Condition category
Not Applicable
Date applied
12/05/2010
Date assigned
03/06/2010
Last edited
11/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ciesin.columbia.edu/mvpeval

Contact information

Type

Scientific

Primary contact

Prof Jeffrey Sachs

ORCID ID

Contact details

Low Library
Room 314
535 West 116th St
New York
10027
United States of America
+1 212 854 8704
sachs@columbia.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01125618

Protocol/serial number

N/A

Study information

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

Acronym

MVP

Study hypothesis

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

Columbia University Institutional Review Board approved on the 30th of January 2005 (ref: AAAA8202). The latest ethical review was approved on the 17th of April 2009.
Approval has also been received from all host-country IRBs

Study design

Pair-matched community intervention trial

Primary study design

Interventional

Secondary study design

Case-control study

Trial setting

Other

Trial type

Other

Patient information sheet

See www.mvpeval.ciesin.columbia.edu for patient information sheets and informed consents.

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 5’s with diarrhoea in past 2 weeks
5. Proportion of under 5’s 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 trial start date

01/06/2006

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

6000 households followed at baseline and after 3 and 5 years of intervention exposure

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2006

Recruitment end date

01/06/2012

Locations

Countries of recruitment

Ethiopia, Ghana, Kenya, Malawi, Mali, Nigeria, Rwanda, Senegal, Tanzania, Uganda

Trial participating centre

Low Library
New York
10027
United States of America

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.undp.org

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes