Piloting the global subsidy: the impact of subsidised artemisinin-based combination therapies distributed through private drug shops in rural Tanzania

ISRCTN	ISRCTN39125414
DOI	https://doi.org/10.1186/ISRCTN39125414
Protocol serial number	N/A
Sponsor	Tanzanian Ministry of Health and Social Welfare (Tanzania)
Funder	Bill and Melinda Gates Foundation (USA)

Submission date: 31/05/2009
Registration date: 07/08/2009
Last edited: 07/06/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Oliver Sabot
Scientific

383 Dorchester Avenue
Suite 400
Boston
02127
United States of America

Phone	+1 646 264 8302
Email	ojsabot15@yahoo.com

Study information

Primary study design	Interventional
Study design	Non-clinical district-randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Tanzania Ministry of Health and Social Welfare approved on the 20th July 2007
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	500
Key inclusion criteria	All consumers purchasing anti-malarials from a private drug shop (duka la dawa baridi) in target districts (no age or gender restrictions).
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Tanzania
United States of America

Study participating centre

383 Dorchester Avenue

Boston
02127
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/09/2009		Yes	No
Results article	results	02/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes