Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi

NCT03376217 | Completed

• 1 other identifier: P.08/17/2232
• Study Type: interventional
• Target: 1,447
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.

Conditions

Malaria in Pregnancy

Keywords

malaria; malaria in pregnancy; intermittent preventive treatment in pregnancy (IPTp); community health workers; Sulfadoxine-pyrimethamine (SP)

Outcome Measures

Primary Outcomes (1)

• 3 or more doses of IPTp (IPTp3+)

  Proportion of recently pregnant women who received at least 3 doses of IPTp

  through study completion, 18 months

Secondary Outcomes (4)

• IPTp doses received

  through study completion, 18 months

• IPTp doses delivered by ANC

  through study completion, 18 months

• Total ANC visits

  through study completion, 18 months

• Gestational age at first IPTp

  through study completion, 18 months

Study Arms (2)

Control

NO INTERVENTION

IPTp delivered at antenatal clinic

Intervention

EXPERIMENTAL

IPTp delivered by HSAs

Other: IPTp delivered by HSAs

Interventions

IPTp delivered by HSAs OTHER

Pregnant women will have the option to receive IPTp-SP from Health surveillance assistants (HSAs). SP is recommended in Malawi for prevention of malaria during pregnancy, but currently it is only available at antenatal clinics.

Also known as: community IPTp (cIPTp)

Intervention

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women:
• All pregnant women residing in study catchment area are eligible to receive SP from HSAs, with the exception of HIV positive women.
• Providers:
• At each facility we will randomly select one ANC provider who has had at least six months of work experience
• HSA supervisor
• Health facility in-charge
• HSAs:
• All HSAs working in the study areas will be eligible; we will select at least 36 at random to be participate in interviews and focus groups discussions.

You may not qualify if:

• Pregnant women: Women who experienced a delivery in the past 12 months, but are \<16 or \>49 years will be excluded. Those who last delivered a child over twelve months ago will be excluded from survey questions specific to recently pregnant women, but may answer questions related to community perception or general demographics. For qualitative research, the same criteria will be used.
• Health facility providers: Those who have been working in the health service for less than six months will not be interviewed due to low levels of relevant experience or exposure to the intervention.
• HSAs: All HSAs are eligible to participate.

Sponsors & Collaborators

• Kamuzu University of Health Sciences: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Malawi: collaborator
• Peace Corps: collaborator
• Management Sciences for Health: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Malaria Alert Center, University of Malawi College of Medicine

Liwonde, Malawi

Location

Related Publications (6)

• Okeibunor JC, Orji BC, Brieger W, Ishola G, Otolorin E', Rawlins B, Ndekhedehe EU, Onyeneho N, Fink G. Preventing malaria in pregnancy through community-directed interventions: evidence from Akwa Ibom State, Nigeria. Malar J. 2011 Aug 5;10:227. doi: 10.1186/1475-2875-10-227.

  PMID: 21819579 BACKGROUND

• Ndyomugyenyi R, Tukesiga E, Katamanywa J. Intermittent preventive treatment of malaria in pregnancy (IPTp): participation of community-directed distributors of ivermectin for onchocerciasis improves IPTp access in Ugandan rural communities. Trans R Soc Trop Med Hyg. 2009 Dec;103(12):1221-8. doi: 10.1016/j.trstmh.2009.03.006. Epub 2009 May 20.

  PMID: 19467686 BACKGROUND

• Mbonye AK, Magnussen P, Bygbjerg IB. Intermittent preventive treatment of malaria in pregnancy: the effect of new delivery approaches on access and compliance rates in Uganda. Trop Med Int Health. 2007 Apr;12(4):519-31. doi: 10.1111/j.1365-3156.2007.01819.x.

  PMID: 17445143 BACKGROUND

• Msyamboza KP, Savage EJ, Kazembe PN, Gies S, Kalanda G, D'Alessandro U, Brabin BJ. Community-based distribution of sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria during pregnancy improved coverage but reduced antenatal attendance in southern Malawi. Trop Med Int Health. 2009 Feb;14(2):183-9. doi: 10.1111/j.1365-3156.2008.02197.x. Epub 2009 Jan 15.

  PMID: 19207178 BACKGROUND

• Gies S, Coulibaly SO, Ky C, Ouattara FT, Brabin BJ, D'Alessandro U. Community-based promotional campaign to improve uptake of intermittent preventive antimalarial treatment in pregnancy in Burkina Faso. Am J Trop Med Hyg. 2009 Mar;80(3):460-9.

  PMID: 19270299 BACKGROUND

• Rubenstein BL, Chinkhumba J, Chilima E, Kwizombe C, Malpass A, Cash S, Wright K, Troell P, Nsona H, Kachale F, Ali D, Kaunda E, Lankhulani S, Kayange M, Mathanga DP, Munthali J, Gutman JR. A cluster randomized trial of delivery of intermittent preventive treatment of malaria in pregnancy at the community level in Malawi. Malar J. 2022 Jun 21;21(1):195. doi: 10.1186/s12936-022-04216-4.

  PMID: 35729612 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Jobiba Chinkhumba, MBBS PhD

  Malaria Alert Center, Malawi College of Medicine

  PRINCIPAL INVESTIGATOR

• Julie Gutman, MD MSc

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical epidemiologist

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 18, 2017
• Study Start: December 1, 2017
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

MA (1)