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Implementing early infant diagnosis of HIV infection at the primary care level: Experiences and challenges in Malawi

Authors:

Abstract

Problem: Malawi's national guidelines recommend that infants exposed to the human immunodeficiency virus (HIV) be tested at 6 weeks of age. Rollout of services for early infant diagnosis has been limited and has resulted in the initiation of antiretroviral therapy (ART) in very few infants. Approach: An early infant diagnosis programme was launched. It included education of pregnant women on infant testing, community sensitization, free infant testing at 6 weeks of age, active tracing of HIV-positive infants and referral for treatment and care. Local setting: The programme was established in two primary care facilities in Blantyre, Malawi. Relevant changes: Of 1214 HIV-exposed infants, 71.6% presented for early diagnosis, and 14.5% of those who presented tested positive for HIV. Further testing of 103 of these 126 apparently HIV-positive infants confirmed infection in 88; the other 15 results were false positives. The initial polymerase chain reaction testing of dried blood spots had a positive predictive value (PPV) of 85.4%. Despite active tracing, only 87.3% (110/126) of the mothers of infants who initially tested positive were told their infants' test results. ART was initiated in 58% of the infants with confirmed HIV infection. Lessons learnt: Early infant diagnosis of HIV infection at the primary care level in a resource-poor setting is challenging. Many children in the HIV diagnosis and treatment programme were lost to follow-up at various stages. Diagnostic tools with higher PPV and point-of-care capacity and better infrastructures for administering ART are needed to improve the management of HIV-exposed and HIV-infected infants.
Bull World Health Organ 2012;90:699–704 | doi:10.2471/BLT.11.100776
Lessons from the field
699
Implementing early infant diagnosis of HIV infection at the primary
care level: experiences and challenges in Malawi
Queen Dube,a Anna Dow,b Chawanangwa Chirambo,a Jill Lebov,b Lyson Tenthani,c Michael Moore,a
Robert S Heydermana & Annelies Van Rieb for the CHIDEV study team
Background
According to the recommendations of the World Health Or-
ganization (WHO), infants known to have been exposed to
the human immunodeciency virus (HIV) should undergo a
virological test for infection at 4 to 6 weeks of age.1,2 Antiret-
roviral therapy (ART) should be initiated upon diagnosis of
HIV infection in children aged less than 24 months.3 However,
implementing programmes for such early infant diagnosis and
treatment has proved challenging.47
In Malawi, 13.8% of the children born to HIV-positive
mothers in 2009 were themselves HIV-positive as infants,8
but only 29% of those in need of ART received such treat-
ment.9 National guidelines in Malawi recommend that infants
exposed to HIV be tested by polymerase chain reaction (PCR)
for the detection of viral deoxyribonucleic acid (DNA) at
6 weeks of age wherever the facilities and resources for these
assays are available.10 In Malawi, as in several other countries,
most early infant diagnosis is hospital-based and few infants
receive ART aer testing.8,11
We report here the experiences and challenges encoun-
tered during implementation of early infant diagnosis in two
community health centres in Malawi.
Setting and approach
As part of recruitment procedures for a study assessing the
impact of HIV infection on child neurodevelopmental pro-
cesses, early infant diagnosis services were established at two
health-care facilities in Blantyre. One of these facilities, the
Zingwangwa Health Centre, is an urban primary care centre
that does not initiate or administer ART but that refers those
in need of ART to a hospital. e other study facility, the
Mlambe Mission Hospital, is located in a semi-rural area and
serves as a primary and secondary care centre with on-site
ART services. Both study facilities run programmes for the
prevention of mother-to-child transmission (PMTCT) of
HIV and both recommend breastfeeding and cotrimoxazole
prophylaxis for all HIV-exposed infants.
As pregnant women and mothers with infants attended
the study centres for PMTCT and postnatal visits, study sta
explained to them the importance of early infant HIV diagno-
sis and the benets of early ART for infants. To further increase
awareness of early infant diagnosis, posters and brochures
were distributed and community sensitization was performed.
Each HIV-positive mother was given an appointment card. At
6 weeks of age (or at the earliest visit thereaer), each infant
of an HIV-positive mother was referred for cotrimoxazole
prophylaxis and tested for HIV DNA. Permission for home
visits was requested from the infant’s mother, who was asked
to return with the infant, for a follow-up, 4 weeks later.
A sample of blood was collected from each HIV-exposed
infant via a heel prick. ese samples were transferred to
Protein Saver 903® cards (Whatman Ltd, Piscataway, United
States of America), which were then dried and individually
packaged with desiccant sachets before being transported to
the Malawi–Liverpool–Wellcome Trust research laboratory in
Blantyre. At the laboratory, the dried blood spots on the cards
Problem Malawi’s national guidelines recommend that infants exposed to the human immunodeficiency virus (HIV) be tested at 6 weeks
of age. Rollout of services for early infant diagnosis has been limited and has resulted in the initiation of antiretroviral therapy (ART) in very
few infants.
Approach An early infant diagnosis programme was launched. It included education of pregnant women on infant testing, community
sensitization, free infant testing at 6 weeks of age, active tracing of HIV-positive infants and referral for treatment and care.
Local setting The programme was established in two primary care facilities in Blantyre, Malawi.
Relevant changes Of 1214 HIV-exposed infants, 71.6% presented for early diagnosis, and 14.5% of those who presented tested positive for
HIV. Further testing of 103 of these 126 apparently HIV-positive infants confirmed infection in 88; the other 15 results were false positives.
The initial polymerase chain reaction testing of dried blood spots had a positive predictive value (PPV) of 85.4%. Despite active tracing,
only 87.3% (110/126) of the mothers of infants who initially tested positive were told their infants’ test results. ART was initiated in 58% of
the infants with confirmed HIV infection.
Lessons learnt Early infant diagnosis of HIV infection at the primary care level in a resource-poor setting is challenging. Many children in
the HIV diagnosis and treatment programme were lost to follow-up at various stages. Diagnostic tools with higher PPV and point-of-care
capacity and better infrastructures for administering ART are needed to improve the management of HIV-exposed and HIV-infected infants.
a Malawi–Liverpool–Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital, Blantyre, Malawi.
b Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, 135 Dauer Drive, Campus Box 7435, Chapel Hill, NC 27599, United
States of America.
c HIV Unit, Malawi Ministry of Health, Lilongwe, Malawi.
Correspondence to Annelies Van Rie (e-mail: vanrie@email.unc.edu).
(Submitted: 31 January 2012 – Revised version received: 5 May 2012 – Accepted: 11 May 2012 – Published online: 18 June 2012 )
Lessons from the field
Bull World Health Organ 2012;90:699–704 | doi:10.2471/BLT.11.100776
700
Lessons from the field
Early infant diagnosis of HIV infection in Malawi Queen Dube et al.
were tested for HIV DNA using version
1.5 of the Amplicor® HIV-1 DNA test
kit (Roche, Basel, Switzerland), which
is based on a PCR. e laboratory
included internal quality control pro-
cedures for each 4-weekly testing batch
and participated in an external quality
control programme run by the United
States Centers for Disease Control and
Prevention.
At follow-up, mothers of the chil-
dren found to be PCR-negative for
HIV DNA were counselled on how to
minimize transmission risk and the
importance of repeat testing while
breastfeeding. e mothers of the PCR-
positive infants were counselled on the
importance of early infant ART and
their infants were referred to the near-
est ART clinic. Community health sta,
who were reimbursed by study funds,
were asked to trace the mothers of PCR-
positive infants who did not return for
the scheduled follow-up.
Attempts were made to retest each
child who was initially found PCR-posi-
tive. In most cases, the same PCR-based
assay as used initially was employed to
test a second blood spot on the child’s
6-week sample card. However, if the rel-
evant sample card could not be located,
the HIV ribonucleic acid (RNA) in a
second blood sample collected from the
child was quantied, at the University
of North Carolinas project laboratory
in Lilongwe, using version 1.5 of the
Amplicor® HIV-1 Monitor (Roche). If
the retest sample gave a positive result,
the child was considered truly positive.
If the retest sample appeared negative,
another blood sample was collected
from the child and either tested for HIV
DNA or assayed for HIV RNA. If this
sample was found negative, the child’s
result was considered a false positive.
e nal result for any child who was
found rst positive and then negative
and then was unavailable for a second
retest was recorded as inconclusive.
Both the University of Malawi Col-
lege of Medicine Research and Ethics
Committee and the University of North
Carolina at Chapel Hill Institutional Re-
view Board approved the study protocol.
Results
Between January 2008 and June 2010,
7234 women, of whom 1214 (16.8%;
95% condence interval, CI: 15.9%–
17.6%) were HIV-infected, participated
in PMTCT activities at either of the two
study centres. Although 920 (75.8%) of
the infants of the HIV-positive moth-
ers presented for early infant diagnosis,
consent for the necessary testing was
only obtained from the mothers of 869
(94.5%; 95% CI: 93.0%–95.9%) of these
children. In consequence, only 71.6%
(95% CI: 69.0%–74.1%) of the HIV-
exposed infants seen at the two study
centres during the study period were
tested for HIV DNA. Although all but
one of the 50 women who declined to
give consent for the infant testing said
that they wanted to get permission from
their spouses, none of these women
ever returned for early infant diagnosis.
Self-reported PMTCT coverage, for both
mothers and infants at the two study
sites, was 92.4%.
Overall, 126 (14.5%) of the 869 in-
fants tested for HIV DNA gave a positive
initial result. e original sample cards
for 61 of the PCR-positive children were
relocated and another blood spot from
each of these cards was checked for HIV
DNA in the PCR-based assay. Of the 61
children who were retested in this way,
41 gave a positive result on retesting and
20 gave a negative result. Although fresh
blood samples were collected from 17
of the 20 children found PCR-negative
on retesting, only two of these 17 fresh
samples gave a positive result when
checked for HIV DNA (5 samples) or
assayed for HIV RNA (12 samples).
e original sample cards for 65 of
the children who were initially found
positive for HIV DNA had been thrown
away aer the initial testing. Fresh blood
samples were obtained from 45 of these
65 children and all 45 of these samples
gave a positive result when assayed for
HIV RNA. Conrmatory testing was not
possible for the 20 children who were
lost to follow-up. Among the 106 infants
with any conrmatory testing, 88 were
conrmed as HIV-infected and 15 were
considered HIV-negative; the results for
the remaining three children, who could
not be retested fully, were inconclusive.
Overall, 14.6% of the 103 children who
were retested fully were found to have
been falsely positive in the initial round
of testing. e positive predictive value
of the assay used in this initial round,
which was based on the detection, by
PCR, of HIV DNA in dried spots of
blood from infants aged about 6 weeks,
was therefore 85.4%.
Only 521 (60%) of the mothers
of tested infants returned to the study
centres to receive the results of the ini-
tial testing. However, compared with
the other mothers of tested infants, a
mother of a child found HIV-positive
when rst tested by PCR was signi-
cantly more likely to have received the
results of her infants test (87.3% versus
55.3%; P < 0.0001). e initiation of
ART was recorded for 51 children, who
represented 58% of all of the children
with conrmed HIV infection.
Discussion
Important lessons can be drawn from
our experience (Box 1). Routine early
infant diagnosis at the primary care level
in a resource-poor setting is feasible but
challenging, even when well supported
by research funds. A strength of our
approach was the integration of the
early infant diagnosis programme into
the existing PMTCT services, which
facilitated delivery of messages about
the importance and availability of early
infant diagnosis and early ART to the
target population of HIV-infected preg-
nant women. e scheduling of appoint-
ments for early infant diagnosis so that
they coincided with routine visits for the
vaccination of infants at 6 weeks of age
eliminated the need for additional visits
for the sole purpose of testing infants
for early diagnosis. ese approaches
resulted in the HIV testing of more than
two thirds of the HIV-exposed infants
seen at the study centres.
Our experiences with the early
infant diagnosis programme also high-
Box 1. Summary of main lessons learnt
• Integration of early infant diagnosis services with existing PMTCT services is feasible and
facilitates delivery of messages about the importance of early infant diagnosis to HIV-
infected women.
• Despite active tracing of HIV-infected children, there are high rates of loss to follow-up at
every stage of the early infant diagnosis programme.
• Improved diagnostic tools with point-of-care capacity are necessary to allow for more
streamlined testing programmes with the potential for better linkage to infant antiretroviral
treatment.
HIV, human immunodeficiency virus; PMTCT, prevention of mother-to-child transmission.
Bull World Health Organ 2012;90:699–704 | doi:10.2471/BLT.11.100776 701
Lessons from the field
Early infant diagnosis of HIV infection in Malawi
Queen Dube et al.
lighted many challenges. Unfortunately,
since HIV exposure was not docu-
mented on the standard infant health
passports and there was limited privacy
in the clinics, it proved impossible to
integrate the services for early infant
diagnosis with vaccination clinics.
e high percentage of false positive
results in the initial round of HIV tests
(14.6%) was unexpected, given the
previously reported high specicity of
the PCR-based assay that was used.12,13
Further investigations indicated that
laboratory contamination, resulting
from the manual manipulation of the
sample cards, was the most likely cause
of the low specicity. is observation
underscores the need for stringent qual-
ity control and conrmatory testing. e
long delay between the collection of the
initial blood samples and the availability
of the results of conrmatory testing
complicated the communication of an
initial positive result and the manage-
ment of the children with such a result.
Knowing the overwhelming benets of
early ART, we did not withhold such
treatment until the conrmatory results
were available. We carefully counselled
the mothers of infants who were initially
found PCR-positive while realizing that
a positive result on an infant’s HIV test
is devastating news and that the oc-
currence of false positive results can
undermine community trust in early
infant diagnosis.
e use of dried blood spots, which
can be collected at any clinic and
transported without refrigeration to
a laboratory equipped for PCR-based
analysis,12 has been an important step
towards universal access to early infant
diagnosis. However, by eliminating the
need to transport samples or to return
to a clinic to retrieve the test results, a
rapid point-of-care test for infant HIV
diagnosis14 could still greatly enhance
the operational feasibility of early infant
diagnosis programmes in resource-poor
settings.
A unique aspect of our approach
was the active tracing of HIV-positive
infants, which resulted in the receipt
of the infants’ HIV test results by the
families of 87% of these infants. Trac-
ing is unlikely to be possible without
dedicated funds. Sustainable strategies
to improve the communication of test
results to the caregivers of infants in
routine settings need to be explored.
Infant treatment programmes also need
to be scaled up to maximize the number
of HIV-infected infants who initiate
ART – the ultimate goal of early infant
diagnosis programmes.
While promising, the 71.6% cover-
age with early infant diagnostic services
that was recorded in the present study
indicates that one in four HIV-exposed
infants did not access such services. Ad-
ditionally, the coverage recorded here
may be an underestimate of the true
value, since the 28% of women in Malawi
who deliver at home, with the help of
traditional birth attendants,15 may never
be oered early infant diagnostic testing
(Fig. 1). e involvement of traditional
birth attendants in early infant diagno-
sis programmes and the integration of
early infant diagnosis into vaccination
clinics with community outreach could
complement any clinic-based activities.
e routine seeking of permission for
infant testing from both the mother
and her partner should be explored, as
permission from the partner was the pri-
mary reason that women who presented
for early infant diagnosis gave for not
proceeding with the testing.
Although careful documentation
and a large sample size were important
strengths of this evaluation, the research
setting limits the generalizability of our
ndings. e substantial human re-
sources and nancial support that were
available in the present study, through
linkage with the research team, probably
created a “best-case scenario” for a set-
ting that is usually resource-poor. Even
under these conditions, however, the
implementation of early infant diagnosis
at the primary-care level was challeng-
ing, with the dropouts that occurred
at every step diminishing the number
of HIV-infected children who gained
access to ART. Our experience suggests
that, to maximize the benets of early
infant HIV diagnosis programmes, a
simple, aordable and highly specic
point-of-care test for infant HIV diag-
nosis and better linkage to care are both
needed.
Acknowledgements
e Malawi–Liverpool–Wellcome Trust
Research Programme receives funding
from the Wellcome Trust. e authors
are grateful to all study and clinical sta
at Mlambe Mission Hospital, Zingwang-
wa Health Centre and Queen Elizabeth
Central Hospital, and to all participating
women and children.
Funding: Funding was provided by the
United States National Institutes of
Health/National Institute of Child Health
and Human Development, via grant R01
HD053216.
Competing interests: None declared.
Fig. 1. Opportunities to improve early infant diagnosis of HIV infection, based on
experiences at two primary care centres, Malawi, 2008–2010
87% of infants with
positive result are
informed and referred for
care and confirmatory test
Explanation of importance
and availability of EID
services at
PMTCT visit
6-week vaccination visit
6-week postnatal visit
60% of tested
infants attend
results visit after
active tracing of
infants with
positive results
72% present for infant
testing at 4–6 weeks
58% of HIV-infected
infants initiate ART
28% of women
access alternatives to
clinic-based care
28% do not attend
EID services
13% of HIV-infected
infants do not return
and are untraceable
42% of HIV-infected
infants, informed of
status, do not report
for treatment
Gaps in
coverage
4 weeks
Education and
awareness Infant testing
Distribution of results and
referral for treatment
ART, antiretroviral therapy; EID, early infant diagnosis; HIV, human immunodeficiency virus; PMTCT,
prevention of mother-to-child transmission.
Bull World Health Organ 2012;90:699–704 | doi:10.2471/BLT.11.100776
702
Lessons from the field
Early infant diagnosis of HIV infection in Malawi Queen Dube et al.
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88

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PPV
)126/110  


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
   

  
       
    




摘要
在初级保健等级实施艾滋病毒感染婴儿早期诊断:马拉维的经验和挑战
问题 根据马拉维的国家指导方针的建议,暴露于艾滋病
病毒(HIV)的婴儿要在6 周龄时接受检测。婴儿早期诊
断服务的推广受到了限制,导致接受抗逆转录病毒疗法
(ART)的婴儿人数极少。
方法 推出婴儿早期诊断计划。它包括对孕妇进行婴儿检测
教育、社区宣传、婴儿在 6 周龄的免费检测以及艾滋病毒
呈阳性的婴儿的积极跟踪和转诊治疗与护理。
当地状况 该计划在马拉维的布兰太尔两个初级保健医院
中展开。
相关变化 暴露于艾滋病毒的1214 名婴儿中,71.6%接受
早期诊断,其中14.5%检测为HIV阳性。对这些明显艾滋病
毒呈阳性的126 名婴儿当中的103 名进行进一步检测,确
认感染88 例;其他15 个结果为假阳性。初步的干血点聚
合酶链反应检测阳性预测值(PPV)为85.4%。尽管积极
跟踪,只有87.3%(110/126)的初步检测呈阳性的婴儿
的母亲被告知其婴儿的检测结果。证实感染艾滋病毒的婴
儿中有58% 开始接受ART治疗。
经验教训 在资源贫乏的环境中开展初级保健等级的感染
艾滋病毒的婴儿早期诊断充满挑战。艾滋病毒诊断和治
疗方案中有许多儿童在后续的各个阶段无法进行跟踪。
需要具有更高PPV和即时能力的诊断工具以及更好的管理
ART的基础设施,以改善对暴露于艾滋病毒和艾滋病毒感
染的婴儿的管理。
Résumé
Mise en œuvre du diagnostic précoce de l’infection par le VIH des nourrissons, au niveau des soins primaires: expériences et
défis au Malawi
Problème Les lignes directrices nationales du Malawi recommandent
que les nourrissons exposés au virus de l’immunodéficience humaine
(VIH) soient testés à l’âge de 6 semaines. Le déploiement des services
pour le diagnostic précoce chez les nourrissons a été limité et n’a donné
lieu au lancement de la thérapie antirétrovirale (TAR) que chez très peu
de nourrissons.
Approche Un programme de diagnostic infantile précoce a été
lancé. Il comprenait l’éducation des femmes enceintes quant aux tests
des nourrissons, la sensibilisation des communautés, le test gratuit
des nourrissons âgés de 6 semaines, le traçage actif des nourrissons
séropositifs et l’aiguillage pour le traitement et les soins.
Environnement local Le programme a été établi dans deux
établissements de soins de santé primaires à Blantyre, au Malawi.
Changements significatifs Sur 1 214 nourrissons exposés au VIH,
71,6% bénéficiaient d’un diagnostic précoce, et 14,5% des nourrissons
présentés étaient séropositifs. Des tests supplémentaires effectués sur
103 de ces 126 nourrissons apparemment séropositifs ont confirmé
l’infection de 88 d’entre eux; les 15 autres résultats étant faussement
positifs. Les tests initiaux de réaction en chaîne par polymérase sur des
taches de sang séché avaient une valeur prédictive positive (VPP) de
85,4%. Malgré le traçage actif, seules 87,3% (110/126) des mères de
nourrissons initialement testés positifs ont été informées des résultats
des tests de leurs nourrissons. Un TAR a été initié chez 58% des
nourrissons dont l’infection par le VIH a été confirmée.
Leçons tirées Le diagnostic précoce de l’infection par le VIH des
nourrissons est un défi au niveau des soins primaires dans un contexte
Bull World Health Organ 2012;90:699–704 | doi:10.2471/BLT.11.100776 703
Lessons from the field
Early infant diagnosis of HIV infection in Malawi
Queen Dube et al.
de ressources limitées. Le suivi de nombreux enfants, dans le programme
de diagnostic et de traitement du VIH, s’est interrompu à divers stades.
Les outils de diagnostic avec une VPP et une capacité de lieu de soins
plus élevées, et de meilleures infrastructures pour l’administration du
TAR, sont nécessaires pour améliorer la prise en charge des nourrissons
exposés et infectés par le VIH.
Резюме
Осуществление ранней диагностики ВИЧ-инфекции у младенцев на уровне первичной медицинской
помощи: знания и задачи в Малави
Проблема Согласно национальным нормативам Малави,
тестирование младенцев, подверженных вирусу иммунодефицита
человека (ВИЧ), рекомендуется проводить в шестинедельном
возрасте. Внедрение услуг по ранней диагностике инфекции
у младенцев было ограничено, что привело к проведению
антиретровирусной терапии (АРТ) у очень малого числа
младенцев.
Подход Произведен запуск программы по ранней диагностике
инфекции у младенцев. Программа включала в себя
информирование беременных женщин о тестировании
младенцев, проведение разъяснительной работы среди
местного населения, бесплатное тестирование младенцев
шестинедельного возраста, активное наблюдение за ВИЧ-
положительными младенцами и направление их на лечение и
уход.
Местные условия Программа реализовывалась в двух
учреждениях первой медицинской помощи в г. Блантайр, Малави.
Соответствующие изменения Из 1214 младенцев, подверженных
риску заражения ВИЧ, 71,6% направлялись на раннюю
диагностику, и у 14,5% из числа направленных, результат на ВИЧ
оказался положительным. Дальнейшее тестирование 103 из 126
вероятно ВИЧ-положительных младенцев подтвердило наличие
инфекции у 88 детей; остальные 15 результатов были ошибочно-
положительными. Положительное предсказательное значение
(ППЗ) первоначального тестирования на основе полимеразной
цепной реакции сухих капель крови составляло 85,4%. Несмотря
на активное отслеживание, только 87,3% (110/126) матерям, чьи
младенцы изначально имели положительные результаты, были
сообщены результаты теста. АРТ проводилась у 58% младенцев
с подтвержденной ВИЧ-инфекцией.
Извлеченные уроки Проведение ранней диагностики ВИЧ-
инфекции у младенцев на уровне первичной медицинской
помощи в условиях нехватки ресурсов является затруднительным.
Многие младенцы, участвовавшие в программе лечения и
диагностики ВИЧ, выбывали из наблюдения на различных стадиях.
Средства диагностики с высоким ППЗ и вместимость центров
предоставления медицинских услуг и лучшая инфраструктура
для назначения АРТ необходимы для улучшения ведения ВИЧ-
инфицированных младенцев и младенцев, подверженных риску
заражения ВИЧ.
Resumen
La aplicación de un diagnóstico temprano de la infección por VIH en lactantes en el ámbito de la atención primaria:
Experiencias y desafíos en Malawi
Situación Las directrices nacionales de Malawi recomiendan que se
realice la prueba del virus de la inmunodeficiencia humana (VIH) a los
lactantes expuestos al mismo cuando cumplan las 6 semanas de edad.
Se ha restringido el desarrollo de los servicios de diagnóstico temprano
de lactantes, lo que ha dado como resultado que muy pocos lactantes
hayan comenzado con una terapia antirretroviral (TAR).
Enfoque Se lanzó un programa de diagnóstico temprano de lactantes
que incluyó la formación de mujeres embarazadas acerca de las pruebas
para lactantes, la sensibilización de la comunidad, pruebas gratuitas para
lactantes de 6 semanas de edad, el seguimiento activo de lactantes
seropositivos y la derivación para su tratamiento y atención sanitaria.
Marco regional El programa se estableció en dos centros de atención
sanitaria primaria en Blantye, Malawi.
Cambios importantes De los 1214 lactantes expuestos, el 71,6%
acudió al diagnóstico temprano y de ellos, el 14,5% dio positivo para
el VIH. Otras pruebas realizadas a 103 de los, al parecer, 126 lactantes
seropositivos confirmaron la infección en 88 lactantes, los otros 15
resultados fueron falsos positivos. La reacción en cadena de la polimerasa
inicial de muestras de sangre seca tuvo un valor predictivo positivo (VPP)
del 85,4%. A pesar del seguimiento activo, sólo se comunicó el resultado
de las pruebas al 87,3% (110/126) de las madres de lactantes que en un
principio dieron positivo. La TAR se comenzó en el 58% de los lactantes
con una infección por VIH confirmada.
Lecciones aprendidas El diagnóstico temprano para la infección
por VIH en lactantes en el ámbito de la atención primaria en entornos
con pocos recursos requiere un gran esfuerzo. En las distintas etapas
se perdió el rastro de muchos niños del programa de diagnóstico y
tratamiento del VIH. Las herramientas de diagnóstico con un VPP alto
y la capacidad de los puntos de atención, así como la mejora de las
infraestructuras para la administración de la TAR son necesarias para
mejorar la gestión de los lactantes expuestos al VIH e infectados por él.
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[accessed 15 May 2012].
... H IV/AIDS remains a disease of great public health importance, and vertical transmission of HIVfrom mother to childcontinues to be a common route of transmission, accounting for the vast majority of new infections in children. 1 In 2012, about 330,000 children under 15 years of age worldwide were infected with HIV, according to estimates by the Joint United Nations Programme on HIV and AIDS (UNAIDS), with more than 90% of paediatric HIV infections occurring in sub-Saharan Africa. 1 Most of these infections occurred during pregnancy, delivery, or breastfeeding, thereby making the prevention of mother-to-child transmission (PMTCT) an important public health strategy for reducing HIV transmission. 2 PMTCT programmes provide antiretroviral therapy (ART) to HIV-positive pregnant women to prevent their infants from acquiring the virus. ...
... H IV/AIDS remains a disease of great public health importance, and vertical transmission of HIVfrom mother to childcontinues to be a common route of transmission, accounting for the vast majority of new infections in children. 1 In 2012, about 330,000 children under 15 years of age worldwide were infected with HIV, according to estimates by the Joint United Nations Programme on HIV and AIDS (UNAIDS), with more than 90% of paediatric HIV infections occurring in sub-Saharan Africa. 1 Most of these infections occurred during pregnancy, delivery, or breastfeeding, thereby making the prevention of mother-to-child transmission (PMTCT) an important public health strategy for reducing HIV transmission. 2 PMTCT programmes provide antiretroviral therapy (ART) to HIV-positive pregnant women to prevent their infants from acquiring the virus. ...
... The WHO recommends DNA realtime PCR (RT-PCR) HIV testing at 4 to 6 weeks of life for infants of HIV-positive mothers, and commencement of ART for HIV-positive children below 24 months of age. 1,2,9 This study examined EID with DNA RT-PCR at 3 health facilities in Bujumbura, Burundi, with the aim of assessing the effectiveness of PMTCT interventions towards reducing vertical transmission of HIV. ...
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Background: Prevention of mother-to-child transmission (PMTCT) programmes aim to both eliminate vertical transmission of HIV and optimise the health and survival of infants born with HIV. Therefore, early infant diagnosis (EID) of HIV infection via DNA polymerase chain reaction (PCR) testing is a key component of PMTCT programming. We assessed the effectiveness of EID and PMTCT interventions at health-care facilities in Bujumbura, Burundi. Methods: This was a prospective analytical study of infants born to HIV-positive mothers on antiretroviral therapy (ART), who were followed from December 2016 to March 2017 at 3 centres providing PMTCT services in Bujumbura. Babies enrolled in this study received once-daily nevirapine from birth through to 6 weeks of life, after which HIV DNA PCR testing was conducted. Results: Of 122 HIV-exposed infants, 60 were boys and 62 were girls. The mother-to-child transmission rate at 6 weeks of life was 0.9%. Eighty-three (68%) of the women had commenced ART before pregnancy and 39 (32%) during pregnancy. The mean CD4 lymphocyte count was 653±308 cells/μl. Ninety-two (75.4%) of the pregnancies were planned, and 98 (80%) of the births were via spontaneous vaginal delivery. After birth, 111 (91.0%) infants were exclusively breastfed, and 11 (9.0%) infants received exclusive replacement feeding. Conclusion: There was a low rate of transmission of HIV from women taking ART to children who were given nevirapine for the first 6 weeks of life. Infants of HIV-positive women can live healthy lives free from HIV infection if their mothers participate in PMTCT programmes.
... Some countries (Armenia, Belarus, Cuba, the Caribbean, Thailand and Malaysia) have achieved "zero MTCT" due to adherence to well-coordinated integrated services (antenatal, immunisation, paediatric care, community healthcare and HIV healthcare and surveillance programs [3,6,7]. In contrast, in many sub-Saharan African countries such as Malawi, poor retention to integrated services in resource-limited countries is thought to play a significant role in the failure to achieve "zero MTCT" [1,8]. ...
... While 14 infants (2.0% of all infants tested) were diagnosed with HIV, only six infants were receiving paediatric ART at their last follow-up and a further infant had commenced ART at diagnosis (3.5 months postpartum) but was subsequently lost to follow-up. While we could not ascertain whether HIV-positive infants were receiving HIV treatment at another facility, other studies support the suboptimal use of ART in HIVpositive infants; in 2016, access to ART in 21 priority countries, including Sub-Saharan Africa, was~51%, [6] and in 2012, Dube et al. found ART initiation in Malawi was~58% [8]. ...
... While we were unable to ascertain why 29% of HIV testing data was missing, these findings are consistent with the HIV testing rates in Malawi at the time of the study [8]. However, it is unlikely that missing HIV testing data is the result of data entry error as HIV testing data had extensive quality control checks against MoH facility HIV testing data. ...
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Background Retention of HIV-infected mothers in integrated HIV and healthcare facilities is effective at reducing mother-to-child-transmission (MTCT) of HIV. In the context of Option B+, we examined maternal and HIV-exposed infant retention across three study arms to 18 months postpartum: mother-and-infant clinics (MIP), MIP with short-messaging service (MIP + SMS) and standard of care (SOC). In particular, we focused on the impact of mothers receiving an infant’s HIV PCR test result on maternal and infant study retention. Methods A quantitative sub-study nested within a cluster randomised trial undertaken between May 2013 and August 2016 across 30 healthcare facilities in rural Malawi enrolling HIV-infected pregnant mothers and HIV-exposed infants on delivery, was performed. Survival probabilities of maternal and HIV-exposed infant study retention was estimated using Kaplan-Meier curves. Associations between mother’s receiving an infant’s HIV test result and in particular, an infant’s HIV-positive result on maternal and infant study retention were modelled using time-varying multivariate Cox regression. Results Four hundred sixty-one, 493, and 396 HIV-infected women and 386, 399, and 300 HIV-exposed infants were enrolled across study arms; MIP, MIP + SMS and SOC, respectively. A total of 47.5% of mothers received their infant’s HIV test results < 5 months postpartum. Receiving an infant’s HIV result by mothers was associated with a 70% increase in infant non-retention in the study compared with not receiving an infant’s result (HR = 1.70; P-value< 0.001). Receiving a HIV-positive result was associated with 3.12 times reduced infant retention compared with a HIV-negative result (P-value< 0.001). Of the infants with a HIV-negative test result, 87% were breastfed at their final study follow-up. Conclusions Receiving an infant’s HIV test result was a driving factor for reduced infant study retention, especially an infant’s HIV-positive test result. As most HIV-negative infants were still breastfed at their last follow-up, this indicates a large proportion of HIV-exposed infants were potentially at future risk of MTCT of HIV via breastfeeding but were unlikely to undergo follow-up HIV testing after breastfeeding cessation. Future studies to identify and address underlying factors associated with infant HIV testing and reduced infant retention could potentially improve infant retention in HIV/healthcare facilities. Trial registration Pan African Clinical Trial Registry: PACTR201312000678196.
... Strategies to test infants were mostly clinic-based and targeted HIV-exposed infants (HEI) (n = 11, 8.0%). Early infant diagnosis (EID) programs successfully increased testing rates [82,83]. Point-of-care EID also provided shorter intervals between testing and receiving results, faster time to ART initiation, and increased number of infants started on ART [84,85]. ...
... In addition to privacy concerns, low risk perception, needing partner permission and time constraints, declining a test was associated with fear of stigma and intimate partner violence [16,18,82,96,111,112]. This indicates the need for HIV awareness campaigns to reduce stigma and intimate partner violence associated with HIV-positive status and also promote autonomy among women [18,56,113]. ...
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HIV/AIDS remains a looming presence in public health across the world, particularly in Sub-Saharan Africa. The HIV Care Cascade hinges on testing and knowledge of HIV status. Though significant advances have been made in diagnosing people living with HIV (PLHIV), limitations in understanding which strategies are best suited to certain regions or populations have contributed to the uneven distribution in the success of various HIV testing strategies. Here, we present a conceptual framework that outlines effective HIV testing strategies for four target groups. This framework is based on a systematic literature review of articles published from January 1st, 2008, to December 31st, 2019. The effectiveness of HIV testing strategies depends on various factors including the setting, type of test and service providers. Multiple strategies are needed to reach the UNAIDS target of 95% of individuals knowing their HIV status. Expansion of community-based approaches, self-testing and HIV testing services in antenatal care will further improve the state of HIV testing in Sub-Saharan Africa.
... 25 Furthermore, a Malawian study showed that community health workers are capable of conducting house visits, providing counseling, and educating people on EID of HIV services as long as they are well trained and this resulted in improved knowledge on the testing process, adherence to EID guidelines and yielded positive attitude toward EID of HIV care. 26 In our study, mothers were willing to have EID of HIV services within VHCs because it accelerates the time it takes for their children to have an HIV test and shortens the distance covered to access the services at health centers. 27 A reduction in the distance removes the burden to reach facilities by mothers thus enhancing access and use of the services. ...
... Mothers and HCWs indicated that integration of services would minimize rates of loss-to-follow-up which cements earlier findings from Tanzania where loss-to-follow-up was addressed through the integration of EID services into community health systems. 26 Although integration of EID into community health services safeguards the lives of HIV-infected infants and children, it will require collaboration and networking among stakeholders in EID to achieve optimal service delivery. 44 Our findings on reduced congestion in HIV clinics at the hospital corroborates with findings from a study that identified models of HIV care and treatment service delivery in Tanzania, Uganda, and Zambia and found that integration and use of lay workers reduced clients load and enhanced delivery of services. ...
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Integration of Early Infant Diagnosis(EID) of HIV into Village Health Clinics (VHCs) would increase the uptake of services. This study assessed mothers and health care workers' acceptability of integration of EID of HIV services into VHCs in Ntcheu, Malawi. We conducted an exploratory qualitative study in the phenomenological tradition among 20 mothers of either HIV exposed or non-exposed infants and 18 health care workers (HCWs) from February to July 2019. We analyzed the data using a thematic approach and guided by the theoretical framework for acceptability. There were positive perceptions of the integration of services. Acceptability is influenced by attitudes, perceived burden, intervention coherent services, and perceived effectiveness of services. The successful integration of EID of HIV into VHCs requires strengthening of the health system and community awareness. Efforts to mitigate stigma should be prioritized when integrating the services to optimize uptake of the services at a community level.
... Because GMAb levels are quite high in patients with autoimmune PAP and low or undetectable in other PAP-causing diseases, other lung diseases, and healthy people (Trapnell et al., 2003;Uchida et al., 2004;Uchida et al., 2014) and dried blood spot card (DBSC) testing has been successful for a number of other diseses (Farnert et al., 1999;Dube et al., 2012;Taneja et al., 2013;Gakhar and Holodniy, 2014;Smit et al., 2014a;Smit et al., 2014b;Govender et al., 2016;van Loo et al., 2017), the present study was undertaken to develop a novel DBSC-based method to detect GMAbs in blood specimens, and to evaluate its sensitivity, specificity, accuracy, precision, and ruggedness as a diagnostic test for autoimmune PAP. ...
Article
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Granulocyte/macrophage colony-stimulating factor autoantibodies (GMAbs) mediate the pathogenesis of autoimmune pulmonary alveolar proteinosis (autoimmune PAP) and their quantification in serum by enzyme-linked immunosorbent assay (ELISA) – the serum GMAb test – is the ‘gold standard’ for diagnosis of autoimmune PAP. Because GMAbs are high in autoimmune PAP and low or undetectable in healthy people, we hypothesized that the ELISA could be adapted for evaluation of blood obtained from the fingertip using a dried blood spot card (DBSC) for specimen collection. Here, we report development of such a method – the DBSC GMAb test – and evaluate its ability to measure GMAb concentration in blood and to diagnose autoimmune PAP. Fresh, heparinized whole blood was obtained from 60 autoimmune PAP patients and 19 healthy people and used to measure the GMAb concentration in blood (by the DBSC GMAb test). After optimization, the DBSC GMAb test was evaluated for accuracy, precision, reliability, sensitivity, specificity, and ruggedness. The coefficient of variation among repeated measurements was low with regard to well-to-well, plate-to-plate, day-to-day, and inter-operator variation, and results were unaffected by exposure of prepared DBSC specimens to a wide range of temperatures (from -80 °C to 65 °C), repeated freeze-thaw cycles, or storage for up to 2.5 months before testing. The limit of blank (LoB), limit of detection (LoD), and lower limit of quantification (LLoQ), were 0.01, 0.21, and 3.5 μg/ml of GMAb in the blood, respectively. Receiver operating curve characteristic analysis identified 2.7 μg/ml as the optimal GMAb concentration cutoff value to distinguish autoimmune PAP from healthy people. This cutoff value was less than the LLoQ and the ranges of GMAb results for autoimmune PAP patients and healthy people were widely separated (median (interquartile range): 22.6 (13.3–43.8) and 0.23 (0.20–0.30) μg/ml, respectively). Consequently, the LLoQ is recommended as the lower limit of the range indicating a positive test result (i.e., that autoimmune PAP is present); lower values indicate a negative test result (i.e., autoimmune PAP is not present). Among the 30 autoimmune PAP patients and 19 healthy people evaluated, the sensitivity and specificity of the DBSC GMAb test were both 100% for a diagnosis of autoimmune PAP. Results demonstrate the DBSC GMAb test reliably measures GMAbs in blood and performs well in the diagnosis of autoimmune PAP.
... We also found EID prophylaxis and testing among HIV-exposed infants to be a significant gap in the PMTCT cascade. Although the PMTCT program has made significant progress toward testing and managing HIV-positive pregnant women, the incorporation and coverage of EID services has been hindered by loss to follow-up, limited laboratory capacity, and reliance on centralized PCR laboratories [27][28][29]. Despite established EID guidelines and procedures, challenges have continued after the survey [27,30,31]. ...
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Background Malawi spearheaded the development and implementation of Option B+ for prevention of mother-to-child transmission of HIV (PMTCT), providing life-long ART for all HIV-positive pregnant and breastfeeding women. We used data from the 2015–2016 Malawi Population-based HIV Impact Assessment (MPHIA) to estimate progress toward 90-90-90 targets (90% of those with HIV know their HIV-positive status; of these, 90% are receiving ART; and of these, 90% have viral load suppression [VLS]) for HIV-positive women reporting a live birth in the previous 3 years. Methods MPHIA was a nationally representative household survey; consenting eligible women aged 15–64 years were interviewed on pregnancies and outcomes, including HIV status during their most recent pregnancy, PMTCT uptake, and early infant diagnosis (EID) testing. Descriptive analyses were weighted to account for the complex survey design. Viral load (VL) results were categorized by VLS (<1,000 copies/mL) and undetectable VL (target not detected/below the limit of detection). Results Of the 3,153 women included in our analysis, 371 (10.1%, 95% confidence interval [CI]: 8.8%–11.3%) tested HIV positive in the survey. Most HIV-positive women (84.2%, 95% CI: 79.9%–88.6%) reported knowing their HIV-positive status; of these, 94.9% (95% CI: 91.7%–98.2%) were receiving ART; and of these, 91.2% (95% CI: 87.4%–95.0%) had VLS. Among the 371 HIV-positive women, 76.0% (95% CI: 70.4%–81.7%) had VLS and 66.5% (95% CI: 59.8%–73.2%) had undetectable VL. Among 262 HIV-exposed children, 50.8% (95% CI: 42.8%–58.8%) received EID testing within 2 months of birth, whereas 17.9% (95% CI: 11.9%–23.8%) did not receive EID testing. Of 190 HIV-exposed children with a reported HIV test result, 2.1% (95% CI: 0.0%–4.6%) had positive results. Conclusions MPHIA data demonstrate high PMTCT uptake at a population level. However, our results identify some gaps in VLS in postpartum women and EID testing.
... Before 2016, POC EID testing was primarily introduced in controlled environments such as research and pilot projects in sub-Saharan Africa. 5,6,7 Many POC platforms for various diagnostic tests have been deployed in healthcare settings. However, few implementers have tried to describe and explain the actual real-life process for introducing and integrating a new POC into a national health system for routine use. ...
Article
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Background: New technologies for rapid point-of-care (POC) diagnostic tests hold great potential for improving the health outcomes of HIV-exposed infants. POC testing for HIV early infant diagnosis (EID) was introduced in Lesotho in late 2016. Here we highlight critical requirements for selecting routine POC EID sites to ensure a sustainable and optimised EID diagnostic network. Intervention: Lesotho introduced POC EID in a phased approach that included assessments of national databases to identify sites with high test volumes, the creation of local networks of sites to potentially increase access to POC EID, and a standardised capacity assessment to determine site readiness. Potential site networks comprising ‘hub’ testing sites and ‘spoke’ specimen referring sites were created. Lessons learnt: After determining optimal placement, a total of 29 testing facilities were selected for placement of POC EID to potentially increase access to 189 facilities through the use of a hub-and-spoke model. Site capacity assessments identified vital human resources and infrastructure capacity gaps that needed to be addressed before introducing POC EID and informed appropriate POC platform selection. Recommendations: POC placement involves more than just purchasing the testing platforms. Considering the relatively small proportion of sites that can be eligible for placement of a POC platform, utilising a hub-and-spoke model can maximise the number of health facilities served by a POC platform while reducing the necessary capacity building and infrastructure investments to fewer sites.
... A study in Malawi reported similar findings showing that lack of privacy in the clinics limited uptake of PITC services for infants. 31 Lack of adequate resources required to implement PITC has also demoralised service providers, thus constraining effective provision of PITC services. A number of studies 27,32,33 have discussed the importance of incentives for health workers, such as good salaries and training, to increase motivation and commitment and ultimately improve performance. ...
Article
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Background: There is low utilisation of provider-initiated HIV testing and counselling (PITC) services for infants and children under 5 years old in many low- and middle-income countries including Tanzania. Studies have shown that various factors contribute to low use of PITC, includes the unavailability of the polymerase chain reaction (PCR) test and other specialised techniques for testing children less than 18 months old as well as the reluctance of some parents and caregivers to undertake HIV testing for their children because of the fear of stigma associated with HIV/AIDS. This study explored health system barriers at the district and community levels affecting the provision of PITC for infants and children under 5 in Tanzania using a case study of 2 districts. Methods: A qualitative study was conducted in 1 urban and 1 rural district in the southern part of Tanzania. In-depth interviews, focus group discussions, and a desk review of documents were used to obtain the information. Respondents were purposively enrolled in the study and thematic analysis was used to generate findings. Results: Provision of PITC services faces a number of district-level health system barriers, including lack of adequate health staff in health facilities both in number and skills, lack of adequate infrastructure, and erratic shortage of supplies. At the community level, community members' low understanding about the importance of PITC services as well as existing stigma associated with HIV/AIDS have constrained the provision of PITC services. Conclusion: This study concludes that for effective implementation of PITC, the health system should strengthen health facilities through training of service providers on PITC, deploying adequately skilled health workers, supplying sufficient medicines and other supplies, and promoting health campaigns focused on educating community members about the importance of early HIV testing for infants and children under 5.
... On the other hand, the nding of this study is lower as compared with the ndings of studies conducted in Bishoftu Hospital, Ethiopia (66.7%) [19] and other similar African countries such as Malawi (72%) [20] and Nigeria (69%) [21]. The deference may arise from setting or methodological deference as the study conducted in Bishoftu hospital included only hospital births and the EID de nition used was extended to two months unlike this study that used 6 weeks. ...
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Background: The World Health Organization recommends testing of all HIV exposed infants at 4–6 weeks of age to optimize detection of intrauterine, intrapartum, and early postnatal HIV transmissions. However, the global coverage of early infant diagnosis remains low. With less than 25% national coverage, the progress of this early diagnosis in Ethiopia is one of the slowest in the World. Furthermore, local studies are limited to determine the status and identify the associated factors in many parts of the country in general and in West Shoa Zone in particular. Thus, this study aimed to fill this gap. Methods: A mixed method study by using retrospective record review of four years facility data of 342 mother-infant pairs supplemented by qualitative method was conducted in West Shoa Zone, Oromia Region, Ethiopia in 2018. The quantitative data related to maternal and HIV exposed infants’ cares were collected by using questionnaire. The qualitative data related to facility related barriers were collected by key-informants interview with selected mothers and service providers. Factors associated with early infant diagnosis of HIV infection were identified by using multivariable logistic regression analysis. The qualitative data were analyzed thematically and triangulated with the quantitative findings. Results: The status of early infant diagnosis was 58.5% (95%CI: 53.3%, 63.7%). Attending secondary education or above (AOR=2.41; 95%CI: 1.54, 3.28), having <4 living children (AOR=4.76, 95%CI: 02.56, 9.09), knowing HIV sero-status during or before pregnancy (AOR=6.24, 95%CI: 2.40, 10.08) and sero-status disclosure (AOR=8.30, 95%CI: 3.30, 20.60) were significantly associated with early infant diagnosis. Attending ANC visit (AOR=5.32; 95%CI: 2.53, 8.11), giving birth in health facility (AOR=62; 95%CI: 3.39, 11.85) and Neverapine provision at enrolment (AOR=6.05; 95%CI: 2.48, 14.73) were also significantly associated with early infant diagnosis of HIV infection. Conclusion: The status of early infant diagnosis in the study area is low to achieve the national target of 95% coverage by 2020. Maternal socio-demography, maternal behavior in knowing sero-status and disclosing and using services during pregnancy and delivery were among the determinants of early infant diagnosis. Promoting ANC and PMTCT cascade through behavioral interventions and fulfilling the essential equipments and supplies are required.
Article
Résumé Position du problème Au Cameroun, la couverture des enfants éligibles au traitement antirétroviral (TARV) (15 %) était l’une des plus faibles des 21 pays prioritaires du Fonds Mondial en 2012. Le but de cette étude était de faire une analyse situationnelle de l’offre des soins pour améliorer la prise en charge du VIH pédiatrique (PECP) au Cameroun. Méthodes Une étude transversale descriptive a été menée pendant quatre mois (avril à août 2014) dans 12 formations sanitaires de sept régions du Cameroun sélectionnées par un sondage systématique. Les données ont été recueillies à l’aide d’un auto-questionnaire administré aux personnels soignants et aux responsables administratifs inclus dans l’étude. Résultats Au total 142 personnels en charge du VIH pédiatrique ont été inclus dans cette étude : 115 du niveau opérationnel parmi lesquels 59 (51,2 %) personnels de santé, 44 (38,3 %) agents communautaires, 12 (10,4 %) chefs de services, 19 responsables du niveau régional et 8 du niveau central. La grande majorité des personnels soignants impliqués dans la PECP étaient des infirmiers, nécessitant ainsi la délégation effective des tâches médicales institutionnalisée au Cameroun. Très peu de documents normatifs nationaux prenaient en compte la PECP. La faible vulgarisation de ces documents normatifs à tous les niveaux de la pyramide sanitaire pourrait justifier le non-respect des protocoles de prise en charge observé dans les formations sanitaires offrant la PECP. Conclusion La mise à jour et la diffusion à large échelle des documents nationaux normatifs, prenant en compte des spécificités de l’enfant infecté par le VIH, sont nécessaires pour améliorer l’application des directives de la PECP au niveau opérationnel.
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There is a significant increase in survival for HIV-infected children who have early access to diagnosis and treatment. The goal of this multi-country review was to examine when and where HIV-exposed infants and children are being diagnosed, and whether the EID service is being maximally utilized to improve health outcomes for HIV-exposed children. In four countries across Africa and Asia existing documents and data were reviewed and key informant interviews were conducted. EID testing data was gathered from the central testing laboratories and was then complemented by health facility level data extraction which took place using a standardized and validated questionnaire In the four countries reviewed from 2006 to 2009 EID sample volumes rose dramatically to an average of >100 samples per quarter in Cambodia and Senegal, >7,000 samples per quarter in Uganda, and >2,000 samples per quarter in Namibia. Geographic coverage of sites also rapidly expanded to 525 sites in Uganda, 205 in Namibia, 48 in Senegal, and 26 in Cambodia in 2009. However, only a small proportion of testing was done at lower-level health facilities: in Uganda Health Center IIs and IIIs comprised 47% of the EID collection sites, but only 11% of the total tests, and in Namibia 15% of EID sites collected >93% of all samples. In all countries except for Namibia, more than 50% of the EID testing was done after 2 months of age. Few sites had robust referral mechanisms between EID and ART. In a sub-sample of children, we noted significant attrition of infants along the continuum of care post testing. Only 22% (Senegal), 37% (Uganda), and 38% (Cambodia) of infants testing positive by PCR were subsequently initiated onto treatment. In Namibia, which had almost universal EID coverage, more than 70% of PCR-positive infants initiated ART in 2008. While EID testing has expanded dramatically, a large proportion of PCR- positive infants are initiated on treatment. As EID services continue to scale-up, more programmatic attention and support is needed to retain HIV-exposed infants in care and ensure that those testing positive initiate treatment in a timely manner. Namibia's experience demonstrates that it is feasible for a rural, low-income country to achieve high national coverage of infant testing and treatment.
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Background: In Tanzania, less than a third of HIV infected children estimated to be in need of antiretroviral therapy (ART) are receiving it. In this setting where other infections and malnutrition mimic signs and symptoms of AIDS, early diagnosis of HIV among HIV-exposed infants without specialized virologic testing can be a complex process. We aimed to introduce an Early Infant Diagnosis (EID) pilot program using HIV DNA Polymerase Chain Reaction (PCR) testing with the intent of making EID nationally available based on lessons learned in the first 6 months of implementation. Methods: In September 2006, a molecular biology laboratory at Bugando Medical Center was established in order to perform HIV DNA PCR testing using Dried Blood Spots (DBS). Ninety-six health workers from 4 health facilities were trained in the identification and care of HIV-exposed infants, HIV testing algorithms and collection of DBS samples. Paper-based tracking systems for monitoring the program that fed into a simple electronic database were introduced at the sites and in the laboratory. Time from birth to first HIV DNA PCR testing and to receipt of test results were assessed using Kaplan-Meier curves. Results: From October 2006 to March 2007, 510 HIV-exposed infants were identified from the 4 health facilities. Of these, 441(87%) infants had an HIV DNA PCR test at a median age of 4 months (IQR 1 to 8 months) and 75(17%) were PCR positive. Parents/guardians for a total of 242(55%) HIV-exposed infants returned to receive PCR test results, including 51/75 (68%) of those PCR positive, 187/361 (52%) of the PCR negative, and 4/5 (80%) of those with indeterminate PCR results. The median time between blood draw for PCR testing and receipt of test results by the parent or guardian was 5 weeks (range <1 week to 14 weeks) among children who tested PCR positive and 10 weeks (range <1 week to 21 weeks) for those that tested PCR negative. Conclusions: The EID pilot program successfully introduced systems for identification of HIV-exposed infants. There was a high response as hundreds of HIV-exposed infants were registered and tested in a 6 month period. Challenges included the large proportion of parents not returning for PCR test results. Experience from the pilot phase has informed the national roll-out of the EID program currently underway in Tanzania.
Article
Low mother/infant retention has impeded early infant diagnosis of HIV in rural Mozambique. We enhanced the referral process for postpartum HIV-infected women by offering direct accompaniment to the location of exposed infant testing before discharge. Retrospective record review for 395 women/infants (September 2009 to June 2010) found enhanced referral was associated with higher odds of follow-up (adjusted odds ratio = 3.18, 95% confidence interval: 1.76 to 5.73, P < 0.001); and among those followed-up, earlier infant testing (median follow-up: 33 days vs. 59 days, P = 0.01) compared with women receiving standard referral. This simple intervention demonstrates benefits gleaned from attention to system improvement through service integration without increasing staff.
Article
The objective of this study was to identify the vital status and reasons for children becoming loss to follow-up (LTFU) from a large program in western Kenya. This was a prospective evaluation of a random sample of 30% of HIV-exposed and HIV-positive children LTFU from either an urban or rural HIV Academic Model Providing Access to Healthcare clinic. LTFU is defined as absence from clinic for >6 months if on combination antiretroviral therapy and > 12 months if not. Experienced community health workers were engaged to locate them. There were 97 children sampled (78 urban, 19 rural). Of these, 82% were located (78% urban, 100% rural). Among the HIV positive, 16% of the children were deceased, and 16% had not returned to clinic because of disclosure issues/discrimination in the family or community. Among the HIV exposed, 30% never returned to care because their guardians either had not disclosed their own HIV status or were afraid of family/community stigma related to their HIV status or that of the child. Among children whose HIV status was unknown, 29% of those found had actually died, and disclosure/discrimination accounted for 14% of the reasons for becoming LTFU. Other reasons included believing the child was healed by faith or through the use of traditional medicine (7%), transport costs (6%), and transferring care to other programs or clinics (8%). After locating >80% of the children in our sample, we identified that mortality and disclosure issues including fear of family or community discrimination were the most important reasons why these children became LTFU.
Article
A key challenge inhibiting the timely initiation of pediatric antiretroviral treatment is the loss to follow-up of mothers and their infants between the time of mothers' HIV diagnoses in pregnancy and return after delivery for early infant diagnosis of HIV. We sought to identify barriers to follow-up of HIV-exposed infants in rural Zambézia Province, Mozambique. We determined follow-up rates for early infant diagnosis and age at first test in a retrospective cohort of 443 HIV-infected mothers and their infants. Multivariable logistic regression models were used to identify factors associated with successful follow-up. Of the 443 mother-infant pairs, 217 (49%) mothers enrolled in the adult HIV care clinic, and only 110 (25%) infants were brought for early infant diagnosis. The predictors of follow-up for early infant diagnosis were larger household size (odds ratio [OR], 1.29; 95% confidence interval [CI], 1.09-1.53), independent maternal source of income (OR, 10.8; 95% CI, 3.42-34.0), greater distance from the hospital (OR, 2.14; 95% CI, 1.01-4.51), and maternal receipt of antiretroviral therapy (OR, 3.15; 95% CI, 1.02-9.73). The median age at first test among 105 infants was 5 months (interquartile range, 2-7); 16% of the tested infants were infected. Three of four HIV-infected women in rural Mozambique did not bring their children for early infant HIV diagnosis. Maternal receipt of antiretroviral therapy has favorable implications for maternal health that will increase the likelihood of early infant diagnosis. We are working with local health authorities to improve the linkage of HIV-infected women to HIV care to maximize early infant diagnosis and care.
Article
The availability of rapid, point-of-care (POC) tests has significantly expanded the capacity of both developed and resource-constrained countries (RCCs) to diagnose HIV, with immunochromatographic tests most commonly used in these settings. This has been especially important in programs for prevention of mother-to-child transmission, in both RCCs and the developed world. However, suitable POC tests are not yet commercially available for diagnosis of neonatal HIV, where persistence of maternal antibody in the infant precludes the use of current antibody tests during the first 12 to 18 months. In addition, measurement of CD4+ T cells, CD4%, and HIV viral load still relies on sophisticated laboratory infrastructure, constraining the delivery of appropriate care to many HIV-infected patients. Continued effort is required in the development and validation of additional POC tests to support HIV patient care, and in quality assurance in manufacturing and in test performance in the field to ensure appropriate use of existing and new POC tests.
Article
Diagnosis of human immunodeficiency virus (HIV) is essential for accessing treatment. Current HIV diagnostic protocols for infants require adaptation and validation before they can be implemented in the developing world. The timing and type of HIV assays will be dictated by country-specific circumstances and experience from similar settings. The performance of an HIV-1 DNA polymerase chain reaction (PCR) test, and in particular a single test at 6 weeks of age, in diagnosing HIV subtype C infection acquired in utero or peripartum was assessed. A retrospective review of 1825 Amplicor HIV-1 DNA PCR version 1.5 tests performed between 2000 and 2004 in 2 laboratories in Johannesburg, South Africa on 769 effectively non-breast-fed infants from 3 clinically well characterized cohorts was undertaken. The HIV status of each infant was used as the standard against which the HIV PCR results were compared. The overall sensitivity and specificity of the HIV PCR test were 99.3 and 99.5% respectively. A single test was 98.8% sensitive and 99.4% specific in the 627 infants tested at 6 weeks of age (58 HIV-infected and 569 HIV-uninfected). Repeat testing of all positive HIV PCR tests minimized false positive results. In resource-poor settings where HIV PCR testing in an environment of good laboratory practice is feasible, a single 6-week HIV DNA PCR test can increase identification of HIV-infected children substantially from current levels. Further operational research on how best to implement and monitor such a diagnostic protocol in specific local settings, especially in breast-fed infants, is necessary.
Article
Diagnosing human immunodeficiency virus (HIV) infection in infants is difficult because maternal HIV antibodies cross the placenta, causing positive serologic tests in HIV-exposed infants for the first several months of life. Early definitive diagnosis of HIV requires virologic testing such as polymerase chain reaction (PCR), which is the diagnostic standard in resource-rich settings but has been too complex and expensive for widespread use in most countries with high HIV prevalence. Early PCR testing can help HIV-infected infants access treatment, provide psychosocial benefits for families of uninfected infants, and help programs for prevention of mother-to-child transmission of HIV monitor their effectiveness. HIV testing, including PCR, is increasingly available for infants in resource-limited settings, but there are many barriers and complex policy decisions that need to be addressed before universal early testing can become standard. This paper reviews challenges and progress in the field and suggests ways to facilitate early infant testing in resource-limited settings.