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

Primary Purpose

Malaria

Status

Completed

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

RDT Training and Subsidy Offered

Information/Education Campaign

About this trial

This is an interventional health services research trial for Malaria focused on measuring Malaria Diagnosis, Rapid Diagnostic Tests, RDTs, Private Sector, Retail Sector, Drug Shops

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinton Health Access Initiative
Innovations for Poverty Action-Uganda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

RDT Training and Subsidy Offered

Information/Education Campaign

RDT Training/Subsidy + Information/Education Campaign

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Fraction of Illnesses Diagnosed for Malaria

Comparison of the rate of malaria diagnosis in treatment vs. control. Comparison will be at the village level and at the shop level. Denominator will be: all illnesses, febrile illnesses only or suspected malaria episodes only.

Secondary Outcome Measures

Mean RDT Price Charged by Shops

Mean RDTs Purchased by Shops from Wholesaler

Fraction of Monitoring Checklist Items Performed Correctly by Shops

Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken

Comparison of rate of antimalarial taking for illnesses in treatment vs. control Comparison of rate of ACT taking for illnesses in treatment vs. control Comparison of rate of antibiotic taking for illnesses in treatment vs. control

Full Information

NCT ID

NCT01652365

First Posted

July 24, 2012

Last Updated

July 27, 2012

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

Clinton Health Access Initiative, Nigeria, Innovations for Poverty Action-Uganda, Uganda Health Marketing Group

1. Study Identification

Unique Protocol Identification Number

NCT01652365

Brief Title

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

Official Title

Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard School of Public Health (HSPH)

Collaborators

Clinton Health Access Initiative, Nigeria, Innovations for Poverty Action-Uganda, Uganda Health Marketing Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2800 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RDT Training and Subsidy Offered

Arm Type

Experimental

Arm Description

Arm Title

Information/Education Campaign

Arm Type

Experimental

Arm Description

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.

Arm Title

RDT Training/Subsidy + Information/Education Campaign

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

RDT Training and Subsidy Offered

Intervention Type

Behavioral

Intervention Name(s)

Information/Education Campaign

Primary Outcome Measure Information:

Title

Fraction of Illnesses Diagnosed for Malaria

Description

Time Frame

Up To One Year

Secondary Outcome Measure Information:

Title

Mean RDT Price Charged by Shops

Time Frame

Up to One Year

Title

Mean RDTs Purchased by Shops from Wholesaler

Time Frame

Up To One Year

Title

Fraction of Monitoring Checklist Items Performed Correctly by Shops

Time Frame

Up To One Year

Title

Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken

Description

Time Frame

Up To One Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Cohen, PhD

Organizational Affiliation

Harvard School of Public Health (HSPH)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gunther Fink, PhD

Organizational Affiliation

Harvard School of Public Health (HSPH)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

William Dickens, PhD

Organizational Affiliation

Northeastern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinton Health Access Initiative

City

Kampala

Country

Uganda

Facility Name

Innovations for Poverty Action-Uganda

City

Kampala

Country

Uganda

12. IPD Sharing Statement

Learn more about this trial

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

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