Due July 26 at 11:59 PM Evaluating Qualitative and Quantitative Studies Using the South University Online Library, find one qualitative and one quantitative study. Summarize each study using short pa

Research \brticle Percepti\bns \bf Pe\bp\fe Living with HIV and HIV Hea\fthcare Pr\bviders \bn Rea\f-Time Measuring and M\bnit\bring \bf Antiretr\bvira\f Adherence Using Ingestib\fe Sens\brs: A Qua\fitative Study Susan Kama\f ,1Marc I. R\bsen, 2Christina Lazar, 2Lisa Siqueir\bs, 3Yan Wang, 1,4 Eric S. Daar, 3and H\bnghu Liu 1,4,5 \fUniversity of California, Los \bngeles, School of Dentistry, Division of Public Health and Community Dentistry, Los \bngeles, C\b, US\b 2Yale University School of Medicine, Department of Psychiatry, New Haven, CT, US\b3'e Lundquist Institute at Harbor-UCL\b Medical Center, Los \bngeles, C\b, US\b4University of California, Los \bngeles, Fielding School of Public Health, Department of Biostatistics, Los \bngeles, C\b, US\b5University of California, Los \bngeles, David Geffen School of Medicine, Department of Medicine, Los \bngeles, C\b, US\b Correspon\bence shou\f\b be a\b\bresse\b to Susan Kama\f; susan.kama\f@gmai\f.co\bm Received 14 January 2020; Revised 25 April 2020; Accepted 8 May 2020; Published 1 June 2020 Aca\bemic E\bitor:

Davi\b Katzenstein Copyright ©2020 Susan Kama\f et a\f. *is is an open access artic\fe \bistribute\b un\ber the Creative Commons Attribution License, which permits unrestricte\b use, \bistribution, an\b repro\buction in any me\bium, provi\be\b the origina\f work is proper\fy cite\b.

Objective. To \bescribe an\b ana\fyze the perception an\b attitu\bes of peop\fe \fiving with HIV (PLWH) an\b HIV HCPs towar\bs me\bication a\bherence with a focus on a \bigita\f me\bicine program (DMP) with ingestib\fe sensors (ISs). Methods. *is is a qua\fitative ana\fysis pi\fot stu\by of PLWH who were using DMP recruite\b by purposive samp\fing. A convenience samp\fe of HCPs was interviewe\b. Semistructure\b interviews were con\bucte\b, an\b thematic ana\fysis was performe\b. Results. Fifteen PLWH were interviewe\b, an\b thematic ana\fysis resu\fte\b in three main themes: se\ff-i\bentifie\b me\bication a\bherence patterns, experiences with the DMP, an\b recommen\bing the DMP to others. Six hea\fth care provi\bers (HCPs) \bescribe\b barriers an\b faci\fitators to a\b- herence, as we\f\f as a\bvantages an\b \bisa\bvantages of using or recommen\bing the DMP to PLWH. Conclusion. *is stu\by eva\fuate\b participant an\b provi\ber responses to DMP, which is a nove\f techno\fogy for rea\f-time measuring an\b monitoring a\bherence with the IS. Participant an\b provi\ber responses were mixe\b, high\fighting both the a\bvantages an\b \fimitations of the techno\fogy.

Practice Implications. Taking PLWH experiences into consi\beration wi\f\f enhance the \beve\fopment of this an\b other usefu\f too\fs that c\finicians an\b researchers can use for enhance\b patient care. 1. Backgr\bund *e success of antiretrovira\f therapy (ART) has ma\be HIV infection a manageab\fe, chronic con\bition [1]. A\fthough current regimens are more forgiving to occasiona\f misse\b \boses, a\bherence remains an important pre\bictor of suc- cessfu\f viro\fogic suppression [2]. Me\bication a\bherence is genera\f\fy \befine\b as the extent to which the patient fo\f\fows a me\bication regimen as inten\be\b by the prescriber in co\f- \faboration with the patient [3]. Me\bication a\bherence has three phases: initiation, which marks the start of the treatment; imp\fementation, which marks the extent to which the patient fo\f\fows the \bosing regimen; an\b fina\f\fy, persis- tence, which marks the continuation of treatment [4].

Nona\bherence can occur in any of those phases, such as, noninitiation, premature interruption of treatment, \befine\b as nonpersistence, or suboptima\f imp\fementation with iso\fate\b or c\fustere\b misse\b \boses. ART nona\bherence may cause suboptima\f c\finica\f outcomes such as an increase\b vira\f \foa\b an\b a \becrease\b CD4 ce\f\f count [5]. A mu\fti- centere\b stu\by con\bucte\b among 768 HIV patients in the U.S., which assesse\b the re\fationship between the \fength of HindawiAIDS Research and TreatmentVolume 2020, Article ID 1098109, 10 pageshttps://doi.org/10.1155/2020/1098109 consecutive treatment interruption an\b increase\b vira\f \foa\b, showe\b that vira\f \foa\b starts to increase after 48 hours of consecutive treatment \biscontinuation [6]. Hence, time\fy fee\bback on \fapses in me\bication a\bherence is necessary to maintain vira\f suppression.*ere are severa\f ways to measure me\bication a\bherence, such as pi\f\f counts, patient se\ff-reports, pharmacy refi\f\f, an\b e\fectronic monitors [7]. Even though these measures are wi\be\fy use\b in c\finica\f practice an\b research, they are a\f\f proxies an\b infer to actua\f \brug intake behavior. A\b\bi- tiona\f\fy, they \bo not actua\f\fy confirm ingestion of the me\bication or provi\be rea\f-time fee\bback to patients or provi\bers about true a\bherence. Prior to rea\f-time a\bherence monitoring, e\fectronic monitoring (e.g., Me\bication Event Monitoring System (MEMS©)) was consi\bere\b as high\fy accurate [7]. However, there are a number of prob\fems with e\fectronic monitoring that make their measurement of a\bherence suboptima\f, such as “pocket-\bosing” when pa- tients take severa\f pi\f\fs out of the pi\f\fbox in a\bvance for \fater use or when the pi\f\fbox is opene\b but pi\f\fs are not ingeste\b [8, 9]. Other more accurate metho\bs such as \brug \feve\fs (p\fasma, urine, an\b sa\fiva) are expensive an\b subject to “white-coat” a\bherence [10]. Rea\f-time monitoring with ingestib\fe sensors of a\bherence can provi\be a more re\fiab\fe a\fternative to e\fectronic monitors [11–13]. In a\b\bition, rea\f- time monitoring provi\bes the possibi\fity for patients to receive \bistant counse\fing, for examp\fe, when they miss taking their me\bication. It a\fso prevents exten\be\b perio\bs of time with poor a\bherence which may otherwise go un- \bocumente\b an\b unnotice\b by the hea\fthcare provi\ber.

Furthermore, not a\f\f rea\f-time a\bherence monitoring \be- vices confirm actua\f pi\f\f-ingestions, for examp\fe, Wisepi\f\f© (an Internet-enab\fe\b me\bication \bispenser). A \bigita\f me\bication program (DMP) (Figure 1), which inc\fu\bes an ingestib\fe sensor coencapsu\fate\b with me\bica- tions (Figure 2), a wearab\fe patch, a patient mobi\fe app (iPa\b), an\b a provi\ber web porta\f for rea\f-time assessments of me\bication ingestion, was recent\fy \beve\fope\b. ARV pi\f\fs are coencapsu\fate\b with an ingestib\fe sensor in each pi\f\f. *e sensor is activate\b when the patient swa\f\fows the pi\f\f an\b it enters the stomach. Once the capsu\fe \bisso\fves an\b the stomach flui\b reaches the sensor, it then sen\bs a signa\f to a wearab\fe patch on the in\bivi\bua\f’s bo\by which, in turn, sen\bs the \bata to a mobi\fe \bevice via B\fuetooth. *ese \bata are transferre\b from the \bevice to a secure server that can be accesse\b by authorize\b thir\b parties, such as their HCPs, via a web-interface. *is a\f\fows rea\f-time confirmation of in- gestion, which in turn a\f\fows for rea\f-time monitoring of a\bherence an\b appropriate \birection of resources for en- hancement of interventions by HCPs an\b researchers, e.g., SMS remin\bers in case of a misse\b \bose. *e DMP was \beve\fope\b by Proteus Digita\f Hea\fth an\b has been approve\b by the FDA. Severa\f peer-reviewe\b pub\fications have \be- scribe\b its safe use an\b accuracy in measuring a\bherence in patients with tubercu\fosis, schizophrenia, an\b ki\bney transp\fantation [8, 14–17]. In our stu\by, Proteus provi\be\b technica\f te\fephone support in case there were prob\fems encountere\b with the \bevice use. In this stu\by, our aim was to \bescribe an\b ana\fyze the perception an\b attitu\bes of PLWH an\b HIV HCPs towar\bs me\bication a\bherence in genera\f an\b rea\f-time me\bication a\bherence with a focus on the DMP. 2. Meth\bds PLWH were recruite\b as part of an open-\fabe\f pi\fot stu\by prece\bing an ongoing c\finica\f tria\f (tria\f registration number is https://c\finica\ftria\fs.g\bov/ct2/show/NCT02797262 for measuring an\b monitoring a\bherence to ART with the DMP between February an\b September 2017. *e aim of the pi\fot stu\by was to \betermine the acceptabi\fity an\b feasibi\fity regar\bing the use of the DMP before the tria\f starte\b among PLWHIV [18]. HCPs were recruite\b an\b interviewe\b in June-Ju\fy 2019. *e initia\f resu\fts were share\b in the 12th Internationa\f Conference on HIV Treatment an\b Prevention A\bherence (IAPAC) in June 2017 [19], an\b the resu\fts confirme\b that the \brug \feve\fs of six \bifferent coencapsu\fate\b ARVs were consistent with historica\f va\fues. *e ongoing c\finica\f tria\f has a bigger samp\fe size (n �120) an\b \fonger fo\f\fow-up (28 weeks) than the pi\fot stu\by.

2.\f. Setting, Recruitment, Inclusion Criteria, and Data Collection. *e recruitment of PLWH who participate\b in the pi\fot DMP stu\by an\b HIV HCPs was con\bucte\b at the Los Ange\fes Biome\bica\f Research Institute at Harbor-UCLA Me\bica\f Center, a research institute of a safety net hospita\f in Los Ange\fes, Ca\fifornia, via purposive samp\fing [20]. *e inc\fusion criteria were as fo\f\fows: HIV-infecte\b in\bivi\bua\fs in HIV care; greater than 17 years of age; ab\fe to take coencapsu\fate\b ARVs at the time of screening; ab\fe to provi\be informe\b consent; on ART with current or at an increase\b risk of suboptima\f a\bherence estimate\b by either the patient (se\ff-reports <90% a\bherence over \fast 28 \bays by asking patients how many \boses were misse\b) or treating HCP perception (e.g., base\b on misse\b c\finic visits or vira\f \foa\b e\fevations (vira\f \foa\b >200 copies/mL) within the \fast 6 months). Patient fo\f\fow-up was per stan\bar\b of care, in c\finic, accor\bing to the US Department of Hea\fth an\b Human Services (DHHS) gui\be\fines [21]. Participants in the pi\fot DMP stu\by were approache\b about the stu\by an\b, if wi\f\fing, provi\be\b fu\f\f stu\by \bisc\fosure an\b metho\bo\fogy, as we\f\f as provi\be\b informe\b consent for qua\fitative interviews, au\bio taping, an\b ana\fysis of the information. Semi- structure\b te\fephone interviews were con\bucte\b three \bays after beginning use of the system an\b again at week two an\b at the first of the month\fy face-to-face \bata co\f\fection visits for the DMP pi\fot stu\by. *e interviews were a\f\f con\bucte\b by the stu\by coor\binator (L. S.), who was traine\b in qua\f- itative interviewing an\b was provi\be\b with a semistructure\b interview gui\be (Appen\bix I-a). *e interview gui\be referre\b to this a\bherence measuring an\b monitoring system as the Ingestion Sensory System but is referre\b to here as the DMP. Each patient was pai\b $50 compensation for each DMP pi\fot stu\by visit (of the three interviews inc\fu\be\b in the qua\fitative stu\by, one was con\bucte\b \buring a face-to-face 2 AIDS Research an\b Treatment DMP stu\by visit an\b was compensate\b, an\b the rest were con\bucte\b over the phone).HIV HCPs working in the c\finic where the DMP pi\fot stu\by was con\bucte\b were recruite\b through convenience samp\fing for enro\f\fment in a qua\fitative interview stu\by by sen\bing them informationa\f emai\fs about the stu\by an\b fo\f\fow-up remin\ber emai\fs to nonrespon\bers. Some of the HIV HCPs care\b for PLWH enro\f\fe\b in the DMP pi\fot stu\by, an\b others \bi\b not have any PLWH enro\f\fe\b in the stu\by.

*e interviews were con\bucte\b by phone, an\b a\f\f partici- pants agree\b to au\bio-recor\b the interviews. HCPs were interviewe\b using semistructure\b interviews using a semi- structure\b interview gui\be (Appen\bix I-b), by the first au- thor (S. K.) who is a pharmacist an\b a traine\b qua\fitative researcher. HCPs were not remunerate\b for participation.

2.2. Data \bnalysis. Demographic an\b c\finica\f characteristics of participants inc\fu\bing PLWH an\b HIV HCPs were \be- scribe\b using frequencies an\b percentages or me\bian an\b interquarti\fe ranges as appropriate. A\f\f ana\fyses were comp\fete\b using the R statistica\f package, version 3.3, an\b RStu\bio version 1.0.136 (R, a \fanguage an\b environment for statistica\f computing, R Foun\bation for Statistica\f Com- puting, Vienna, Austria (URL: http://www.R-project.org)).\b A\f\f interviews were transcribe\b verbatim by the computer- assiste\b qua\fitative \bata ana\fysis package “QSR NVIVO version 10” [22]. Content ana\fysis was con\bucte\b to i\bentify patterns an\b commona\fities in the \bata [23]. *e co\bing was \bone by two in\bepen\bent raters (S. K. an\b C. L.). *e first rater (S. K.) i\bentifie\b an\b groupe\b the \bifferent themes together, an\b then the other rater (C. L.) \biscusse\b them.

*ere was consensus between the two raters on the themes i\bentifie\b, which strengthens the re\fiabi\fity of the ana\fysis.

2.3. Ethical Review.

*is stu\by was approve\b by the UCLA- Harbor Institutiona\f Review Boar\b (IRB) committee (IRB number 30621-01, approve\b on 06/07/2017) an\b UCLA IRB committee (IRB number IRB#19-000910, approve\b on 6/13/ Figure 1: Digita\f me\bicine program. Figure2: Coencapsu\fation of antiretrovira\fs. AIDS Research an\b Treatment 3 The app allows patients to see their medicationtaking, activity, and rest patterns and share this with their healthcare team via the portal The patch records heart rate, body position, and time of medication detection andrelays this information to the app The sensor sends a signal to the patch when it reaches the stomach Medication with sensor Patch Discover app Discover portal Used by patient Used by healthcare teams The sensor is coated to createthe small Proteus sensor pill.

Prescribed medication The sensor is the size of a grain of sand and made from minerals found in food. it passes through the body naturally, just like fiber. On order of a physician, a pharmacist puts a Proteus sensor pill inside a capsule, along with each dose of a patient’s medication 2019). A\f\f co\f\fecte\b \bata an\b information were store\b on a passwor\b-protecte\b computer an\b accesse\b on\fy by the researchers. Fu\f\f names of participants inc\fu\bing PLWH an\b HIV HCPs were not recor\be\b; they were assigne\b co\bes instea\b to ensure their anonymity.

3. Resu\fts Fifteen PLWH were inc\fu\be\b. One \bec\fine\b au\bio-recor\b- ing. Base\fine characteristics are presente\b in Tab\fe 1. Six HCPs were inc\fu\be\b an\b are \bescribe\b in Tab\fe 2. *e thematic ana\fysis resu\fte\b in themes pertaining to the fo\f- \fowing broa\b topics: se\ff-i\bentifie\b patient me\bication a\b- herence patterns; experiences with the DMP system inc\fu\bing the patch, the pi\f\f, the text messages, an\b the tab\fet; opinions on the DMP system technica\f support; recom- men\bations for improving the system for patient interviews.

*e main themes (co\be categories) from the HCP interviews were as fo\f\fows: barriers an\b faci\fitators to antiretrovira\f a\bherence; a\bvantages an\b \bisa\bvantages of the DMP; an\b recommen\bing the DMP. In the fo\f\fowing sections, we \biscuss the themes in more \betai\f.

4. Secti\bn I: PLWH 4.\f. Self-Identified Medication \bdherence Patterns.PLWH \bescribe\b severa\f se\ff-management techniques when aske\b how they usua\f\fy took their me\bication an\b how they remembere\b to take it. For examp\fe, six participants \bescribe\b taking the me\bication at a specific time every \bay: “I pretty much take the medication approximately within 2 hours of waking up in the morning around 8 am to 9 am” (P8, ma\fe, b\fack, 51, an\b \betectab\fe), “I take it with food around 7 o’clock” (P7, ma\fe, b\fack, 51, an\b un\betectab\fe). One participant \bescribe\b keeping the me\bication in a certain \focation, to he\fp them remember: “I keep it on the night stand next to me in the bed, so it’s really the first, first, thing I do when I wake up” (P11, ma\fe, Latino, 44, an\b un\betectab\fe). Two \bescribe\b using a\farms: “Well I have my alarm set on my phone every night at 7pm. So, when it goes off I either take it with a piece of fruit or something. For when I am not home, I make sure to take it when I get home immediately” (P1, ma\fe, b\fack, 51, an\b un\betectab\fe). One \bescribe\b the ai\b of pi\f\fboxes: “I put the medication in weekly little boxes Monday to Sunday and that’s how I’m remembering to take it and I have all my meds in one little pillbox like they’re all divided each day.

Everything’s just together and that way I don’t have to go through all the bottles” (P14, ma\fe, white, 57, an\b un\betectab\fe).

When PLWH were aske\b how they remember to get their me\bication from the pharmacy, for examp\fe, one \bescribe\b getting a ca\f\f to pick it up: “My pharmacist calls me up every month on the phone or even message that the medication is ready to pick it up and I go pick it up immediately, I don’t wait a day or two” (P2, ma\fe, Latino, 58, an\b \betectab\fe). Partic- ipants were aske\b about times when they change\b their me\bication-taking routine an\b how they a\bapte\b their me\bication a\bherence behavior. One respon\be\b as fo\f\fows: “I only change it when I go to my cousin’s house to spend the night with them or my sister’s house. So I’ll have a little container that contains my evening and morning medication” (P2, ma\fe, Latino, 58, an\b \betectab\fe).

4.2. Experiences with the DMP. PLWH were aske\b to \bescribe their experiences using the DMP at \bay 3, week 2, an\b week 4 of the 16-week DMP pi\fot stu\by. *ey were aske\b about specific aspects of the DMP inc\fu\bing the coencapsu\fate\b pi\f\f, the patch, getting text messages, an\b using the tab\fet.

4.3. Coencapsulated Pill. PLWH were aske\b about using the coencapsu\fate\b pi\f\fs with the sensor in them. Five participants foun\b it easy to take: “It’s not difficult, if anything it’s easier because of the coating of the capsule, it’s not too big, I just take the pill, I swallow with water or coffee, it’s pretty simple, easy not too hard to digest” (P8, ma\fe, b\fack, 53, \betectab\fe). Another sai\b as fo\f\fows: “It’s just a little bigger than usual because I’m used to taking, but it’s probably no bigger than an 800 mg Ibuprofen, so I don’t have a problem with it” (P11, ma\fe, Latino, 44, an\b un\betectab\fe). Others ha\b a \bifferent opinion: “'ey are over-sized. I guess you can make them smaller to be more swallow-able” (P7, ma\fe, b\fack, 51, an\b un\betectab\fe). T\bble1: Base\fine characteristics of PLWH.

Characteristics (n �15) Mean (SD) or n (%) Age, yrs 50 (6.9) Gen\ber Ma\fe 13 (86.7%) Race an\b ethnicity B\fack 7 (46.7%) Hispanic white 6 (40.0%) Non-Hispanic white 2 (13.3%) Se\ff-i\bentifie\b major source of HIV infection MSM 9 (60.0%) Heterosexua\f sex 5 (33.3%) IV \brug use 1 (6.7%) Duration since HIV \biagnosis, yrs 16 (7.0) Most recent CD4 count, ce\f\fs/uL (min, max) 774.2 (275, 1375) Most recent p\fasma HIV RNA Un\betectab\fe (<20 copies/mL) 10 (66.7%) Detectab\fe (≥20 copies/mL) 4 (26.7%) Unknown 1 (6.7%) Se\ff-reporte\b misse\b \boses in the past month ∗ 0 3 (20%) 1-2 3 (20%) >2 5 (33.3%) Unknown 4 (26.7%) Misse\b c\finic visits in the past 6 months None 8 (53.3%) 1 2 (13.3%) >1 3 (20%) Unknown 2 (13.3%) ∗A\f\f patients were on one pi\f\f once-\bai\fy ARV regimens. SD, stan\bar\b \beviation; MSM, men who have sex with men; HIV, human immuno\be- ficiency virus; IV, intravenous; ARV, antiretrovira\f; PLWH, peop\fe \fiving with HIV. 4 AIDS Research an\b Treatment 4.4. Patch.PLWH were aske\b about wearing the DMP patch. Seven participants foun\b it inconvenient, for exam- p\fe, P7 (ma\fe, b\fack, 51, an\b un\betectab\fe), “Sometimes it itches. Sometimes when I sweat it won’t stick, then it falls off then I have to change the patch. I wanted to make sure it stuck to my skin so I might have pushed it too hard, so if I take it off it kind of hurts. It is kind of inconvenient to me when I take a shower” an\b P15 (ma\fe, b\fack, 53, an\b un\betectab\fe), “Well it keeps frustrating me because it’s been quite hot and I’ve been sweating and most of the time it’s about problems keeping it patched on.” Others have a\bapte\b to it over time: “\bt first I had to get used to it, but I’m used to it now. \bnd I put a piece of like medical adhesive tape over it, so it won’t fall off and make sure it stays on. 'e heat loosens it.” (P14, ma\fe, white, 57, an\b un\betectab\fe). Others reporte\b no prob\fems: “It is comfortable, it has not given me any side effects of any sort, it is working well” (P2, ma\fe, Latino, 58, an\b \betectab\fe).

4.5. Text-Messaging. When aske\b about getting text mes- sages, five PLWH foun\b them he\fpfu\f: “'ey’re good because they remind me, I didn’t take my pills and it’s a good re- minder” (P7, ma\fe, b\fack, 51, an\b un\betectab\fe). On the other han\b, three \bi\b not \fike it: “'ey send the text like don’t forget don’t forget don’t forget and it was like nerve wrecking, it just kept going on and on.” (P8, ma\fe, b\fack, 53, an\b \betectab\fe) an\b “I did get text messages saying to ‘now take your med- ication’ but I already took it” (P14, ma\fe, white, 57, an\b un\betectab\fe).

4.6. Smart Tablet/iPad. PLWH were given a tab\fet for use \buring the stu\by as part of the DMP. Two participants ha\b technica\f \bifficu\fties with using the tab\fet, for examp\fe, P15 (ma\fe, b\fack, 53, un\betectab\fe), “it was just one time when the tablet I was provided with wasn’t responding it was all black so I had to turn it off and let it reboot and in about \f0 min it was fine.” an\b P6(male, black, 5\f, detectable) who took the pi\f\f but was not c\fose to the tab\fet, so it was not imme\biate\fy registere\b: “I worried a lot about the tablet because sometimes it says I didn’t take my meds but then I knew about keeping it in my pocket or near my body.” Others seeme\b to \fike the features of the tab\fet: “It tells me how many steps I took and my heart rate, which I enjoy” (P11, ma\fe, Latino, 44, an\b un\betectab\fe).

4.7. Experience with DMP-Related Technical Support.

PLWH were aske\b to \bescribe the communication with the DMP technica\f team when they nee\be\b it. *ose who ha\b contacte\b them \bescribe\b the communication as fo\f\fows: “It was good. Communication was simple. I wasn’t with the iPad at that time so we set up another time and that was great as there were some problems but they (Proteus Call Center) were courteous and friendly” (P8, ma\fe, b\fack, 53, an\b \betectab\fe).

“Yeah. 'ey were all very helpful. Very, very helpful. \bnd patient. So, I’d give them a ten on that” (P13, fema\fe, Latina, 59, an\b un\betectab\fe).

4.8. Overall Experience with the DMP. When aske\b to \be- scribe their overa\f\f experience with the DMP, six partici- pants reporte\b \fiking it: “It’s been cool, really interesting. 'e iPad works, the capsules work, it works! What I really like about this system it monitors your heart, so this really helps me, it also monitors my steps, and how far how long I laid down” (P1, ma\fe, b\fack, 51, an\b un\betectab\fe). Two revea\fe\b that it he\fpe\b them with their me\bication-taking: “It’s been good, I’m used to it. It teaches me a point where taking my medicine at the right time. I believe taking it at the same time a day is really important” (P14, ma\fe, white, 57, an\b un- \betectab\fe). Others reporte\b using the system was incon- venient: “It’s been a new kind of responsibility, as far as having a reminder of the medication and wearing the patch and to follow to replace it constantly, so it’s kind of like babysitting myself” (P5, ma\fe, Latino, 49, an\b un\betectab\fe) an\b “It’s been inconvenient because I didn’t have this problem before, that somebody is watching, for me it is kind of in- convenient” (P3, ma\fe, b\fack, 55, an\b un\betectab\fe).

4.9. Recommending the DMP to Others. PLWH were aske\b if they wou\f\b recommen\b the DMP to others an\b why. A\f\f who offere\b an opinion recommen\be\b it: “'ey should do it if they want to help maintain the practice of taking their meds. 'ey should be taking them at certain times” (P7, ma\fe, b\fack, 51, an\b un\betectab\fe). “If they are having trouble taking their medication, I’d advise them to participate” (P3, ma\fe, b\fack, 55, an\b un\betectab\fe). “I would reassure them that it’s worth the while, it’s very interesting, it’s not hard to use, it does everything itself, it’s something that will benefit not only ourselves but other people” (P5, ma\fe, Latino, 49, an\b un\betectab\fe).

T\bble 2: Base\fine characteristics of HIV hea\fthcare provi\bers.

Characteristics (n �6) Mean (SD) orn(%) Age, yrs 48 (14) Gen\ber Fema\fe 4 (66.6%) Race an\b ethnicity Asian 3 (50%) Caucasian/white 1 (16.7%) Hispanic/Latino 1 (16.7%) Mixe\b race 1 (16.7%) Years of work experience 17 (12.5) Profession Nurse practitioner 4 (66.6%) Physician 1 (16.6%) Resi\bent 1 (16.6%) Number of HIV + patients seen per week 17 (8.2) Patients’ main source of HIV infection MSM 5 (83.3%) Heterosexua\f sex 1 (16.6%) Number of patients using DMP 0 1 (16.6%) 1–5 4 (66.6% >5 1 (16.6%) SD, stan\bar\b \beviation; MSM, men who have sex with men; HIV, human immuno\beficiency virus; DMP, \bigita\f me\bicine program.

AIDS Research an\b Treatment 5 5. Secti\bn II: HIV Hea\fthcare Pr\bviders 5.\f. Barriers and Facilitators to \bntiretroviral \bdherence.

HCPs \bescribe\b the barriers that their patients face\b with ARV a\bherence. *ese inc\fu\be\b substance use, menta\f hea\fth issues, financia\f issues, home\fessness, unacceptance of HIV \biagnosis, an\b forgetfu\fness. Factors that faci\fitate\b ARV a\bherence inc\fu\be\b trusting their HCP, patient mo- tivation an\b taking responsibi\fity of their hea\fth, patients’ perceive\b hea\fth benefit, me\bications that are easy to take with simp\fe one-pi\f\f-a-\bay regimens, proactive HCPs that remin\b patients about their c\finic appointments, socia\f an\b psycho\fogica\f support (from fami\fy an\b frien\bs), an\b rou- tinizing the patient’s pi\f\f-taking behavior, for examp\fe, taking the me\bication every \bay with breakfast or at be\b- time. *ey a\fso mentione\b the use of ai\bs to he\fp with a\bherence such as a\farms, pi\f\f organizers, an\b pi\f\f packs.

5.2. \bdvantages and Disadvantages of the DMP.A\f\f HCPs knew of the DMP prior to the interview, as the DMP pi\fot stu\by was con\bucte\b at their workp\face. Five of six were treating patients in the DMP stu\by. HCPs a\fso seeme\b to un\berstan\b how it works. When aske\b how the DMP he\fpe\b their patient with ARV a\bherence, they mentione\b that the text remin\bers are the most important aspect in a\b\bition to the fact that the patients fee\f monitore\b by their HCPs, which can motivate them to remember to take their me\bication. On the other han\b, when aske\b about potentia\f \bifficu\fties with the system, provi\bers mentione\b that the patch can be un- comfortab\fe an\b that some patients can fin\b it stigmatizing.

Furthermore, the avai\fabi\fity of a stab\fe Internet connection nee\be\b to operate the system can be impossib\fe for some patients with socioeconomic \bifficu\fties who are unab\fe to purchase wire\fess Internet services. When aske\b if their pa- tients ha\b use\b other e\fectronic monitors in the past, some mentione\b using Wisepi\f\f© an\b MEMS©. *ey exp\faine\b that the DMP wou\f\b be better in measuring a\bherence compare\b to MEMS© as some patients opene\b the pi\f\fbox without ingesting their pi\f\fs, which gave an inaccurate measure of a\bherence. For the Wisepi\f\f©, HCPs comp\faine\b that the box was too big an\b there were no text message remin\bers.

5.3. Recommending the DMP. When aske\b if they wou\f\b recommen\b the DMP, HCPs sai\b that they wou\f\b recom- men\b it to patients who have \bifficu\fties with a\bherence for short-term use, up to 6 months. One HCP puts it as fo\f\fows:

“For those patients with adherence difficulties, there isn’t much left to offer, we tried everything, social work, patient navigators, reminders, none of it was a success. I definitely recommend the IS system” (H4). *ey a\fso mentione\b that for patients inc\fu\be\b in the stu\by, there was a financia\f compensation to use the DMP an\b that perhaps patients wou\f\b be \fess motivate\b to continue to use it once they no \fonger receive compensation.

6. Discussi\bn and C\bnc\fusi\bn 6.\f. Discussion. In this stu\by, we \bescribe an\b ana\fyze PLWH experiences an\b HIV HCPs’ opinions on rea\f-time a\bherence monitoring with a focus on the DMP. *e views of PLWH an\b HCPs were very simi\far. *ey on\fy \biffere\b on the in-\bepth exp\fanation of faci\fitators an\b barriers to ARV a\bherence, where HCPs provi\be\b more comprehensive reasons on why their patients were not a\bherent.

Both PLWH an\b HCPs agree\b that DMP can be he\fpfu\f in the management of ARV a\bherence. *is was simi\far\fy reporte\b by persons \fiving with schizophrenia an\b their HCPs [24] an\b PLWH who use\b other rea\f-time ARV a\b- herence monitoring \bevices such as Me\b-e-Monitor an\b Wisepi\f\f© [25, 26]. In\bee\b, there are severa\f a\bvantages of rea\f-time a\bherence monitoring, as reporte\b by our PLWH who use\b the DMP an\b the HCPs. Not on\fy \boes rea\f-time a\bherence monitoring provi\be a remin\ber, but it a\fso he\fps patients change their behavior as they become aware of their own a\bherence patterns an\b try to mitigate nona\bherence in nonroutine circumstances such as being away from home. *e interviews showe\b that PLWH ha\b a\frea\by \beve\f- ope\b se\ff-management too\fs for me\bication-taking before using the DMP such as storing their me\bication at a specific \focation, taking their me\bication at the same time every \bay, or using a\farm c\focks. Despite that, PLWH were se\fecte\b for this pi\fot stu\by because they were having suboptima\f a\b- herence (signifie\b by misse\b \boses an\b/or \betectab\fe vira\f \foa\b) prior to their inc\fusion in the DMP pi\fot stu\by. *is meant that there was sti\f\f a nee\b for a too\f that wou\f\b further enhance their a\bherence. By combining se\ff-management with imme\biate intervention in case of a \fapse in a\bherence, DMP may provi\be greater support to patients with ina\be- quate a\bherence. Some patients foun\b this usefu\f an\b cou\f\b incorporate it into their \bai\fy routines. Simi\far experiences were reporte\b for patients with schizophrenia an\b hyper- tension who use\b the DMP [24, 27]. In contrast, others foun\b the DMP too \beman\bing, to the extent of being “nerve-wrecking,” an\b mentione\b that it takes getting use\b to. *is confirms that a\bherence is a very in\bivi\bua\f behavior an\b that there is no one so\fution that fits a\f\f. It a\fso shows that there is a nee\b to improve the frequency of text mes- saging to suit each patient’s nee\bs. Furthermore, some PLWH reporte\b inconvenience whi\fe using the a\bhesive patch. Simi\far fee\bback was re- porte\b on ear\fy versions of the patch with \fess than 10% of the participants reporting re\bness an\b skin itchiness [16, 28].

*ere is room for improvement in the techno\fogy for future \beve\fopments of the patch. *ere is a\fso a concern for \bisc\fosure of HIV status, as high\fighte\b by the HCPs. Simi\far concern for unwante\b HIV \bisc\fosure was reporte\b for Wisepi\f\f© an\b MEMS© [29–31]. For the DMP to function seam\fess\fy, it nee\bs a re\fiab\fe wire\fess Internet connection an\b an e\fectric supp\fy to re- charge the iPa\b/tab\fet battery. *is is something to take into consi\beration when \beve\foping DMP for settings that may not have a re\fiab\fe network or many power out\fets, for the purpose of rea\f-time a\bherence monitoring. If rea\f-time monitoring is not require\b but rather time\fy monitoring the patch can store ingestion \bata for up to 8 \bays, so as \fong as there is connectivity at \feast once every 8 \bays, there shou\f\b be no \fost \bata; once the patient connects to the iPa\b, a\f\f \bata from the \fast 8 \bays wi\f\f sync automatica\f\fy. Some PLWH 6 AIDS Research an\b Treatment reporte\b an inconvenience of having to be physica\f\fy c\fose to the tab\fet whi\fe wearing the patch to ensure a\bequate \bata transferabi\fity. Simi\far concerns were reporte\b for Wisepi\f\f© [26]. *is prob\fem may be part\fy mitigate\b as the system can uti\fize ce\f\f phones instea\b of tab\fets for communicating with the server an\b this was intro\buce\b as a change to the main tria\f that fo\f\fowe\b the pi\fot stu\by. Regar\bing cost, as most \bevices were fun\be\b as part of a stu\by an\b were provi\be\b free of charge for the participants, we are unab\fe to \be\buce the cost imp\fications for the patients if they were to purchase those \bevices themse\fves or if that wou\f\b be covere\b by their hea\fth insurance. Fina\f\fy, the \bata generate\b by the DMP can \beepen our un\berstan\bing of in\bivi\bua\f me\bication-taking behavior an\b timing, a\f\fowing the \beve\fopment of inter- ventions tai\fore\b to each patient’s nee\bs.

6.2. Strengths and Limitations.*e strength of this stu\by is in the triangu\fation of sources between PLWH experiences an\b HCPs’ opinions, which gives a 360-\begree view on a new ARV a\bherence measuring an\b monitoring techno\fogy. *e weaknesses inc\fu\be the sma\f\f number of participants, most\fy ma\fe, mi\b\b\fe age, MSM (stu\by not genera\fizab\fe with \fimite\b transferabi\fity or externa\f va\fi\bity), an\b the re\fative\fy short \buration of using the DMP (4 weeks). However, the main tria\f of the stu\by with a \farger samp\fe size (n �120) an\b more ba\fance\b ma\fe-to-fema\fe participant ratio is current\fy on- going, which wi\f\f provi\be rich information on re\fate\b issues once the tria\f is comp\fete\b. Simi\far\fy, regar\bing the samp\fe size of the HCPs, it is re\fative\fy sma\f\f an\b not representative of the opinions of a\f\f HCPs. However, given this is a new techno\fogy an\b not yet wi\be\fy avai\fab\fe for a\f\f HCPs an\b PLWH in a c\finica\f setting, our stu\by provi\bes some initia\f insights that are of importance. Further research with a bigger samp\fe size wou\f\b be possib\fe in the future after the wi\besprea\b of the techno\fogy to provi\be more genera\fizab\fe resu\fts.

7. C\bnc\fusi\bns Techno\fogy wi\f\f continue to evo\fve to a\bvance the ways we can measure me\bication a\bherence for research purposes an\b c\finica\f practice. *e DMP is a nove\f techno\fogy of rea\f- time measuring an\b monitoring of me\bication a\bherence with a\bvantages an\b potentia\fs for improvement. Incor- porating changes to the DMP base\b on the experiences of PLWH an\b provi\bers wi\f\f he\fp improve the acceptabi\fity of such systems an\b make it more \fike\fy to optima\f\fy meet the patients’ nee\bs.

8. Practica\f Imp\ficati\bns Ana\fyzing the content of the qua\fitative interviews from this pi\fot stu\by gui\be\b intro\bucing some changes in the main tria\f of the DMP that is current\fy being con\bucte\b. For examp\fe, using smart phones instea\b of tab\fets is now an avai\fab\fe option. Future research aims to assess those changes in a\b\bition to assessing one’s experience with the DMP over a \fonger time frame. Appendix Appendix I-a:. Ingestib\fe Sens\br Qua\fitative Interviews Interviewer instructions are given as follows:. Before begin- ning the au\bio taping, rea\b the fo\f\fowing: I would like to talk to you about how you take your medications, and about the Sensor System for taking medications. Your feedback will help us understand what it is like to use the Sensor System. I will start by turning on the audiotape and I will begin to ask you questions. I am very interested in what you have to say. Take as much time as you would like to answer the questions. 'is is not a test---there are no right or wrong answers. I am interested in hearing how you really feel. Remember, your answers will only be shared with people involved in the study. Nobody else will know what you say. Do you have any questions before we begin?

Medication-taking:. First, I would like to talk to you about how you take your medication. Tell me about that. [Probes: How do you typically get medication from the pharmacy? Where do you store it? How do you remember to take it?] Tell me about times you have had to change your system for taking medicines.

[Probe by asking about the steps the client has described.

'en ask about times the system can’t work because the pharmacy is closed, person isn’t home to take meds with usual routine, forgets a dose, etc.] Clients’ Enrollment into Study:. Now, I’d like to ask you about how you came to be in this study. Tell me about how you decided to enroll in this study.

[Probes: How did you hear about the study? Whose idea was it? Were you pressured to enroll or was it just left up to you?] 'e Orientation Program:

\b few days ago, someone from the study explained the Ingestible Sensor System to you. Tell me about that meeting. [Probes: What things did you go over? What parts were helpful? Not so helpful? Were there things you didn’t go over that you wish you did?] Now, I’d like to talk to you about the person who explained the Sensor System to you. What’s this person like? Tell me your understanding of how the Ingestible Sensor System works. [Probes if not spontaneously mentioned: Tell me about the patch. Tell me about using pills with a special sensor. Tell me about receiving text messages.] Clients’ Overall Experience of the Sensor System:. Tell me about your experience with the Sensor System. What has it been like for you?

AIDS Research an\b Treatment 7 [Probes: What did you find helpful about the Sensor System? What was not helpful about the counseling?]· · · What advice would you give to a friend asking whether or not to participate in the Sensor System?

Clients’ Experience of Specific \bspects of the Sensor System:.

I’m now going to ask you about specific aspects of the sensor system.

Tell me about using the special pills with the sensor in them. What’s that like for you? Tell me about wearing the special Sensor System patch.

What’s that like for you. Tell me about getting text messages. What’s that like for you? Tell me about any text messages you received this week.

[Probes: Were there messages you found helpful? Were there messages you found not so helpful?]· · · Did you talk to anyone in the Sensor System group? Tell me about it.

Closing:. Do you recommend any changes in the Sensor System? 'ank you very much for sharing your thoughts with me. I appreciate it. Is there anything I haven’t asked you about that you want to tell me? 'ank you. Weeks 2 and 4 qua\fitative interview f\br prepi\f\bt phase Omit the following sections:. Medication-taking:First, I would like to talk to you about how you take your medication. Tell me about that. . .

Clients’ Enrollment into Study:

Now, I’d like to ask you about how you came to be in this study· · · 'e Orientation Program:

\b few days ago, someone from the study explained the Ingestible Sensor System to you. Tell me about that meeting. . .

F\br weeks 2 and 4 \bn\fy:

\bfter introducing the interview:. Tell me about the last two weeks using the sensor system.

F\br weeks 2 and 4 \bn\fy:

Before closing the interview:. Since you started, have you changed how you use the Sensory System? How has using it changed over time? \bre there things about it that have been better over time? Worse over time?

Appendix I-b Ingestible Sensor Qualitative Interviews for HCP Interviewer Instructions (before beginning the audio taping): I wi\f\f provi\be a \bescription of the stu\by.

I am intereste\b in asking your opinion, this wi\f\f be he\fpfu\f in the stu\by, I wi\f\f au\bio recor\b the conver- sation. Is this Ok with you? *e au\bio-recor\bing wi\f\f be anonymous, an\b your i\bentity wi\f\f on\fy be revea\fe\b to me. Do you agree? If not I wi\f\f take notes.

What you share with me wi\f\f be anonymous\fy pub- \fishe\b an\b share\b with other peop\fe, \bo you agree?

Healthcare providers questions: Name:

Age:

Profession:

Years of experience in HIV care:

Work Setting:

E\bucation:

Number of patients seen per week:

HIV source of infection/patient group (MSM/Drug use/Hetero):

(1) How wou\f\b you \bescribe the a\bherence of the patients you see? (probe: Low/mo\berate/high) (2) What \bo you think are the barriers to the a\bherence?

(3) What \bo you think are the faci\fitators to a\bherence?

(4) Do you know of any a\bherence ai\bs that can he\fp your patients a\bhere to their treatment?

(5) Have you hear\b of the IS? What is your un\ber- stan\bing of how it works?

(6) Do you think IS can he\fp your patients with a\b- herence? How? (patch, sensor, text messages) (7) What issues have your patients been having/\bo you expect patients wi\f\f have with IS?

(8) How wou\f\b IS be \bifferent from other a\bherence rea\f-time monitoring metho\bs?

(9) Do you think IS is a \fong-term so\fution or short- term so\fution to a\bherence issues? How \fong \bo you think patients can be monitore\b using IS?

(10) Wou\f\b you recommen\b IS to your patients? If yes, which patient group? (high/\fow/mo\berate a\bher- ence) an\b why?

(11) Wou\f\b you recommen\b IS to other HCPs? (If no, why?) (12) Do you know/hear\b about IS, what \bo you think the biggest prob\fem (s) IS may be for using IS tech- no\fogy to monitor HIV patients’ a\bherence?

(13) Is there anything e\fse you wou\f\b \fike to a\b\b? Data Avai\fabi\fity *e \bata are not avai\fab\fe pub\fic\fy \bue to the i\bentifying nature of the qua\fitative interviews.

8 AIDS Research an\b Treatment Disc\f\bsure Eric S. Daar an\b Honghu Liu are equa\f senior co-authors.

C\bnf\ficts \bf Interest *e authors \bec\fare that there are no conflicts of interest.

Auth\brs’ C\bntributi\bns SK wrote the initia\f version of the manuscript, an\b a\f\f au- thors cooperate\b towar\bs the fina\f version. SK an\b LS co\f\fecte\b the \bata. SK an\b CL ana\fyze\b the \bata. MIR an\b HL supervise\b the \bata ana\fysis. HL provi\be\b insights into the \bata ana\fysis an\b manuscript writing. ESD provi\be\b HIV c\finica\f expertise.

Ackn\bw\fedgments *e authors wou\f\b \fike to thank the Nationa\f Institute of Menta\f Hea\fth/Nationa\f Institute of Hea\fth an\b the Swiss Nationa\f Science Foun\bation for their support. *is work was supporte\b by the grant R01-MH110056 from the Na- tiona\f Institute of Menta\f Hea\fth/Nationa\f Institute of Hea\fth an\b grant P2GEP3_181061 from the Swiss Nationa\f Science Foun\bation.

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