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Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector

NCT ID: NCT01652365

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to assess the feasibility and impact of introducing subsidized malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a randomized controlled trial at the village level, taking place in 6 districts in Eastern Uganda. Licensed drug shops in selected villages were trained in proper RDT storage, administration, interpretation and disposal and were given access to subsidized RDTs for sale. This study explores whether drug shop owners--when given access to training and subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume and what price. The investigators also explore whether shops will safely store, administer, interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment recommendations. Finally, the study explores whether making RDTs available for sale in local drug shops has a community level impact on diagnostic testing and appropriate treatment for malaria.

Detailed Description

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Conditions

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Malaria

Keywords

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Malaria Diagnosis Rapid Diagnostic Tests RDTs Private Sector Retail Sector Drug Shops

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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RDT Training and Subsidy Offered

Licensed drug shops within villages selected randomly to be in this arm will be invited to training on RDTs and offered access to subsidized RDTs available for purchase at a local wholesale pharmacy in Mbale, Uganda.

Group Type EXPERIMENTAL

RDT Training and Subsidy Offered

Intervention Type BEHAVIORAL

Information/Education Campaign

Community meetings describing RDTs and encouraging community members to be diagnosed prior to taking malaria treatment will be held in villages randomly assigned to this treatment arm.

Group Type EXPERIMENTAL

Information/Education Campaign

Intervention Type BEHAVIORAL

RDT Training/Subsidy + Information/Education Campaign

Includes both the training and subsidy component and the information/education campaign component.

Group Type EXPERIMENTAL

RDT Training and Subsidy Offered

Intervention Type BEHAVIORAL

Information/Education Campaign

Intervention Type BEHAVIORAL

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RDT Training and Subsidy Offered

Intervention Type BEHAVIORAL

Information/Education Campaign

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Drug Shops:

* Licensed and registered as a Drug Shop with the Ugandan National Drug Authority

Households:

* Live in the village of participating drug shop
* Female household head is 18 or over

Exclusion Criteria

Drug Shops:

* Drug Shop not registered with Ugandan National Drug Authority
* Female household head is under 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinton Health Access Initiative, Nigeria

OTHER

Sponsor Role collaborator

Innovations for Poverty Action-Uganda

UNKNOWN

Sponsor Role collaborator

Uganda Health Marketing Group

UNKNOWN

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Jessica Cohen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Gunther Fink, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

William Dickens, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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Clinton Health Access Initiative

Kampala, , Uganda

Site Status

Innovations for Poverty Action-Uganda

Kampala, , Uganda

Site Status

Countries

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Uganda

Related Links

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http://www.poverty-action.org/project/0508

Project Description

http://www.hsph.harvard.edu/faculty/gunther-fink/

G Fink (PI) website

Other Identifiers

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HS805

Identifier Type: OTHER

Identifier Source: secondary_id

19371-106

Identifier Type: -

Identifier Source: org_study_id