MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEALTH NATIONAL INSTITUTE OF HYGIENE AND EPIDEMIOLOGY ---*--- DAO DUC GIANG THE CURRENT SITUATION OF ARV TREATMENT ADHERENCE, RELATED F
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MINISTRY OF EDUCATION
AND TRAINING
MINISTRY OF HEALTH
NATIONAL INSTITUTE OF HYGIENE AND EPIDEMIOLOGY
-* -
DAO DUC GIANG
THE CURRENT SITUATION OF ARV TREATMENT ADHERENCE, RELATED FACTORS AND INTERVENTION EFFECTIVENESS AT SELECTED OUT PATIENT CLINICS
IN HANOI
SUMMARY OF DOCTOR OF PHILOSOPHY THESIS IN
PUBLIC HEALTH
HA NOI – 2019
Trang 2The work was accomplished at: The National Institute of Hygiene and Epidemiology
Supervisors:
1 Assoc Prof Nguyen Anh Tuan
2 Assoc Prof Bui Duc Duong
This doctoral thesis will be defended at the Institutional Committee for Thesis
Examination, National Institute of Hygiene and Epidemiology at
(time/month/date/year)
The thesis is available at:
1 The Na tional Library of Vietnam
2 Libra ry of the Na tional Institute of Hygiene a nd Epidemiology
Trang 31981 in men who have sex with men, HIV / AIDS ha s quick ly b ec ome a n e p id emic wit h nega tive impacts on a global scale a nd Vietnam is no exception According to the statistics o f the Depa rtment of HIV / AIDS Prevention and Control by the end of 2017, AR V t re a tme nt
wa s implemented in a ll 63 provinces / cities, with 401 ARV outpat ie nt c lin ic s wit h a b out 124,000 patients treated with a ntiretroviral therapy (ARV)
Antiretrovira l drugs for HIV / AIDS trea tment a re seen a s a n importa nt step in significa ntly reducing HIV-related mortality and the introduction of AR V d ru gs t h a t ha v e tra nsformed HIV / AIDS infection from a deadly disease to a chronic dise ase wh ic h c a n b e controlled The main goal of antiretrovira l therapy is to a chieve sustained vira l su p p ressio n
a nd maintain immune function, thereby reducing mortality a s well a s the burden o f d ise a se
To a chieve this, a dherence to treatment plays a n importa nt ro le H o wev er, a dh ere nc e t o trea tment is not ea sy a nd most patients face difficulties with a dherence to treatment
Drug resista nce is a nother cause for concern as a result of non-compliance Although
it is difficult to accurately quantify the effects of noncompliance, a ntiretroviral treatment is identified a s one of the major causes of major public health threats Because of the risk of developing resista nce, not only to individuals but a lso to society
Fa ctors realted to compliance and interventions to enhance a dherence to ART are
a lso diverse Interventions to enhance treatment adherence should be implemented to ensure socia l, cultural a ppropria teness a nd practical circumstances at the sites of intervention
The thesis "The current situation of ARV treatment adherence, related f ac to rs a nd intervention effectiveness at selected out-patient clinics in Hanoi" wa s c on duc te d wit h t h e
2 Contribution of the thesis
This thesis is a n effort to systematically study the sit u a tio n a nd se le c te d f a ct ors rela ted to ARV treatment adherence 03 out-patient clinics in Ha noi It is the first study to u se
a multi-dimensional a ssessment tool to a ssess treatment adherence in Vietnam The design o f interventions is built ba sed on effective interventional models in the world a nd base d o n t he cha racteristics of outpatient clinics in Vietna m Interventions through on -site counselin g a nd periodic telephone support for high -risk groups ha ve demonstra ted effectiveness in strengthening patient a dherence
1 Situa tion of ARV trea tment a dherence and some related factors in HIV / AIDS
pa tients being treated a t some outpatient clinics in Ha noi in 2016
- The proportion of patients a dhering to high, medium a nd low levels of trea tment was 66.2%; 23.8% a nd 10%, respectively About half of patients reported receiving support f rom
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fa mily, pa rents, or spouses in treatment 9% of patients had encountered ARV side effe c ts in the la st 3 months a nd 1.2% of patients had to temporarily stop ART due to side effects
- Experiencing side effects of drugs (AOR = 0.58; 95% CI: 0.41 - 0.82) is a n e ga t iv e
fa ctor a ffecting pa tients' a dherence to ARV treatment Supportive factors f or a dh ere nc e t o trea tment include the support of friends (AOR = 2.56; 95% CI: 1.49 - 4 3 5 ); d isc lo sure o f HIV sta tus to family a nd relatives (AOR = 3.7; 95% CI: 1.32 - 10.00), not drinking a lcohol in the pa st 30 days (AOR = 3.62; 95% CI: 1 , 95 - 6,7); ha ve social support from health workers (AOR = 2.51; 95% CI: 1.40 - 4.52) a nd trust that oral medications a re effective in help in g t o control the disease (AOR = 1.92; 95% CI: 1.78 - 3.56)
2 Effectiveness of the study interventions to increase AR V c o mp li a nc e in so me outpatient clinics in Ha noi in 2017:
- The proportion of patients a dhering to high levels of trea tment increased from 66.2%
to 84.4% The proportion of patients joining peer support groups, reporting havin g re c e iv e d the support of a spouse or pa rtner with ARV trea tment, havin g a sta b le j o b in c rea se d b y 10.6%; 53.6% a nd 43.5% before the study to 17.4%; 63.9% a nd 54.2% a fter the study, respectively The proportion of pa tients experiencing side effects of the drug, ha ving to temporarily stop taking ARV because the side effects significantly decrease d f rom 9 0 % t o 3.5% a nd from 1.2% to 0.65%, respectively
3 Scientific and practical significance of the thesis
3.1 Scientific significance
The thesis uses community intervention research design with comparison before and
a fter the intervention Tools, da ta collection techniques, a nd a ccura te a nd relia ble da ta
a nalysis With the collected data, the thesis has determined the ARV a dherence ra te a nd some
fa ctors rela ted to ARV a dherence in HIV / AIDS pa tients in the study area
3.2 Practical significance
The study has assessed the status of ARV a dherence, relevant factors to have
a ppropriate preventive interventions in ARV pa tients at some outpatient clinics in Ha noi The resea rch interventions a re feasible, pra ctical, a nd a pplicable on a broader scale
4 The structure of the thesis
The ma in body of the thesis is presented with 129 page s ( e x cl udi ng a ppe ndi ce s, tables of contents, abbreviations) a nd is divided into: Introduction 2 pa ges; Cha pter 1 -
Overview: 44 pages; Chapter 2 - Resea rch methodology: 16 pa ge s; C ha pt e r 3 - R e se a rc h results: 38 pa ges; Chapter 4: Discussion 24 pages; Conclusion: 02 pages; Recomme nda t ion :
01 pa ge a nd list of research projects 01 page The thesis includes 47 tables, 06 f igures and 0 5 pictures References include 122 documents (15 Vietnamese, 107 En glish ) Th e a pp end ix includes a flowchart of counseling for compliance at outpatient clinics, tra in ing d o c umen ts tha t reminds patients a bout the process of disclosing HIV status to their partners, and pre- a nd post-intervention data collection forms
CHAPTER I : OVERVIEW 1.1 Antiretroviral treatment and benefits of antiretroviral treatment (ARV)
Ma rch 19, 1987 was considered a n important milestone when for the first time the
US Food a nd Drug Administration (US FDA) officia lly a pproved Zidovudine
(Azidothymidine, AZT, ZDV) for HIV / AIDS trea tment Since then, efforts in drug resea rch
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a nd development have allowed the introduction of many ARV drugs to be a pplied for
trea tment US FDA sta tistics show that up to now, more than 40 ARV drugs have been licensed a nd there a re dozens of other research and development studies on new ARVs in the world Diversity of trea tment mechanisms as well a s the diversity of drugs in ea ch subgroup is
a good opportunity, a llowing patients a ccess to many different treatment alternatioves, it, on the other hand, also shows the complex nature of ARV treatment as well a s difficulties with
a dherence
in the Minister of Health's Guidelines for HIV / AIDS Ma nagement, Treatment a nd Care, a nd
la ter on, it wa s updated in the HIV / AIDS Trea tment a nd Care Guidelines, issu e d t o ge the r with the Minister of Hea lth's Decision No 5418 / QD-BYT of December 1, 2017 ARV trea tment has now been covered by Health Insurance since early 2019 b e ca use f ore ign a id sources have been cut, a nd strict control of treatment a dherence is im p o rta n t t o lim it d ru g resista nce, which will lea d to the use of the 2nd line a nd 3rd line regimens with signific a ntly higher costs
The benefit of ARV treatment is not debatable a nd has been demonstrated in ma ny clinica l tria l studies a s well a s in routine practice Antiretroviral therapy provides patients with the opportunity to maintain a low vira l loa d in the blood a nd below the undetectable threshold (less than 200 copies / ml of blood), which has been confirmed to have a protective effect for patients' health a nd prevent HIV transmission to sexual partners UNAID official reports indicate that "a n undetectable level of HIV viral loa d means that HIV is no longer tra nsmitted"
1.2 The definition, importance of adherence to treatment, the asse ssme nt a nd the factors that influence adherence to treatment
According to the WHO definition, a dherence to trea tment refers to "a patient's behavior in following a physician's instructions reg arding the use of the medication as well as
on diet or lifestyle" Measuring patient adherence is a big cha llenge because of the subject ive
a nd private nature of the patient's medication behavior These challenges a re compounded b y the fa ct that compliance is not only affected by the behavior of the patie nt , b u t a lso b y t h e hea lth system, socioeconomic status, a nd related factors to drugs
Adherence to a ntiretroviral therapy is a special concern due to concerns a bou t H IV drug resista nce Although no studies have a ccurately quantified the extent of noncomplianc e,
a nd for how long it will lea d to drug resistance, there is a high consensus in a ll st u d ie s a nd findings sta ting tha t non-a dherence to trea tment crea tes the risk of drug resista nce, a nd therefore it is necessary to identify patients who do not comply wit h t re a t ment f or t im e ly support Studies and reports show that ARV resista nce in Vietnam is not a big problem u p t o now However, this does not guarantee that ARV drug resistance will not become a p ro bl e m
in Vietna m in the future
Adherence to a ntiretrovira l thera py ha s a lso been confirmed in studies to be positively a ssociated with a chieving viral suppression, increasing pa tient survival, a s we ll a s with CD4 immune sta tus There ha ve been ma ny studies on a ntiretrovira l trea tment
a dherence, showing that a dherence to antiretrovira l therapy below 95% increases the risk o f not a chieving vira l suppression sta tus A la rge-sca le study of 2,821 a dult HIV-infected
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pa tients in India compared the prevalence of vira l suppression a mong patients wh o we re o n 80% to 89% of a dherence to 100% of adherence and patients who were o n 9 0% t o 9 9 % o f trea tment complia nce compa red with 100% of trea tment a dherence showed tha t the proportion of patients who a chieved viral suppression define d a s H IV-1 R NA b e lo w 4 00 copies / ml increa sed significantly when treatment a dherence ra tes increased
Adherence to treatment increases the life expectancy o f p a t ie nts a nd v ic e v ersa ,
pa tients who do not comply with trea tment will ha ve shorter life expecta ncy A study conducted in India of 239 patients found that 57% of patients were determined to comply with ART The study recorded 104 patients died during 358.5 pa t ie nts -y ea r a nd t h e refo re t h e
a uthor calculated the death ra te wa s 29 per 100 patients-year (95% confidence interva l (C I ): 23.9–35.2) a nd median duration of life of the patient was 6.5 months (9 5% C I : 2 7 –10.9 ) Morta lity wa s statistically significantly higher a mong pa tients who did not comply with AR T (64.5, 95% CI: 50.5–82.4) than patients who were on a dherence (15.4 95% C I : 1 1 3 –2 1.0) The risk of dying in pa tients who do not comply with ARV is 04 times higher t h a n p a t ie nts who do not comply with ARV (Adjusted hazard ratio: 3.9; 95% CI: 2.6–6.0)
There a re different ways to a ssess a dherence to treatment a nd it c a n b e b a sic a lly divided into direct and indirect methods Indirect methods such a s c o unt ing le f t o ver p ills, interviewing pa tients, interviewing pharmacists dispensing drugs, using high -tech equipme nt
to monitor drug use such a s MEMS devices (Medications Event Monitoring System) Dire c t methods such as measuring drug concentration in blood or urine, direct monitoring of patie n t medication use Ea ch method has its a dvantages a nd disa d van ta ges Th e Un it e d St a t es Agency for Interna tiona l Development (USAID) ha s supported the development of this multidimensional a ssessment tool a nd has assessed the consistency a nd relia bility of scales in
a number of scareresourced countries a nd has shown the usefulness of this tool This m u lt i dimensional combination assessment tool wa s used in this study to investigate t h e st a t us o f trea tment a dherence a t some outpatient clinics in Ha noi
-The a ntiretroviral a dherence rate is estimated in many studies around t h e wo rld a s well a s in Vietna m Studies a round the world ha ve shown that a dherence ra te s va ry wid e ly between loca tions, a nd ra tes ra nge from 37% to 90% In Vietna m, the use of different
a ssessment tools a t different locations also gives very different results A study by Tran Xuan
Ba ch et a l conducted in 2013 used a VAS visua l toolkit to evaluate the re su lt o f t rea t ment compliance rate of 94.5% A study by Phan Thi Thu Huong et a l in H a i Du o n g a nd Die n Bien province in 2016 reported lower trea tment complia nce (60.4% and 63.4%) A number of other domestic studies have shown that complia nce with treatment ranges from 60% to 80%
Fa ctors rela ted to treatment a dherence have been reviewed a nd evalua t ed b y ma n y
a uthors According to Reiter a nd Ickovics, it is possible to divide the fa ctors a ffecting
a dherence to antiretroviral therapy into 5 main groups: factors belonging to patients, groups of
fa ctors belonging to treatment regimens, groups of factors belonging to the medical condition,
a group of factors belonging to the rela tionship between patients and hea lt h wo rke rs a nd a group of fa ctors belonging to the treatment facility
Fa ctors belonging to pa tients rela ted to ARV a dherence include: a ge, gender, ethnicity, education level, income level, rea ding status, a nd disclosure of infectio n st a tu s t o others Pa tients who disclosed their sta tus to others reported in numerous studies a re a positive factor in a dherence to treatment Disclosing one's status to others does not require the
pa tient to hide the treatment which interfere with a dherence
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Fa ctors associated with the treatment regimen that may be rela ted to a dherence to the trea tment include: side effects of the drug, number of tablets in the regimen, complexity of the regimen (number of da ily doses, how use with or without certa in foods), specific
a ntiretroviral drugs, discrete tablets or fixed dose regimens The research results la rgely show tha t the side effects of the drug ha ve a nega tive effect on pa tient a dherence Severa l interna tional studies have demonstrated that the use of a single pill regimen improves patie n t
sa tisfaction, a dherence a nd maintenance of viral suppression better than the mu lt i -p ill AR V regimen Pa tient has never been on ARV
Fa ctors rela ted to ARV a dherence can include co-infection such a s malaria, dia betes,
a nd hypertension Compliance with antiretrovira l therapy will be reduced if t h e p a tie n t h a s
a dditional co-infections Pa tients with immune reconstitution syndrome (IRIS) a re reported to
ha ve lower a dherence ra tes than patients without this syndrome (RR 1.7; 95% CI 1.2 –2.2 ; P
= 0.001) A study by Vu Cong Thao in 2010 evaluating the status a nd effectiv ene ss o f c a re
a nd support activities for HIV / AIDS pa tients showed that hepatitis B co -in f e ct ion (H BV)
a nd or hepatitis C (HCV) were identified to have a strong correlation wit h p a tie n t d ro pou t with ORs of 10.8 a nd 8.99, respectively
Fa ctors that rela te to the rela tionship between the patient a nd the health care p rovider tha t may affect a dherence to treatment a re patient satisfaction in general, patient confidence in the clinic, a nd patient confidence in staff members Factors belonging to the treatment
fa cilities rela ted to ARV a dherence include tra nsportation convenience, clea n a nd friendly environment, rea sonable schedule, confidential trea tment room, the service is provided comprehensively
1.3 Interventions to increase ARV adherence
According to the World Health Orga nization (WHO), intervent io ns t ha t in c rea se ARV a dherence can be classified into groups such as Cognitive B e hav iora l I n t erv ent io ns (CBT), Educational Interventions, Treatment Support Interventio ns, I n te rve ntio ns d ire c t trea tment supervision, Intervention of a ctive drug reminders, System-building interve ntio ns, Counseling interventions, Nutrition support interventions, Pa ssive use of devic e re m in ders, Fina ncial support interventions, Substance abuse treatment intervention, Depression treatment intervention
Different authors also have different wa ys of cla ssifying interventions that in c rea se
a dherence In the review of this document, for the purpose of analysis a nd comparison, we use the cla ssification of interventions to enhance a dherence to treatment a ccording t o t h e la te st
pa per by Steve Ka nters 2016 Interventions strengthening adherence to this treatment includes the following groups:
- Standard of Care (SOC): Including counseling, ca re and treatment practices at health
fa cilities including a dherence counselling, routine medica l exa mina tion a nd trea tment
a ctivities
- Enhanced Standard of Care (eSOC): Including sta nda rd ca re combined with
a dditional patient support, including a dditional counseling rela ted t o t rea t ment a dhe ren ce
a dvice such as incorporating educational content a nd patient encou ragement
- Phone interventions: Includes interventions on the phone t o a ssist p a tie n ts Th e
frequency of calls ca n be from every 2 weeks to every 2 m ont hs I n so me n e wly t re a te d
pa tients, the frequency of calls may be more frequent in the ea rly stages
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- Messaging (SMS): This includes texting to the patient's mobile phone or research cell
phone; including one-wa y a nd two-wa y messa ges, short messa ges or long messa ges a t different frequencies (daily, weekly…)
- Training in behavioral skills or treatment adherence training: Includes tra inin g f o r
pa tients on how to comply with ART, including modular tra ining a nd interventions, a s well as interventions a nd training life skills, beha viors, knowledge and a ttitudes
- Multimedia intervention: use online materials or information transmission materials
- Cognitive behavioral therapy (CBT): Includes interventions to change behaviors and
perceptions, as well a s interventions from counselors using patient-encouraging interviews
- Supporter: including the use of a n individual (selected by the clinic or a p a tie nt o f
his or her own choice) to support patient adherence, including peer support, home visits, dru g
a dministration, treatment support, direct treatment monitoring therapy and customized d ire c t trea tment monitoring therapy
- Financial support: Including conditional a nd unconditional financial supports, c a sh
or vouchers
- Reminder device: Medication reminders include calendars, a larms, p a ge rs, d osin g
boxes, a nd other devices for managing a nd treating diseases
In fa ct, the application of measures to increase adherence to a ntiretro vira l t h e ra py
ma y be a single mea sure or a combina tion of two or more a t the sa me time A litera ture review comparing the effectiveness of interventions to increase a dherence to ARV b y St e ve
Ka nters ga thered a nd compared the results of 85 studies with 16,271 patients on the Cochrane Libra ry, Embase, a nd MEDLINE Research results show that short text messagin g (SM S) is superior to routine ca re a nd treatment when a nalyzing studies globally (o dds ratio [OR] 1.4 8; 95% KTC [CrI] 1,00–2,16) a nd resea rch in developing countries (1,49; 1,04 –2,09) Interventions that incorporate many measures have been shown to b e m ore e f fe ct ive t ha n interventions using single measures Considering the virus suppression status, only cognit ive beha vioral therapy (CBT) (1.46; 95% CI: 1.05–2.12) a nd supporter intervention (1, 2 8 ; 9 5 % CI: 1.01–1.71) is higher tha n standard care a nd treatment
Trea tment a dherence interventions for pa tients using mobile phones, ca lling a t
a ppropriate frequencies, in combination with a dherents for a dherence to treatment, have bee n shown to be most effective interventions with odds ra tio of 6.74 (95% CI: 2.87-16.55) in t h e
a nalysis of global studies The results of this intervention in dev elo pin g c o un trie s (LM IC network a nalysis) a lso showed simila r results with the difference ra tio of 6.59 (95% CI: 2.95 -16.06) The most pronounced effect of a combination of adherence to treatment adv isor a nd
pa tient phone for patients suggests this a pplication due to its h igh f e a sib ilit y a nd e a se o f implementation in countries with limited resources like Vietnam
1.4 Information on Outpatient clinics (OPC)
Upda ted statistics from the Administration of HIV / AIDS Preventio n a nd C ont rol show tha t a t the beginning of 2018, there were 271 outpatient clinics na tionwid e t o pa y f or ARV trea tment-related services a nd drugs As international a id sources are re d u cin g a nd t o
a chieve the 90-90-90 goal set by the United Na tions (90% of people know their H I V st a tu s, 90% of people ha ve been dia gnosed with HIV infection is continua lly receiving ARV trea tment a nd 90% of people on ART a chieve low a nd stable viral loa d), Ministry o f H ea lt h stra tegies clearly define the continuation of OPC clinics a nd adopt the paymen t m ec h a nism through health insurance since 2018
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CHAPTER 2 STUDY SUBJECTS AND RESEARCH METHODS
2.1 Study subjects
ART a t outpatient clinics in the survey program
2.2 Location, time and research design
Pre-intervention research a ctivities were co nducted in October 2 0 16 t o De c e mbe r
2016 Post-intervention a ctivities were conducted from November 2017 to December 2017
Research design
Self-control intervention research method, with comparison b ef ore a nd a f te r t h e intervention At the selected research facilities, the research team, along with sta ff working a t outpatient clinics trea ting HIV / AIDS, ra ndomly selected patients based on a sampling frame
a t the time of pre- a nd post-intervention surveys
2.3 Sample size and sampling methods
2.3.1 Sample size
estima te a proportion for cross-sectional survey
n = Sa mple size; 𝑝1 = Pre-intervention adherence rate (estimated at 70%)
𝑝2 = Post-intervention a dherence ra te (estimated a t 85%); 𝑝̅ = 𝑝1 + 𝑝2
2
𝛼 = Type I error (0,05); 𝛽 = Type II error (0,1)
It shows that 322 patients are needed for this study An a dditional 10% is estimated for loss to follow-up, so the study expects to recruit about 350 patients for pre - a nd post-intervention surveys In fact, the study interviewed 352 pre -intervention patients and 350 post-intervention patients
2.3.2 Sampling method
The sa mpling frame was developed based on the list of pa t ie nts e n ro lle d in AR V outpa tient clinics Ra ndom sa mpling is ca rried out using a single, non -repea t ra ndom
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- Ba sed on the results of building a nd piloting interventions, drawin g e x p erie n ce t o complete the model a nd deploy the model to other outpatient clinics
2.4.2 Study subjects, location and timing of interventions
trea tment a t Hoang Mai District Outpatient Clinic, Ung Hoa District Outpatient Clinic a nd Ba Vi District Outpa tient Clinic
2.4.3 Content and intervention activities of the model
interventions, combined with telephone reminders, a re highly effective in developing
countries The person supporting the patient wa s the OPC clinic sta ff These staff a re direct counselors a s well a s to a ssist in reminding pa tients of a dherence to treatment over the phone
In order to ensure effective counseling a nd telephone support, refresher trainings have been provided to OPC sta ff On the other hand, due to the high workload at OPC, the intervention
wa s identified as targeting only those at high risk of non-complia nce Interventions included
• Refresher training for counselors and health care workers on adherence to treatment based on input surveys
• Maintain regular review activities on ARV treatment adherence in HIV / AIDS patients being treated at each visit
• Counseling every 2 weeks over the phone, focus on the subjects at high risk of non compliance on ARV
-2.4.4 Indicators to evaluate the effectiveness of the intervention
Ba sed on research objectives
2.5 Tools and methods for data collection
Questionnaire for direct interview and medical records at OPC
2.6 Data management and analysis
Da ta were entered on EXCEL a nd a nalyzed using Stata 13 software
2.7 Measures to control bias in research
Tra ining on survey methodology, practice of survey skills for field supervisio n a nd qua lity control of questionnaires, selection of experienced investigators in social resea rch
2.8 Research ethics
The study was reviewed a nd a pproved by the Ethics Council of the Na tional Institute
of Hygiene a nd Epidemiology (Decision # IRB-VN01057-21 / 2016)
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CHAPTER 3 RESEARCH RESULTS
3.1 Characteristics of research subjects before and after the intervention
The study collected da ta from 352 pre-intervention a nd 350 post-intervention
pa tients, which is in line with the initia l expected number of 350 patients Among the subjects selected for this study, some did not a nswer a few questions or la cked some data to collect, so the sta tistics presented in the results of this study will be less tha n 350 or 352 and will ref le c t the number of patients with a nswers to each question
Surveys before a nd a fter the intervention showed tha t men a ccounted for a significa nt proportion (about 2/3) of the study subjects The educational le v e l o f t h e st u dy subjects wa s not significantly different in the pre-intervention survey compared with the post-intervention with approximately 10% of the study subjects with primary education, a bout 1 / 3
of the resea rch subjects have secondary school education a nd more than 1/3 of t h e re sea rc h subjects have the secondary school level The study noted a very small percentage of illitera te resea rch subjects a nd a pproxima tely 10% of the resea rch subjects ha d university a nd postgra duate degrees in the pre- a nd post-survey
The study subjects ha d a n a vera ge a ge (sta nda rd devia tion) of 37.0 (± 7.4), the
a verage HIV infection time wa s 5.1 (± 2.8) years, the duration of ART wa s 4.5 (± 2.5 ) y e a rs
a nd the time from the time of diagnosis of HIV infection to the time of AR T in it ia t io n wa s 265.8 days with a la rge standard deviatio n (456.4 days) The data was a lso repeated in 2 0 1 7, showing tha t the duration of HIV infection a nd the duration of ARV treatment is longer t h a n
a bout one year before the survey
The sta tistics show that the weight in the la st visit before the study was 53 7 (± 7 7 )
kg a nd the weight in the la st visit a fter the study wa s 54.4 (± 8) kg The dif f e re nc e in b o dy weight of the study subjects was not statistically significant (p> 0.05) The stud y n ot ed t ha t the prevalence of hepatitis C wa s 26.4%, Hepatitis B wa s 9.1% while other in f e ct io ns we re less common About two-thirds of the patients did not have any opportunistic infections in the
2016 survey
The ma jority of patients participating in the study before a nd after the intervention were those living in Ha noi (a pproximately 80%), ea rning less than 5 million VND / month (a pproximately 80%), living with their fa milies or rela tives (a pproximately 95%) About two -thirds of the patients are married, a bout 15% a re single a nd 17% are divorced or widowed This result is simila r in both pre-intervention a nd post-intervention surveys
3.2 Situation of ARV treatment before and after intervention
3.2.1 ARV regimens at outpatient clinics
The regimens used a t OPC clinics include: 1c regimen (NVP + 3TC + AZT), 1d (EFV + 3TC + AZT), 1e (NVP + 3TC + TDF), 1f (EFV + 3TC + TDF) a nd other re gim e n is the one that does not belong to one of the four regimens The point to note in ca lculatin g t h e percenta ges in this ta ble is tha t a lthough there were 352 pa tients surveyed before the intervention and 350 patients surveyed after the intervention, a small number of patients could
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not be a ccurately identified the patient's current regimen due to la ck of medical info rma tio n
or la ck of a n original medical record, these patients were exclude d from the denominator
Table 3.1 ARV regimens used at research OPCs
(n=342)
Post- intervention 2017
(n=343)
P value
The number of times ta king ARV during the da y a s well a s the number of pill
pa tients use in a day wa s compared between the pre-intervention survey in 2016 and after t h e intervention in 2017 The results show the ra te of patients taking ARV once / day in 2016 was 72.1%, a significa nt increa se of 82.1% in 2017 (p = 0.002) The use of fixed -dose combination pills a lso improved before and after the intervent ion f rom 6 9 3% in 2 0 16 t o 82.4% in 2017 (p <0.001)
The study found that about 3.7% of patients in the 2 01 6 su rve y h a d a c h a nge o f trea tment regimen in the la st 1 year a nd this percentage increased slightly to 8.3% in the 2017 post-intervention survey This regimen change is presented in more d e ta il in t h e re se a rc h results section, which shows a higher trend of shifting to a first line regimen in 2017 compared to 2016 The proportion of patients experiencing the effects side effect o f AR V in the 2016 pre-intervention survey was 9.0%, in which a small proportion of 1.2% o f p a tie n ts discontinued due to side effects of ARV
The 2016 pre-intervention study noted a significant proportion (a pproximately 95% )
of pa tients had not been tested for vira l loa d in the la st 12 months a nd only 5% of patients had
a vira l loa d test in the la st 12 months The reason was due to some technical dif f ic ult ie s, so the vira l loa d test has not been implemented in these outpatie nt clin ic s d u rin g 2 0 1 5-201 6 This test wa s only performed in special ca ses, or in pa tients who have move d f rom a no the r pla ce to the study OPC Regarding the support received for ARV trea tme nt , t h e 2 0 16 p re -intervention survey showed that a bout 50% of patients received support f rom sp o uses a nd
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a lso a bout 50% of patients received support from friends Less than a half of patients (43.5%)
ha ve stable jobs a nd only a bout 10% of them join peer support groups
3.3 Situation of ARV adherence at the time before the 2016 intervention
3.3.1 Assess adherence to treatment by interviewing patients
Pa rt 1 of the multi-dimensiona l a ssessment toolkit consists of four qua lita tive questions used to a sk patients a bout adherence Patients who a nswer a ll 4 quest io ns a s "n o" will be ca tegorized a s "high level a dherence", patients with 1 a nswer "yes" will be ca tegorized
a s "moderate a dherent to level therapy" a nd two or more "yes" answers will be ra nked as"low level a dherence"
Survey results before the study showed that 88.5% had no difficulty remembering t o
ta ke the drug, corresponding to 11.5% of patients still find it difficult to remembe r t h e n ee d for medication, a lthough the patient is still continue taking the medicine when feelin g b e tt er (99.4%) a nd the patient did not quit when he felt more tire d (9 8 8%) Wh e n a ske d a bou t whether a medicine has been missed in the past 4 days, 7.7% o f p a tie n ts re p ort ed h a vin g forgotten at lea st one dose
3.3.2 Assess treatment adherence with a visual scale (VAS) at the time prior to the
intervention
reported an average adherence ra te of 9.3 with a standard deviation of 0.73 The proportion of
pa tients with a VAS score of 9.5 or higher (patients classified a s highly adherent to treatment)
in the pre-intervention survey rea ched 78.8%
3.3.3 Assess adherence to treatment by checking knowledge of ARV use at the time prior to intervention
Component 3 of the multidimensional a ssessment is a knowledge-based assessment
Pa tients were a sked for information about the medication they we re t a kin g t o c h ec k t h eir knowledge a bout the usage, dosage, timing, a nd other precautions Research sh ows t ha t a n
a pproximate 14% of patients a nswered incorrectly about the name of the drug, the way it wa s
ta ken, or the dose, the timing of the medication, a s well a s the precautions for use
3.3.4 Assess adherence to treatment by counting the number of tablets in the period at the time before the intervention
the pa tient If a patient does not bring a via l or bag to check for the remaining number of pills, effort should be made to a sk how many doses are left until today, thus calculating the
a dherence rate The pre-intervention survey noted a high proportion (98.8%) of patients who brought the empty vial/bag of medicine to research sites to show that they have used up, or
sa id tha t they have used up the medicine but did not bring the vial or m edicine bag with them
3.3.5 Assess adherence to treatment by multidimensional assessment scale at the time before the intervention
on a visua l scale (Visua l Analog Scale-VAS), knowledge of medication, a nd inventory of leftover medications The results presented in Ta ble 3.2 a re based on the number of patients who responded a dequately (349 patients) rega rding treatment a dherence questions among the surveyed patients (352 patients)