Impact on refill persistence after implementation of a new

therapy scheduled follow-up call by community-based

specialty pharmacists with patients initiated on HIV pre-
exposure prophylaxis

Rawan Zayed, PharmD.

Walgreens/UIC Community PGY1 Resident
Walgreens Specialty Pharmacy

Mentor: Andrew Halbur, BSPharm, BCACP, AAHIVP.

Walgreens at Howard Brown Sheridan
Clinic Pharmacy Manager
  I have no relevant financial conflicts of interest in relation to
this activity to disclose.

Disclosure  My mentor have no relevant financial conflicts of interest in

relation to this activity to disclose.
 Abbreviations

PrEP Pre-exposure Prophylaxis

STI Sextually Transmitted Infection

FTC emtricitabine

TAF tenofovir alafenamide

TDF tenofovir disoproxil fumarate

Truvada TDF/FTC

Descovy TAF/FTC
 In 2020, there were approximately 37.7 million
HIV-positive people worldwide

Incidence of HIV infections worldwide has

declined 30% since 2010, with 1.5 million new
Background HIV infections worldwide in 2020

An estimated 1.2 million persons have indications

for PrEP use

As an HIV prevention tool, pre-exposure

prophylaxis (PrEP) is becoming increasingly
popular
1. UNAIDS. Global AIDS Update 2020. Geneva: UNAIDS; 2020.
2. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update Clinical Practice Guideline. Accessed March 25, 2022.
 What is PrEP?

 PrEP (pre-exposure prophylaxis)
 FDA-approved daily regimen of anti-HIV medications that
greatly reduces risk of infection for HIV-negative people
 Truvada (TDF/FTC) approved in 2014
 Descovy (TAF/FTC) approved October 2019 – excludes those
who have receptive vaginal sex and cisgender women
 Daily PrEP proven to be safe and highly effective, reducing
the risk of getting HIV from sex by more than 90%
 Among patients with IVDU, HIV acquisition risk
reduced by more than 70%

Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410.
Product Information: TRUVADA(R) oral tablets, emtricitabine tenofovir disoproxil fumarate oral tablets. Gilead Sciences, Inc. (per FDA), Foster City, CA, 2013.
Product Information: DESCOVY(R) oral tablets, emtricitabine, tenofovir alafenamide oral tablets. Gilead Sciences Inc (per FDA), Foster City, CA, 2019.
 High Risk Populations

Men Who Have Sex with Men Heterosexual Women and Men Injection Drug Users

• Sexual partner with HIV • Sexual partner with HIV • HIV-positive injecting partner
• Recent bacterial STD • Recent bacterial STD High • Sharing injection equipment
• High number of sex partners number of sex partners • Recent drug treatment (but
• History of inconsistent or no • History of inconsistent or no currently injecting)
condom use Commercial sex condom use
work • Commercial sex work Lives in
high prevalence area or network

1. Product Information: TRUVADA(R) oral tablets, emtricitabine tenofovir disoproxil fumarate oral tablets. Gilead Sciences, Inc. (per FDA), Foster City, CA, 2013.
2. Product Information: DESCOVY(R) oral tablets, emtricitabine, tenofovir alafenamide oral tablets. Gilead Sciences Inc (per FDA), Foster City, CA, 2019.
3. USPHS. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014. http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
4. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update Clinical Practice Guideline. Accessed March 25, 2022.
PrEP Follow-Up

Timepoint Action Item

• Assess for adverse drug reactions

• Serum creatinine
30-day follow up • Assess for signs and symptoms of acute HIV infection
• Adherence and risk reduction counseling. Stress condom use.

• Repeat HIV testing and assess for signs or symptoms of acute infection to document that patients are still HIV negative
• Provide a prescription or refill authorization of daily PrEP medication for no more than 90 days
• Assess and provide support for medication adherence and risk-reduction behaviors

Every 3 months • Conduct STI testing for sexually active persons with signs or symptoms of infection and screening for asymptomatic MSM at
high risk for recurrent bacterial STIs
• Respond to new questions and provide any new information about PrEP use

• Document HIV status

PrEP Discontinuation • Understand reason for discontinuing PrEP

• Counsel based on recent adherence and risk behaviors

1. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update Clinical Practice Guideline. Accessed March 25, 2022.
 PrEP Persistence

 Survey evaluating persons undergoing HIV rapid

testing in Philadelphia between July 2012 and Dec 9.5%
2013
SELF Perception
 A large proportion of patients at high-risk for HIV
infection do not perceive themselves at high risk
 Access barriers to PrEP:
 Community stigma against PrEP use
 Individual knowledge and beliefs surrounding PrEP 
TESTERS Evaluation
 Adverse effects 68.5%
 Behavioral barriers
 Financial barriers
KwaKwa, H. et al. IAC 2014 Melbourne, Australia #TUPE090

1. KwaKwa, H. et al. IAC 2014 Melbourne, Australia #TUPE090

2. Jackson-Gibson M, Ezema AU, Orero W, et al. Facilitators and barriers to HIV pre-exposure prophylaxis (PrEP) uptake through a community-based intervention strategy among adolescent girls and young women in Seme Sub-County,
Kisumu, Kenya. BMC Public Health. 2021;21(1):1284. Published 2021 Jul 1. doi:10.1186/s12889-021-11335-1
3. Mayer KH, Agwu A, Malebranche D. Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review. Adv Ther. 2020;37(5):1778-1811. doi:10.1007/s12325-020-01295-0
PrEP Persistence
Study Design

• Coy et. Al persistence study

• N = 7,148 PrEP users in U.S. over a 2-year period
• Participants classified as persistent if they had 16 or more days of PrEP dispensed in 1 month for at least 3 quarters of a defined
timeframe

Persistence

• Year 1: 56%
• Year 2 : 63%

Factors associated with increased persistence:

• Male gender
• Age > 24 years
• Average monthly copay of < $20
• Commercially insurance
• Filling at local community specialty pharmacy

Coy et. Al. Persistence on HIV preexposure prophylaxis medication over a 2-year period among a national sample of 7148 PrEP users, United States, 2015 to 2017.  J Int AIDS Soc. 2019;22(2):e25252.
 PrEP Uptake

Co-located Prep & Primary Care vs. Separate Prep &

Primary Care
1.0
PrEP retention linked to being a primary
care patient in the clinic where PrEP was PrEP + primary care
0.8 PrEP care only
prescribed
0.6

On PrEP
HR 2.55, p<0.0001
0.4
PrEP in primary care associated with
increased retention and persistence 0.2

0.0
0 462 925 1388

Time in days

MSM, Men who have sex with men; SUNY, State University of New York; HR, Hazard ratio
1. Endreny, N, et al. AIDS 2020. PEC0603
2. MSM, Men who have sex with men; SUNY, State University of New York; HR, Hazard ratio Endreny, N, et al. AIDS 2020. PEC0603
 Medication Persistence

Telephone calls initiated within one month of diagnosis were associated with a small but
statistically significant increase in refill adherence

Delaying the phone call intervention until 1 month after diagnosis had no impact on adherence

Base analysis conducted at the study intervention site from January 2021 demonstrated that 26%
of patients failed to refill after initial 30-day supply of PrEP

Traditional Walgreens model initiates refill phone reminders at 25 days from previous fill

1. Rinfret et al. Telephone contact to improve adherence to dual antiplatelet therapy after drug-eluting stent implantation. Heart. 2013;99(8):562-569.
2. Eussen SR, et al. A pharmaceutical care program to improve adherence to statin therapy: a randomized controlled trial. Ann Pharmacother. 2010;44(12): 1905-1913.
3. Solomon et al. Osteoporosis telephonic intervention to improve medication regimen adherence: a large, pragmatic, randomized controlled trial. Arch Intern Med. 2012;172(6):477-483.
4. O’Connor PJ et al. Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes. Diabetes Care. 2014;37(12): 3317-3324.
Study Objectives

Primary objective

• Assess a pharmacist’s new to therapy seven-day follow-up call on

patient persistence at 30 days after PrEP initiation
• Persistence: A timely refill one month from initial fill with a
permissible range of 7 days

Secondary Objective

• Identify factors associated with PrEP adherence at 30 days

Methods – Study Design
Pharmacist conducted a new to therapy follow-up call
• Within 7 days of patient initiating PrEP

New to therapy follow up call collected information on the following:

• Adverse drug reactions
• Possible adherence barriers or access to care barriers
• Payment assistance or access to support services
• Confirmation of PrEP follow-up appointment with provider 

Participants were screened between July 1, 2021, to December 31, 2021

• Intervention started: October 1, 2021
• Pre- and post-intervention data was analyzed 

The project received an IRB exemption from Howard Brown Health 

Methods
Setting

• Three community-based specialty pharmacy locations centered in outpatient-based

primary health care clinics which serve an LGBTQ+ population.

Intervention site

• Howard Brown Health (HBH) Sheridan

Control site

• Howard Brown Heath (HBH) Clark and Halsted

 Methods

Inclusion Criteria Exclusion Criteria Data Analysis

• Participants > 18 years of • Persons with prior HIV or • Data collected was
age newly initiated on hepatitis B (HBV) analyzed using a chi-
PrEP between July 2021 to infection square test to measure
December 2021 • Patients using either statistical significance for
Descovy (TAF/FTC) or the 30-day persistence
Truvada (TDF/FTC) for
post-exposure prophylaxis
(PEP)
• Pregnant patients
• Children and adolescents
< 18 years of age
Methods
Inclusion Criteria

• Participants > 18 years of age newly initiated on PrEP between July 2021 to December 2021

Exclusion Criteria

• Persons with prior HIV or hepatitis B (HBV) infection, patients using either Descovy (TAF/FTC)
or Truvada (TDF/FTC) for post-exposure prophylaxis (PEP), pregnant patients, and children and
adolescents < 18 years of age

Data Analysis

• Data collected was analyzed using a chi-square test to measure statistical significance for the 30-
day persistence
30-day Refill Persistence Pre/Post-Intervention
 Results

Impact of counseling and scheduled follow-up on one-month persistence in

intervention group

Yes No/Unknown p-Value

Clinic Follow-up 44/48 (91.7%) 37/76 (48.7%) p <0.00001

Appointment
Completed Intervention 53/62 (85.5%) 28/62(45.2%) p <0.00001
 COVID-19 Impact on PrEP

Potential impacts of COVID-19 pandemic surge

• 85% of HIV programs in 106 countries have been affected by disruptions to service delivery
• Production and distribution of generic antiretrovirals declining due to lockdowns and border closures and results
in increased costs
• WHO predicts that a six-month disruption of ART could cause more than 500,000 additional AIDS-related
deaths

COVID-19 has highlighted long standing issues influencing exclusion from access to
health services
• COVID-19 hot spots overlap with areas with higher HIV incidence and prevalence in the United States
• Role of social determinants of health (access to health care, education, employment, housing, discrimination,
cultural competence, quality of care, etc.)
Conclusion
A new therapy phone call initiated within 7 days of PrEP initiation did not impact refill
persistence as seen by the lack of statistical significance for the primary outcome.

Statistically significant differences were observed among participants who completed the
intervention and/or had a follow-up appointment scheduled

Sub-analyses review suggests that patients are more likely to be engaged in their care are
also more likely to schedule clinic follow-ups or answer their phone.

Efforts to expand and optimize HIV prevention services should focus on interventions
that improve retention in PrEP care as PrEP uptake continues to increase.
Post-Test Question #1: Which of the following predictive factors is
not associated with increased PrEP persistence?

a) Use of traditional retail pharmacy

b) Average monthly copays of less than $20
c) Use of a specialty pharmacy
d) Access to a health insurance
Post-Test Question #1: Which of the following predictive factors is
not associated with increased PrEP persistence?

a) Use of traditional retail pharmacy

b) Average monthly copays of less than $20
c) Use of a specialty pharmacy
d) Access to a health insurance
Post-Test Question #2: Which of the following is an example of an
access barrier that would lead a patient to stop PrEP?

a) Adverse drug effect

b) Change in sexual behavior
c) Language barrier
d) PrEP stigma
Post-Test Question #2: Which of the following is an example of an
access barrier that would lead a patient to stop PrEP?

a) Adverse drug effect

b) Change in sexual behavior
c) Language barrier
d) PrEP stigma
Acknowledgements

Drew Halbur, PharmD, BCACP, AAHIVP

Judy Sommers-Hanson, PharmD, FAPhA

Michelle Evers, CNP

Questions?
 1. UNAIDS. Global AIDS Update 2020. Geneva: UNAIDS; 2020.
2. Centers for Disease Control and Prevention (CDC), US Public Health Service. Preexposure Prophylaxis for the Prevention of
HIV Infection in the United States—2017 Update: A Clinical Practice Guideline. CDC website. 
https://www-cdc-gov.proxy.cc.uic.edu/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Published March 2018. Accessed
August 28, 2021.
3. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J
Med. 2012;367(5):399-410. doi:10.1056/NEJMoa1108524
4. Product Information: TRUVADA(R) oral tablets, emtricitabine tenofovir disoproxil fumarate oral tablets. Gilead Sciences, Inc.
(per FDA), Foster City, CA, 2013.
5. Product Information: DESCOVY(R) oral tablets, emtricitabine, tenofovir alafenamide oral tablets. Gilead Sciences Inc (per
FDA), Foster City, CA, 2019.
6. USPHS. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014.
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
7. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update Clinical Practice Guideline.
Accessed March 25, 2022.
8. KwaKwa, H. et al. IAC 2014 Melbourne, Australia #TUPE090

References 9. Jackson-Gibson M, Ezema AU, Orero W, et al. Facilitators and barriers to HIV pre-exposure prophylaxis (PrEP) uptake
through a community-based intervention strategy among adolescent girls and young women in Seme Sub-County, Kisumu,
Kenya. BMC Public Health. 2021;21(1):1284. Published 2021 Jul 1. doi:10.1186/s12889-021-11335-1
10. Mayer KH, Agwu A, Malebranche D. Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative
Review. Adv Ther. 2020;37(5):1778-1811. doi:10.1007/s12325-020-01295-0
11. Coy KC, Hazen RJ, Kirkham HS, Delpino A, Siegler AJ. Persistence on HIV preexposure prophylaxis medication over a 2-
year period among a national sample of 7148 PrEP users, United States, 2015 to 2017. J Int AIDS Soc. 2019;22(2):e25252.
doi:10.1002/jia2.25252
12. Endreny, N, et al. AIDS 2020. PEC0603
13. MSM, Men who have sex with men; SUNY, State University of New York; HR, Hazard ratio
14. Rinfret S, Rodés-Cabau J, Bagur R, et al. Telephone contact to improve adherence to dual antiplatelet therapy after drug-eluting
stent implantation. Heart. 2013;99(8):562-569. doi:10.1136/heartjnl-2012-303004
15. Eussen SR, van der Elst ME, Klungel OH, et al. A pharmaceutical care program to improve adherence to statin therapy: a
randomized controlled trial. Ann Pharmacother. 2010;44(12): 1905-1913. doi:10.1345/aph.1P281
16. Solomon DH, Iversen MD, Avorn J, et al. Osteoporosis telephonic intervention to improve medication regimen adherence: a
large, pragmatic, randomized controlled trial. Arch Intern Med. 2012;172(6):477-483. doi:10.1001/archinternmed .2011.1977
17. O’Connor PJ, Schmittdiel JA, Pathak RD, et al. Randomized trial of telephone outreach to improve medication adherence and
metabolic control in adults with diabetes. Diabetes Care. 2014;37(12): 3317-3324. doi:10.2337/dc14-0596