Health Trials

Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy

ConditionMalaria Prevention
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The purpose of this study is to demonstrate the feasibility, acceptability, and preliminary effectiveness of a focal mass drug administration program for household members of pregnant women to protect against malaria in pregnancy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Primary residence (i.e., where a person lives for ≥ 6 months per year) in Kasese District with no plans to change residency in subsequent 6 months

Able and willing to comply with all study procedures and be available for the duration of the study

Able and willing to consent to study procedures as documented on informed consent form. For children (age <18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent.

Disqualifiers

Temporary or part-time residence in Kasese District (i.e., where a person lives for < 6 months per year)

Known plans to move within the next 6 months

Unable or unwilling to provide consent

Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

Trial design

Design model

Factorial

Treatments tested in this trial

  • Dihydroartemisinin Piperaquine

    Drug

    A single or monthly dose of Dihydroartemisinin Piperaquine based on weight will be taken orally.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: A single dose of Dihydroartemisinin PiperaquineExperimental treatment 1 intervention
Group B: Monthly dose of Dihydroartemisinin PiperaquineExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percent of eligible household members receiving fMDA

Proportion of eligible household members that receive fMDA intervention according to dosing schedule (i.e., one time or monthly)

Time frame
Day 1 to study completion, generally 5 months

Secondary outcomes

1

Percent of household members enrolled

Proportion of household members who consent to participate

Time frame
At enrollment visit (Day 1)
2

Refusal to receive fMDA

Proportion of eligible household members who decline any fMDA intervention

Time frame
Day 1 to study completion, generally 5 months
3

fMDA Adherence

Proportion of DP blister packs returned with all medication taken (i.e., pill counts)

Time frame
Day 1 to study completion, generally 5 months
4

P. falciparum parasitemia among household members

Prevalence of P. falciparum parasitemia among household members at three time points (enrollment, mid-point, delivery) as measured by malaria rapid diagnostic test

Time frame
Day 1 to study completion, generally 5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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