Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201502000770329 Date of Approval: 10/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title African Health Markets for Equity (AHME) Impact Evaluation
Official scientific title African Health Markets for Equity (AHME) Impact Evaluation
Brief summary describing the background and objectives of the trial The African Health Markets for Equity (AHME) Impact Evaluation aims to rigorously evaluate the extent to which transforming the business model of franchised healthcare providers and expanding access to demand-side financing generates effective and cost-effective coverage of priority technologies and interventions amongst the poor. The evaluation is a collaborative effort between Innovations for Poverty Action and researchers from multiple institutions, and is funded by the Bill and Melinda Gates Foundation and the Department for International Development of the United Kingdom of Great Britain and Northern Ireland (DFID). The AHME intervention package will seek to improve efficiencies in private health care delivery by reducing both supply-side and demand-side constraints. Specifically, supply-side intervention will include (1) the social franchising of private clinics in order to improve consistency and quality of care and to reduce costs and (2) quality monitoring linked to capital financing in order to help clinics expand and improve clinical services. On the demand side, AHME interventions, such as vouchers, health insurance schemes and medical savings accounts will be integrated into the AHME package in later years to reduce financial barriers to accessing provider services. In addition opportunities to improve the operational efficiency of supply and/or demand-side financing interventions using information and communication technology (ICT) interventions will be explored.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AHME
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Maternal Care Services, Diarrhea, Pneumonia, Malaria,Pregnancy and Childbirth,Respiratory
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Education /Training
Anticipated trial start date 24/07/2013
Actual trial start date 07/07/2013
Anticipated date of last follow up 01/01/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 10000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
AEARCTR-0000217 American Economic Association: RCT Registry
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified Allocation using STATA 13 Allocation was determined by an investigator, and delivered to implementing partners after randomization was completed. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AHME franchising supply side and demand side financing NA NA Social franching of private clinics by PSI and MSI to improve quality of clinical practices through training, supply train management and quality monitoring. Supply side financing by PharmAccess SafeCare Medical Credit fund. Demand side financing TBD in later years. 1200
Control Group Existing Practices NA NA Clinics will not be franchised, and will continue services under existing practices 1200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We are targeting private clinics: -That are not already franchised -In Eastern or Western Kenya -In counties in which PSI and MSK (implementing partners) plan to expand franchising and link franchising to Medical Credit Fund (MCF; supply side financing scheme) Franchising Exclusion Criteria: -Facility does not provide maternal and child health services -Facility is not a clinic -Clinic does not have business registration -Business registration is out of date, and the clinic owner is not planning on renewing it -Clinic is already franchised -Clinic owner is not willing to offer family planning services -Clinic owner is unwilling to partake in franchising activities of training, record-keeping and quality assurance visits -Clinic owner is unwilling to follow recommended pricing -Clinic owner is unwilling to pay a membership fee -Clinic is within 5km of another clinic (MSK specific) -Clinic is closer to another Tunza clinic than minimum district-level distance identified by PSI. (PSI specific) MCF Exclusion Criteria: -Clinic is financially dependent on an outside organization (e.g. church, community, NGO, etc.) -Clinic owner has no interest in expanding the volume of existing services offered or the set of services offered -Already have an existing loan that will not be paid off by a set date (TBD) -Clinic/owner must have collateral -Not interested in taking a loan -Not interested in keeping records in order to get a loan -The facility has to have a bank account AND does not keep financial records -Clinics services that are more than 20% below the minimum of 3000 patients per year which works out to be 250 patients per month the equivalent of 8 patients per day -Clinic owner has no form of tangible security (ownership of the clinic, house, other land title, car log books, or shares) -Clinic owner not willing to use assets as collateral for a loan. 0 Year(s) 0 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/06/2013 Kenya Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200 Nairobi Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Provider Quality Baseline (Q4: 2013) Year 2 (Q1: 2015) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Primary Outcome Cost of Care Baseline (Q4: 2013) Year 2 (Q1: 2015) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Primary Outcome Client Load (by service category) Baseline (Q4: 2013) Year 2 (Q1: 2015) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Primary Outcome Patient Utilization -- self-report through household survey Baseline (Q4: 2013) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Primary Outcome Facility Revenues and Costs Baseline (Q4: 2013) Year 2 (Q1: 2015) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Primary Outcome Facility Management Practices Baseline (Q4: 2013) Year 2 (Q1: 2015) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Primary Outcome Integration with Financial Institutions Baseline (Q4: 2013) Year 2 (Q1: 2015) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Secondary Outcome Market Impacts Year 4 (Q1: 2017)
Secondary Outcome Child Weight-for-Height -- Household sample Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Secondary Outcome Child Height-for-Age -- Household sample Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Secondary Outcome Child Mid-Upper-Arm Circumfrence --Houshold Sample Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Secondary Outcome Child Diarrhea Symptoms -- Houshold Sample Baseline (Q4: 2013) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Secondary Outcome Child ARI Symptoms -- Houseohld sample Baseline (Q4: 2013) Year 3 (Q1: 2016) Year 4 (Q1: 2017)
Secondary Outcome Malaria Incidence -- Household sample Year 3 (Q1: 2016) Year 4 (Q1: 2017)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Innovations For Poverty Action (IPA) Jonathan Court, Ngong Road Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle, WA 98109 United States of America
Department for International Development of the United Kingdom of Great Britain and Northern Ireland (DFID) 22 Whitehall London SW1A 2EG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Innovations for Poverty Action 101 Whitney Ave New Haven 06510 United States of America Charities/Societies/Foundation
Primary Sponsor Innovations for Poverty Action 101 Whitney Ave New Haven 06510 United States of America Charities/Societies/Foundation
Primary Sponsor Innovations for Poverty Action 101 Whitney Ave New Haven 06510 United States of America Charities/Societies/Foundation
Primary Sponsor Innovations for Poverty Action Jonathan Court, Ngong Road Nairobi Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Marie Stopes International (MSI) Kindaruma Road Kilimani Off Ngong Road Nairobi Kenya
Population Services International, Kenya P.O. Box 22591-00400 Nairobi Kenya
PharmAccess International (PharmAccess) P.O Box 22700 Amsterdam 1100 DE Netherlands
Garmeen Foundation (GF) The Greenhouse on Ngong Road Third Floor, Suite 21 Nairobi P.O. Box 63184-0061 Kenya
International Financing Corporation (IFC)-World Bank¿s Health in Africa Initiative (HIA) P.O Box 30577-00100 Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Gertler gertler@haas.berkeley.edu +1 (510) 642 1418 University of California, Hass School of Business #1900
City Postal code Country Position/Affiliation
Berkeley 94720 United States of America Professor of Economics
Role Name Email Phone Street address
Public Enquiries Elana Safran esafran@poverty-action.org +1 (202) 386 6200 101 Whitney Ave
City Postal code Country Position/Affiliation
New Haven 06510 United States of America Acting Country Director -- IPA, Zambia
Role Name Email Phone Street address
Scientific Enquiries Elana Safran esafran@poverty-action.org +1 (202) 386 6200 101 Whitney Ave
City Postal code Country Position/Affiliation
New Haven 06510 United States of America Acting Country Director -- IPA, Zambia
REPORTING
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