Background
Conceptual framework
Methods
Systematic review
Selection criteria
Document review
Key informant interviews
KI | Sex | Expertise | Experience | Role |
---|---|---|---|---|
1 | Male | Malaria epidemiologist | Over 15 years in malaria research | Researcher/advisor |
2 | Male | Medical epidemiologist | Over 10 years in malaria research | Researcher/advisor |
3 | Female | Malaria epidemiologist | Over 30 years in malaria research | Researcher/advisor |
4 | Male | Clinician and malaria epidemiologist | Over 40 years in malaria research | Researcher/advisor |
5 | Male | Malaria epidemiologist | Over 10 years malaria research | Researcher/advisor |
6 | Male | Senior malaria scientist | Over 40 years in malaria research | Researcher/advisor |
7 | Female | Clinical epidemiologist | 6 years | Policy maker |
8 | Male | Malaria in pregnancy coordinator | Over 5 years in malaria research | Policy maker |
9 | Male | Chief of health services | Five years | Policy maker |
10 | Female | Malaria in pregnancy coordinator | Over 5 years in malaria research | Programme/project coordinator |
11 | Male | Malaria advisor | 15 years | Programme/project coordinator |
12 | Male | Malaria advisor | 5 years | Programme/project coordinator |
13 | Male | Policy development and analysist | 4 years | Programme/project coordinator |
14 | Male | Malaria advisor | 5 years | Programme/project coordinator |
15 | Male | Malaria program specialist | 20 years | Programme/project coordinator |
Themes covered in the in-depth interviews
Data management and analysis
Results
Systematic review
Description of the publications
No. | Publication | Study objective and type | Study population | Study type | Approach | Results found | Conclusion |
---|---|---|---|---|---|---|---|
1 | Verhoeff et al. [17] March 1993 to June 1994 study period | Compared and evaluated parasite prevalence, anaemia and LBW in mothers who received one, two or three doses of SP during pregnancy, and the incidences of LBW in the infants | 575 pregnant women attending antenatal facility at Chikwawa district hospital in Malawi | Interventional, longitudinal study | Assessment was in women who received one, two or three doses of SP during pregnant | No significant difference in parasite prevalence in peripheral or placental blood between women who received one or two SP doses although multigravidea with two dose SP had higher haemoglobin concentrations than those who received one dose (P = 0.009). The mean birthweights were higher, and incidence of LBW lower in babies born to primi- and multi-gravidea who had received two or three doses of SP than those from women who received just one dose (P < 0.03 for each) | SP use was not associated with maternal side-effects or perinatal complications and that multiple doses of SP during pregnancy will lead to a highly significant reduction in the incidence of LBW. |
2 | Taylor et al. [18] July 1997 to August 2006 study period | Explored relationships between IPTp-SP, the presence of resistant parasite at delivery, and multiple measures of adverse delivery outcome, including parasite densities, placental histology, maternal haemoglobin concentration and birth weight | 177 genotyping and antenatal data of pregnant women delivering at Queens Elizabeth Central Hospital in Blantyre, Malawi | A serial cross section analysis | SP receipt records were obtained from antenatal clinical cards, peripheral and placental blood obtained, and a subset of 25% of available sample from women with positive peripheral blood thick smear were tested for genotyping | Women who received full IPTp with SP (≥2 doses) had lower peripheral (P = 0.018) and placental (P < 0.0001) parasite densities than women who received suboptimal IPTp (<2 doses), mean birthweight in the full IPTp group of 2892 g compared to 2776 g in the suboptimal group (P = 0.086), or LBW prevalence of 11.8% in the full IPTp group compared to 15.8% in the suboptimal group (P = 0.481) | The receipt of SP as IPTp did not raise PAM morbidity despite the increasing prevalence and fixation of SP-resistant P. falciparum haplotypes and therefore SP may be used in modified IPTp regimens as a component of comprehensive antenatal care |
3 | Rogerson et al. [19] July 1997 to April 1999 study period | Assessed operational effectiveness of SP by examining the relationship between number of doses of SP prescribed in antenatal clinic and health indicators | 1044 women attending the maternity unit at Queen Elizabeth Central Hospital in Blantyre, Malawi | Clinical study | Samples from peripheral and placental blood were collected and tested. With 251 women having received no SP, 555 received 2SP-dose, and 238 received ≥2 SP-doses | SP was associated with a decrease in placental malaria prevalence from 31.9% with no SP to 22.8% with ≥2 SP-doses. Decreased prevalence of LBW from 23% in women not receiving SP to 10.3% in the group receiving ≥2 SP-doses, while maternal and cord blood malaria prevalence and mean cord blood haemoglobin concentrations did not differ with SP usage | IPTp-SP had a positive impact on some indicators while improved implementation and surveillance are critical |
4 | Filler et al. [14] October 2002 to March 2005 study period | Determined the efficacy of monthly SP compared to the 2-dose regimen in preventing placental malaria in both HIV positive and negative women. (Results of HIV negative women only are considered in this review) | 432 HIV negative women were randomized (216 received 2-dose SP while 216 received monthly SP) | Randomized, non-blinded study | Participants were randomized into either receiving 2-dose SP or monthly SP | In the HIV negative group 2.3% who received monthly SP compared to 6.3% who received 2-dose SP had placental malaria (RR, 0.37) | Monthly IPTp-SP is more efficacious than a 2-dose regimen in preventing placental malaria and that monthly IPTp-SP should be adopted in areas of intense transmission of falciparum malaria |
5 | Luntamo et al. [21] December 2003 to October 2006 study period | Examined the potential to prevent preterm deliveries and LBW through intensified gestational intermittent preventive treatment containing antibiotics against malaria and reproductive tract infections | 1320 women with uncomplicated second trimester pregnancies at Lungwena Health center, Mangochi, Malawi | A single-center, randomized, partially placebo controlled, outcome assessor-blinded clinical trial | The compared interventions included a standard 2-dose SP as a control group (436), monthly SP (441), and monthly SP combined with two doses of azithromycin (AZI-SP) (443) | Preterm incidence was 17.9% in the controls, 15.4% in the monthly SP group (P = 0.32), and 11.8% in the AZI-SP group (P = 0.01). While comparing with the controls the AZI-SP group had a risk ratio of 0.61 (P = 0.02) and the monthly SP group had a risk ratio of 0.71 (P = 0.09) for LBW | The incidence of preterm delivery and LBW can in some conditions be reduced by treating pregnant women with monthly SP and two dose azithromycin |
6 | Luntamo et al. [22] December 2003 to October 2007 study period | Assessed the effect of monthly SP and AZI-SP treatments on peripheral malaria parasitemia at delivery in a population of both HIV-positive and –negative women of all gravidities using the PCR-methodology | 484 samples from women with uncomplicated second trimester pregnancies at Lungwena Health center, Mangochi, Malawi | A single-center, randomized, partially placebo controlled, outcome assessor-blinded clinical trial | The compared interventions included a standard 2-dose SP as a control group (162), monthly SP (151), and monthly SP combined with two doses of azithromycin (AZI-SP) (171) | Comparing with controls, the monthly group had a risk ratio of 0.33 (P < 0.001) and in the AZI-SP group 0.23 (P < 0.001) for malaria at delivery. While in only HIV-negative women the corresponding figures were 0.26 (P < 0.001) in the monthly SP group ad 0.24 9 (P < 0.001) in the AZI-SP group for malaria at delivery | Increasing the frequency of SP doses during pregnancy improves efficacy against malaria at delivery among HIV-negative women, including a population of both HIV-negative and –positive women of all gravidities |
7 | Luntamo et al. [23] December 2003 to October 2006 period of study | Assessed the ability to reduce foetal and neonatal growth faltering through IPTp of malaria and reproductive tract infections with monthly SP, alone or with two doses of azithromycin | 1320 women with uncomplicated second trimester pregnancies at Lungwena Health center, Mangochi, Malawi | A randomized, partially placebo controlled, outcome assessor-blinded clinical trial | Participants received either two doses of SP (control) (436), SP monthly (441), or SP monthly and azithromycin (1 g) twice (AZI-SP) (443) | Babies in the AZI-SP group were on average 140 g heavier at birth and 0.6 cm longer at four weeks of age than in the control group | Monthly IPTp-SP regimen provided to all pregnant women is likely to increase mean birthweight and length at four weeks of age in malaria holoendemic areas and adding azithromycin to the regimen seems to increase the benefit in reduction of fetal and neonatal growth faltering |
Babies in the monthly SP group were on average 80 g heavier and 0.3 cm longer than in the control group | |||||||
Compared to controls, the AZI-SP group had a relative risk of 0.61 LBW, 0.60 stunting, and 0.48 underweight at four weeks of age | |||||||
Compared to controls, the monthly SP group had a relative risk of 0.71 LBW, 1.02 stunting, and 0.87 underweight | |||||||
8 | Gutman et al. [24] March and August 2010 study period | Assessed the effectiveness of IPTp-SP | 703 HIV-negative women were enrolled at Machinga district hospital in Malawi | Cross-sectional delivery survey | Assessment was made in 22% (154) of women who received <2 SP-doses and those that received ≥2 SP-doses | IPTp-SP was associated with a dose-dependent protective effect on composite birth outcomes in primigravidae of an adjusted prevalence ratio of 0.50, 0.30, and 0.18 for 1, 2, and ≥3 doses respectively when compared to 0 doses | IPTp-SP did not reduce the frequency of placental infection but was associated with improved birth outcomes and that IPTp-SP should still continue to be administered although alternative strategies and drugs should be explored |
Document review
Stakeholders and their roles during the IPTp-SP policy change
Stakeholder | Main responsibility | Role in policy change |
---|---|---|
NMCP | Development of malaria policies, and implementation of malaria programs | Drafting of guidelines, leading the process, and finalization of guidelines |
RHD | Implementation of reproductive health services in the MOH | Drafting of the guidelines, and policy implementation |
SSDI-services | Effective integration and delivery of quality services under the Malawi Essential Health Package (EHP), and to strengthen the national health system in line with the National Health Sector Strategic Plan for 2011–2016 | Coordination of activities, drafting of guidelines, finalizing, printing, dissemination of guidelines, and training of health workers |
WHO | Provision of technical advice and recommendation | Overseeing of the whole process in accordance to WHO recommendations |
PMI/USAID | Provision of technical and financial support for the NMCP | Provided financial support for all activities and provided technical advice |
NMAC | Provide expert opinion to the NMCP in policy and programme development | Vetting and final approval of the guidelines |
Malaria Care | Provision of malaria diagnostic and treatment services | Training of health workers |
CHAI | Strengthening of integrated health systems | Revision of case management guidelines, training of health workers |
Malaria researchers | Conducting malaria research to provide evidence and guide policy formulation | Provided technical review of evidence and guidelines |
The process of change
Steps for IPTp-SP policy change in Malawi
Context of policy change
“In fact there is no need for launching when it’s a revised policy but if it’s a new policy that’s when the launching comes in” (Programme/Project Coordinator)
“We noted a big challenge that there was a misunderstanding in terms of application by the service providers because it [the policy] was saying at 13 weeks give the first dose of SP then the second dose at 28 weeks…so people just complied to those dates…so if one comes at 18th week or 20th week then [they] will not be given SP and who comes at 32 weeks would not be given the second dose…so the previous guidelines made some limitation and that was our main challenge for low coverage but this policy change to 3 doses or more means that a pregnant woman can get IPTp even after 36 weeks…there are no restrictions so that’s one of the advantages”. (Programme/Project Coordinator)
“We do not have any other alternative that’s why they are recommended that we should just use 3 or more doses but studies by College of Medicine are underway to explore other drugs”. (Programme/Project Coordinator)
Opportunities for smooth policy transition
“Funding component and technical support was assured by the project…but also PMI who are the funders of the project…a malaria section…I think they have been very supportive….I think they wanted this to succeed as such their pressure made it easier for us to move forward”. (Programme/Project Coordinator)
“SP is frankly pretty [an] inexpensive drug…so we can usually cover the entire need for a few hundred thousand dollars a year…compared to ACTs and RDTs and others”. (Programme/Project Coordinator)
“WHO has also been pushing that we change… and the policy brief was backed by a lot of scientific evidence that was done extensively across the globe… so that push from these global stakeholders also enabled us to work fast”. (Programme/Project Coordinator)
“Actually we just adapted the WHO guidelines…revised the malaria treatment guidelines accordingly…that was really straight forward”. (Researcher/Advisor)
“Overall the National Malaria Control Programme who are the mandated programme to look at malaria, also had keen interest for this to happen and be implemented”. (Programme/Project Coordinator)
“I need to point out that the reproductive health directorate [as a] key department in malaria in pregnancy issues were also very supportive…you know we cannot talk of malaria in pregnancy without the reproductive health directorate because [it] is a platform that we use to implement IPTp”. (Programme/Project Coordinator)
Challenges encountered in the policy process
“But now malaria in pregnancy were embedded in malaria case management….. and what was lacking in those documents were the detailed health education that goes with it…financing, partnership…all those things were missing because it was only considered as a treatment component not necessarily as a strategy…so the challenge was that we had to develop [the] guidelines from a scratch”. (Programme/Project Coordinator)
“To get different stakeholders come together and agree on something it takes time because people have got a lot of demands on their work…so for them also to dedicate their time to this, it’s a little bit of time”. (Programme/Project Coordinator)
“This time around we are conducting cascade training not as the way we always do, because things change, partners change the way of doing business, so as we are going down to the districts to do the actual trainings it will be a little bit slow because others are still using the two dose…….because of the way we are implementing due to funders money. But otherwise in a nutshell we just believe that by the end of the year we [will] have finished and the whole country is [will] implement one policy”. (Policy maker)
Lessons learnt during the policy change
“The most important element for a policy to be effectively developed, the relevant government department should have the interest in that policy and they drive the whole process…. the NMCP team were so keen to have this done…that’s why we didn’t find a lot of problems”. (Programme/Project Coordinator)
“Normally when we want to effect a policy change there must have been a study that was conducted or an assessment that was conducted…so that has always been the trend in Malawi that we are guided by studies”. (Researcher/Advisor)
“When you are embarking on policy change you should have everything available, you should have the money for the change, for everything that means the drugs themselves, for the guideline change, information to the general public because you can have the money to do the trainings but if you don’t inform the public it is very difficult for them to welcome the intervention quickly. So when you have all this together the policy change is very smooth”. (Policy maker)