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.: PACTR202209524746573 Date of Approval: 20/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Men for Periods; assessing the effectiveness of using male champions in enhancing better menstrual hygiene management among adolescent girls and young women in Mombasa County.
Official scientific title Men for Periods; assessing the effectiveness of using male champions in enhancing better menstrual hygiene management among adolescent girls and young women in Mombasa County.
Brief summary describing the background and objectives of the trial In Kenya, inequitable gender dynamics become pronounced during puberty and leave girls and young women unable to negotiate access to vital health care services and products. This in greater length limits full potential to achieve the ambitious universal health coverage (UHC) goals in our country. Menstruation is considered unclean or dirty in many societies. Taboos, myths, and restrictions associated with menstruation leave a negative impact on adolescent girls. Formative research shows that girls face monthly challenges, with 65% of women and girls unable to afford sanitary pads, only 50% of girls discuss menstruation at home and just 12% are comfortable receiving information from their mother, hence pushing 2 out of 3 of pad users in rural Kenya to transactional sex, receiving them from sexual partners. This leads to new HIV infections among adolescent girl and young women, hence the need to have Men for periods project to bridge the gap. General objective: The main objective is to evaluate the effectiveness of using male champions in enhancing better Menstrual Hygiene Management (MHM) among adolescent girls and young women to reduce incidence of sex for pads thereby reducing acquisition and transmission rates of HIV and other STIs. Specific objectives: 1. To determine the proportion of adolescent girls and young women engaged in transactional sex to acquire money for sanitary pads. 2. To evaluate the effectiveness of male champions in reducing the incidence of sex for pads and stigma around Menstrual Hygiene among adolescent girls And young women 3. To determine the acceptability and feasibility of male champions in enhancing MHM, to inform future scale-up.”
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Sexually transmited infections
Purpose of the trial Enhancing better menstrual hygiene management among adolescent girls and young women in Mombasa County
Anticipated trial start date 01/02/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date 30/11/2022
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 725 Kenya Medical Research Institute - Scientific Ethics Review Unit
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Not Applicable Not Applicable 6 months Men for Periods study project will employ a randomized control trial design in assessing the effectiveness of using male champions in enhancing better Menstrual Hygiene Management (MHM) among adolescent girls in Mombasa County. Approximately 10 MHM champions will be enrolled in the study; 5 males and 5 females. The study team will then conduct a household census mapping approximately 300 households within the study area and a list of names of households identified will be prepared. The 300 households captured on the list will be randomly selected to 4 study groups; intervention arm one, control arm one, Intervention arm two and control arm two. Under control arms one; AGYW in households will not be sensitized by male champions. Under control arm two; AGYW will not be sensitized by female champions. 150 Uncontrolled
Experimental Group Not applicable Not applicable 6 months Men for Periods study project will employ a randomized control trial design in assessing the effectiveness of using male champions in enhancing better Menstrual Hygiene Management (MHM) among adolescent girls in Mombasa County. Approximately 10 MHM champions will be enrolled in the study; 5 males and 5 females. The study team will then conduct a household census mapping approximately 300 households within the study area and a list of names of households identified will be prepared. The 300 households captured on the list will be randomly selected to 4 study groups; intervention arm one, control arm one, Intervention arm two and control arm two. Under intervention arm one; Adolescent girls and young women (AGYW) will be sensitized by male champions Under intervention arm two; Adolescent girls and young women (AGYW) will be sensitized by female champions The champions will conduct home visits where they will speak to the adolescent girl and/ or young woman on issues around MHM and their experiences and train the household on MHM. For the AGYW, the session will be carried out within the household at an area convenient for them to ensure privacy and confidentiality. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. AGYW aged 12 to 24 years. b. Adolescent girls who have ever experienced menstruation c. Young women who are willing and capable of giving their consent to participate in the study d. Parents/ guardians who are willing and capable of giving parental consent for the adolescent girl’s participation in the study. e. AGYW who will reside in the study site during the study period. a. AGYW below 12 years and those above 24 years of age. b. Adolescent girls who have never experienced menstruation c. AGYW who are not willing and capable of giving their consent to participate in the study d. Parents/ guardians who are not willing and capable of giving parental consent for the adolescent girl’s participation in the study. e. AGYW who will not reside in the study site during the study period Adult: 19 Year-44 Year,Child: 6 Year-12 Year 12 Year(s) 24 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 04/06/2021 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Raila Odinga way Nairobi 00200 Kenya
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 26/08/2021 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way, Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved Menstrual Hygiene management among adolescent girls and young women. This will be assessed by a three-way comparison of data in the study groups: i) Proportion of adolescent girls reporting improved Menstrual Hygiene Management in intervention arm one compared to control arm one, ii) Proportion of adolescent girls reporting increased household support on MHM in intervention arm two compared to control arm two, and iii) Proportion of adolescent girls reporting increased household support on MHM between intervention arm one compared to intervention arm two. At endline month 6
Secondary Outcome 1. Reception of the intervention by the targeted population. This will be assessed by looking at the propotionparticipants screened for enrolment and those who are enrolled in the study. 2. Reduced incidence of sex for pads and stigma around Menstrual Hygiene among adolescent girls and young women. This will be assessed by a three-way comparison of data in the study groups: i) Proportion of adolescent girls reporting increased household support on MHM and not having sex for pads in intervention arm one compared to control arm one, ii) Proportion of adolescent girls reporting increased household support on MHM and not having sex for pads in intervention arm two compared to control arm two, and iii) Proportion of adolescent girls reporting increased household support on MHM and not having sex for pads between intervention arm one compared to intervention arm two. 3. Identification of the barriers and facilitators of implementing the intervention. This will be collected from the champions and adolescent girls reached with the intervention. Acceptability of the intervention at baseline month 1, Effectiveness of the intervention at endline month 6 and Feasibility of the intervention at endline month 6.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mombasa County Jomvu and Changamwe Mombasa 80102 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle, WA98102, USA Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Impact Research and Development Organization Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway Kisumu Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator James Atito amesatito@gmail.com 0718385457 Changamwe-Mombasa.
City Postal code Country Position/Affiliation
Mombasa 80102 Kenya Stretchers Youth Organization
Role Name Email Phone Street address
Public Enquiries Kawango Agot kawango@impact-rdo.org +254736505046 Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo@kemri.go.ke +254724993118 Rail way
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Kenya Medical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are committed to public dissemination of results of the study to participants, local stakeholders in Kenya, the global scientific community and global policymakers. Dissemination of study results will follow principles of good participatory practice. Results will be published in conference abstracts and peer-reviewed journals. Study results will be disseminated through presentations to the relevant stakeholders. Statistical Analysis Plan,Study Protocol One year Upon completion of study analysis, the final dataset will be striped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Results from research conducted under this project will be shared in several ways. • Manuscripts will be submitted for publication in high-quality peer-reviewed journals • The MPI and Co-Investigator will also disseminate results from this research through presentations at public lectures, scientific institutions and meetings, as well as to the community in which the research took place as detailed in the enclosed
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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