NCT01002066

Brief Summary

The purpose of this study is to study the effectiveness of wide scale RDT use at the primary health care level in previously high malaria endemic area during malaria pre-elimination phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic alertness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,890

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 15, 2011

Status Verified

November 1, 2011

Enrollment Period

5 months

First QC Date

October 26, 2009

Last Update Submit

November 14, 2011

Conditions

Keywords

FeverMalariaRDTIMCIChildren<5 years of ageACT

Outcome Measures

Primary Outcomes (1)

  • Adherence to Rapid diagnostic tests (RDT) result

    Five months

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary health care units (PHCUs) and Primary health care centres (PHCCs) in North A and Micheweni Districts in Zanzibar

You may qualify if:

  • All patients \>2 months of age with confirmed fever, with a measured axillary temperature of ≥37.5˚C, or history of fever within the preceding 24 hours
  • Presenting to the health facility from 8.00 to 16.00 Monday to Friday.
  • Informed consent

You may not qualify if:

  • Previous enrolment in the study within the last 28 days.
  • Severe disease that requires immediate referral as defined by the clinician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary health care centers (PHCC)s and Primary health care units (PHCUs)

Kivunge and Micheweni, Zanzibar, Tanzania

Location

Related Publications (1)

  • Shakely D, Elfving K, Aydin-Schmidt B, Msellem MI, Morris U, Omar R, Weiping X, Petzold M, Greenhouse B, Baltzell KA, Ali AS, Bjorkman A, Martensson A. The usefulness of rapid diagnostic tests in the new context of low malaria transmission in Zanzibar. PLoS One. 2013 Sep 4;8(9):e72912. doi: 10.1371/journal.pone.0072912. eCollection 2013.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood collected on Rapid diagnostic tests (RDT)s and Filter paper (FP)

MeSH Terms

Conditions

FeverMalaria

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Anders Björkman, Professor

    Karolinska University Hopsital

    PRINCIPAL INVESTIGATOR
  • Andreas Mårtensson, Ph.D, M.D.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR
  • Kristina Elfving, M.D.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR
  • Mwinyi Msellem, MSc

    Zanzibar Malaria Control Programme

    PRINCIPAL INVESTIGATOR
  • Delér Shakely, M.D.

    Karolinska University Hopsital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

February 1, 2011

Last Updated

November 15, 2011

Record last verified: 2011-11

Locations