The Millennium Villages Project (MVP): Integrating the delivery of health and development interventions and assessing the impact on child survival in sub-Saharan Africa

ISRCTN	ISRCTN24907704
DOI	https://doi.org/10.1186/ISRCTN24907704
ClinicalTrials.gov number	NCT01125618
Secondary identifying numbers	N/A

Submission date: 12/05/2010
Registration date: 03/06/2010
Last edited: 13/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Jeffrey Sachs
Scientific

Low Library
Room 314
535 West 116th St
New York
10027
United States of America

Phone	+1 (0)212 854 8704
Email	sachs@columbia.edu

Study information

Study design	Pair-matched community intervention trial
Primary study design	Interventional
Secondary study design	Case-control study
Study setting(s)	Community
Study type	Other
Participant information sheet	See www.mvpeval.ciesin.columbia.edu for patient information sheets and informed consents.
Scientific title	A pair-matched community intervention trial to assess the impact of an integrated health and development intervention on child survival and the Millennium Development Goals (MDG) in 10 sub-Saharan African countries
Study acronym	MVP
Study objectives	1. After 5 years of operation, villages exposed to the MVP intervention will have a lower rate of under-5 mortality and parallel gains in MDG-related secondary outcomes when compared to similar villages not receiving the intervention. 2. That the coordinated delivery a multi-sector package of health and development interventions implemented through a broad-based local partnership is feasible in a diversity of sub-Saharan African contexts, and; 3. The intervention package can be delivered at a scalable cost of US$40 per person per year in the health sector and US$110 per person per year in total
Ethics approval(s)	Columbia University Institutional Review Board approved on 30/01/2005 (ref: AAAA8202). The latest ethical review was approved on 17/04/2009. Approval has also been received from all host-country IRBs
Health condition(s) or problem(s) studied	Child mortality, Millennium Development Goals
Intervention	The Millennium Villages Project involves the coordinated and simultaneous delivery of a package of proven interventions in health, agriculture, infrastructure and education at a projected annual cost of US$110 per capita.
Intervention type	Other
Primary outcome measure	Under 5 mortality rate, measured at baseline, after 3 years and after 5 years of intervention exposure
Secondary outcome measures	1. Proportion of under 5s who are: 1.1. Stunted (low height for age Z-score) 1.2. Wasted (low weight for height Z-score) 1.3. Underweight (low weight for age Z-score) 2. Duration of breastfeeding 3. Age at introduction of complementary feeding 4. Proportion of under 5s with diarrhoea in past 2 weeks 5. Proportion of under 5s with diarrhoea in past 2 weeks who receive ORS 6. Proportion under 1s immunized against measles 7. Proportion of under 5s treated for pneumonia 8. Prevalence of malaria among under 5s 9. Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment 10. Proportion of under 5s sleeping under Long lasting insecticide treated bed-nets 11. Proportion of pregnant women who received an HIV test 12. Proportion of newborns receiving a post-natal check in the first week of life 13. Proportion of women who receive at least 4 ante-natal care (ANC) visits 14. Proportion of births attended by skilled health personnel 15. Survival rate to last grade of primary education 16. Asset based wealth index 17. Proportion of households reporting not enough food for 1 of past 12 months 18. Proportion of the population using an improved drinking water source 19. Proportion of the population using an improved sanitation source Outcomes will be measured at baseline, after 3 years and after 5 years of intervention exposure
Overall study start date	01/06/2006
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	6000 households followed at baseline and after 3 and 5 years of intervention exposure
Key inclusion criteria	Resident in a Millennium Village Cluster and informed consent to undergo periodic assessments. Selection of comparison villages is based on village-level parameters with the potential to influence child mortality and related MDG outcomes including: 1. agro-ecological zone 2. accessibility (distance to tar roads and markets) 3. principal livelihood strategies 4. crop types 5. levels of electrification 6. numbers of clinics and schools 7. presence of other development projects in the area
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/2006
Date of final enrolment	01/06/2012

Locations

Countries of recruitment

Ethiopia
Ghana
Kenya
Malawi
Mali
Nigeria
Rwanda
Senegal
Tanzania
Uganda
United States of America

Study participating centre

Low Library

New York
10027
United States of America

Sponsor information

United Nations Development Program (UNDP) - Regional Bureau for Africa (RBA)
Government

One United Nations Plaza, DCI-2458
New York
10017
United States of America

Website	http://www.undp.org
"ROR"	https://ror.org/051777d98

Funders

Funder type

Government

United Nations Development Program (UNDP) - Regional Bureau for Africa (RBA) (UNDP CU08-8798)

No information available

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	09/06/2012	13/03/2019	Yes	No

Editorial Notes

13/03/2019: Publication references added.