R E S E A R C H A R T I C L E Open Access
Patients who restart antiretroviral
medication after interruption remain at
high risk of unfavorable outcomes in
Alula M. Teklu
and Kesetebirhan D. Yirdaw
Background: Achieving optimal adherence to highly active antiretroviral therapy (HAART) is necessary to attain
viral suppression and hence optimal clinical outcome. Interruptions in antiretroviral therapy medication often occur,
but a substantial proportion restart treatment. Long-term care engagement practices and clinical outcomes have
not been described among cohorts of individuals on HAART in Ethiopia.
Methods: In this study we describe treatment interruption patterns over time among clients who interrupt and
subsequently resume HAART, and those who are continuously engaged in treatment, and determine clinical factors
associated with loss to engagement.
An observational, longitudinal, retrospective cohort design was engaged, using secondary treatment program data.
We analyzed differences in treatment interruption among clients who were continuously active and those that
interrupted and restarted treatment at months 6, 12, 18, and 24. Cox proportional hazards regression analysis was
used to identify predictors of loss from treatment. We estimated time to first treatment interruption, time to
restarting after interruption, and time to second interruption. Data from all clients registered to receive HAART in
ten study health facilities, from 2005 to 2014, were used to study clinical and treatment outcomes up to 60 months
or study end.
Results: In this study, 39% (8,759/22,647) of clients interrupted treatment for more than 1 month at least at one
point during follow-up. Of these, only 35% ever restarted treatment. At the end of follow-up, the hazard of
unfavorable treatment outcome (dead, lost, stopped HAART) for clients who restarted treatment at months 6, 12, 18
and 24 was higher by a factor of 1.9, 2.4, 2.6 and 2.4, as compared to those who never discontinued treatment at
Conclusion: HAART treatment interruption was common in the study population. In those with a history of
treatment interruption, long term clinical outcomes were found to be suboptimal. Targeted interventions are
required to address follow-up challenges and prevent treatment interruption.
Keywords: Treatment interruption, Antiretroviral medication, Lost, Tracking, Treatment Outcome, Ethiopia
* Correspondence: firstname.lastname@example.org
St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia
MERQ Consultancy Services PLC, Addis Ababa, Ethiopia, Addis Ababa,
Full list of author information is available at the end of the article
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Teklu and Yirdaw BMC Health Services Research (2017) 17:247
Since the initiation of programs to provide free Highly
Active Antiretroviral Therapy (HAART) in many low-
and middle-income countries worldwide, the number of
people living with HIV/AIDS who are receiving treat-
ment has been increasing; reaching 17 million in 2015
. Such programs have helped prevent mortality and
new HIV infection among people irrespective of gender,
age, race or economic status. The UNAIDS reports a
decline in HIV/AIDS-associated mortality and in the
rate of new HIV infection globally; an indication of both
the success of HAART treatment programs and other
methods to prevent disease transmission. Progress is
specifically pronounced in sub-Saharan African coun-
tries, where AIDS-associated mortality and new infec-
tion have declined by 29% and 12%, respectively, since
Many people who start HAART discontinue treat-
ment, undermining the morbidity, mortality and pre-
vention benefits of therapy. Stigma and discrimination,
lack of psychosocial support, inaccessibility to services,
opportunistic infections, and drug side effects are all
commonly-sited reasons for discontinuing therapy .
Attrition varies at different times since initiation of
therapy. A multi-site assessment conducted in low- and
middle- income countries estimated average retention
at 12, 24, and 60 months post-initiation was 81%, 75%,
and 67%, respectively . Attrition in HAART in
Ethiopia appears to vary similarly, but data are limited.
In four health centers in Tigray region, retention was 92%
and 85% at 6 and 12 months, respectively. Variation was
also present between facilities; in the sites evaluated, 12-
month retention ranged from 78 to 92% .
Many clients restart treatment on their own after an
initial episode of discontinuation. But for those who do
not reinitiate treatment independently, supportive ser-
vices including phone-based patient tracking and home
visits from peer supporters or health care workers may
be conducted to encourage re-engagement. Even with
supportive mechanisms such as patient tracking, not all
clients re-engage in care, and those who re-engage may
subsequently exit treatment again. Treatment interrup-
tion practices among those who reinitiate therapy after
discontinuation were described in a study in Uganda,
where 43% of re-starters were lost to follow-up (LTFU)
within 18 months of reinitiating treatment . Although
it’s possible similar trends may be present in chronic
HIV care settings in Ethiopia, treatment discontinuation
and attrition patterns have not been described in this
setting. The objective of this study is to describe treat-
ment interruption among HAART re-starters, to exam-
ine longer-term trends in engagement and loss from
care among re-starters, as well as to determine clinical
factors associated with treatment interruption.
This study is conducted in ten randomly selected hospi-
tals from among 38 hospitals in Ethiopia located in
Addis Ababa, Benishangul Gumuz, Gambella, and
Southern Nations Nationalities and Peoples Region
(SNNP). The cumulative total of unique patients who
had ever started HAART in the selected facilities com-
bined was over 22,700 in 2014. Fee-based HAART was
available before 2005, when free HAART services be-
came available nationwide . Follow-up services were
customized to clients according to their need, ranging
from every month to every 3 months. Follow-up was
made by doctors, health officers or nurses trained in
management of chronic HIV care, treatment and sup-
port. Starting in 2007, peer educators or “adherence
supporters”were available to assist medical providers
with providing adherence counseling to patients and
conducting patient tracking following missed appoint-
was updated in registers, medical records, and elec-
tronic databases, kept in secure and confidential locations.
The most common antiretroviral medications used were
as follows: First-line HAART was a combination of stavu-
dine, zidovudine, abacavir or tenofovir plus lamivudine
plus neverapine or efavirenz; Second-line regimen
contained lopinavir/ritonavir in the place of neverapine or
efavirenz . A nationally-standardized system for moni-
toring and evaluation was in place at every study site. At
the time of treatment, clinicians documented care and
therapy in personal medical records. Relevant data from
medical records were then transferred to facility registers
and electronic database by data clerks. Two data clerks
trained specifically in the management of HIV care and
treatment data were maintained at antiretroviral (ART)
treatment clinics to track and update records and docu-
mentation, to alleviate work load among clinicians. Data
quality assurance measures, supervision and mentorship
programs for clinicians and data clerks were in place to
ensure data was properly generated, recorded and used
onsite. Information with regard to patient tracking was re-
corded by peer educators, and was then reconciled with
individual medical records, facility registers and electronic
database at ART clinics. Pharmacy records at facilities
were also consulted to cross-check medication pick-up
data from medical records.
This is an observational retrospective cohort study,
using medical records documented as part of the routine
care from clients who started HAART in selected facil-
ities in Ethiopia from September 2005 to November
2013. Data was captured electronically from the patient
records. Clients who started treatment at other facilities
Teklu and Yirdaw BMC Health Services Research (2017) 17:247 Page 2 of 8
but received follow-up at a study facility (transfers) were
excluded. From the full cohort, we evaluated the average
time to 1
episode of treatment interruption, average
time to restarting treatment after the 1
episode of treat-
ment interruption, and average time to 2
treatment interruption. We identified clients who had a
documented episode of treatment interruption followed
by restarting treatment (“restarters”, and compared them
with clients with un-interrupted treatment (“continuous
treated”), to compare longer-term outcomes over
specific comparable time periods in individual treatment
history. For example, all clients who discontinued treat-
ment before month six of HAART treatment but
restarted treatment by month six or before, were com-
pared with those who never discontinued treatment by
month six of follow-up. Subsequent treatment interrup-
tions were determined and compared among restarters
and continuously treated, for a maximum duration of 60
months of follow-up. In order to examine patterns of
treatment interruption for clients who restarted treat-
ment at different time periods in treatment history, the
same comparisons were made between restarters who
re-engaged in care matched with continuously-treated
individuals at months 12, 18 and 24. Finally, predictors
of retention in treatment were examined to identify dif-
ferentiating demographic and clinical characteristics
among restarters to identify those who were more likely
to remain in care.
Treatment interruption was defined as having termi-
nated HAART treatment for more than 1 month. This
could be due to being lost from care at treatment
initiating health facility, decision to stop treatment, or
Loss was defined as failure to present for HAART
medication refill at the treatment-initiating health facil-
ity, with inability to be traced back by phone or home
visit for more than 1 month, without a documented rea-
son for failing to present (eg. no confirmed death nor
decision to stop treatment in agreement with health care
Death was defined as a known client death from any
cause, confirmed by health care worker or post-loss
Stop was defined as discontinuation of HAART in
agreement with health care worker at treatment-initiating
Restart was defined as resuming treatment at the
treatment-initiating health facility after treatment
Retention was defined as active antiretroviral treat-
ment therapy at the treatment- initiating health facility.
Favorable treatment outcome was defined as being
active in treatment up to 60 months post-HAART initi-
ation, or up until September 2014 (whichever came
first), at treatment- initiating health facility.
Unfavorable treatment outcome was defined as be-
ing classified as lost, dead, or stopped from treatment
following agreement with treating health care worker, at
the last contact visit prior to 60 months post-HAART
initiation at treatment-initiating health facility.
Transfer out: when a patient is referred from the fa-
cility where s/he started ART to another health facility.
Transfer in: when a patient is received from another
health facility after s/he is started on ART at that facility.
Variables and data collection
The following variables were abstracted from patient
medical records and included in study: age at treatment
initiation, gender, baseline WHO Stage, baseline CD4
cell count, HAART start date, date of each follow-up,
HAART treatment status (active, lost, dead, stop, trans-
fer out, transfer in). The primary outcomes of interest
were unfavorable treatment outcome on or before
month-60 of follow-up, from the date of re-initiation
among re-starters and the comparable date for the com-
parison group of continuously-treated. Patient medical
record data was ascertained from an MS Access elec-
tronic database kept at the health facilities selected as
study sites, for the purpose of generating routine
monthly reports. Data entry was made from paper based
medical records daily by trained data clerks. Data quality
assessment was made routinely onsite as well as by ex-
Data cleaning and analyses were conducted using
STATA version 11 (Stata Corp, College Station, TX,
USA) statistical software. Time to 1
episode of treat-
ment interruption, time to restart, and time to 2
sode of treatment interruption were described using
mean, median, and inter-quartile ranges, and were plot-
ted graphically using histograms. Survival analysis was
carried out to compare the retention experience between
re-starters and those that had not discontinued treat-
ment. Clients were uncensored at the time of loss, death
or stopped treatment (unfavorable treatment outcome).
Those remaining active in treatment engagement at
60 months of follow-up or at September 2014 (which-
ever came first) were considered to have had favorable
treatment outcome, and were censored at that time.
Regression analysis was made using Cox proportional
hazards model. Within-site correlation of patient
characteristics were controlled by stratification. αwas
Teklu and Yirdaw BMC Health Services Research (2017) 17:247 Page 3 of 8
set to be 0.05 for all analyses [11, 12]. The dataset is
available as Additional file 1.
The total study population included 22,647 unique individ-
uals. The median follow-up time was 2.7 years (inter-quar-
tile range (IQR): 8 months–6 years). Most study
participants were adults (98%), and females accounted for
54%. The median age was 34 years (IQR: 28–40 years).
Most clients, approximately 68%, started treatment in
WHO clinical stage III or IV. Median baseline CD4 cell
count was 148 (range: 65–195/mm
). Additional baseline
characteristics are presented in Table 1 below.
Approximately 39% of clients had discontinued treatment
for a month or more at least once throughout the dur-
ation of follow up (8,759) (see Table 1). Among clients that
had discontinued at least once, the median time to first
discontinuance was one year (IQR: 0.3–2.6 years). Only
35% (n= 3,061) of clients restarted HAART after the first
interruption following enrollment. Among those who did
restart, median time to restarting treatment was 7 months
(IQR: 2.2 months–1.7 years). Figure 1 depicts the distribu-
tion of time to 1
treatment interruption. A substantial
number of clients discontinued treatment in the first few
weeks after starting HAART. Similar trends are seen for
time to return to treatment (Fig. 2). Of those who
restarted treatment, 24% (735) discontinued treatment for
second time over follow-up. Half, or 50% of the cases who
discontinued a second time, had done so within
five months of follow-up (Fig. 3).
Unfavorable treatment status at the end of observation
was observed for 28.5% (6,459) of the study population:
2,188 (34%) died, and 4,271 (66%) were lost to follow-
up. Compared to individuals that were active in treat-
ment at 6 months, those that had discontinued but
restarted treatment within the first 6 months were 1.9
times (95% confidence interval 1.5–2.4) more likely to
have an unfavorable outcome at the end of 5 years. One-
year retention in care was 83% for those that had discon-
tinued and re-started before six months, while it was
91% for those that had never discontinued. At the end of
follow-up, retention was 57% for restarters within 6
months, and 76% among comparable individuals who
had not discontinued by 6 months. Being adult, male,
having higher WHO stage (III or IV) and having lower
CD4 cell count at baseline were associated with higher
hazard of unfavorable treatment outcome at the end of
follow-up. Similar patterns were observed for assess-
ments at months 12, 18 and 24. For all time periods
assessed, re-starters experienced more than two-fold
excess hazard of unfavorable outcome (HR = 2.4 (95%
confidence interval 2.0–2.8), HR = 2.6 (95% confidence
interval 2.2–3.1), and HR = 2.4 (95% confidence inter-
val 2.0–2.8), respectively). (Tables 2 and 3) Among
Table 1 Baseline Characteristics (n= 22,647)
Variable Sub-category Number (%)
Age <15 513 (2)
≥15 22,134 (98)
Gender Female 12,226 (54)
Male 10,421 (46)
Baseline WHO Stage I or II 7,286 (32)
III or IV 15,361 (68)
Baseline CD4 <100 8,445 (37)
100–349 12,384 (55)
≥350 1,818 (8)
Ever discontinued ART No 13,888 (61)
Yes 8,759 (39)
Fig 1 Time to 1
treatment interruption (years)
Fig 2 Time to treatment restart after 1
Teklu and Yirdaw BMC Health Services Research (2017) 17:247 Page 4 of 8
those who discontinued and restarted treatment, be-
ing male, being WHO stage (III or IV), discontinuing
treatment for the first time before 6 months of
follow-up, and restarting treatment within 6 months
of interruption were associated with unfavorable treat-
ment outcome at the end of follow-up (Table 4).
Treatment interruptions were common in the study
population. A substantial proportion (39%), of clients
who started HAART in the study facilities discontinued
treatment at least once. Of these, 35% restarted treat-
ment, but approximately a quarter of those discontinued
treatment again. Among those who discontinued and re-
started, unfavorable outcomes at the end of follow-up
were at least twice as likely as among those who had
never discontinued treatment at months 6, 12, 18, and
Estimates of retention in care, or active engagement
on HAART among patients who have initiated therapy,
vary in different settings. In an observational,
prospective, multi-site cohort study of HIV-infected pa-
tients who initiated ART for the first time in Tigray,
Ethiopia, the 12 month retention was 85%. In a different
multi-clinic observational study in three regions in
Ethiopia, at 3 years, survival among 93,418 patients on
HAART was 70% [5, 13]. Estimates of survival from the
current study are comparable. But, only a few studies
have assessed long term treatment outcome among
those who interrupt and restart therapy. A study in
Uganda  found that of clients who interrupted but
subsequently resumed treatment, only 52% were active
in care after 18 months. This is similar with the current
study’s estimate of 56%. In the Uganda study, those who
returned to care on their own were more likely to re-
sume care after second treatment interruption than were
those who were traced by health care workers and re-
engaged: 61% vs. 39%. In our study, analysis indicates
that those that discontinued and restarted again earlier
were more likely to have unfavorable outcomes in the
long term. It is possible that re-starters that were tem-
porarily lost from care may tend to have barriers to care
that remain unaddressed upon re-entry, undermining
subsequent adherence to treatment. These may be re-
lated to lack of access to care and support programs,
distance from treatment site, advanced disease stage, or
lack of proper adherence counseling [14, 15]. A study in
British Columbia  describes a slightly different trend
in treatment interruption experiences. In this setting,
only 29% of patients were active on treatment continu-
ously, though the follow-up period was longer than the
current study (1996–2012). However, in contrast to our
study, patients of younger age, higher CD4 count, and
earlier WHO clinical stages were more likely to be lost.
It may be that healthier patients may not feel the need
to adhere to treatment, as their present health status may
give them a false assurance of health. In our study, how-
ever, we found the reverse: sicker clients were more likely
Fig 3 Time to 2
interruption after restart (years)
Table 2 Determinants of unfavorable treatment outcome at 60 months among those active in treatment at month six
Variable Sub-category Hazard ratio, crude P- value Hazard ratio, adj P-value
Age <15 1 1
≥15 1.6 0.001 1.6 0.002
Gender Female 1 1
Male 1.3 <0.001 1.2 <0.001
Baseline WHO Stage I or II 1 1
III or IV 1.5 <0.001 1.4 <0.001
Baseline CD4 <100 1 1
100–349 0.7 <0.001 0.8 <0.001
≥350 0.8 0.008 0.9 0.106
Ever discontinued HAART before 6 months No 1 1
Yes 1.8 0.000 1.9 0.000
Teklu and Yirdaw BMC Health Services Research (2017) 17:247 Page 5 of 8
to discontinue follow-up. The explanation for this could
be that sicker people may be unable to ambulate easily
and struggle to travel to attend clinic and acquire medica-
This study clearly describes the distribution of time
between treatment initiation and interruption, among
treatment interrupters. Clients were generally more
likely to interrupt medication in early stages of treat-
ment than later stages. This may be due to drug side
effects, resurgence of opportunistic infections, non-
disclosure of status or fear of stigma and discrimination
[17–20]. But, the time to the first occurrence of treat-
ment interruption was 1 year, as compared to an average
of 5 months to next occurrence after restarting. This re-
duction in time on treatment may be an indication of
adherence fatigue . Or as explained earlier, recur-
rence of problems that were unaddressed the first time
treatment was interrupted. This points to the need for a
more targeted intervention to help clients achieve long-
term treatment goals, including viral suppression. In
most high burden facilities where providers are bur-
dened with a high work load, treatment supporters are
available to assist with counseling of patients. Counsel-
ing may be targeted to support those with a pattern of
poor adherence, by sharing personal experiences and
teaching ways to cope with challenges [22–24]. Peer sup-
porters may also be able to reduce the length of inter-
ruption before restarting treatment.
The median time taken to restart treatment in this
study was seven months, although nearly a third of
those who restarted did so in the first few weeks.
Health care workers may be able to do more to reduce
this time by preparing patients before re-starting treat-
ment, and addressing emerging challenges as they ap-
pear. Improving accessibility of care is one important
approach to reducing loss from care. Bringing treat-
ment closer to patients’vicinity may alleviate barriers,
but such approaches may be complex to introduce, and
may not result in improvements in engagement in all
settings. In a study conducted by Médecins Sans
Table 4 Determinants of unfavorable treatment outcome at the end of follow-up among those who restarted treatment for HAART
after treatment interruption (n= 3,922)
Variable Sub-category Hazard ratio, crude P- value Hazard ratio, adj P-value
Age <15 1
≥15 1.4 0.300
Gender Female 1 1
Male 1.6 <0.001 1.6 <0.001
Baseline WHO Stage I or II 1 1
III or IV 1.2 0.061 1.3 0.014
Baseline CD4 <100 1
100–349 0.8 0.049 0.9 0.138
≥350 0.8 0.112 0.8 0.178
Time to 1
interruption <6 months 1 1
≥6 months 0.4 <0.001 0.3 <0.001
Time to 1
restart < 6 months 1 1
≥6 months 0.3 <0.001 0.2 <0.001
Table 3 Hazard of unfavorable treatment outcome at the end of follow-up among those active in HAART care at months 6, 12, 18
and 24 months
Variable Sub-category Hazard ratio, adj P-value
Ever discontinued HAART before 6 months No 1
Yes 1.9 0.003
Ever discontinued HAART before 12 months No 1
Yes 2.4 <0.001
Ever discontinued HAART before 18 months No 1
Yes 2.6 <0.001
Ever discontinued ART before 24 months No 1
Yes 2.4 <0.001
Teklu and Yirdaw BMC Health Services Research (2017) 17:247 Page 6 of 8
Frontières in 25 HAART treatment programs in mul-
tiple countries in Africa and Asia, program scale-up to
larger geographic coverage was associated with more
lost to follow-up, though it did result in improved mor-
tality. The reduction in mortality was comparable to
the incremental increase in loss rate. Further work may
need to be done to identify and re-engage clients that
are lost, which is more likely to happen with increased
frequency as more people are initiated on HAART. As
healthier patients are initiated earlier, it may be more
difficult to encourage adherence to treatment. For test-
and-treat strategy to result in mortality reduction, these
barriers will need to be addressed [1, 3, 25].
Among re-starters, male gender, being in advanced
WHO stage III or IV at baseline, history of treatment
interruption in the first 6 months after starting HAART,
and restarting treatment within 6 months of interruption
were significant predictors of subsequent loss from care.
We believe other factors may be helpful in identifying
those at risk of loss. This study used existing electronic
medical records and data, and therefore was limited to
the information that was previously collected. We were
therefore unable to explore other potential parameters
of interest. More studies are recommended, to inform
the development of a proper tool to help prioritize cli-
ents at risk, so that health care workers can target those
most in need of support.
Our analysis assumed that all lost patients interrupted
treatment, when in fact there is a possibility that some
restarted treatment at a different facility. This was dem-
onstrated in one study where nearly 20% of patients con-
sidered lost were found to be on treatment at a different
facility . Therefore, our analysis represents the
“worst case scenario”and may over-estimate loss from
treatment. The strength of this study comes from the
large number of clients followed over a long duration
of time, including from the beginning of free HAART
initiation in Ethiopia. This study relied on secondary
data collected for program purposes. Although the
original data may have had some errors or missing in-
formation, we took utmost precaution in our data ab-
straction to maintain accuracy as originally recorded.
This study indicates that treatment outcomes of
HAART defaulters are often unfavorable, and provides
evidence of the need for approaches to improve reten-
tion in care. Those who interrupt treatment follow-up
and then return to care experience less frequent re-
engagement upon subsequent interruptions from care.
Frequent delayed return to care and early relapse indi-
cate that there is much room for improvement in pa-
tient preparation and tracing as treatment coverage
expands further and healthier clients initiate treatment.
Additional file 1: Excel file containing study dataset used for analysis.
(XLS 3617 kb)
CD4: Cluster differentiation 4; HAART: Highly active antiretroviral therapy;
HIV: Human-immune deficiency; LTFU: Lost to follow-up; WHO: World health
We would like to thank health care providers, data clerks and peer
supporters that contributed to the documentation of medical and electronic
records at facilities.
Availability of data and material
All the data used in this study are included in this published article.
AMT participated in the conception of study, collection and analysis of the
quantitative data, compilation and review of documents, and drafting of the
manuscript. KD participated in the conception of study, collection and analysis
of the quantitative data, compilation and review of documents, and drafting of
the manuscript. Both authors read and approved the final manuscript.
The authors declare that they have no competing interests.
Consent for publication
Ethics approval and consent to participate
Existing data was used which was de-identified and de-linked before acquisition
and during analysis for which reason consent forms were not required.
Ethical approval was obtained from the National Research Ethics Review
Committee of Ethiopia.
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia.
MERQ Consultancy Services PLC, Addis Ababa, Ethiopia, Addis Ababa,
University of South Africa, Addis Ababa, Ethiopia.
Received: 9 August 2016 Accepted: 18 March 2017
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