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.: PACTR202205619986957 Date of Approval: 04/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact Evaluation of a Menstrual Hygiene and Health Development Impact Bond in Ethiopia
Official scientific title Impact Evaluation of a Menstrual Hygiene and Health Development Impact Bond in Ethiopia
Brief summary describing the background and objectives of the trial This trial assesses the impact of an intervention to encourage the adoption of improved menstrual health and hygiene (MHH) practices and the change of beliefs related to menstruation in Adama, Ethiopia. The three areas of intervention are 1.Awareness-raising of communities on MHH and advocacy; 2. Production and distribution of affordable, quality, environmentally friendly menstrual hygiene products; and 3.Construction/rehabilitation and maintenance of sanitary infrastructure in schools. Three outcomes will be evaluated using a quasi-experimental survey anchored in the difference-in-difference method. These outcomes are 1. Mobility and Inclusion of women and girls during menstruation, 2. MHH needs met and 3.MHH knowledge by the community (including boys and men).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mobility and inclusion of women and girls during menstruation, MHH needs met and MHH knowledge
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 05/05/2022
Actual trial start date
Anticipated date of last follow up 05/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1340
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Menstrual Hygiene and Health Development Impact Bond in Ethiopia 32 months Agence Française de Développement (AFD), together with KOIS, CARE, and Pro Pride, is embarking on an innovative results-based financing mechanism – a Development Impact Bond – to improve menstrual hygiene and health (MHH) for adolescent girls and women in Adama, Oromia, Ethiopia. The three intervention pillars are: 1.Awareness-raising of communities on MHH and advocacy 2. Production and distribution of affordable, quality, environmentally friendly menstrual hygiene products 3.Construction/rehabilitation and maintenance of sanitary infrastructure in schools. The intervention is targeted at a number of groups each with specific entry points. Schoolgirls in 91 schools in Adama will receive interventions from each of the three pillars above. Women in factories, Adama university and communities with village savings and loan associations (VSLAs) are specific intervention groups. Boys in schools and men in communities in which the programme is active will be targeted through the awareness raising pillar. 670
Control Group Menstrual Hygiene and Health Development Impact Bond in Ethiopia 32 months The control group for the study is drawn from Jimma. Jimma is located in the same region as Adama (Oromia) but is separated by approximately 465 km by road. It is the next largest city in Oromia after Adama and shares an important socio-economic, cultural, linguistic and regional policy context. Jimma also has the biggest state university in Oromia. 670 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Girls in schools aged 12-18 Women in university 18-25 Women in community 18-45 Boys in schools 12-18 Men in community 18+ Locations that are not targeted by the CARE intervention Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 12 Year(s) 45 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 08/11/2021 IRB Ethiopian Public Health Association
Ethics Committee Address
Street address City Postal code Country
Gabon St, Kirkos Sub City Addis Ababa Addis Ababa 7117 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mobility and Inclusion of women and girls during menstruation (including self reported absences from school, work, and other social activities) Baseline, midline and endline
Secondary Outcome MHH needs met Baseline, midline and endline
Secondary Outcome MHH knowledge by the community (incl. boys and men) measured using a knowledge quiz Baseline, midline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
JarCo Consulting Old Airport Area behind Switzerland Embassy Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
AFD 5 rue Roland Barthes PARIS 75598 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ITAD Ltd Preece House, Davigdor Rd Hove BN3 1RE United Kingdom Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Julie Hennegan The Burnet Institute 85 Commercial Road Melbourne VIC 3004 Australia
JaRco Consulting Old Airport Area Behind Switzerland Embassy Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gil Yaron gil_yaron@gya.co.uk +447876598155 32 Amenbury Lane
City Postal code Country Position/Affiliation
Harpenden AL5 2DF United Kingdom Director
Role Name Email Phone Street address
Public Enquiries Callum Taylor Callum.Taylor@itad.com +44127391506 Preece House Davigdor Road
City Postal code Country Position/Affiliation
Hove BN3 1RE United Kingdom Consultant
Role Name Email Phone Street address
Scientific Enquiries Julie Hennegan julie.hennegan@burnet.edu.au +61406609020 85 Commercial Road
City Postal code Country Position/Affiliation
Melbourne Australia Senior Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified data used in peer-review publications will be shared using secure transfer upon reasonable request made to the research team for the purposes of reviewing or re-validating the findings published Informed Consent Form,Study Protocol Within 12 months of the study completion date Deidentified data used in peer-review publications will be shared using secure transfer upon reasonable request made to the research team for the purposes of reviewing or re-validating the findings published. Requests should be submitted to Callum.Taylor@itad.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.afd.fr/en/actualites/one-way-reduce-gender-inequality-menstruation-education No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information