2 Young Lives: mentoring teenagers for safer pregnancy and birth in Sierra Leone
| ISRCTN | ISRCTN32414369 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32414369 |
| Secondary identifying numbers | HR/DP-21/22-26320 |
- Submission date
- 10/03/2022
- Registration date
- 14/03/2022
- Last edited
- 24/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Sierra Leone has one of the highest death rates in young girls and their infants, and they usually die because of complications during pregnancy and childbirth. Young girls are particularly vulnerable and many times belong to disadvantaged communities, usually driven by poverty and lack of education and employment opportunities. Many factors such as stigma, abandonment and neglect lead to a low update of life-saving antenatal care or birth at facilities or with trained staff. In 2017, a community-based mentoring scheme for adolescent girls was developed locally and piloted in a few areas. The preliminary data looks promising. The aims of this study are to assess the feasibility and implementation of the 2 Young Lives mentoring scheme for young girls and to inform trial procedures for a subsequent full trial.
Who can participate?
Pregnant adolescent girls under 18 years old, family members or friends, mentors, staff, and community stakeholders from participating areas
What does the study involve?
Twelve participating areas in Sierra Leone are randomly allocated to the intervention group or the control group. The control group receive standard maternity care, and the intervention group are offered a mentoring scheme in addition to standard maternity care. The mentoring scheme is a locally-designed intervention that provides mentoring from pregnancy through to 1 year after birth for women aged under 18 years. Overall, this encourages mentees to take up antenatal care and hospital birth, re-establish family connections where this is safe and appropriate, promotes health-seeking behaviour, provides practical advice about childbirth, parenting and contraception, and supports mentees to return to education or start vocational training.
What are the possible benefits and risks of participating?
The study will help to find out the best way of running the mentoring scheme so it can be tested out on a larger scale to improve the lives of young women and their babies. Participating in interviews, focus groups discussions or the photovoice project will help the researchers to better understand adolescent girls' everyday lives and their experiences of pregnancy, motherhood and the mentoring scheme. Some girls may find talking about their experiences helpful, or they may find it upsetting, and if they are upset and want someone to talk to, the team will help them to find someone.
Where is the study run from?
This study is running in communities in Sierra Leone and is being sponsored by King’s College London (UK)
When is the study starting and how long is it expected to run for?
September 2021 to June 2024
Who is funding the study?
National Institute for Health Research (NIHR) Global Health Research Group (CRIBS) (UK)
Who is the main contact?
1. Dr Cristina Fernandez Turienzo, cristina.fernandez_turienzo@kcl.ac.uk
2. Mrs Lucy November, lucy.november@kcl.ac.uk
3. Mrs Mangenda Kamara, mangenda@welbodipartnership.org
Contact information
Scientific
King's College London
Department of Women and Children's Health
Faculty of Life Sciences and Medicine
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Phone | +44 (0) 207 188 3637 |
|---|---|
| cristina.fernandez_turienzo@kcl.ac.uk |
Scientific
King's College London
Department of Women and Children's Health
Faculty of Life Sciences and Medicine
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Phone | +44 (0)207 188 3637 |
|---|---|
| lucy.november@kcl.ac.uk |
Scientific
Welbodi Partnership
Freetown
-
Sierra Leone
| Phone | +232 (0)79 355372 |
|---|---|
| mangenda@welbodipartnership.org |
Study information
| Study design | Cluster interventional unblinded randomized controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Please use contact details to request a participant information sheet |
| Scientific title | Feasibility and implementation of '2 Young Lives', a mentoring scheme from pregnancy through to 1-year post-birth for adolescent girls n Sierra Leone |
| Study acronym | 2 Young Lives |
| Study objectives | Implementation of a community-based mentoring scheme for adolescent girls is feasible, acceptable and can inform trial procedures for a subsequent fully powered cluster randomised controlled trial (RCT). |
| Ethics approval(s) | 1. Approved 04/02/2022, King's College London Ethics Committee (Franklin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Road, London, SE1 9NH, UK; +44 (0)20 7848 4020/4077; rec@kcl.ac.uk), ref: HR/DP-21/22-26320 2. Approved 22/02/2022, Sierra Leone Ethics and Scientific Review Committee (Government of Sierra Leone. Office for the Sierra Leone Ethics and Scientific Review Committee, Directorate of Training and Research, 5th floor, Youyi Building Brookfields, Freetown, Ministry of Health and Sanitation, Sierra Leone; +232 (0)78 36 64 93; efoday@mohs.gov.sl), ref: not applicable |
| Health condition(s) or problem(s) studied | Reduction of mortality among pregnant adolescent girls and their infants |
| Intervention | The allocation ratio of the intervention will be 1:1. Randomisation will be managed via a secure web-based randomisation facility hosted by Medscinet which will with the randomisation programme and hold the allocation code. Intervention: mentoring scheme + standard maternity care in Sierra Leone (see below details of standard maternity care) 1. Recruitment and training of mentors 2. Weekly 1:1 between mentor + mentee 3. Accompaniment for antenatal and birth care, or emergency care if required 4. Reminders to attend appointments 5. Health education and promotion 6. Flexible support with postnatal care and baby care 7. Support to consider small business options and accompaniment to purchase the first supply of goods 8. Advocacy for girls and with families (if safe + appropriate) 9. Encourage staying in/returning to school/starting vocational training 10. Workshop with teachers in schools (radical inclusion policy) 11. Monthly meetings with all mentors and mentees, cook and eat, peer support, and visitors (e. g. health discussion with midwife, community leaders) 12. Graduation celebration at the end of the mentoring scheme The mentoring intervention is provided from pregnancy through to 1 year after birth. Control: standard maternity care in Sierra Leone Usual maternity care in Sierra Leone (e.g. eight antenatal checks, screening for HIV, Hep B, Intermittent preventive treatment (IPT) against malaria, free insecticide-treated bednet (ITN) at the first antenatal visit, deworming meds, tetanus toxoid immunisations, birth with a skilled birth attendant in a health facility, post-birth observation for 24 hours, baby immunisations, postnatal check, free contraception etc). Semi-structured interviews, focus groups discussions and a photovoice project will be conducted at 6 and 9-12 months after intervention implementation. |
| Intervention type | Mixed |
| Primary outcome measure | Current feasibility outcome measures as of 17/11/2022: 1. The number of participants identified, recruited and retained, measured using routinely collected data at pregnancy, at birth, at 6 weeks, and 1 year after birth 2. The number of participants ineligible or withdrawing from the study, and data collection and completion of outcome measures, measured using routinely collected data at pregnancy, birth, 6 and 1 year after birth 3. Selection of most appropriate primary outcome measure and sample size calculation, measured at pregnancy, birth, and 6 weeks after birth Previous feasibility outcome measures: The feasibility of a future definitive trial assessed using: 1. The number of participants identified, recruited and retained, as measured using routinely collected data at pregnancy, at birth, at 6 weeks, and 1 year after birth 2. The acceptability and experience of the trial process including ineligibility or withdrawal from the study, randomisation, rolling programme, and data completion of outcome measures, measured using routinely collected data, interviews, focus groups and report forms monthly, at 6, 9-12 months after birth 3. The performance of the selected primary outcome in relation to the level of acceptability and relevance, measured using focus groups, interviews and report forms monthly, at 6, 9-12 months 4. Data completeness at follow up, variance of the likely primary outcome and variability of intervention across individuals and sites, measured using routinely collected data, report forms, interviews and focus groups at 6 weeks, monthly, 6, 9-12 months Primary clinical outcome measures: The primary clinical outcome is a composite of: 1. Maternal death (all-cause, occurring during pregnancy, labour, or within 42 days of birth), measured using routinely collected data following birth and 6 weeks after birth 2. Stillbirth (born with no signs of life at or after 28 weeks of pregnancy, but before or during birth), measured using routinely collected data following birth 3. Neonatal death (deaths among live births during the first 28 days), measured using routinely collected data following birth and 6 weeks after birth |
| Secondary outcome measures | Secondary outcome measures: 1. Maternal outcomes measures including i.e. IPT for malaria, number of tetanus toxoid immunisations, caesarean sections, birth at facility, postpartum haemorrage, place of birth, presence of birth attendant, measured using routinely collected data following birth; and contraception uptake measured using routinely collected data and interviews at 6 weeks, 9-12 months after birth; recurrent pregnancy measured using interviews at 9-12 months after birth. 2. Perinatal outcomes measures including birthweight, Apgar score at 5 minutes, newborn resuscitation, breastfeeding, Kangaroo mother care, admission to neonatal unit, measured using routinely collected data following birth; postnatal immunisation uptake measured using routinely collected data at 6 weeks after birth; and 1-year infant death measured using routinely collected data at 1 year after birth 3. Process and implementation outcomes measures including: 3.1. Antenatal checks, antenatal checks with blood pressure measurement, referrals, postnatal check, measured using routinely collected data following birth and 6 weeks after birth 3.2. Acceptability/satisfaction with the intervention among girls, mentors, healthcare providers and local stakeholders, measured using routinely collected data, interviews and focus groups at 6, 9-12 months 3.3. Reach/number of participating girls when compared to the site population included, measured using routinely collected data at 9-12 months 3.4. Adoption/engagement and uptake of the mentoring scheme, measured using routinely collected data, interviews, and focus groups monthly, 6, 9-12 months 3.5. Fidelity/intervention implemented as intended i.e. number of mentors and team coordinators recruited, number of trainings and workshops, weekly 1:1 meetings, monthly social gatherings, women being accompanied by mentees to register for antenatal care, during labour and to purchase first supply of goods; number of visits from mentor to mentee’s family, measured using routinely collected data, report forms, interviews, and focus groups monthly, 6, 9-12 months 4. Adolescent girls’ experiences by exploring their views and perspectives on the mentoring, maternity care, thriving, economic, social progress/wellbeing, and potential mechanisms of change, measured using interviews, photovoice at 9-12 months 5. The feasibility of measuring resource use and costs benefits associated with the mentoring scheme measured using cost-consequence analysis at pregnancy, at birth, at 6 weeks, and 1 year after birth |
| Overall study start date | 01/09/2021 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Upper age limit | 18 Years |
| Sex | Female |
| Target number of participants | 12 clusters |
| Total final enrolment | 673 |
| Key inclusion criteria | Pregnant adolescent girls under 18 years old |
| Key exclusion criteria | Pregnant women older than 18 years old |
| Date of first enrolment | 04/07/2022 |
| Date of final enrolment | 30/11/2023 |
Locations
Countries of recruitment
- Sierra Leone
Study participating centres
Bonthe District
-
Sierra Leone
Moyamba District
-
Sierra Leone
Moyamba District
-
Sierra Leone
Sierra Leone
-
Sierra Leone
Bonthe District
-
Sierra Leone
-
Sierra Leone
-
Sierra Leone
-
Sierra Leone
-
Sierra Leone
-
Sierra Leone
-
Sierra Leone
Sponsor information
University/education
8th Floor, Melbourne House
44-46 Aldwych
London
WC2B 4LL
England
United Kingdom
| Phone | +44 (0)20 7848 3224 |
|---|---|
| EA-VPResearch@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 15/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals and presentations at conferences and seminars. |
| IPD sharing plan | Fully anonymised participant-level quantitative data may be available upon reasonable request and approval. Participants in the qualitative interviews and focus groups discussions are not consenting for their data to be shared publicly or be released to anyone other than the research team and regulatory bodies auditing research practice. Given the very sensitive nature of some topics and the small setting, assurances regarding participant privacy and confidentiality are crucial to meaningful data collection. For inquiries regarding or requests for the data, please contact Mrs Lucy November (lucy.november@kcl.ac.uk) or Dr Cristina Fernandez Turienzo (cristina.fernandez_turienzo@kcl.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 25/03/2024 | 26/03/2024 | Yes | No | |
| Results article | primary analysis | 18/06/2025 | 24/06/2025 | Yes | No |
Editorial Notes
24/06/2025: A publication reference was added, and 673 participants were added to the total final enrolment.
26/03/2024: Publication reference added.
17/11/2022: The primary outcome measures were updated.
06/07/2022: Internal review.
05/07/2022: The recruitment start date was changed from 25/05/2022 to 04/07/2022.
11/03/2022: Trial's existence confirmed by Kings College London and Sierra Leone Ethics and Scientific Review Committee.
