Engaging adolescent boys in a gender-transformative programme to prevent unintended pregnancy and promote sexual health: Trialing the 'If I Were Thabo' intervention in South Africa and Lesotho
| ISRCTN | ISRCTN14738724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14738724 |
| Secondary identifying numbers | N20/09/101 |
- Submission date
- 10/03/2022
- Registration date
- 20/04/2022
- Last edited
- 01/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
'If I Were Thabo' is a gender-transformative sexual and reproductive health intervention for young adolescents that aims to promote safe sexual behaviour and prevent and unsafe sex, unplanned pregnancy, and STI/STD transmission. 'If I Were Thabo' uses a gender transformative approach that challenges harmful masculinities, gender norms, and power relations. It consists of group-based sessions (interactive video and other activities), materials for intervention facilitators to implement the sessions, and educational materials for parents/caregivers, which aim to support caregivers to engage in conversations about sexual and reproductive health with their children.
Who can participate?
Students will be recruited from a select group of schools in Khayelitsha, South Africa, and schools and community groups for out-of-school adolescents in Maseru, Lesotho.
What does the study involve?
Schools and community groups will be randomized to intervention or control conditions after baseline data collection. Follow-up data collection will occur postintervention and 9 months after the end of the intervention in both sites (counted from the last day of intervention delivery).
If I Were Thabo is a gender-transformative sexuality and relationships (SRE) intervention, adapted from a Queens University Belfast-developed programme called If I Were Jack. The If I Were Thabo programme is delivered over four sessions at schools or community groups with adolescents in the first year of high school (or of the same age, approximately 13-14 years old). The intervention is based around an interactive video drama which tells the story of Thabo, a teenager who has just found out that his girlfriend is unexpectedly pregnant. It also includes classroom materials to assist teachers in facilitating discussions around the issues raised in the interactive video drama, classroom-based activities for adolescents, homework activities for adolescents, and educational materials for parents.
What are the possible benefits and risks of participating?
Benefits may include reduced engagement in unprotected sex among intervention participants, and contribution to ongoing research about pregnancy prevention and gender-transformative approaches for adolescents in low- and middle-income country settings. There are minimal risks to participating in this intervention.
Where is the study run from?
Institute for Life Course Health Research (South Africa)
When is the study starting and how long is it expected to run for?
February 2021 to December 2023
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof Sarah Skeen, Stellenbosch University, skeen@sun.ac.za
Dr Áine Aventin, Queens University Belfast, a.aventin@qub.ac.uk
Contact information
Principal Investigator
4009 Education Building
Faculty of Medicine and Health Sciences
Stellenbosch University
Cape Town
7505
South Africa
 ORCID ID |
0000-0002-7464-2861 |
|---|---|
| Phone | +27 219389758 |
| skeen@sun.ac.za |
Study information
| Study design | Feasibility cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Feasibility trial of the 'If I Were Thabo' intervention in South Africa and Lesotho: Engaging adolescent boys in a gender-transformative programme to prevent unintended pregnancy and promote sexual health |
| Study acronym | THABO |
| Study hypothesis | Research questions: 1. Is the 'If I Were Thabo' intervention feasible to implement in i) secondary schools in SA, and ii) secondary schools and community groups in LE, and what refinements are suggested? 2. Is the 'If I Were Thabo' intervention acceptable to young adolescents, school staff, community facilitators and parents involved in implementation in i) secondary schools in SA, and ii) secondary schools and community groups in LE, and what refinements are suggested? 3. What are the optimal systems for delivering the intervention in educational and community settings, including selection, training, supervision and support for teachers/facilitators 4. What are the intervention participation rates? 5. What is the fidelity of intervention implementation? 6. What do qualitative data suggest in terms of intervention mechanisms and refinements to and the programme theory of change? 7. How do contextual factors appear to influence implementation of the intervention ? 8. What are the trial recruitment and retention rates? 9. Are the outcome and covariate measures understandable for and acceptable to young adolescents, and what refinements are suggested? 10. Are the outcome and covariate measures reliable and what refinements are suggested? 11. Are methods for economic evaluation in a definitive trial feasible? 12. Are any potential harms evident and how might these be reduced? 13. Based on the pilot RCT across eight schools and two community groups, is progression to a definitive trial justified in terms of pre-specified criteria? GREEN: process evaluation indicates that the intervention is acceptable to a majority of young adolescents, school and community facilitators involved in implementation, the intervention is implemented with fidelity in four out of five intervention sites, participant recruitment rate is >75%, participant retention rate is >80%, randomisation occurs and at least 5 of 6 schools accept randomization and continue within the study. AMBER: the intervention is acceptable to at least half of participants, participant recruitment rate is 50% to 75% OR follow-up data rate 60% to 79%. RED: not acceptable to participants, recruit <50% OR follow-up rate <60%. |
| Ethics approval(s) | 1. Approved 03/02/2021, Health Research Ethics Committee, Stellenbosch University (Education Building, Tygerberg Campus, Faculty of Medicine and Health Sciences, Francie van Zijl Drive, Tygerberg 7505, South Africa; +27 21 938 9819; afortuin@sun.ac.za), ref: N20/09/101 2. Approved 16/04/2021, Faculty of Medicine, Health and Life Sciences Research Ethics Committee (Queen’s University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, UK; no telephone number provided; facultyrecmhls@qub.ac.uk), ref: MHLS_20_151 3. Approved 27/04/2021, Ministry of Health, Research Ethics Committee (O Box 514, Maseru 100, South Africa; no telephone number provided; rcumoh@gmail.com), ref: ID215-2019 |
| Condition | Unprotected sex, unplanned pregnancy, STIs (including HIV) |
| Intervention | The trial will be implemented in Khayelitsha, South Africa (SA), and Maseru, Lesotho (LE). In SA the trial will take place in six schools, and in LE and the trial will take place in two schools and two community groups. Schools/community groups will be randomized to intervention or control groups and follow-up will occur postintervention and 9 months after the end of the intervention in both sites (counted from the last day of intervention delivery). In each country, a random-number generator will be used to randomize schools (SA), and 1 school and 1 community group (LE) to the intervention condition, and 3 schools (SA) and 1 school and 1 community group (LE) to control condition, after evaluating equivalency across a number of domains. Intervention group recipients in eligible classes/groups will receive the 'If I Were Thabo' intervention: a group-based gender-transformative sexual health intervention. The intervention targets adolescent boys (but includes girls) and addresses a gap relating to the successful engagement of boys in SRH initiatives in the region. It uses a gender transformative approach that challenges harmful masculinities, gender norms, and power relations, with the aim of promoting the SRH of boys and girls, and preventing unprotected sex, unintended adolescent pregnancy, and HIV and other sexually transmitted infections (STIs). It includes a) group-based sessions for adolescents during which an interactive video drama is played and other materials are delivered, b) materials for intervention facilitators to implement the sessions, and c) materials for parents/caregivers to support and encourage caregivers to engage in conversations about safe sex with their children. 'If I Were Thabo' will be delivered to students in Grade 8 in SA and Form A (or youth of the grade-corresponding age for community group members) in LE. The number of sessions over which the intervention will be delivered (either 4 or 6) will be subject to testing during the preparatory phase and finalized before baseline. Control group schools (SA) and schools and community groups (LE) will receive an abbreviated version of the intervention after the nine-month follow-up interviews are complete (waitlist control). There is one intervention arm, and one control arm. Randomization will happen at the level of clusters (schools and community groups), and will be done using an online random number generator. The intervention schools and community group will receive the If I Were Thabo intervention, which is a four-session relationships and sexuality education (RSE) programme. The intervention includes a video, class activities, homework assignments, and materials for parents and for teachers. Each of the four sessions is about fifty minutes long, but the exact length varies depending on specific school or community group constraints. Follow up will occur immediately (within 1 month) after the completion of the final intervention session, and again at 9 months after completion of the final intervention session. Control schools will follow care as usual, which is the South African and Lesotho government-mandated in-school SRE curriculum, or the community group equivalent. After the completion of the 9-month follow up data collection, control schools and the control community group will be given the If I Were Thabo materials, which they may then use in their classrooms and deliver to their students. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility outcome measures: 1. Process evaluation indicates that the intervention is acceptable to a majority of young adolescents, school and community facilitators involved in implementation 2. Process evaluation intervention is implemented with fidelity in four out of five intervention sites 3. Participant recruitment rate is >75% 4. Participant retention rate is >80% at 9 months post-intervention 5. Randomisation occurs and at least 5 of 6 schools accept randomization and continue within the study |
| Secondary outcome measures | All secondary outcome measures will be assessed at baseline, at post-intervention follow-up and at the 9-month follow-up. Post-intervention follow-up will occur immediately (within 1 month) after the completion of the final intervention session, and the 9-month follow-up at 9 months after completion of the final intervention session. 1. Knowledge and attitudes, as measured by participant-report study questionnaire at 9 months: 1.1. Knowledge about preventing unintended pregnancy 1.2. Gender equitable attitudes about responsibilities to prevent unintended pregnancy 1.3. Equitable attitudes about gender (Gender Equitable Men Scale) 1.4. Self-efficacy to prevent unintended pregnancy 2. Behaviours, as measured by participant-report questionnaire at 9 months : 2.1. Delayed initiation of sex 2.2. Use of contraception at first and/or last sex 2.3. Consistent correct use of contraception 2.4. Pregnancy 2.5. Incidence of STIs 2.6. Number of sexual partners 2.7. 'Sexual competence' at first sex (willingness, timing, use of contraception) |
| Overall study start date | 03/02/2021 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 240-360 in each country, subject to variability based on class size |
| Participant inclusion criteria | Young adolescents in South Africa and Lesotho (Grade 8 in SA, Form A in LE) |
| Participant exclusion criteria | Unable or unwilling to assent and/or participate |
| Recruitment start date | 01/02/2022 |
| Recruitment end date | 31/08/2022 |
Locations
Countries of recruitment
- Lesotho
- South Africa
Study participating centres
Faculty of Medicine and Health Sciences
Stellenbosch University
Cape Town
7505
South Africa
Care4Basotho Office Building
Maseru
682
Lesotho
Sponsor information
University/education
Francie Van Zijl Dr
Parow
Cape Town
7505
South Africa
| Phone | +27 219389111 |
|---|---|
| info@sun.ac.za | |
| Website | http://www.sun.ac.za/english/faculty/healthsciences |
"ROR" |
https://ror.org/05bk57929 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publications include a protocol paper, as well as description of the results of the feasibility trial in high-impact peer-reviewed journals; further ongoing dissemination efforts with partners (Stellenbosch University, Queens University Belfast, Ministries of Education in SA and LE) and their networks are also envisioned. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
01/06/2022: The secondary outcome measures have been updated to correct the omission of post-baseline timepoints, which was an error introduced by an ISRCTN editor. Therefore the previous incorrect version has not been made publicly visible.
31/03/2022: Trial's existence confirmed by Stellenbosch University.
