Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies

NCT03600844 | Completed

• 2 other identifiers: TIPTOP_HHS_20182017-13-TIPTOP
• Study Type: interventional
• Target: 10,602
• Locations: 4 countries
• Sites: 12

Brief Summary

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

Conditions

Malaria in Pregnancy

Outcome Measures

Primary Outcomes (1)

• IPTp3 Coverage

  Proportion of women who had a pregnancy ending in the past 12 months and have received three or more doses of IPTp-SP

  1 year

Secondary Outcomes (5)

• IPTp1 Coverage

  1 year

• ANC 4 coverage

  1 year

• ANC 1 Coverage

  1 year

• Early ANC Coverage

  1 year

• C-IPTp Knowledge

  1 year

Study Arms (2)

Phase 1 Intervention

EXPERIMENTAL

Phase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project.

Behavioral: Community distribution of SP for IPTp

Phase 1 Comparison/Phase 2 Intervention

ACTIVE COMPARATOR

During Phase 1 (intervention months 1 through 12), these communities will be offered only usual treatment--SP for IPTp at in facilities during routine ANC. During Phase 2 (intervention month 13 through the end of the project), these communities will be offered Community distribution of SP for IPTp, in addition to routine ANC IPTp distribution.

Behavioral: Community distribution of SP for IPTp

Interventions

Community distribution of SP for IPTp BEHAVIORAL

SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.

Also known as: C-IPTp-SP

Phase 1 Comparison/Phase 2 Intervention; Phase 1 Intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women who had a pregnancy that ended in the 12 months preceding the survey
• Being resident in the study area during for at least 4 months before the end of the pregnancy
• Willing to participate in the household survey (signing informed consent/assent, in line with country guidelines)

You may not qualify if:

• Anyone considered to be a minor in their country.
• Not willing to provide informed consent

Sponsors & Collaborators

• Jhpiego: lead
• Barcelona Institute for Global Health: collaborator

Study Sites (12)

Kenge District, Community Setting

Kenge, Kwango, Democratic Republic of the Congo

Location

Bulungu District, Community Setting

Bulungu, Kwilu, Democratic Republic of the Congo

Location

Community Setting

Kunda, Maniema Province, Democratic Republic of the Congo

Location

Mananjary District, Community Setting

Mananjary, Fianarantsoa, Madagascar

Location

Community Setting

Toliara, Fianarantsoa, Madagascar

Location

Community Setting

Vohipeno, Vatovavy-Fitovinany, Madagascar

Location

Meconta District, Community Setting

Meconta, Nampula, Mozambique

Location

Community Setting

Murrupula, Nampula, Mozambique

Location

Nhamatanda District, Community Setting

Nhamatanda, Sofala, Mozambique

Location

Community Setting

Ohaukwu District, Ebonyi State, Nigeria

Location

Community Setting

Bosso, Niger State, Nigeria

Location

Community Setting

Akure South, Ondo State, Nigeria

Location

Related Publications (2)

• Gonzalez R, Manun'Ebo MF, Meremikwu M, Rabeza VR, Sacoor C, Figueroa-Romero A, Arikpo I, Macete E, Mbombo Ndombe D, Ramananjato R, LIach M, Pons-Duran C, Sanz S, Ramirez M, Cirera L, Maly C, Roman E, Pagnoni F, Menendez C. The impact of community delivery of intermittent preventive treatment of malaria in pregnancy on its coverage in four sub-Saharan African countries (Democratic Republic of the Congo, Madagascar, Mozambique, and Nigeria): a quasi-experimental multicentre evaluation. Lancet Glob Health. 2023 Apr;11(4):e566-e574. doi: 10.1016/S2214-109X(23)00051-7.

  PMID: 36925177 DERIVED

• Pons-Duran C, Llach M, Sanz S, Ramirez M, Mendez S, Roman E, Tholandi M, Pagnoni F, Menendez C, Gonzalez R. Community delivery of malaria intermittent preventive treatment in pregnancy: protocol of a quasi-experimental evaluation through multistage cluster sampling household surveys in four sub-Saharan African countries. BMJ Open. 2021 Mar 25;11(3):e044680. doi: 10.1136/bmjopen-2020-044680.

  PMID: 33766844 DERIVED

Study Officials

• Clara Menendez, MD, PhD

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Districts in high malaria transmission zones were assigned to intervention and comparison areas.

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 26, 2018
• Study Start: April 2, 2018
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (3); MO (3); NG (3); DE (3)