Brownson, Ross C.

Chan, Philip A.

Crane, John S.

Harrison, Laura C.

Mayer, Kenneth H.

McBride, Timothy

Nunn, Amy S.

Oliver, Cheryl

Patel, Rupa R.

Perez, Maria M.

Salter, Amber

English

Digital Commons@Becker

Washington University School of MedicineDigital Commons@BeckerOpen Access Publications2019Successful linkage to pre-exposure prophylaxis forHIV prevention using a multicomponentimplementation strategy among the uninsured/underinsuredRupa R. PatelWashington University School of Medicine in St. LouisAmy S. NunnBrown UniversityKenneth H. MayerHarvard UniversityTimothy McBrideWashington University in St. LouisRoss C. BrownsonWashington University in St. LouisSee next page for additional authorsFollow this and additional works at: https://digitalcommons.wustl.edu/open_access_pubsThis Open Access Publication is brought to you for free and open access by Digital Commons@Becker. It has been accepted for inclusion in OpenAccess Publications by an authorized administrator of Digital Commons@Becker. For more information, please contact engeszer@wustl.edu.Recommended CitationPatel, Rupa R.; Nunn, Amy S.; Mayer, Kenneth H.; McBride, Timothy; Brownson, Ross C.; Oliver, Cheryl; Perez, Maria M.; Harrison,Laura C.; Salter, Amber; Crane, John S.; and Chan, Philip A., ,"Successful linkage to pre-exposure prophylaxis for HIV preventionusing a multicomponent implementation strategy among the uninsured/underinsured." AIDS Patient Care and STDs.33,2. 45-48.(2019).https://digitalcommons.wustl.edu/open_access_pubs/7711AuthorsRupa R. Patel, Amy S. Nunn, Kenneth H. Mayer, Timothy McBride, Ross C. Brownson, Cheryl Oliver, MariaM. Perez, Laura C. Harrison, Amber Salter, John S. Crane, and Philip A. ChanThis open access publication is available at Digital Commons@Becker: https://digitalcommons.wustl.edu/open_access_pubs/7711LETTER TO THE EDITORSuccessful Linkage to Pre-Exposure Prophylaxisfor HIV Prevention Using a MulticomponentImplementation Strategy Amongthe Uninsured/UnderinsuredRupa R. Patel, MD, MPH,1 Amy S. Nunn, MS, ScD,2,3 Kenneth H. Mayer, MD,4–6 Timothy McBride, PhD,7,8Ross C. Brownson, PhD,7 Cheryl Oliver,9 Maria M. Perez, PharmD,10 Laura C. Harrison, BA,11Amber Salter, PhD, MPH,12 John S. Crane, BA,1 and Philip A. Chan, MD, MS13To the Editor:Pre-exposure prophylaxis (PrEP) scale-up can con-tribute to reducing national HIV incidence.1 The PrEPcontinuum of care provides a programmatic framework inwhich linking HIV-uninfected individuals to care is a crucialstep for successful implementation.2 Barriers to linkage tocare (LTC) include lack of insurance coverage, access tocare, and clinic referral relationships with community part-ners.3–7 States with limited public insurance options havedisproportionate prescription-to-need ratios,8 emphasizinginsurance coverage’s prominent role in PrEP care.3,4,6 Weassessed LTC rates of a multicomponent community-basedimplementation strategy designed to link uninsured individ-uals to PrEP care in Missouri.The Washington University in St. Louis (WUSTL) Divi-sion of Infectious Diseases (ID) PrEP Program piloted amulticomponent implementation strategy to link individualsin the community to PrEP services from July 2014 to October2015. Strategy components included a telephone hotline,PrEP education, insurance navigation, medication paperworksupport, and appointment coordination.9,10 The hotline wasdisseminated to community partners, health departments, andother organizations through listservs, word of mouth and socialnetworks, flyers, and social media. Health providers also re-ferred individuals for LTC to the WUSTL PrEP Program.Referred individuals did not call the hotline. An ID physiciancontacted individuals who called or were referred within 7days. During this initial phone call, individuals were sur-veyed, presented information on PrEP and medication as-sistance programs, notified of insurance navigation andmedication paperwork support services and their contact in-formation, and provided a clinic appointment within 4 weeksthrough a network of PrEP clinics.Insurance navigation was provided by a local AIDS serviceorganization (ASO). Navigators were notified of individualswithout insurance or who requested support. Navigators con-tacted individuals, met them at their desired location within 1week, discussed insurance eligibility, assisted in enrollment,and reviewed PrEP clinic locations in the context of their in-surance options. Medication paperwork support was providedby an HIV specialty pharmacy. Pharmacists were notified ofindividuals who requested their services. Pharmacists con-tacted individuals and scheduled sessions to fill out paperwork.A retrospective analysis of LTC rates was performed. Theprimary outcome was LTC, defined as attendance of the firstPrEP clinical visit as a binary measure (yes/no). Time toLTC was measured by the number of days between the dateof the call/referral and clinic attendance, with an observa-tion period from the call/referral date to November 2015.1Division of Infectious Diseases, Washington University in St. Louis, St. Louis, Missouri.2Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.3The Rhode Island Public Health Institute, Providence, Rhode Island.4The Fenway Institute, Fenway Health, Boston, Massachusetts.5Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.6Division of Infectious Diseases, Harvard Medical School, Boston, Massachusetts.7George Warren Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri.8Center for Health Economics and Policy, Washington University in St. Louis, St. Louis, Missouri.9St. Louis Effort for AIDS, St. Louis, Missouri.10Gateway Apothecary, St. Louis, Missouri.11Warren Alpert Medical School, Brown University, Providence, Rhode Island.12Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.13Division of Infectious Diseases, Brown University, Providence, Rhode Island.Presented in part at the 2015 National HIV Prevention Conference; December 6–9, 2015, Atlanta, Georgia.AIDS PATIENT CARE and STDsVolume 33, Number 2, 2019ª Mary Ann Liebert, Inc.DOI: 10.1089/apc.2018.016545Downloaded by Washington Univ from www.liebertpub.com at 05/07/19. For personal use only. Lost to follow-up was defined as those unreachable after fivephone calls. Individuals were contacted to assess PrEP ini-tiation and 3-month retention, defined as self-reportedmedication use. This study was approved by the WUSTLInstitutional Review Board.Bivariate analyses were performed between the primaryoutcome and the covariates of age, gender, insurance type,men who have sex with men (MSM), having a current HIV-infected partner, called or referred, and navigation referraland attendance using logistic regression. Significant covari-ates were incorporated into the final multivariable logisticregression model to determine predictors of LTC. Odds ratios(ORs) and 95% confidence intervals (CIs) are reported. Allstatistical tests were two sided and the significance level wasset at 0.05. Analyses were performed using STATA version12.1 (College Station, TX).A total of 132 individuals called the hotline (n = 81) orwere referred (n = 51) for LTC. Follow-up occurred with93.8% of calls (vs. 76.5% referrals, p < 0.01). Callers re-ported learning about the hotline through an ASO (41.4%)or friend (26.4%). Most (86.3%) referrals were by WUSTLproviders. Only 10 callers sought information (i.e., sideeffects and costs), whereas the remaining 105 callers/re-ferrals requested PrEP. These individuals had a median ageof 30 years [interquartile range (IQR) 26–36], 91.4% weremen, 1.0% were transgender, 39.1% were black, 1.9% La-tino/Hispanic, 28.6% were uninsured, 79.1% identified asMSM, 45.7% had a current HIV-infected partner, 6.7% hadpericonception plans with their HIV-infected partner, andwere followed a median of 16.0 days (IQR 6.0–82.0) (range,2.0–315.0).Sixty-seven percent (70/105) of PrEP seekers were linkedto care; the median time to linkage was 7.5 days (IQR 5.0–17.0) (range, 2.0–164.0). Callers (vs. referrals) were morelikely to be linked (OR: 8.00, 95% CI: 3.21–19.95) and timeto linkage was sooner (median 7.0 vs. 16.0 days; p = 0.03).Individuals attended appointments at WUSTL (85.7%) orVeterans Affairs (2.9%) ID clinics, two community healthcenters (CHCs) (2.9%), three primary care private practices(5.7%), and an immigrant/refugee clinic (2.9%).Most (91.4%, 64/70) received a prescription, 98.4% (63/64) self-reported initiation, and 91.8% (45/49) had 3-monthretention. Reasons for not receiving a prescription includedindividuals declined citing their low risk (2/6), were not of-fered because their HIV-infected partners were undetectable(2/6) or had future periconception plans (1/6), and had in-complete laboratory testing (1/6).Forty-three percent (13/30) of the uninsured were linkedcompared with 76.0% (57/75) of the insured (OR: 0.24, 95%CI: 0.10–0.59). Ninety percent (27/30) of the uninsuredagreed to navigation, but 63.0% (17/27) attended and 47.0%(8/17) obtained insurance. The uninsured (vs. insured) hadover twice as long time to linkage (median 19.0 vs. 7.0 days;p = 0.01). Uninsured callers (vs. referrals) were more likely tolink to care (OR: 10.50, 95% CI: 1.89–58.36). Receivingnavigation (OR: 3.33, 95% CI: 0.63–17.57) and obtaininginsurance (OR: 4.38, 95% CI: 0.56–33.95) were associatedwith LTC.Fifty-four percent (22/41) of blacks were linked comparedwith 75.0% (48/64) of non-blacks (OR: 0.39, 95% CI: 0.17–0.89). Racial differences in baseline insurance coverage wereapparent (33.3% of blacks vs. 66.7% of non-blacks wereinsured; p = 0.06). Notably, 40.0% (10/25) of insured blacksdid not link to care versus 16.0% (8/50) of insured non-blacks( p = 0.02).Race, insurance, caller versus referral, and identifying asMSM were significant in bivariate analyses. When adjustingfor race and MSM, the insured (OR: 2.81, 95% CI: 1.03–7.68) and callers (OR: 5.12, 95% CI: 1.86–14.09) were morelikely to be linked (Table 1).Among individuals not linked (n = 35), 48.6% missed oneand 8.6% missed two appointments; 8.6% wanted to deter-mine insurance eligibility (i.e., attend a navigation and/orfuture Marketplace enrollment session) in anticipation of out-of-pocket costs before scheduling an appointment during thestudy period. Some (17.1%) were lost to follow-up due tobeing unreachable (2/6) or had changed contact informationduring appointment coordination (4/6). Others (17.1%)changed their minds about wanting PrEP citing high costs (2/6), altered periconception plans (1/6), or changed riskTable 1. Multivariable Logistic Regression Analysis for HIV Pre-Exposure Prophylaxis Linkage to CareAmong 105 Individuals in St. Louis, MissouriCharacteristics Unadjusted OR (95% CI) p Adjusted ORa (95% CI) pRace 0.025 0.575Non-black 1.0 1.0Black 0.39 (0.17–0.89) 0.75 (0.27–2.08)Insurance 0.002 0.045Uninsured 1.0 1.0Insured 4.14 (1.69–10.14) 2.81 (1.03–7.68)MSM 0.006 0.373No 1.0 1.0Yes 4.01 (1.50–10.67) 1.73 (0.52–5.82)Contact method <0.001 0.002Referral 1.0 1.0Caller 8.00 (3.21–19.95) 5.12 (1.86–14.09)aAdjusted for race, insurance, MSM, and contact method.OR, odds ratio; 95% CI, 95% confidence interval; aOR, adjusted odds ratio; MSM, men who have sex with men.46 PATEL ET AL.Downloaded by Washington Univ from www.liebertpub.com at 05/07/19. For personal use only. behaviors (3/6). Missed initial appointments were becauseindividuals forgot (4/20), were unavailable (2/20), hadchanging work schedules (3/20), had anticipated out-of-pocket costs beyond their budget (2/20), had unfinished in-surance processing (3/20), or were unknown (i.e., individualswere unreachable) (6/20).We demonstrated high linkage to PrEP care (66.7%) usinga multicomponent implementation strategy that was tailoredto meet the needs of residents with varying and dynamicallychanging insurance coverage in a state where public insur-ance eligibility is limited. This strategy built upon existinglocal stakeholder relationships for HIV care (e.g., navigation,pharmacy) and created new ones (e.g., clinics) to oper-ationalize PrEP LTC.9,10 Our study’s PrEP LTC (66.7%) washigher than that at a CHC (21.3%)6 or a public sexuallytransmitted diseases clinic (31.4%)7 due to differences instudy settings.Having insurance was a correlate of LTC in this study. Incontrast, Flash et al. and Bhatia et al. reported that ser-odiscordant relationships6 and age,7 respectively, werepredictors of LTC. However, similar to these studies, mostof the individuals who linked to care in our study also ini-tiated PrEP and had early retention. Furthermore, racialdifferences in LTC were observed in all three studies, whichoccurred in distinguishably different settings. Together,these findings highlight the need for implementation re-search surrounding culturally tailored LTC interventiondevelopment.We observed a notable number of missed appointmentsand prolonged LTC due to insurance processing and PrEPappointment scheduling during which individuals were lost.A longer observation time would have identified more ac-curate LTC estimates in this cohort since navigation atten-dance and fixed Marketplace enrollment periods delayedLTC for many, especially the uninsured. Identified chal-lenges in scheduling clinical visits included trying to coor-dinate individual and clinic availability in the context ofdynamic work schedules, uncertainty in insurance processingtimes, awaiting navigation attendance, and changing tele-phone numbers or being unreachable during business hours.Clinic referral relationships needed strengthening at the or-ganizational (vs. provider) level because scheduling centersrequired several phone calls for appointment approval withPrEP prescribing doctors and overbooking within 6 weeks. Inthe context of available resources, LTC interventions shouldincorporate evidence-based strategies such as appointmentreminders and accompaniment,9 nontelephone communica-tion (i.e., e-mail and text messages during evening andweekend hours), on-site insurance navigation, on-site visitswith same-day prescribing, and strengths-based case man-agement.11,12The study limitations include a small sample size, sin-gle site, few women, and limited individual characteristicson survey assessment. The hotline was affiliated with aprivate sector academic ID clinic, promoting selectionbias.Medicaid nonexpansion states have comparatively lowPrEP utilization.8 Therefore, tailoring LTC strategies toovercome structural barriers unique to this context is criti-cal.3,4 We demonstrated high rates of linkage to PrEP careusing a multicomponent implementation strategy, which in-cluded multiple community partnerships, to address theneeds of uninsured and underinsured individuals. Studyfindings can inform urgently needed LTC intervention de-velopment to improve outcomes at this critical step within thePrEP continuum of care.AcknowledgmentsR.R.P. is supported by the Washington University Instituteof Clinical and Translational Sciences grant UL1TR000448,subaward KL2TR000450, from the National Center for Ad-vancing Translational Sciences of the National Institutes ofHealth, and NIH R25MH83620. P.A.C. is supported by NIHgrants R34DA042648, R34MH110369, R21MH113431, andR21MH109360. P.A.C. and A.S.N. are supported by NIHgrants R34MH109371 and R01MH114657. A.S.N. is sup-ported by the NIH grant R25MH083620. K.H.M. is supportedby the Harvard Center for AIDS Research (P30 AI06354).Author Disclosure StatementR.R.P. receives compensation for consulting from GileadSciences, Inc. and ViiV Healthcare. K.H.M. has receivedunrestricted research grants from Gilead Sciences and ViiVHealthcare. For the remaining authors, there are no conflictsof interest.References1. Smith DK, Van Handel M, Grey J. Estimates of adults withindications for HIV pre-exposure prophylaxis by jurisdic-tion, transmission risk group, and race/ethnicity, UnitedStates, 2015. Ann Epidemiol 2018. [Epub ahead of print];DOI: 10.1016/j.annepidem.2018.05.003.2. Nunn AS, Brinkley-Rubinstein L, Oldenburg CE, et al.Defining the HIV pre-exposure prophylaxis care contin-uum. AIDS 2017;31:731–734.3. Patel RR, Mena L, Nunn A, et al. Impact of insurancecoverage on utilization of pre-exposure prophylaxis forHIV prevention. PLoS One 2017;12:e0178737.4. Marks SJ, Merchant RC, Clark MA, et al. Potentialhealthcare insurance and provider barriers to pre-exposure prophylaxis utilization among young men whohave sex with men. AIDS Patient Care STDs 2017;31:470–478.5. Doll M, Fortenberry JD, Roseland D, McAuliff K, WilsonCM, Boyer CB. Linking HIV-Negative Youth to Preven-tion Services in 12 U.S. Cities: Barriers and facilitators toimplementing the HIV prevention continuum. J AdolescHealth 2018;62:424–433.6. Flash CA, Adegboyega OO, Yu X, et al. Correlates oflinkage to HIV preexposure prophylaxis among HIV-testing clients. J Acquir Immune Defic Syndr 2018;77:365–372.7. Bhatia R, Modali L, Lowther M, et al. Outcomes of pre-exposure prophylaxis referrals from public STI clinics andimplications for the preexposure prophylaxis continuum.Sex Transm Dis 2018;45:50–55.8. Siegler AJ, Mouhanna F, Mera Giler R, et al. Distributionof Active PrEP Prescriptions and the PrEP-to-Need Ratio,US Q2 2017. Presented at: Conference on Retroviruses andOpportunistic Infections. Boston, MA. Abstract 1022LB.2018.LETTER TO THE EDITOR 47Downloaded by Washington Univ from www.liebertpub.com at 05/07/19. For personal use only. 9. Bradford JB, Coleman S, Cunningham W. HIV SystemNavigation: An emerging model to improve HIV care ac-cess. AIDS Patient Care STDs 2007;21:S49–S58.10. Powell BJ, Waltz TJ, Chinman MJ, et al. A refined com-pilation of implementation strategies: Results from theExpert Recommendations for Implementing Change(ERIC) project. Implement Sci 2015;10:21.11. Gilman B, Hidalgo J, Thomas C, Au M, Hargreaves M.Linkages to care for newly diagnosed individuals who testHIV positive in nonprimary care settings. AIDS PatientCare STDs 2012;26:132–140.12. Craw JA, Gardner LI, Marks G, et al. Brief strengths-basedcase management promotes entry into HIV medical care:Results of the antiretroviral treatment access study-II.J Acquir Immune Defic Syndr 2008;47:597–606.Address correspondence to:Rupa R. Patel, MD, MPHDivision of Infectious DiseasesWashington University in St. Louis660 South Euclid AvenueCampus Box 8051St. Louis, MO 63110E-mail: rupapatel@wustl.edu48 PATEL ET AL.Downloaded by Washington Univ from www.liebertpub.com at 05/07/19. For personal use only. 

Successful linkage to pre-exposure prophylaxis for HIV prevention using a multicomponent implementation strategy among the uninsured/underinsured

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Successful linkage to pre-exposure prophylaxis for HIV prevention using a multicomponent implementation strategy among the uninsured/underinsured

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