Dataset Information

Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso.

ABSTRACT: The WHO recommends that children living in areas of highly seasonal malaria transmission in the Sahel subregion should receive seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ). We evaluated the use of dihydroartemisinin-piperaquine (DHAPQ) as an alternative drug that could be used if SPAQ starts to lose efficacy. A total of 1,499 children 3 to 59 months old were randomized to receive SMC with SPAQ or DHAPQ over 3 months. The primary outcome measure was the risk of clinical malaria (fever or a history of fever with a parasite density of at least 3,000/?l). A cohort of 250 children outside the trial was followed up as a control group. Molecular markers of drug resistance were assessed. The risk of a malaria attack was 0.19 in the DHAPQ group and 0.15 in the SPAQ group, an odds ratio of 1.33 (95% confidence interval [CI], 1.02 to 1.72). Efficacy of SMC compared to the control group was 77% (67% to 84%) for DHAPQ and 83% (74% to 89%) for SPAQ. pfdhfr and pfdhps mutations associated with antifolate resistance were more prevalent in parasites from children who received SPAQ than in children who received DHAPQ. Both regimens were highly efficacious and well tolerated. DHAPQ is a potential alternative drug for SMC. (This trial is registered at ClinicalTrials.gov under registration no. NCT00941785.).

SUBMITTER: Zongo I

PROVIDER: S-EPMC4505196 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso.

Zongo Issaka I Milligan Paul P Compaore Yves Daniel YD Some A Fabrice AF Greenwood Brian B Tarning Joel J Rosenthal Philip J PJ Sutherland Colin C Nosten Francois F Ouedraogo Jean-Bosco JB

Antimicrobial agents and chemotherapy 20150427 8

The WHO recommends that children living in areas of highly seasonal malaria transmission in the Sahel subregion should receive seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ). We evaluated the use of dihydroartemisinin-piperaquine (DHAPQ) as an alternative drug that could be used if SPAQ starts to lose efficacy. A total of 1,499 children 3 to 59 months old were randomized to receive SMC with SPAQ or DHAPQ over 3 months. The primary outcome measure wa ...[more]

PMID: 25918149

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Project description:Burkina Faso implemented the seasonal malaria chemoprevention (SMC) in 2014 in seven pilot health districts, following the new recommendation by the WHO in 2012 for the prevention of the disease in children under five years old, for areas of highly seasonal malaria transmission.The objective of this study was to assess the implementation fidelity of the seasonal malaria chemoprevention strategy in one of the districts, Kaya Health District.We conducted a case study, with a quantitative and qualitative mixed methods. Data were collected after two campaigns of implementation of the intervention, in 2014 and 2015, through a review of specific documents of SMC intervention, and individual interview with key informants (n = 21) involved at various levels in the implementation of the strategy and a household survey with the parents (n = 284) of eligible children for the SMC strategy in 2015 in the Kaya health district. The analysis framework focused on the fidelity of the intervention's content, its coverage, and its schedule, as well as the potential moderating factors, using the model proposed by Hasson, originally from Carroll.All components of the intervention were implemented. Villages and sectors were covered at 100%. In terms of intervention doses received, less than one-third of eligible children (32.3%) received the recommended four doses in 2015. Implementation of the strategy faced some difficulties due to insufficient training of community distributors, inadequate supply of inputs and insufficient financial resources for remuneration, advocacy and supervision, but also because of the contextual constraints due to the rainy season. Moreover, an interaction between the different moderating factors, influencing the degree of implementation of the strategy was noted.Taking into account the moderating factors of the implementation is necessary for achieving the highest possible degree of implementation fidelity and then, reach the expected beneficial effects.

Project description:BACKGROUND:Seasonal malaria chemoprevention (SMC) relies on community health workers to distribute drugs. This study assessed: (1) the capacity of community-based distributors (CBDs) at the start and end of a campaign and from one campaign to another after training or refresher courses before each round; (2) to what extent CBDs' experience over several campaigns contributed to measurable increase in their capacities; and (3) to what extent the training and experience of committed CBDs helped the less productive to catch up. METHODS:A longitudinal analysis was conducted in one Burkina Faso health district during the 2017 and 2018 campaigns. A panel including all CBDs was created. Their capacities were observed after: (1) initial training for the 2017 season; (2) refresher training for that year's fourth round; and (3) initial training for the 2018 season. All were invited to complete a questionnaire at the end of training with 27 multiple-choice questions on their main tasks. Observers noted content coverage and conditions under which training sessions were conducted. RESULTS:The 612 CBDs showed, on average, high understanding of their tasks from the start of the annual campaigns. Tasks related to communicating with parents and reporting were best mastered. Their capacities grew from round to round and campaign to campaign, after most had undergone training and been supervised by head nurses. The greatest progress was in the technical components, considered more complex, which involved selecting eligible children, choosing the correct drug packet, and referring children to health professionals. Retaining CBDs from one round to the next benefited everyone, whatever their starting level. Groups that initially obtained the lowest scores (women, illiterates, youngest/oldest) progressed the most. CONCLUSION:These results confirm the potential of using CBDs under routine programme implementation. Mandating CBDs with targeted tasks is a functional model, as they achieve mastery in this context where investments are made in training and supervision. Losing this specificity by extending CBDs' mandates beyond SMC could have undesirable consequences. The added value of retaining committed CBDs is high. It is suggested that motivation and commitment be considered in recruitment, and that a supportive climate be created to foster retention.

Dataset Information

Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso.

Publications

Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso.

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