A cluster randomized controlled trial for assessing POC-CCA test based praziquantel treatment for schistosomiasis control in pregnant women and their young children: study protocol of the freeBILy clinical trial in Madagascar

• Published in: Current controlled trials in cardiovascular medicine 2021-11, Vol.22 (1), p.822-822, Article 822
• Main Authors: Fusco, Daniela, Rakotozandrindrainy, Raphäel, Rakotoarivelo, Rivo Andry, Andrianarivelo, Mala Rakoto, Rakotozandrindrainy, Njary, Rasamoelina, Tahinamandranto, Puradiredja, Dewi Ismajani, Klein, Philipp, Stahlberg, Karl, Dechenaud, Marie, Lorenz, Eva, Jaeger, Anna, Kreidenweiss, Andrea, Hoekstra, Pytsje T, Adegnika, Akim Ayola, Sicuri, Elisa, Corstjens, Paul L A M, van Dam, Govert J, May, Jürgen, Schwarz, Norbert Georg
• Format: Article
• Language: English
• Subjects: Age; Anemia; Anthelmintics - adverse effects; Antigens, Helminth - therapeutic use; Child, Preschool; Children; Children & youth; Clinical Trials, Phase III as Topic; Consortia; Cost analysis; Demographic aspects; Diagnosis; Diagnostic tests; Diseases; Dosage and administration; Drug therapy; Female; Humans; Infections; Integrated approach; Intervention; Madagascar; Mass drug administration; Point of care-circulating cathodic antigen test; Praziquantel; Praziquantel - adverse effects; Pregnancy; Pregnant Women; Primary care; Public health; Randomized Controlled Trials as Topic; Schistosomiasis; Schistosomiasis - diagnosis; Schistosomiasis - drug therapy; Study Protocol; Testing; Tropical diseases; Urine; Womens health
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05769-6

Mass drug administration (MDA) of praziquantel is one of the main control measures against human schistosomiasis. Although there are claims for including pregnant women, infants and children under the age of 5 years in high-endemic regions in MDA campaigns, they are usually not treated without a diagnosis. Diagnostic tools identifying infections at the primary health care centre (PHCC) level could therefore help to integrate these vulnerable groups into control programmes. freeBILy (fast and reliable easy-to-use-diagnostics for eliminating bilharzia in young children and mothers) is an international consortium focused on implementing and evaluating new schistosomiasis diagnostic strategies. In Madagascar, the study aims to determine the effectiveness of a test-based schistosomiasis treatment (TBST) strategy for pregnant women and their infants and children up until the age of 2 years. A two-armed, cluster-randomized, controlled phase III trial including 5200 women and their offspring assesses the impact of TBST on child growth and maternal haemoglobin in areas of medium to high endemicity of Schistosoma mansoni. The participants are being tested with the point of care-circulating cathodic antigen (POC-CCA) test, a commercially available urine-based non-invasive rapid diagnostic test for schistosomiasis. In the intervention arm, a POC-CCA-TBST strategy is offered to women during pregnancy and 9 months after delivery, for their infants at 9 months of age. In the control arm, study visit procedures are the same, but without the POC-CCA-TBST procedure. All participants are being offered the POC-CCA-TBST 24 months after delivery. This trial is being integrated into the routine maternal and child primary health care programmes at 40 different PHCC in Madagascar's highlands. The purpose of the trial is to assess the effectiveness of the POC-CCA-TBST for controlling schistosomiasis in young children and mothers. This trial assesses a strategy to integrate pregnant women and their children under the age of 2 years into schistosomiasis control programmes using rapid diagnostic tests. It includes local capacity building for clinical trials and large-scale intervention research. Pan-African Clinical Trial Register PACTR201905784271304. Retrospectively registered on 15 May 2019.