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

Barsosio, Hellen, webster, Jayne, Omiti, Fred, K'Oloo, Alloys, odero, Isdorah, Ojuok, MichaelAlaw, Odiwa, Dawn, Omondi, Benard, Okello, Elizabeth, Dodd, James, Taegtmeyer, Miriam ORCID: https://orcid.org/0000-0002-5377-2536, terKuile, Feiko ORCID: https://orcid.org/0000-0003-3663-5617, Lesosky, Maia, Kariuki, Simon and Hill, Jenny ORCID: https://orcid.org/0000-0003-1588-485X (2024) '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'. Lancet Global Health, Vol 12, Issue 10, e1660-e1672.

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Abstract

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

Item Type:	Article
Subjects:	WA Public Health > Preventive Medicine > WA 110 Prevention and control of communicable diseases. Transmission of infectious diseases WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria WQ Obstetrics > Pregnancy Complications > WQ 256 Infectious diseases
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1016/S2214-109X(24)00261-4
Depositing User:	Tracy Seddon
Date Deposited:	30 Jul 2024 11:52
Last Modified:	24 Sep 2024 14:48
URI:	https://archive.lstmed.ac.uk/id/eprint/24960

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