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

March 29, 2022 updated by: Jhpiego

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10602

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo, The Democratic Republic of the
    • Kwango
      • Kenge, Kwango, Congo, The Democratic Republic of the
        • Kenge District, Community Setting
    • Kwilu
      • Bulungu, Kwilu, Congo, The Democratic Republic of the
        • Bulungu District, Community Setting
    • Maniema
      • Kunda, Maniema, Congo, The Democratic Republic of the
        • Community setting
  • Madagascar
    • Fianarantsoa
      • Mananjary, Fianarantsoa, Madagascar
        • Mananjary District, Community Setting
      • Toliary 2, Fianarantsoa, Madagascar
        • Community setting
    • Vatovavy-Fitovinany
      • Vohipeno, Vatovavy-Fitovinany, Madagascar
        • Community setting
  • Mozambique
    • Nampula
      • Meconta, Nampula, Mozambique
        • Meconta District, Community Setting
      • Murrupula, Nampula, Mozambique
        • Community setting
    • Sofala
      • Nhamatanda, Sofala, Mozambique
        • Nhamatanda District, Community Setting
  • Nigeria
    • Ebonyi
      • Ohaukwu District, Ebonyi, Nigeria
        • Community setting
    • Niger
      • Bosso, Niger, Nigeria
        • Community setting
    • Ondo
      • Akure South, Ondo, Nigeria
        • Community setting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Phase 1 Intervention
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
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.
Other Names:
  • C-IPTp-SP
ACTIVE_COMPARATOR: Phase 1 Comparison/Phase 2 Intervention
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
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.
Other Names:
  • C-IPTp-SP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IPTp3 Coverage
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IPTp1 Coverage
Time Frame: 1 year
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
1 year
ANC 4 coverage
Time Frame: 1 year
• Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics four times
1 year
ANC 1 Coverage
Time Frame: 1 year
Proportion of women who have had a pregnancy that ended in the past 12 months and have attended ANC clinics at least once
1 year
Early ANC Coverage
Time Frame: 1 year
Proportion of pregnant women attending the first ANC visit before or at week 14
1 year
C-IPTp Knowledge
Time Frame: 1 year
Proportion of women who have had a pregnancy that ended in the past 12 months who know about the IPTp service provided by CHWs
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jhpiego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Barcelona Institute for Global Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIPTOP_HHS_2018
  • 2017-13-TIPTOP (OTHER_GRANT: Unitaid)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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