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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Mr Oliver Sabot
Scientific
Scientific
383 Dorchester Avenue
Suite 400
Boston
02127
United States of America
| Phone | +1 646 264 8302 |
|---|---|
| ojsabot15@yahoo.com |
Study information
| Study design | Non-clinical district-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | Tanzania Ministry of Health and Social Welfare approved on the 20th July 2007 |
| 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 |
| Primary outcome measure | 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 study start date | 01/11/2007 |
| Overall study end date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Greater than 500 per district |
| 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 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
- United States of America
Study participating centre
383 Dorchester Avenue
Boston
02127
United States of America
02127
United States of America
Sponsor information
Tanzanian Ministry of Health and Social Welfare (Tanzania)
Government
Government
National Malaria Control Program
Samora Avenue
P.O. Box 9083
Dar es Salaam
N/A
Tanzania
| Phone | +255 (0)22 212 0261 |
|---|---|
| ps@moh.go.tz | |
| Website | http://www.moh.go.tz/ |
"ROR" |
https://ror.org/03vt2s541 |
Funders
Funder type
Charity
Bill and Melinda Gates Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
