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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201503001044408 Date of Registration: 20/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Menstruation and the cycle of poverty
Official scientific title Menstruation and the cycle of poverty
Brief summary describing the background and objectives of the trial The proposed research will examine the linkages between menarche, sanitary provisions, reproductive health and girls' educational outcomes in Uganda. Through a randomized trial and qualitative research, our aim now is to provide robust evidence on the effects of sanitary care for girls' educational attainment. The intervention will take place in Kamuli District, located in the eastern-central region of Uganda, where our partner Plan International operates several health and education programmes. The specific objectives of the research are to determine: 1.) whether some combination of puberty education and sanitary pads will improve female educational achievement as measured by attendance, performance, and retention; 2.) whether puberty education and/or sanitary pads will improve girls¿ confidence and concentration, subjective well-being, and participation in community activities; 3) whether the purchase preferences, customs, and attitudes of households related to sanitary products act as a barrier to girls¿ education; and 4) whether sanitary pad disposal causes untoward environmental implications
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Menstruation,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2011
Actual trial start date 01/09/2011
Anticipated date of last follow up 30/11/2014
Actual Last follow-up date 30/11/2014
Anticipated target sample size (number of participants) 560
Actual target sample size (number of participants) 1124
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computer software randomisation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Afripads Pack given 18m Sanitary pads with soap 140
Experimental Group Education only single session 2h standardised education about puberty and menstruation 140
Experimental Group Education plus Afripads Pack given 18m Single session 2h plus sanitary pads with soap 140
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Enrolled in school Schools separated to avoid contamination Willing to participate and work with NGO Schools separated to avoid contamination 12 Year(s) 15 Year(s) Female
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 16/01/2012 SOCIAL SCIENCES & HUMANITIES INTER-DIVISIONAL RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Hayes House, 75 George Street Oxford OX12BQ United Kingdom
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 17/01/2014 The AIDS Support Organisation (TASO)
Ethics Committee Address
Street address City Postal code Country
P.O. Box 10443 Kampala Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome School attendance Baseline Midpoint Follow up 18m
Secondary Outcome Subjective well being Baseline Midpoint Follow up 18m
Secondary Outcome Indicators of agency, confidence, empowerment and a range of cultural beliefs Baseline Midpoint Follow up 18m
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kumuli Uganda Plan International Kumuli UG-205 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Economic and Social Research Council UK Polaris House Swindon sn2 1uj United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Wellington Square Oxford ox1 2er United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr Catherine Dolan Said Business School Oxford ox1 1hp United Kingdom
Prof LInda Scott Said Business School Oxford ox1 1hp United Kingdom
Prof Sue Dopson Said Business School Oxford ox1 1hp United Kingdom
Plan International Uganda Kumuli Kumuli UG-205 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Montgomery paul.montgomery@spi.ox.ac.uk 44 1865 270325 Centre for Evidence Based Intervention, University of Oxford
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor of Psycho-Social Intervention
Role Name Email Phone Street address
Public Enquiries Linda Scott linda.scott@sbs.ox.ac.uk 44 1865 288800 Said Business School
City Postal code Country Position/Affiliation
Oxford ox1 1hp United Kingdom DP World Chair in Marketing
Role Name Email Phone Street address
Scientific Enquiries Paul Montgomery paul.montgomery@spi.ox.ac.uk 44 1865 270325 Centre for Evidence Based Intervention, University of Oxford
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor of Psycho-Social Intervention
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information