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Malaria in PregnancyTIPTOPNCT03600844

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

A study testing Community distribution of SP for IPTp in people with Malaria in Pregnancy, run by Jhpiego at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Malaria in Pregnancy
What is being tested?
Community distribution of SP for IPTp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,602 participants
Where
12 sitesin 4 countries
Study dates
2 Apr 2018to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

Democratic Republic of the Congo3 sites

  • Bulungu District, Community Setting

    Bulungu, Kwilu

  • Kenge District, Community Setting

    Kenge, Kwango

  • Community Setting

    Kunda, Maniema Province

Other trials in Democratic Republic of the Congo

Madagascar3 sites

  • Mananjary District, Community Setting

    Mananjary, Fianarantsoa

  • Community Setting

    Toliara, Fianarantsoa

  • Community Setting

    Vohipeno, Vatovavy-Fitovinany

Other trials in Madagascar

Mozambique3 sites

  • Meconta District, Community Setting

    Meconta, Nampula

  • Community Setting

    Murrupula, Nampula

  • Nhamatanda District, Community Setting

    Nhamatanda, Sofala

Other trials in Mozambique

Nigeria3 sites

  • Community Setting

    Akure South, Ondo State

  • Community Setting

    Bosso, Niger State

  • Community Setting

    Ohaukwu District, Ebonyi State

Other trials in Nigeria

About this study

Official title: Evaluation of Community Delivery of Malaria Intermittent Preventive Treatment in Pregnancy (C-IPTp) (TIPTOP Project)

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).

Read the detailed description

The specific objectives of this study are to determine the change in the following indicators during the course of the TIPTOP project: 1) Proportion of women who have had a pregnancy that ended in the past 12 months and have received 1 or more, 2 or more and 3 or more doses of IPTp-SP; proportion of women with pregnancy in the past 12 months who attended ANC clinics at least once, and who attended at least four times; proportion of pregnant women attending the first ANC visit before or at week 14; proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs; and acceptability of C-IPTp for community delivery of IPTp (note: results will be disaggregated by provider type, age, gravidity and distance from facility). To assess these changes, the study will implement structured household surveys targeting potential beneficiaries of the project (pregnant women) in the intervention and comparison areas, implemented at three time points: baseline, mid- and end-points. In each country an initial implementation area (Phase I) and two expansion areas (Phase II) have been selected for the project. This study will establish if community deliver of IPTp is effective and feasible and whether it influences antenatal care service coverage rates. It is expected that the study will provide information to scale up the approach the 4 study countries for the prevention of malaria in pregnancy. This information is also meant to inform global guidelines on community IPTp delivery and may also be used by other countries.

Being tested
Community distribution of SP for IPTp

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community distribution of SP for IPTpBehavioural

    Also called C-IPTp-SP

    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.

Study groups in NCT03600844
Study groupRoleWhat they receive
Phase 1 InterventionExperimentalPhase 1 intervention communities will be offered Community distribution of SP for IPTp in addition to routine ANC IPTp distribution throughout the project.
Receives: Behavioral: Community distribution of SP for IPTp
Phase 1 Comparison/Phase 2 InterventionActive comparatorDuring 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.
Receives: Behavioral: Community distribution of SP for IPTp

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (5)

  1. IPTp1 Coverage

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

    Measured: 1 year

  2. ANC 4 coverage

    • Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times

    Measured: 1 year

  3. ANC 1 Coverage

    Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once

    Measured: 1 year

  4. Early ANC Coverage

    Proportion of pregnant women attending the first ANC visit before or at week 14

    Measured: 1 year

  5. C-IPTp Knowledge

    Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start2 Apr 2018
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Districts in high malaria transmission zones were assigned to intervention and comparison areas.
Masking
None (open label)
Enrolment
10,602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03600844
Sponsor's protocol ID
TIPTOP_HHS_2018
Other IDs
2017-13-TIPTOP
Acronym
TIPTOP
Status last verified
Mar 2022
First submitted
22 Jun 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share IPD to other researchers

Publications

  • 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.

    PubMed 36925177

  • 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.

    PubMed 33766844

Questions about this trial

What is this clinical trial studying?

A study testing Community distribution of SP for IPTp in people with Malaria in Pregnancy, run by Jhpiego at 12 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Democratic Republic of the Congo, Madagascar, Mozambique, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IPTp3 Coverage (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03600844, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.

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