Condition category
Infections and Infestations
Date applied
31/05/2009
Date assigned
07/08/2009
Last edited
07/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Oliver Sabot

ORCID ID

Contact details

383 Dorchester Avenue
Suite 400
Boston
02127
United States of America
+1 646 264 8302
ojsabot15@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The impact of subsidised artemisinin-based combination therapies distributed through private drug shops on consumer uptake and retail price in rural Tanzania: a non-clinical district-randomised controlled trial

Acronym

Study hypothesis

The introduction of subsidised artemisinin-based combination therapies (ACTs) at the top of the private sector supply chain will lead to a significant increase in consumer purchase and use of these recommended first-line therapies and a corresponding significant decrease in purchase and use of sub-optimal therapies such as amodiaquine and sulphadoxine-pyramethamine.

The lower price for ACTs offered at the top of the supply chain as a result of the subsidy will result in significantly lower retail prices for these drugs, with consumers paying an equivalent amount as for the most commonly purchased suboptimal therapies.

Ethics approval

Tanzania Ministry of Health and Social Welfare approved on the 20th July 2007

Study design

Non-clinical district-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malaria

Intervention

A total of four interventions are applied during the project:
1. Provision of ACTs at a price 95% below standard market level to a pharmaceutical wholesaler with agreement to distributed to drug shops
2. Training of drug shop owners and shopkeepers on recognition of malaria symptoms, the importance of use of ACTs as first-line malaria treatment, and proper storage and dispensing practices for ACTs
3. Comprehensive behaviour change communication activities through a variety of media to promote prompt treatment seeking for malaria, demand for and acceptance of ACTs as first-line malaria treatment, and to generate awareness of low-priced ACT in private shops
4. Placement of a suggested retail price on subsidised ACTs distributed through private shops to provide consumers with a clear indication of the appropriate amount to pay for the product

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Proportion of consumers purchasing anti-malarials at private drug shops that buy ACTs. Measured through exit interviews at all shops in target districts at baseline and four surveys during intervention.
2. Price paid for subsidised ACTs and most common alternative anti-malarials by consumers at private drug shops. Measured through exit interviews and the mystery shopper technique at baseline and four times during intervention.
3. The total volume of ACTs distributed by private drug shops in the previous month. Measured through retail audits conducted twice during each survey period (once to establish baseline stock level and follow-up to measure change due to sales), including baseline.

Secondary outcome measures

1. Socioeconomic status of consumers purchasing ACT and other anti-malarials at private drug shops as determined through principal component analysis of household assets. Measured through exit interviews of consumers at baseline and four times during intervention.
2. Volume of ACTs dispensed by all public and nongovernmental health facilities in target districts during preceding month. Measured through audits of public facilities and NGO health facilities at baseline and four times during intervention.
3. Proportion of private drug shops stocking ACTs and alternative anti-malarials. Measured through retail audits at baseline and four times during intervention.
4. Geographic location of drug shops and public/NGO health facilities distributing anti-malarials. Measured through recording of GPS coordinates of all drug shops and facilities during each audit using Garmin Etrex hand units.

Overall trial start date

01/11/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All consumers purchasing anti-malarials from a private drug shop (duka la dawa baridi) in target districts (no age or gender restrictions).

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Greater than 500 per district

Participant exclusion criteria

1. Consumers purchasing medicines other than anti-malarials from private drug shops
2. Patients obtaining anti-malarials from other sources, including public health facilities, in the target districts

Recruitment start date

01/11/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Tanzania

Trial participating centre

383 Dorchester Avenue
Boston
02127
United States of America

Sponsor information

Organisation

Tanzanian Ministry of Health and Social Welfare (Tanzania)

Sponsor details

National Malaria Control Program
Samora Avenue
P.O. Box 9083
Dar es Salaam
N/A
Tanzania
+255 (0)22 212 0261
ps@moh.go.tz

Sponsor type

Government

Website

http://www.moh.go.tz/

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation (USA)

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://ww.ncbi.nlm.nih.gov/pubmed/19724644
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20594372

Publication citations

  1. Results

    Sabot OJ, Mwita A, Cohen JM, Ipuge Y, Gordon M, Bishop D, Odhiambo M, Ward L, Goodman C, Piloting the global subsidy: the impact of subsidized artemisinin-based combination therapies distributed through private drug shops in rural Tanzania., PLoS ONE, 2009, 4, 9, e6857, doi: 10.1371/journal.pone.0006857.

  2. Results

    Cohen JM, Sabot O, Sabot K, Gordon M, Gross I, Bishop D, Odhiambo M, Ipuge Y, Ward L, Mwita A, Goodman C, A pharmacy too far? Equity and spatial distribution of outcomes in the delivery of subsidized artemisinin-based combination therapies through private drug shops., BMC Health Serv Res, 2010, 10 Suppl 1, S6, doi: 10.1186/1472-6963-10-S1-S6.

Additional files

Editorial Notes