GREAT 2

Implementation Research:

Translating the ABCS into HIV Care

Get Ready and Empowered About Treatment

(GREAT 2)

Use of highly effective, often single pill HIV antiretroviral therapy has dramatically reduced deaths from AIDS-related causes yielding an aging population among people living with HIV (PLH) who increasingly experience cardiovascular (CVD) morbidity and mortality. Age and sex-adjusted deaths from CVD are appreciably higher among PLH than among the general population. This growing CVD risk among PLH can be substantively reduced through use of established interventions, commonly referred to as ABCS, i.e. appropriate use of aspirin, blood pressure control, cholesterol reduction, and smoking cessation, in addition to lifestyle, i.e. diet, physical activity, and safe drinking. Each of these interventions is underused among PLH. There is a fundamental gap in scientific knowledge regarding which strategies will promote shared decision-making regarding ABCS between PLH and their clinicians. Addressing this gap is vital to reducing the growing CVD burden among PLH.


The overall goal of this project is to develop and rigorously test implementation strategies to address this gap in scientific knowledge. We will test the following patient-, clinician-, and practice-level strategies: patient/activation training and texting support, clinician-targeted academic detailing and audit and feedback, and practice-based engagement in a stepped wedge randomized controlled trial (RCT) in 600 PLH across 9 practices in Rochester, NY, New York City and Dallas, Texas. We hypothesize that use of evidence-based, multilevel implementation strategies will improve discussion and uptake of the ABCS among PLH.

Intervention Components 

Each enrolled clinician will participate in the designated intervention activities over the course of eight months (which is the standard intervention duration for each wedge):

Two Academic Detailing (AD) Sessions
Four Online CME Modules
Two Audit Feedback Reports

Academic Detailing (AD) Sessions

 Aspirin for ASCVD Prevention

Individualizing risks and shared decision making are essential when considering aspirin for ASCVD prevention. While the literature suggests people living with HIV may be at increased risk of ASCVD, evidence regarding aspirin for primary or secondary prevention in this population is limited. Therefore data from the general population must be used to guide best practice recommendations.

Key Message 1

Aspirin is recommended for secondary prevention of ASCVD.

Key Message 2

Evidence for aspirin supporting primary ASCVD prevention is comparatively weak. Individual 10-year risk of ASCVD should be carefully considered alongside potential for aspirin-related bleeds before recommending aspirin for primary prevention.

Key Message 3

The online risk calculator (and app) is available to estimate an individualized risks and benefits of aspirin for primary prevention.

 Aspirin for ASCVD Prevention Management Algorithm

Clinical ASCVD (ACS, MI, unstable angina, revascularization, stroke, TIA, PAD, AAA)
YES
NO
YES
Start Aspirin
Unless major contraindication
Consider PPI for GI prophylaxis
Prior intracranial bleed or serious GI bleed, severe aspirin allergy, severe CKD or liver disease?

Avoid Aspirin

10 year ASCVD risk ≥10%

10 year ASCVD risk 5 - < 10%
Assess age, sex, and use Aspirin Guide to calculate NNT* and NNH*
Men
50 – 69 years
Women
50 -69 years
NNT*≥NNH*
(benefit≥harm)
Start Aspirin
Start Aspirin
NNT*≤NNH*
(benefit≤harm)
Avoid Aspirin
Avoid Aspirin

Assess age, sex, and use Aspirin Guide to calculate NNT* and NNH*
Men <50
Women <65
Men ≥50
Women ≥65
NNT*≥NNH*
(benefit≥harm)
Avoid Aspirin
Consider Aspirin
NNT*≤NNH*
(benefit≤harm)
Avoid Aspirin


Increased Bleed Risk

  • Older age
  • Male gender
  • Smoker
  • Diabetes
  • History of bleeding
  • Hypertension
  • Peptic ulcer disease
  • Use of NSAIDs or anticoagulants
              Adapted from http://www.aspiringuide.com                                                                                                                                  *NNT = number needed to treat; NNH = number needed to harm

 Blood Pressure Management

HIV and antiretroviral medications increase potential for hypertension and CV events. Optimal blood pressure control while minimizing potential for drug interactions is an essential component of HIV care.

Key Message 1

Stage I hypertension is defined as a systolic blood pressure of 130 – 139 mmHg or a diastolic blood pressure of 80 – 89 mmHg. For patients with stage I hypertension and a 10-year ASCVD risk, 3 – 6 months of lifestyle management should be attempted prior to starting pharmacotherapy. For those with a 10-year risk ≥10%, CVD, diabetes, or renal dysfunction, one antihypertensive agent should be initiated.

Key Message 2

Stage II hypertension is defined as a systolic blood pressure ≥140 mmHg or a diastolic blood pressure ≥90 mmHg. Two antihypertensive agents from different classes should be initiated in patients with stage II hypertension along with lifestyle changes.

Key Message 3

The pooled cohort calculator may underestimate ASCVD risk among PLH; true risk may be 50 – 100% higher than that estimated by the calculator. Therefore pharmacologic treatment may be appropriate for PLH with stage I HTN and a 10-year risk <10%.

Key Message 4

ACE-Inhibitors, ARBs, dihydropyridine calcium channel blockers, and thiazide/thiazide like diuretics are considered first line therapies. Blood pressure should be assessed monthly after initiation and the regimen should be adjusted as needed to achieve a goal blood pressure of <130/80 mmHg.

BP Category
Systolic BP
Diastolic BP
Treatment & Follow Up
Normal
<120 mmHg
and
<80 mmHg
  • Encourage healthy lifestyle to maintain BP
  • Yearly follow up
Elevated
120 – 129 mmHg
and
<80 mmHg
  • Recommend lifestyle changes
  • Reassess in 3 – 6 months
Hypertension –
Stage I
130 – 139 mmHg
or
80 – 89 mmHg
Assess 10-year risk using ASCVD calculator
Risk <10%
  • Recommend lifestyle changes
  • Reassess in 3 – 6 months
Risk >10% OR CVD, DM, or CKD
  • Lifestyle changes and start 1 medication - reassess in 1 month
  • If goal met after 1 month: reassess in 3 – 6 months
  • If goal not met after 1 month: assess adherence, increase dose, and/or switch medication, and continue monthly follow up until goal is met
Hypertension –
Stage II
≥140 mmHg
or
≥90 mmHg
  • Lifestyle changes and start 2 medications from different classes – reassess in 1 month
  • If goal met after 1 month: reassess in 3 – 6 months
  • If goal not met after 1 month: assess adherence, increase dose, and/or switch medication, and continue monthly follow up until goal is met
Expect 1 mmHg reduction for every 1 kg lost!
Reduction in SBP by Lifestyle Change
  • Aerobic exercise (150 min/week): -5 to -8 mmHg
  • Resistance training (150 mg/week): -4 mmHg
  • Isometric hand grips (4 x 2 min, 3 times weekly for 8 – 10 weeks): -5 mmHg
  • Alcohol intake (≤2 drinks/day for men and ≤1 drink/day for women): -4mmHg







Pharmacotherapy for Hypertension

First Line Therapies
Thiazide & Thiazide-Like Diuretics

Chlorthalidone
Hydrochlorothiazide
Indapamide
Metolazone
  • Thiazides and CCBs are preferred first line for African Americans patients.
  • Minimally effective with GFR <30 ml/min.
  • Higher doses produce more fluid loss but have minimal added benefit on BP.
  • Metabolic effects are dose related, sexual dysfunction is not.
  • Monitor: hyponatremia, hypokalemia, hypomagnesemia. In older adults, risk may be greater with chlorthalidone than HCTZ .
  • Gout: caution in patients who are not receiving uric acid lowering therapies.
  • Diabetes: may increase BGs 5 – 10 points, particularly if used with a beta blocker.
  • Chlorthalidone and indapamide preferred for long half-life and reduction of CV events.
ACE Inhibitors
  • Dry Cough: incidence 5 – 20%. Develops within first 6 months of therapy. Will resolve within 4 days if drug is held and reoccur if the same or another ACE-I is initiated.
  • Angioedema: can develop at any time however 50% of cases occur within first week of therapy. More common in African Americans.
  • Monitor: hyperkalemia and renal function. Up to 30% increase in creatinine is generally acceptable.
ARBs
  • Patients with a history of ACE inhibitor angioedema can receive an ARB 6 weeks after ACE is discontinued.
  • Monitor: hyperkalemia and renal function. Up to 30% increase in creatinine is generally acceptable.
CCBs: Dihydropyridines

Amlodipine
Felodipine
Nifedipine LA
Nicardipine SR
  • Thiazides and CCBs are preferred first line for African Americans patients.
  • Vasodilators with minimal effect on contractility.
  • Caution in HF with reduced EF. If necessary, use amlodipine or felodipine.
  • Edema can be mitigated by reducing dose and/or adding ACE/ARB. CCB edema is due to fluid shifts as opposed to fluid retention and therefore tends not to improve with diuretics.
  • May cause gingival overgrowth/hyperplasia. Most reported with nifedipine, but occurs with other CCBs. Discontinuation is the most effective management.
Target BP is now <130/80 mmHg.
  • Weak recommendation for patient who have a SBP <140 and have an ASCVD <10%.
  • For frail patients or those with limited life expectancy, clinical judgement & patient preference may determine intensity of BP goals.
Consider poor adherence as the first reason blood pressure is not controlled.
  • 25% of patients do not fill the initial prescription they are given.
  • Only 1 in 5 patients follow treatment recommendations sufficiently to achieve benefits seen in clinical trials.
  • Call the pharmacy to verify dates medications were picked up.
    It is critical to identify why a patient is non-adherent.
Second Line Therapies
Aldosterone Antagonists
Spironolactone
Eplerenone
  • Side effects are dose related. Gynecomastia and impotence less common with eplerenone.
  • Eplerenone often requires twice daily dosing for adequate BP control.
  • Monitor: potassium. Risk is greater in CKD and with use of other drugs known to cause hyperkalemia.
Beta Blockers
Selective: Metoprolol, Bisoprolol,
Atenolol
Non-Selective: Propranolol
β & α1 Activity: Carvedilol, Labetalol
  • No longer considered first line for HTN in the absence of another indication.
  • Carvedilol and labetalol have stronger effect on BP.
  • Atenolol require renal dose adjustment if CrCl< 35 ml/min.
  • Avoid abrupt discontinuation. To taper: reduce daily dose by 50% x 1 week then every other day x 1 week. If used with clonidine: withdraw beta blocker before withdrawing clonidine.
  • Interactions with amiodarone, verapamil, diltiazem, digoxin, and Epi-Pens are clinically significant.
CCBs: Non-Dihydropyridines
Verapamil
Diltiazem
  • Less potent vasodilators with negative inotropic effects.
  • Drug interactions can be clinically significant.
  • Risk of bradycardia and heart block if used with beta blockers.
  • Avoid in HF with reduced EF.
Third Line Therapies
Alpha-1 Blockers
Doxazosin
Terazosin
  • Consider as third line for patients with BPH.
  • Appear on Beer’s Criteria due to potential for orthostatic hypotension. To reduce risk, initiate at low dose, titrate slowly, and administer at bedtime.
  • Avoid in HF. ALLHAT trial showed 25% increased risk of HF relative to chlorthalidone.
Central Alpha Agonists
Clonidine
Methyldopa
  • May be poorly tolerated.
  • Hypotension, dry mouth, somnolence, and topical reactions to patch are common (>30% incidence).
  • Clonidine: abrupt discontinuation can cause rebound hypertension. To taper: reduce dose by 50% every 3 days, resume previous dose if withdrawal symptoms develop. Withdrawal risk greatest with IR tablets. If discontinuation clonidine and a beta blocker, withdraw beta blocker several days prior to withdrawing clonidine.
Vasodilators
Hydralazine
  • Multiple daily doses may be a barrier to adherence.
  • Tachycardia is common and often resolves when used with a beta blocker. Edema is dose related.
  • High doses (>200 – 400 mg/day) have been associated with drug induced lupus.

Use of Antihypertensive & Antiretrovirals

Concomitant Drug Class/Name
Effect on HIV Drug and/or Class
Dosing Recommendations & Considerations
Interactions with Integrase Strand Transfer Inhibitors (INSTIs)
Beta Blockers Bictegravir
Dolutegravir
Raltegravir
None
No adjustments necessary.
Elvitegravir/
Cobicistat
↑ beta blocker concentrations
Beta blocker dose may need to be decreased.

Potential for interaction may be minimized by using atenolol, labetalol, nadolol, or sotolal.
Calcium Channel Blockers Bictegravir
diltiazem may ↑ bictegravir
No adjustments necessary.
Dolutegravir
Raltegravir
None
No adjustments necessary.
Elvitegravir/
Cobicistat
↑ calcium channel blocker concentrations
Co-administer with caution. Slowly titrate calcium channel blocker dose and monitor for side effects and toxicities.
Interactions with Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Dihydropyridine
Calcium Channel Blockers
Efavirenz
Etravirine
Nevirapine
↓ calcium channel blocker concentrations
Titrate calcium channel blocker based on clinical response.
Diltiazem,
Verapamil
Efavirenz
Diltiazem: ↓ AUC by 60%

Verapamil: ↓ concentrations possible
Titrate diltiazem of verapamil based on clinical response.
Interactions with Protease Inhibitors (PIs)
Beta Blockers All protease inhibitors
↑ beta blocker concentrations
Beta blocker dose may need to be decreased.

Potential for interaction may be minimized by using atenolol, labetalol, nadolol, or sotolal.

 Cholesterol Management

Cholesterol management is an important part of reducing CVD risk among persons living with HIV. The ACC/AHA Cholesterol Guidelines were updated in 2018 to allow for more individualized treatment interventions, detailed risk assessment (including the introduction of risk-enhancing factors) and thresholds for starting non-statin agents (see Cholesterol Algorithm below) in those at the highest risk for ASCVD as follows.

Key Message 1

Patients with existing ASCVD, history of multiple major ASCVD events, or 1 major ASCVD event, and multiple high-risk conditions, should be prescribed statin therapy unless contraindicated for secondary prevention.

Key Message 2

Patients 40 to 75 years of age with severe hypercholesterolemia (LDL-C ≥190 mg/dL) or who have diabetes and an LDL-C ≥ 70 mg/dL, should be started on statin therapy without further need for calculating 10-year ASCVD risk.

Key Message 3

Patients 40 to 75 years of age without clear indication for statin therapy (i.e., clinical ASCVD, very-high risk for ASCVD, severe hypercholesterolemia, or elevated LDL-C and diabetes) should be evaluated for primary ASCVD prevention using a risk scoring tool to help guide shared decision-making for management.

Drug-drug interactions between statins and antiretrovirals must be considered during prescribing.

Key Message 4

PLH who are/will be prescribed ARVs should have a careful evaluation for drug-drug interactions prior to the initiation of statin (or ARV) therapy.

ARV-Statin Drug-Drug Interactions

ATV/c
ATV/r
DRV/c
DRV/r
LPV/r
DOR
EFV
ETV
NVP
RPV
MVC
BIC
DTG
EVG/c/
EVG/c/
RAL
FTC
F/TAF
TDF
ZDV
F/TAF
F/TAF
F/TDF
3TC
Statins
Atorvastatin
822%
290%
490%
2%
43%
37%
Fluvastatin
Lovastatin
Pitavastatin
26%
20%
11%
Pravastatin
81%
44%
Rosuvastatin
242%
213%
93%
48%
107%
38%
38%
Simvastatin
68%

KEY No clinically significant interaction expected Potential increased exposure of the statin
These drugs should not be coadministered Potential decreased exposure of the statin
Potential interaction which may require dose adjustment or close monitoring No significant effect
Potential interaction of weak intensity. No a priori dose adjustment recommended

  Adapted from https://liverpool-hiv-hep.s3.amazonaws.com/prescribing_resources/pdfs/000/000/031/original/TS_LipidLowering_2019_Feb.pdf?1550073409

Cholesterol Management Algorithm

Clinical ASCVD
ACS, MI, unstable angina, revascularization, stroke, TIA, PAD, AAA
YES
Secondary Prevention
NO
Primary Prevention (age 40 -75)
Multiple major ASCVD events or 1 major ASCVD event + multiple high risk conditionsǂ
LDL
≥ 190 mg/dL
LDL 70 - 189 mg/dL
LDL
< 70
mg/dL
YES
Very high ASCVD risk
NO
Stable ASCVD
YES
NO
Diabetes
Assess 10-year ASCVD risk with the ASCVD Risk Estimator +
≥20%
High
Risk
7.5 - <20% Intermediate Risk
5 - 7.4% Borderline Risk
<5%
Low
Risk
Evaluate risk enhancersǂǂ and CAC score if uncertain
Evaluate risk enhancersǂǂ and patient preference

Treatment

Maximal tolerated statin
High or moderate intensity statin
Maximal tolerated statin
Moderate or high intensity statin
High intensity statin
Moderate intensity statin based on risk enhancers
Moderate intensity statin based on risk enhancers
Lifestyle changes
Assess lifetime
risk
Goals of Therapy
Goal LDL <70 mg/dL. If not met, add ezetimibe and then consider PCSK9 inhibitor
High intensity goal: LDL ↓ ≥50% Moderate intensity goal: LDL ↓30 – 49%
If LDL ≥100 mg/dL, consider ezetimibe and then PCSK9 inhibitor
High intensity goal: LDL ↓ ≥50% Moderate intensity goal: LDL ↓30 – 49%
Goal: LDL ↓ ≥50% from baseline
Goal: LDL ↓ 30 - 49% from baseline
Goal: LDL ↓ 30 - 49% from baseline

High Risk Conditionsǂ
  • Age ≥65 years
  • Heart failure
  • Smoker
  • Diabetes
  • Prior CABG or PCI
  • Hypertension
  • Chronic kidney disease
  • LDL persistently ≥100 mg/dL
  • Heterozygous familial hyperlipidemia
Risk Enhancersǂǂ
  • Family history of early ASCVD
  • LDL persistently ≥160 mg/dL or TG ≥175 mg/dL
  • Chronic kidney disease
  • Metabolic syndrome
  • Inflammatory conditions (RA, psoriasis, HIV)
    Ethnicity (South Asian)
    Conditions in women that increase CV risk (e.g, menopause <40)
Adapted from Grundy S.M., et al. JACC. 2018 Nov 10. www.onlinejacc.org/guidelines/cholesterol

Smoking Cessation for ASCVD Prevention

One in three patients with HIV smokes and smoking accounts for about 60% of deaths among people living with HIV. Though the benefits of smoking cessation are clear, the literature suggests evidence-based treatment for smoking is underutilized, particularly among HIV patients.

Key Message 1

The 5 A’s is a quick and effective method to assess smoking cessation readiness and provide counseling.

Key Message 2

The 4 R’s is a useful method to prompt contemplation among smokers who are not yet ready to quit.

Key Message 3

Pharmacotherapy increases quit success rate. Combination nicotine replacement therapy, varenicline, and bupropion are considered first line and selection should be guided by patient preference and comorbidities.

The 5 A’s for Smoking Cessation

ASK
  • Ask about current and prior tobacco use.
  • Prior smokers: Congratulate and counsel on triggers avoidance to prevent relapse.
  • Current smokers: Assess frequency of use, types of tobacco product(s) used, and prior quit attempts.
ADVISE
  • Advise current users to quit and provide clear, strong, and personalized suggestions to help ensure success.
ASSESS
  • Assess willingness to quit.
  • If patient is not ready, move to the 5 R’s.
ASSIST
  • Assist patients ready to quit in setting a quit date in near future (2 – 4 weeks). Encourage them to share date with friends/family and request support.
  • Offer pharmacotherapy.
ARRANGE
  • Schedule follow up 1 – 2 weeks after quit date.
  • Remember relapses are common and the majority of those who relapse are ready to make another quit attempt within 30 days.

The 5 R’s for Patients Not Ready to Quit

RELEVANCE
  • Collaborate with patient to identify why quitting is personally relevant to them (i.e. comorbidities, cost, other life goals).
RISKS
  • Ask patient to explain their perceived risks of smoking.
REWARDS
  • Ask patient to identify benefits of quitting smoking.
ROADBLOCKS
  • Determine patient’s barriers to quitting. Remind patient that many tobacco users make repeat quit attempts before they are successful.
REPETITION
  • Repeat process at each visit

  • Health Changes After Quitting
    • In 20 min: HR and BP drop
    • In 12 hrs: CO level return to normal
    • In 2 weeks – 3 months: circulation & lung function improve
    • In 1 year: risk of CHD is reduced by half
    • In 5 years: stroke risk is the same as non-smokers











Smoking Cessation Agents
Common Adverse Effects
Interactions with Antiretrovirals
Other Considerations
Nicotine Replacement Therapy

  • Short acting: Gum, lozenges, inhaler, nasal spray
  • Long acting: Patch
  • Gum & lozenges: local irritation, GI upset
  • Inhaler/nasal spray: irritation to eyes, nose, and throat
  • Patch: local irritation, insomnia, vivid dreams
None expected
  • Gum: GI side effects tends to correlate with chewing intensity and are often worse with vigorous chewing.
  • Patch: can remove prior to bed if needed because of insomnia but may take up to 3 hours to return to therapeutic levels once reapplied.
Varenicline (Chantix®)
  • GI upset
  • Insomnia
  • Vivid dreams
None expected
  • Concurrent use with nicotine replacement therapy offers no benefit and may increase adverse effects.
  • Black Box Warning for neuropsychiatric effects removed in 2016 after literature showed no difference in incidence between varenicline and nicotine replacement therapy.
  • Evidence regarding risk of CVD is mixed, but overall indicates little to no excess risk, particularly among patients without existing CVD. The FDA recommends considering risks versus benefit in patients with baseline CVD.
Bupropion (Zyban®, Wellbutrin®)
  • Insomnia
  • Reduced seizure threshold (dose-dependent)
  • Ritonavir boosted PIs, efavirenz, or nevirapine may reduce bupropion concentrations.
  • Elvitegravir/cobicistat may increase bupropion concentrations.
  • Titrate bupropion dose based on clinical response.
  • Avoid in patients with a history of seizures.
  • Use with caution in patients at risk for seizures or using other agents (including alcohol) which may lower seizure threshold.
  • May be beneficial for patients with comorbid anxiety.

 Medication Adherence

Sub-optimal medication adherence is a leading cause of treatment failure. It has been estimated that only 50% of patients with a chronic illness maintain “good” adherence (defined as ≥80% of doses taken as prescribed).

Key Message 1

Consider non-adherence as a leading cause of treatment failure prior to increasing doses or adding additional medications.

Key Message 2

Patients often under-estimate the degree to which they do not take medications as prescribed; this may be intentional or unintentional.

Key Message 3

Create a non-judgmental atmosphere to identify and address underlying cause(s) of poor adherence.

Non-adherence is often unrecognized by patients & providers

Medication non-adherence is commonly overlooked by prescribers and under-reported by patients. A survey found 64% of patients believed they had “good” medication adherence and followed physician instructions “extremely closely” but…



49% had
forgotten to
take a
prescribed
medication


31% had not
filled a
prescription
they were
given


11% used an
OTC product
instead of
filling a
prescription


24% had
taken less
than the
recommended
dose

Uncovering Non-Adherence

  • “What have you read about your medications? Have you come across anything interesting in your research?”
  • “Do you have any concerns about the costs of your medications?”
  • “Before we start a second medication for your blood pressure, let’s talk about how you are taking the first. Your pharmacy history shows the medication was refilled 2 weeks later than we would expect if you were taking it every day. Thinking about the last week, were there any days you missed a dose?"

Addressing Non-Adherent Behaviors

Reason for Poor Adherence
Tools to Identify
Tools to Address
Asymptomatic Disease/
Lack of Perceived Benefit
  • Ask: “Do you feel this medication helps you?”
  • Be mindful, embarrassment or stigma may impact adherence.
  • Address misconceptions around asymptomatic diseases.
  • Empathize and provide access to supportive resources (i.e. patient groups, counselors, etc.).
Medication Cost
  • Ask: “Do you have any concerns about the cost of your medications?”
  • Request staff follows up 5 – 7 days after a new medication is prescribed to make sure it was picked up.
  • Prescribe generic medications whenever possible.
  • Consider combination products to reduce costs.
  • Prescribe agents on pharmacy $4 lists.
  • Use app “MMIT Formulary” to view drug coverage.
  • Even generic medications may be less expensive if the patient uses coupons from goodrx.com.
  • For brand name drugs, use manufacturer coupons or assistance programs: www.needymeds.org.
Lack of Transportation
  • Ask: “Do you have any problems getting to the pharmacy?”
  • Use pharmacy delivery programs (many independent pharmacies offer this free of charge).
  • Consider mail order pharmacies.
  • Prescribe 90-day supplies to minimize trips.
  • Work with the pharmacy to coordinate refills to occur on the same day.
Side Effects
(Fear of or Actual)
  • Ask: “How have you felt since starting the medication?”
  • Ask: “What have you come across in your research about your medications?”
  • Request staff follow up 2 weeks and 4 weeks after a medication is started or a dose is changed to make sure the patient is tolerating.
  • Set expectations for adverse effects and be clear that you will work with the patient to manage any tolerance issues.
  • If patients choose to conduct internet research, encourage use of reputable websites.
Forgetfulness
  • Ask: “What do you use to help you remember your medications?”
  • For patients on regimens with multiple daily doses, ask which dose they are most likely to miss.
  • Encourage use of reminder aids (i.e. alarms, apps).
  • Encourage patients to request refills when they have 5 – 7 days of medication remaining.
  • Use once-daily regimens whenever possible.
  • Advise patients to incorporate their medication timing into daily habits (i.e. place medications near coffee maker or on nightstand by bedroom light to be taken first thing in the morning or at night).
  • Simplify regimens and reduce polypharmacy whenever possible.
Cognitive Impairment or
Low Health Literacy
  • Use teach-back techniques to verify understanding.
  • Simplify regimen as much as possible (once-daily dosing, combination pills, reduce polypharmacy).
  • Engage a caregiver to assist.
  • Consider pre-fill medisets or blister packs.

 Assessing ASCVD Risk

Use of an ASCVD risk calculator improves risk assessment beyond clinician estimates. In the absence of formal risk calculation, clinician’s estimates are inaccurate and tend to underestimate ASCVD risk. In practice, clinicians tend to emphasize one or two risk factors and fail to appreciate the impact of compounded risk. To avoid underutilization of primary prevention strategies consider the following.

Key Message 1

Assessing ASCVD risk among PLH is best done using handheld or online risk calculation using the ACC/AHA ASCVD Risk Estimator Plus.

Key Message 2

Clinicians should recognize that HIV infection enhances risk for ASCVD meaning that actual risk often exceeds that calculated based on traditional risk factors.

Key Message 3

Use the ACC/AHA ASCVD Risk Estimator Plus for shared decision making with patients regarding ASCVD risk reduction using the ABCS (Aspirin, Blood pressure control, Cholesterol management, and Smoking cessation) based on National Guidelines for each.

National Clinical Practice Guidelines for management of hypertension (2017) and cholesterol (2018) recommend use of the American College of Cardiology/American Heart Association (ACC/AHA) ASCVD Risk Estimator Plus Calculator to estimate a patient’s 10-year ASCVD risk.

ASCVD Primary Prevention Pearls

Adults age 40-75 years being evaluated for CV disease prevention should undergo 10-year ASCVD risk estimation and have a clinician-patient risk discussion before starting pharmacologic therapy.
Use of risk calculation improves risk assessment beyond clinician estimates and results in greater reduction in risk factors without clinical harm. Assess ASCVD risk at an initial visit with a patient to establish a reference point and forecast the impact of various interventions on patient risk and reassess after implementing ABCs.

Assess for other risk enhancing factors to help guide decisions about primary prevention interventions in select individuals. HIV infection is a “risk-enhancing” factor associated with increased risk of an ASCVD event, impacting the 10-year risk estimate. HIV often increases risk 50-100% beyond calculated risk.

Risk-Enhancing Factors
  • Family history of early ASCVD

  • LDL persistently ≥160 mg/dL or TG ≥175 mg/dL

  • Chronic kidney disease

  • Metabolic syndrome

  • Inflammatory conditions (RA, psoriasis, HIV)

  • Ethnicity (South Asian)

  • Conditions in women that increase CV risk (e.g, menopause <40)

Shared Decision-Making


Resources and Tools

Inclusion Criteria

Patient
  • Age 40-75 years by 7/1/2018
  • HIV/AIDS diagnosis
  • Receipt of care within the participating practice
  • At ≥5% risk for CVD as calculated using the ASCVD Risk Estimator Plus
  • Current lipid values, i.e. within 15 months of enrollment Own a texting capable cellphone
  • Proficient in English or Spanish and is willing to participate
  • Expects to remain in the study throughout the entire study period

Clinician
  • Physician, nurse practitioner, or physician assistant who provides direct HIV care within a participating practice and is willing to participate

Practice
  • Serve a cohort of at least 100 HIV patients, have an Electronic Health Record (EHR) and agree to collaborate on implementing feasible adaptations of these strategies

Exclusion Criteria

Patient
  • Current participation in other CVD trials
  • Plans to leave the practice within 12 months
  • Pregnant
  • Experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA) or have had a CVD procedure such as installation of a stent or angioplasty
  • Have peripheral vascular disease
  • Intermittent claudication or peripheral arterial disease
  • Lack capacity to consent

Clinician
  • Plans to leave the practice within 12 months
Click Each Letter to View A B C S Goal Cards