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Objective A substantial dropout from the first dose of diphtheria-tetanus-pertussis (DTP1) to the 3rd dose of DTP (DTP3) immunization has been recorded in Pakistan. We conducted a randomized controlled trial to assess the effects of providing a substantially redesigned immunization card, centre-based education, or both interventions together on DTP3 completion at six rural expanded programme on immunization (EPI) centres in Pakistan.
Methods Mother-child pairs were enrolled at DTP1 and randomized to four study groups: redesigned card, centre-based education, combined intervention and standard care. Each child was followed up for 90 days to record the dates of DTP2 and DTP3 visits. The study outcome was DTP3 completion by the end of follow-up period in each study group.
Results We enrolled 378 mother–child pairs in redesigned card group, 376 in centre-based education group, 374 in combined intervention group and 378 in standard care group. By the end of follow-up, 39% of children in standard care group completed DTP3. Compared to this, a significantly higher proportion of children completed DTP3 in redesigned card group (66%) (crude risk ratio [RR] = 1.7; 95% CI = 1.5, 2.0), centre-based education group (61%) (RR = 1.5; 95% CI = 1.3, 1.8) and combined intervention group (67%) (RR = 1.7; 95% CI = 1.4, 2.0).
Conclusions Improved immunization card alone, education to mothers alone, or both together were all effective in increasing follow-up immunization visits. The study underscores the potential of study interventions’ public health impact and necessitates their evaluation for complete EPI schedule at a large scale in the EPI system.
Objectif: Evaluer les effets d’une carte de vaccination profondément redessinée, l’éducation centrée ou les deux interventions ensemble sur la complétion du DTC3 dans six centres ruraux du Programme Elargi de Vaccination (PEV) au Pakistan.
Méthodes: Essai randomisé contrôlé des unités maternelles-infantiles inscrites au DTC1 et randomisées en quatre groupes d’étude: carte redessinée, éducation centrée, intervention combinée et soins standards. Chaque enfant a été suivi pendant 90 jours pour enregistrer les dates de visites pour le DTC2 et le DTC3. L’objectif de l’étude était la complétion du DTC3 avant la fin de la période de suivi dans chaque groupe d’étude.
Résultats: Nous avons recruté 378 unités maternelles-infantiles dans le groupe de la carte redessinée, 376 dans le groupe d’éducation centrée, 374 dans le groupe d’intervention combinée et 378 dans le groupe des soins standard. A la fin du suivi, 39% des enfants du groupe de soins standard avaient complété le DTC3. En comparaison, une proportion plus significative d’enfants ont complété le DTC3 dans le groupe de la carte redessinée (66%) (rapport de risque [RR] brut = 1,7; IC95%: 1,5–2,0), dans le groupe de l’éducation centrée (61%) (RR = 1,5; IC95%: 1,3–1,8) et dans le groupe d’intervention combinée (67%) (RR = 1,7; IC95%: 1,4–2,0).
Conclusions: La seule amélioration de la carte de vaccination, la seule éducation des mères ou les deux ensembles étaient aussi efficaces pour augmenter les visites de vaccination durant le suivi. L’étude souligne l’impact potentiel sur la santé publique des études interventions et la nécessité de leur évaluation pour le schéma complet du PEV à grande échelle dans le système PEV.
Objetivo: Evaluar los efectos de entregar un carnet de vacunación sustancialmente rediseñado, proveer educación materna o ambas intervenciones sobre el completar DTP3, en seis centros rurales del Programa Ampliado de Inmunizaciones (PAI) de Paquistán.
Métodos: Ensayo aleatorizado y controlado, con unidades madre-hijo, incluidas en el momento de recibir DTP1 y aleatorizadas a uno de los cuatro grupos: carnet rediseñado, educación materna, intervención combinada y cuidados estándar. Cada niño fue seguido durante 90 días para tomar nota de las fechas de las visitas de DTP2 y DTP3. El principal resultado del estudio era el haber recibido la DTP3 al final del periodo de seguimiento en cada grupo de estudio.
Resultados: Se incluyeron 378 unidades madre-hijo en el grupo del carnet de vacunación rediseñado, 376 en el grupo de educación materna, 374 en el grupo de intervención combinada y 378 en el grupo de cuidados estándar. Al final del periodo de seguimiento, un 39% de los niños en el grupo de cuidados estándar habían completado la DTP3. En comparación, una proporción significativamente mayor de niños completó la DTP3 en el grupo con el carnet de vacunación rediseñado (66%) (análisis crudo de razón de riesgos [RR] = 1.7; 95% IC = 1.5, 2.0), grupo de educación materna (61%) (RR = 1.5; 95% CI = 1.3, 1.8), y grupo de intervención combinada (67%) (RR = 1.7; 95% IC = 1.4, 2.0).
Conclusiones: La mejora del carnet de vacunación, la educación maternal o ambas intervenciones juntas fueron todas efectivas a la hora de aumentar las visitas de seguimiento de la inmunización. El estudio subestima el potencial impacto sobre la salud pública de los estudios de intervención, y requiere de su evaluación con el calendario completo del PA,I a gran escala, dentro del sistema de PAI.
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The Expanded Programme on Immunization (EPI) offers a series of vaccines to children in Pakistan and many other WHO member states. These include Bacillus Calmette–Guérin (BCG) and oral polio vaccine (OPV) at birth, three doses of diphtheria–tetanus–pertussis (DTP)/OPV/hepatitis B virus (HBV) vaccines at 6, 10 and 14 weeks, and measles vaccine at 9 and 15 months after birth (WHO 2006). A countrywide network of EPI in Pakistan offers these vaccines to children at immunization centres at no cost, supplemented with outreach programmes in some areas.
A principal indicator of immunization coverage levels by the WHO is the completion of three doses of DTP vaccine (DTP3). With some contribution from outreach programmes, nationwide DTP3 coverage is primarily a function of the proportion of newborns that an immunization system brings in for the first immunization and the proportion of these children who return to the EPI centres for subsequent visits to complete DTP3. From 2002 to 2005, the WHO-reported DTP3 coverage in Pakistan was 65–72%. Socio-economically comparable countries in South-East Asia Region of the WHO have consistently achieved higher DTP3 levels than has Pakistan (WHO 2006). The BCG coverage (80–82% during 2002–2005) in Pakistan suggests that a high proportion of newborns receive EPI services, but a substantial proportion of these children fail to return for subsequent immunization visits. Despite progress in last two decades, it is unclear whether the measures currently in place in Pakistan will be sufficient to reach the desired national DTP3 coverage of more than 80%.
In 2003–2004, we designed a reminder-type immunization card and developed a centre-based information and motivation session for mothers/caregivers (henceforth referred to as ‘mothers’) for a randomized controlled trial to assess the effectiveness of providing these interventions on DTP3 completion at urban EPI centres in Pakistan (Usman et al. 2009). In the urban trial, we recorded 36% increase in DTP3 completion among children who received both redesigned card and centre-based education to mothers and 26% increase among children who received redesigned card only, compared with standard care group. Encouraged by the results of the urban study and considering urban rural disparities in literacy rate and socio-ethnic distribution in Pakistan, we conducted a second randomized controlled trial in 2005–2006 to test the effectiveness of same interventions at rural EPI centres in Pakistan.
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Of 2,371 mother–child pairs screened for eligibility between November 2005 and May 2006, 861 (36%) were excluded because they had arrived in the area within the past 6 months and four (0.2%) because they refused to participate (Figure 1). Enrolment was concluded after random allocation of 1506 study participants to four study groups. The follow-up of the last study child enrolled in the study was completed in August 2006. Because the study participants who had not returned to the centres within 90 days of their DTP1 visit were considered DTP3 not completed, no study participant was considered lost to follow-up. In multivariable analysis, we excluded 15 children from the redesigned card group, 11 from the centre-based education group, 7 from the combined intervention group and 12 from the standard care group because of missing child’s age at enrolment.
The majority of informants in all study groups (77–81%) were mothers; most of the other interviewees were other female caretakers, including grandmothers and aunts. The distribution of participants’ socio-demographic characteristics at enrolment was similar (P > 0.05) across study groups except for maternal age (P = 0.03; Table 1).
Table 1. Distribution among study groups of socio-demographic characteristics of study participants at enrolment (Pakistan, 2005–2006)
|Variables||Redesigned card n = 378 Column %||Centre-based education n = 376 Column %||Combined intervention n = 378 Column %||Standard care n = 376 Column %|
|EPI centre of enrolment|
|Mother of child as respondent||77||81||79||80|
|Child’s age at enrolment (days)|
|Total number of living children in the family|
| Three or more||47||57||49||51|
|Mother’s age at enrolment (years)|
|Mother’s years of formal schooling|
|Mother a housewife||96||99||98||98|
|Father’s years of formal schooling|
|≤5 household members||28||27||23||23|
|Monthly household income (Pakistani Rupees)|
|Television in home||57||53||56||54|
|Mode of transport to EPI centre|
| Public bus system||5||9||6||6|
| Privately owned or rented motor vehicles||10||8||6||7|
| On foot||85||84||88||87|
|≤5 min to reach EPI centre from home||20||22||19||17|
By the end of follow-up, 39% of children in the standard care group completed DTP3 (Table 2). Compared to this, a significantly higher proportion of children completed DTP3 in the redesigned card group (66%) (crude risk ratio [RR] = 1.7; 95% CI = 1.5, 2.0), the centre-based education group (61%) (RR = 1.5; 95% CI = 1.3, 1.8) and the combined intervention group (67%) (RR = 1.7; 95% CI = 1.4, 2.0).
Table 2. Crude risk ratios (RRs) and 95% confidence intervals (CIs) for DTP3 completion by intervention group (Pakistan, 2005–2006)
|Study groups||Total||DTP3 completed during 90 days of follow-up n (%)||Crude RR||95% CI|
|Redesigned card||378||252 (67)||1.7||(1.5, 2.0)|
|Centre-based education||376||228 (61)||1.5||(1.3, 1.8)|
|Combined intervention||374||245 (66)||1.7||(1.4, 2.0)|
|Standard care||378||149 (39)||1.0*|| |
In secondary analysis, after adjusting for child’s age at enrolment and mother’s formal years of schooling, a significantly higher proportion of Mohajir children completed DTP3 in the redesigned card group (adjusted risk ratio [Adj. RR] = 3.0; 95% CI = 1.7, 5.3), the centre-based education group (Adj. RR = 3.3; 95% CI = 1.9, 5.8) and the combined intervention group (Adj. RR = 3.0; 95% CI = 1.7, 5.4) compared with the standard care group (Table 3). Although interventions were also effective among non-Mohajir children, the individual or combined effects of interventions on DTP3 completion were much weaker than among Mohajir children.
Table 3. Crude and adjusted risk ratios (RRs) with 95% confidence intervals (CIs) for DTP3 completion by intervention group among Mohajir and non-Mohajir children (Pakistan, 2005–2006)
| ||Study groups||Total||DTP3 completed during 90 days of follow-up n (%)||Crude RR||95% CI||Adjusted RR||95% CI|
|Mohajir||Redesigned card||56||46 (82)||3.0||(2.0, 4.7)||3.0||(1.7, 5.3)|
|Centre-based education||51||46 (90)||3.3||(2.2, 5.1)||3.3||(1.9, 5.8)|
|Combined intervention||49||40 (82)||3.0||(1.9, 4.7)||3.0||(1.7, 5.4)|
|Standard care||59||16 (27)||1.0†|| ||1.0†|| |
|Non-Mohajir||Redesigned card||322||206 (64)||1.5||(1.3, 1.8)||1.5||(1.3, 1.8)|
|Centre-based education||325||182 (56)||1.3||(1.1, 1.6)||1.3||(1.1, 1.6)|
|Combined intervention||325||205 (63)||1.5||(1.3, 1.8)||1.5||(1.3, 1.7)|
|Standard care||319||133 (42)||1.0*|| ||1.0*|| |
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Our results suggest that providing an inexpensive reminder type immunization card or a short centre-based education to mothers is effective intervention for increasing subsequent immunization visits to the EPI centres. We found no evidence that providing both interventions in combination was superior to providing the redesigned immunization card alone.
Compared to our urban trial (Usman et al. 2009), study interventions were more effective at rural EPI centres and resulted in higher percentage increase in DTP3 completion in all three intervention groups. In a resource-constrained setting such as Pakistan, policy makers may prefer implementing the proposed interventions first in rural areas. However, the implementation of these interventions at a large scale may be more cost-effective in urban areas owing to lower administrative and training costs for comparatively high volume and geographically closer urban EPI centres.
In both urban and rural trials, providing redesigned card alone was more effective than education alone in increasing DTP3 completion. Further, combining two interventions at urban centres resulted in even higher DTP3 completion. However, at rural centres, combined effect of two interventions was not higher than the effect of redesigned card alone. This may indicate that a structural intervention such as the redesigned immunization card is best suited for lower literacy rural areas and can achieve the maximum benefit even if implemented without the centre-based education to mothers.
Interventions that have proved effective in stimulating the demand in resource-poor settings for vaccination among children with incomplete immunization include reminders sent to the home of target children (Kuhn & Zwarenstein 1990) and door-to-door household visits to notify parents that their child is late for a vaccine (Cutts et al. 1990; Brugha & Kevany 1996). Redesigning the immunization card for reducing immunization dropouts has not received attention in developing countries. Reviews of published studies (Pegurri et al. 2005) and grey literature (Batt et al. 2004) on strategies to improve childhood immunization coverage in low- and middle-income countries could not identify any study attempting to redesign the immunization card and evaluating its impact on immunization visits. Interventions assessed in our published urban trial (Usman et al. 2009) and this rural trial attempted to increase demand by targeting children who are already in the EPI system. We believe that these studies are a major step forward in demonstrating potential large-scale impact of proposed interventions to the policy makers.
The redesigned immunization card tested in this study has several characteristics that make it an appealing and viable option to improve the vaccine delivery system in rural Pakistan. Because the new card was designed considering the sparse level of EPI staffing and the additional cost incurred to the EPI system, we believe that the large-scale implementation of the new card in the EPI system would not require any additional work from EPI staff and only minimally add to the cost per child immunized. Based on our study estimates of DTP3 completion among the redesigned card and standard care groups (Table 2), a countrywide implementation of the redesigned card in rural areas could potentially translate into more than half a million additional children immunized for DTP3 in an annual rural Pakistani birth cohort of 2.8 million children (Pakistan 2003). Another spinoff benefit of using the redesigned card in the EPI system could be that mothers may retain the new card for a longer period owing to its plastic jacket and larger size, resulting in more accurate estimation of immunization coverage by cross-sectional surveys. At present, these surveys rely heavily on mother’s recall as the existing EPI card is usually not available with the majority of mothers at the time of interview (Mukanga & Kiguli 2006; Torun & Bakirci 2006).
In secondary analysis, we observed that the effects of redesigned card and centre-based education on DTP3 completion were substantially stronger among Mohajir than among non-Mohajir ethnicities (Table 3). The underlying reason for this effect-measure modification by ethnicity is unclear. We explored whether more years of schooling among Mohajir mothers might have played a role in responding more positively to the interventions. However, adjusting for mother’s years of formal schooling did not affect the differences in the effect of interventions between the two ethnic groups. Future studies should further explore this differential responsiveness of ethnic groups to such interventions.
A limitation of our study is that the follow-up of study children for return visits was carried out only at the study centres for a limited period of 90 days. There is a chance that a small proportion of children might have returned to the study centres after the follow-up period or visited non-study EPI centres for DTP2 or DTP3. Nonetheless, we do not have any evidence suggesting higher occurrence of this in standard care group given the randomized design of our study and assume that it did not affect the internal validity of the study. Additionally, survival curves of days to DTP3 for each study group (data not shown) indicated a plateau at around 80 days of follow-up, making it unlikely that a large number of children might have returned for DTP3 after 90 days.
WHO reported coverage of 82% for DTP1 and 72% for DTP3 in Pakistan for 2005. This suggests that 88% (72/82*100) of children who received DTP1 went on to complete DTP3; in contrast, no more than 39% of the children enrolled in the standard care group of our study completed DTP3 in 90 days of follow-up (Table 2). Comparison of these figures must be made with caution because our study estimates are from a cohort of children followed up at EPI centres, whereas the WHO estimates were calculated using DTP1 and DTP3 coverage. Additionally, dropouts in the rural areas where our study was conducted are also likely to be higher than the country-level estimates reported by the WHO because of lower socio-economic conditions in rural areas of Pakistan. Nonetheless, the reasons discussed above might not fully explain the wide gap between the study and the WHO estimates, and the possibility of WHO overestimating childhood immunization in Pakistan cannot be ruled out (Murray et al. 2003).
As a result of limited time and resources, we tested the effect of study interventions only on two follow-up immunization visits (DTP2 and DTP3) scheduled after DTP1. Because complete EPI schedule in Pakistan has five follow-up visits (DTP1, DTP2, DTP3, measles 1 and measles 2) after BCG at birth, it is difficult to predict the effectiveness of proposed interventions for the complete EPI schedule. Furthermore, low immunization coverage cannot be effectively addressed solely by reducing the dropouts; interventions to bring more newborns in the EPI system are equally important.
In conclusion, this study offers strong evidence that redesigned immunization card was effective in enhancing subsequent infant vaccine visits. Because this low-cost intervention has the potential to yield considerable benefits for children, the next step will be to evaluate it for complete EPI schedule at a large scale in the EPI system.