Plain English Summary
Background and study aims
The Goals for Girls study will assess the impact of two school-based health empowerment programmes on sexual and reproductive health (SRH), namely the SKILLZ Health for Girls Programme and the national government sponsored life-skills program (Life Orientation), amongst 14-17 year old adolescent girls attending secondary schools.
Grassroot Soccer is a well-established adolescent health organisation that runs programmes in 23 countries, including South Africa, that use sport as a platform to engage and retain adolescents in health education. Its SKILLZ Health for Girls (SKILLZ) programme consists of a tailored and comprehensive SRH curriculum delivered in interactive, after-school sport sessions. Grassroot Soccer has reported success in HIV prevention education interventions, however, it is as yet unknown how feasible it would be to integrate the SKILLZ programme with other classroom-based, government-led SRH curricula in South Africa.
Who can participate?
Females who are a registered learner in grade 8-10 (approximately aged 14-19 years) at a participating school.
What does the study involve?
Goals for Girls will randomise forty schools 1:1 to receive the SKILLZ intervention or continue with the national curriculum alone. At baseline and post-intervention, learner attitudes and sexual risk behaviour, as well as key sexual and reproductive health indicators (pregnancy, sexually transmitted infections, HIV, and body mass index), will be measured. Sports activities consist predominantly of soccer-activities but include alternative physical exercises. Engaging, sport-based sexual health, HIV and life skills curriculum delivered in 10 sessions by trained “Caring Coaches” (age 20-30 years) over a 6 month period (2 school terms).
What are the possible benefits and risks of participating?
Participants stand to benefit in the short and long term from the sexual health and related information learnt in this study. All the health tests conducted in the study will be free and theri time will be compensated with a R25 food voucher at each study visit (baseline and 8 months). While we do not think this study poses any threat to the participants physical or emotional wellbeing, it is possible that information they discuss during the SKILLZ sessions may not be kept confidential amongst their peers. For this reason, they could suffer loss of privacy or be stigmatised in some way due to their participation. The study team will provide support and referral where appropriate for any difficulties participants may incur whist participating in the study. If medical care is required that we are unable to provide, we will refer participants to the appropriate services or organizations that can provide support. Some of the questions in the survey or health screening are of a sensitive nature and therefore have the potential cause distress. Support staff are aware of this potential and will be on hand to assist and refer to additional services if needed.
Where is the study run from?
Desmond Tutu HIV Foundation (South Africa)
When is the study starting and how long is it expected to run for?
May 2018 to December 2019
Who is funding the study?
ViiV Healthcare (USA)
Who is the main contact?
Carey Pike, Carey.Pike@hiv-research.org.za
Prof. Linda-Gail Bekker, Linda-Gail.Bekker@hiv-research.org.za
Trial website
Contact information
Type
Scientific
Primary contact
Miss Carey Pike
ORCID ID
Contact details
Desmond Tutu HIV Foundation
IDM
Level 1
Werner & Beit Building
UCT North
Faculty of Health Sciences
Anzio Rd
Observatory
7925
South Africa
+27 (0)216501933
Carey.Pike@hiv-research.org.za
Type
Scientific
Additional contact
Prof Linda-Gail Bekker
ORCID ID
https://orcid.org/0000-0002-0755-4386
Contact details
Desmond Tutu HIV Foundation
IDM
Level 1
Werner & Beit Building
UCT North
Faculty of Health Sciences
Anzio Rd
Observatory
7925
South Africa
+27 (0)214066970
Linda-Gail.Bekker@hiv-research.org.za
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
HREC 138/2018
Study information
Scientific title
Goals for Girls: A cluster randomized trial to evaluate the feasibility, acceptability and impact of integrating an in-school sexual and reproductive health (SRH) education programme with an after-school sports-based programme amongst adolescent female learners
Acronym
Study hypothesis
1. The integrated SKILLZ programme will be more effective in achieving the project objectives than the national programme alone
2. The integrated model is predicated to be acceptable amongst adolescents in this setting and that those who participate in the integrated model will have lower rates of STI prevalence and pregnancy incidence
3. Those in the integrated model may show reduced school absenteeism
4. The incidence of HIV in this age group will be too low to demonstrate a significant reduction
Ethics approval
Approved 20/04/2018, The Faculty of Health Science's Human Research Ethics Committee at the University of Cape Town (G50, Old Main Building, Groote Schuur Hospital, Observatory, 7925; +27 (0)21 650 1236; hrec-enquiries@uct.ac.za), ref: 138/2015
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Adolescent sexual and reproductive health
Intervention
The SKILLZ programme provides an enhanced sport-focused curriculum, framed as after-school sport lessons. Sports activities consist predominantly of soccer-activities but include alternative physical exercises. Engaging, sport-based sexual health, HIV and life skills curriculum delivered in 10 sessions by trained “Caring Coaches” (age 20-30 years) over a 6 month period (2 school terms). The sessions culminate in graduation, where participants who have attended seven or more sessions are considered to have received a sufficient “dose” to have an impact.
The curriculum is integrated with the national curriculum because it was designed to complement that subject matter rather than duplicate it.
Participants in control schools will receive the national curriculum as normal.
The school was the unit of randomisation. A list of all eligible secondary schools in the study area (the Klipfontein/Mitchells Plain Health Sub-district) was constructed. School names were printed, sealed, and picked at random for allocation to the control and intervention arms. Schools were later allocated to cohort 1 (year 1) or cohort 2 (year 2) to conduct the study via geographical location: intervention and control schools in the Metro South district were allocated to cohort 1, while intervention and control schools in the Metro Central district were allocated to cohort 2.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Prevalence of sexually transmitted diseases (Chlamydia trachomatis and Neisseria gonorrhoea) testing was conducted at baseline and 8 months, with samples collected using a self-administered vaginal swab, and the test carried out using a GeneXpert machine (samples sent for laboratory testing)
2. Incidence of pregnancy at baseline and 8 months using a standard urine test
3. Incidence of HIV at baseline and 8 months (final study visit, post-intervention) using a nurse-administered HIV rapid test
Secondary outcome measures
1. Body mass index was measured at baseline and 8 months using a BMI scale
2. A health screening questionnaire, which included questions related to sexual health history and sexual risk behaviour, was administered by a study nurse or counsellor at baseline and 8 months in conjunction with the biomedical tests
3. A sociobehavioural questionnaire, which included questions related to socioeconomic status, family support, and attitudinal questions related to gender, self-esteem, body perception, and sexual risk behaviour, was self-administered at baseline and 8 months
4. Attendance at intervention sessions was recorded per session
5. School attendance records for enrolled participants were collected from participating schools for a three-term (9 month) period
6. A post-intervention survey, which included questions on the quality of the session, the perception of the coach, session likes and dislikes, and ease of access to sessions, was self-administered at the final study visit to participants in the intervention arm
7. Participants and school staff who took place in the qualitative research took part in focus group discussions and in-depth interviews where the conversations were recorded, translated and transcribed
8. A registration form administered at baseline was completed by all participants. This form collects information related to basic demographics (date of birth, race, home address, contact details, next of kin) and permissions for contact (home visit, phone call, SMS).
9. The informed consent form was administered to all participants by a dedicated research staff member. Signed copies were retained by both parties
Overall trial start date
01/01/2018
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female
2. A registered learner in grade 8-10 (approximately aged 14-19 years) at a participating school
3. Not pregnant at baseline
Participant type
Healthy volunteer
Age group
Other
Gender
Female
Target number of participants
2800 participants across 40 schools (70 participants per school, 20 schools per arm)
Participant exclusion criteria
1. Not attending or having dropped out of the participating school
2. Grade 12 (final year) learners
Recruitment start date
16/05/2018
Recruitment end date
01/07/2018
Locations
Countries of recruitment
South Africa
Trial participating centre
Desmond Tutu HIV Foundation
IDM
Level 1
Werner & Beit Building
UCT North
Faculty of Health Sciences
Anzio Rd
Cape Town
7925
South Africa
Sponsor information
Organisation
Desmond Tutu HIV Foundation
Sponsor details
IDM
Level 1
Werner & Beit Buiding
UCT North
Faculty of Health Sciences
Anzio Rd.
Observatory
7925
South Africa
+27 21 650 1933
Linda-Gail.Bekker@hiv-research.org.za
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
ViiV Healthcare
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results of this evaluation will be shared with the relevant Ministries and used to guide South Africa’s national strategic plan for improved uptake and retention of services by adolescents. We are working closely with the Western Cape Departments of health and education to pave the way for successful adolescent interventions. Our team will work closely with the Minister of Health (MOH) and Minister of Education (MOE) throughout study implementation to ensure that services are integrated, streamlined and sustainable. The National Department of Health and the Office of the President launched the “She Conquers” Campaign in 2016, as a pledge to reducing the impact of HIV among SA youth. As such, the national government is very keen to see evidence of successful interventions in this age group. Our study is a pragmatic trial with implementation and evaluation in a real-world setting. Hence, our results will have strong external validity and applicability to other sub-Saharan countries with a similar sociodemographic and epidemic profiles. Study results will in addition be disseminated to teachers, parents, and learners of participant schools through written reports and a dissemination event. Study results will be published in peer reviewed journals, including the primary paper, an implementation review paper, and paper detailing results from the participatory qualitative research.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Data requests can be sent to: Carey Pike, Carey.Pike@hiv-research.org.za
Data type: Annoymised, delinked datasets pertaining to the sociobehavioural questionaire responses and the health screening outcomes.
Data availability: Data will be made available to qualified investigators within 6 months of acceptance of the manuscripts describing major findings, for a 5 year period. Investigators who request to use the datasets will be required to have ethical approval (as necessary) and a data use agreement in place prior to any data being released to them. The team of investigators and partners involved in this study will discuss any data request and agree access prior to that being granted. Our collective aim is for data sharing and requests will not be unreasonably withheld. In the event that the investigator team disagree on whether to grant access, independent, external mediation will proceed in accordance with Desmond Tutu HIV Foundation and University of Cape Town guidance.
Intention to publish date
01/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list