TY - JOUR
T1 - Delivery effectiveness of and adherence to intermittent preventive treatment for malaria in pregnancy with dihydroartemisinin–piperaquine with or without targeted information transfer or sulfadoxine–pyrimethamine in western Kenya: a three-armed, pragmatic, open-label, cluster-randomised trial
AU - Barsosio, Hellen
AU - Webster, Jayne
AU - Omiti, Frederick
AU - K'Oloo, Alloys
AU - Odero, Isdorah A.
AU - Ojuok, Michael A.
AU - Odiwa, Dawn
AU - Omondi, Benson
AU - Okello, Elizabeth
AU - Dodd, James
AU - Taegtmeyer, Miriam
AU - Kuile, Feiko O.ter
AU - Lesosky, Maia
AU - Kariuki, Simon
AU - Hill, Jenny
PY - 2024/9/18
Y1 - 2024/9/18
N2 - Background: High-level sulphadoxine-pyrimethamine (SP) resistance threatens the efficacy of the WHO-recommended intermittent-preventive-treatment (IPTp) with single-dose SP to prevent malaria in pregnancy. Monthly dihydroartemisinin-piperaquine (IPTp-DP), a 3-day regimen, is an emerging alternative, but poses potential implementation and adherence challenges. We aimed to assess women’s adherence to the multiday IPTp-DP, and its delivery effectiveness in routine antenatal care (ANC) settings in western Kenya.Methods: We conducted a pragmatic three-arm cluster-randomised trial in 18 facilites (6 per arm). Clusters were facilities providing routine ANC services with ≥100 ANC attendances. We excluded private or mission hospitals, dispensaries, referral hospitals, and trial sites. Women in their first trimester, living with HIV, or whose previous ANC visit was <28 days were excluded. Two arms received IPTp-DP either with or without targeted information transfer (TI) (DP/TI or DP-alone), compared to standard of care (IPTp-SP). The primary endpoint, adherence, was defined as the proportion of women completing their most recent 3-day DP regimen, verified by pill count during home visits. The secondary endpoint, delivery effectiveness, was defined as the proportion of women who received the correct number of IPTp tablets and correctly repeated dosing instructions at ANC exit. We used generalised linear mixed models to compare endpoints. The trial is registered with ClinicalTrials.gov (NCT04160026).Findings: 15 facilities (5 per arm) completed the study, involving 1,189 (SP (N=377), DP-alone (N=404), DP/TI (N=408)) and 586 (DP-alone (N=267), DP/TI (N=319)) women who had exit interviews and home visits from September 08 to December 10, 2020. Relative to DP-alone, adherence was 16% higher (266/319 [83%] vs 196/267 [73%], adjusted relative risk (aRR)=1·16, 95% CI 1.03-1.31; p=0·0140) in the DP/TI arm. Delivery effectiveness in DP/TI arm was comparable to SP arm (352/403 [87%] vs 335/375 [89%], aRR=0·98, 95% CI 0·90-1·06; p= 0·5430).Interpretation: Targeted information transfer to healthcare providers and pregnant women boosts ANC delivery effectiveness and adherence to multiday IPTp-DP.Funding: EDCTP2 (TRIA.2015-1076); UK Joint-Global-Health-Trials-Scheme of FCDO/MRC/NIHR/Wellcome (MR/P006922/1); SIDA
AB - Background: High-level sulphadoxine-pyrimethamine (SP) resistance threatens the efficacy of the WHO-recommended intermittent-preventive-treatment (IPTp) with single-dose SP to prevent malaria in pregnancy. Monthly dihydroartemisinin-piperaquine (IPTp-DP), a 3-day regimen, is an emerging alternative, but poses potential implementation and adherence challenges. We aimed to assess women’s adherence to the multiday IPTp-DP, and its delivery effectiveness in routine antenatal care (ANC) settings in western Kenya.Methods: We conducted a pragmatic three-arm cluster-randomised trial in 18 facilites (6 per arm). Clusters were facilities providing routine ANC services with ≥100 ANC attendances. We excluded private or mission hospitals, dispensaries, referral hospitals, and trial sites. Women in their first trimester, living with HIV, or whose previous ANC visit was <28 days were excluded. Two arms received IPTp-DP either with or without targeted information transfer (TI) (DP/TI or DP-alone), compared to standard of care (IPTp-SP). The primary endpoint, adherence, was defined as the proportion of women completing their most recent 3-day DP regimen, verified by pill count during home visits. The secondary endpoint, delivery effectiveness, was defined as the proportion of women who received the correct number of IPTp tablets and correctly repeated dosing instructions at ANC exit. We used generalised linear mixed models to compare endpoints. The trial is registered with ClinicalTrials.gov (NCT04160026).Findings: 15 facilities (5 per arm) completed the study, involving 1,189 (SP (N=377), DP-alone (N=404), DP/TI (N=408)) and 586 (DP-alone (N=267), DP/TI (N=319)) women who had exit interviews and home visits from September 08 to December 10, 2020. Relative to DP-alone, adherence was 16% higher (266/319 [83%] vs 196/267 [73%], adjusted relative risk (aRR)=1·16, 95% CI 1.03-1.31; p=0·0140) in the DP/TI arm. Delivery effectiveness in DP/TI arm was comparable to SP arm (352/403 [87%] vs 335/375 [89%], aRR=0·98, 95% CI 0·90-1·06; p= 0·5430).Interpretation: Targeted information transfer to healthcare providers and pregnant women boosts ANC delivery effectiveness and adherence to multiday IPTp-DP.Funding: EDCTP2 (TRIA.2015-1076); UK Joint-Global-Health-Trials-Scheme of FCDO/MRC/NIHR/Wellcome (MR/P006922/1); SIDA
U2 - 10.1016/s2214-109x(24)00261-4
DO - 10.1016/s2214-109x(24)00261-4
M3 - Article
SN - 2572-116X
VL - 12
SP - e1660-e1672
JO - The Lancet Global Health
JF - The Lancet Global Health
IS - 10
ER -
