daily; Max 480 mg/24 h)	Avoid using with beta blockers Avoid in heart failure or atrioventricular blocks May cause constipation
Third line agents
Mineralocorticoid agonists	Spironolactone	12.5→25 mg→50 mg→100 mg (once daily) Max 100 daily	Avoid in: CrCl <40ml/min K+ >5.5, Na+ <130

Table 3. General and special considerations when selecting antihypertensive therapy.

General considerations	Special considerations
All patients should be on at least 2 first line agents assuming no contraindications	Ischemic heart disease: Requires beta blocker use
A routine basic chemistry panel when adding: ACEI/ARB Thiazide diuretic Mineralocorticoid	Heart Failure with reduced EF: Should be on ARNI or ACEI or ARB ARNI should NOT be combined with ACEI or ARBs Non-DHP CCBs should not be used
Avoid combining: Beta blocker AND non-DHP CCBs Two medications of the same class ACEI and ARBs	Chronic kidney disease: Should be on ACEI or ARB
	Diabetes mellitus: Should be on ACEI or ARB
	Aortic heart disease: Should be on a beta blocker

ACEI: angiotensin converting enzyme inhibitor; ARB: angiotensin receptor blocker; CCB: calcium channel blockers; DHP: dihydropyridine.