+ Attendance at, and interim effects of the PREPARE intervention, Cape Town Cape Town team Maastricht team Leif Aarø

+ Overview Background PREPARE aims and objectives Intervention: After-school program Study Design Attendance at intervention: Which participants were exposed to the intervention? Effects at first follow-up? ITT analysis Effects among participants with differing levels of intervention exposure?

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+ Why was SATZ intervention not effective in Cape Town? SATZ was solely curriculum based, competing against a good curriculum, and did not change the school environment SATZ was implemented by teachers: We question whether it was implemented with fidelity. SATZ did not provide condoms or increase access to sexual and reproductive health (SRH services SATZ did not adequately address sexual violence and IPV; We know IPV increases risk of HIV incidence through influencing sexual behaviour.

+ PREPARE aim and objectives AIM To develop, implement and evaluate interventions to reduce sexual risk behavior and intimate partner violence (IPV) among young adolescents PRIMARY OBJECTIVES/OUTCOMES Postponing sexual debut Condom use SECONDARY OBJECTIVES/OUTCOMES Number of sexual partners IPV Three year incidence of conceptions among female participants.

+ PREPARE Intervention 1. Educational component: After-school program of 21 educational sessions with focus on relationships: HIV, IPV and sexual violence 2. School environment component focusing on students, teachers and parents: School safety program to reduce acceptability and prevalence of IPV and sexual violence, and to change norms 3. School health service to increase access to SRH and mental health services, designed to be compatible with current approaches and polices

+ Educational sessions: after-school “club” One hour after school for 18 weeks; interactive delivery Young, dynamic, trained facilitators employed and mentored and monitored closely by PREPARE Sessions focus on relationships, developed through formative research and piloting Mapped on to the LO curriculum Certificates, gifts; Loyalty Card; Snacks to motivate Compatible with “MOD Centre” approach

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+ School safety program Aims for an environment free of sexual violence and IPV Uses principles of community development We involved school safety teams: principal, safety officer, SGB rep, parent, police officer Trained by Centre for Justice and Crime Prevention (17/20 schools participated) Sexual violence and the law Participatory safety audits Participatory safety plans Involves students and parents in a Photovoice project

+ Photovoice 1) Group discussions 3) Caption writing (VOICE) 2) Picture taking (PHOTO) 4) Forum meeting presentation

+ School Health Service Aims to increase access to sexual, reproductive and mental health Package of care modeled on ISHP: screening, health education, and referral to local PHC services (no condoms, HIV testing, STI treatment) Collaboration with City and Provincial DoH, WCED and Desmond Tutu HIV Foundation Nurses (and health promoter) visit the school once a week and provide a “health check” for each PREPARE participant Trained to detect violence and abuse and respond

+ Study Design Cluster RCT 42 Western Cape High Schools (20 intervention) Grade 8 students (75 – 100 per school) Primary outcomes measured in questionnaires at baseline, 6 and 12 months. Questionnaires were done in school hours. Data from individual participants is linked over time, In intervention schools participant data is linked to their intervention attendance records Review of cental records of births and terminations for 3 year incidence of conceptions

+ Students’ responses to the survey “Thank you MRC of South Africa for helping me be open to myself during this questionnaire.” “It makes me think twice about the things I done in my life. It will help me understand life more.” “Ewe, thank you to this project because now I feel happy when I share everything bad that I have been through to me.”

+ Baseline survey response rate Response rate: 3455/6244 (55%) Parental refusals 69/6224 (1%) FemalesMales Median age13 years 14 years Sexual debut8%26%

+ Follow-up surveys: response rates 1st follow-up: 3314/3455 (96% of learners who were surveyed at baseline) 2nd follow-up: 3054/3455 (88.4% of learners who were surveyed at baseline).

+ Accessibility of after-school intervention? Will students attend after-school SRH intervention (educational sessions and SHS)? Can we recruit and retain adolescents who are vulnerable to adverse SRH outcomes? In these analyses, vulnerable adolescents were : those who at baseline had had sexual debut those who had been exposed to IPV and sexual violence We also investigated whether mental health (as measured with SDQ), and school climate were associated with attendance

+ Methods Facilitators kept attendance registers at every after-school session Nurses kept records of every participant who visited the SHS We linked participant baseline survey data with their attendance at education sessions and SHS Bivariate and multiple Poisson regression analyses were used to assess which factors were associated with attendance rate at educational sessions Bivariate and multiple logistic regression analyses were used to assess which factors were associated with having visited SHS

+ Attendance at 21 educational sessions

+ Participant attendance of PREPARE educational sessions In 18/20 intervention schools we implemented all 21 after- school educational sessions participants were in the 18 schools and are included in these analyses Mean attendance at after-school sessions: 8.0 sessions FemalesMales Mean attendance8.8 sessions6.9 sessions >/= 5 sess.59.2%48.8% >/= 10 sess.43.6%32.9% >/= 15 sess.30.6%21.9%

+ Attendance of educational sessions by vulnerable adolescents Attendance rates Even had sex*Yes6.3 No8.5 Sexual violence vict*Yes7.0 No8.6 IPV victim*Yes6.5 No8.2 IPV perpetrator*Yes5.2 No8.3

+ Factors associated with rate of attendance of educational sessions: multivariate analysis (Table 2 ) Higher rate of attendance Gender: being female Being bullied in past 6 months Scoring higher on the school connectedness scale Scoring higher on the SDQ prosocial scale Lower rate of attendance: Age: older students Having ever had sex School performance: those who had ever repeated a year Delinquency: those who reported more frequent fighting, stealing or vandalism in past three months Being a perpetrator of IPV

+ Attendance at the school health service (SHS)

+ Attendance of school health service 17.3% of participants in 18 schools visited the school nurse (14.9% of males and 18.7% of females) Attended SHS (%) Had had sexYes14.3% No18.2% Sexual violence victYes16.9% No17.3% IPV victimYes19.0% No17.1% IPV perpetratorYes15.4% No17.7%

+ Attendance at school health service: multivariate analysis (Table 3) Factors associated with attendance: Gender: being female Having been bullied in past 6 months Scoring higher on the condom knowledge scale

+ Summary: attendance at after- school intervention Adolescent girls had a higher rate of attendance at educational sessions and SHS Adolescents who had had “early” sexual debut had a lower rate of attendance at education sessions, but they were no less likely to visit the SHS Adolescents with higher prosocial scores had a higher rate of attendance of education sessions but were no more/less likely to visit the SHS. Adolescents who felt more “school connectedness” had a higher rate of attendance at educational sessions but were no more or less likely to visit the SHS. Magnitude of rate differences: not very large

+ Reasons for non-attendance of after-school sessions? Our observations Transport and ensuring safe means of travel Social pressures: if friend group not attending Uncool to be enthusiastic: need visible encouragement Competing activities including homework Change over of facilitators (Dis) Organisational environment of the school School ownership of and commitment to intervention Facilitator even 1 minute late: don’t trust it will happen

+ Reasons for attendance in participants’ words I wanted to be protected if something happened My parents said I had to go/ My mother forced me People told us it was interesting I wanted to share my feelings/It helps you to talk and feel free all the time/Helped me to feel relieved and tell the truth/ Makes me feel better I wanted to be honest: no-one here to open up to I want the people to learn more about me Just to have fun It tells me things/ You learn more about the future

+ Reasons for non-attendance: participants’ words I have to get home and I don’t like it Going after my friends Not enough time I had school work to do Scary to walk back alone after school/ the bus would leave me I was just shy It was too long for me The learners were badly behaved/ The people in school like to bully I just did not feel so

+ IMPACT AT FIRST FOLLOW-UP (6- Months post-baseline)

+ Interim evaluation: Objectives and methods Are there changes in theoretical mediators and behaviours 6 months post-baseline: intention to treat analysis (ITT) Is there a dose-response? We compared control group to: “Exposed”, ie attended at least 1 session “Highly exposed”, ie attended >10 sessions) Intervention effects were assessed with linear and logistic regressions (adjusted for clustering) with the outcome as dependent variable, study arm as factor, and baseline score, gender and age as covariates.

+ See Results Table

+ Theoretical MediatorsITT>/=1>10 Knowledge condoms+++ Knowledge HIV/AIDS+++ Attitudes condoms (pros)ns Attitudes condoms (cons)ns + Attitudes delay sex (pros)ns++ Attitudes delay sex (cons)ns++ Social norms condomsns Social norms delaying sexns Self efficacy condomsns Self efficacy delaying sexns Action planning condomsns + Action planning delaying sexns Intentions to have sexns Intentions to use condomsns

+ Summary: theoretical mediators for sexual risk behaviour Substantial improvements in knowledge (ITT) Eg Condom knowledge: Control 28% to 29%; Intervention 29% to 37% (43% in highly exposed group) Improvements in attitudes and action planning in exposed groups vs control Eg Negative attitudes to delaying sex: Control means 2.56 to 2.38; Intervention: 2.51 to 2.28 (2.08 in highly exposed group) No significant differences in self-efficacy and social norms All differences in theoretical mediators favoured the intervention group.

+ Sex behaviour outcomesITT>/=1>10 Ever had sex (vaginal, anal)ns Sexual debut during study (vag, anal)ns Ever had sex (vag, anal, oral)ns - Sexual debut (vag, anal, oral) in studyns-- Vaginal sex frequencyns Anal sex frequencyns Casual sex (with non-partner)ns Condom use last sex (in sub sample)ns Condom use ever (in sub-sample)ns Condom use frequency (in sub- sample) ns Ever carried a condomns

+ Summary: Sexual risk behaviours No significant differences in sexual debut (vaginal and anal sex) during 6 months follow-up Control 10.5%; Intervention 12.7% When sexual debut includes oral sex, the exposed groups were more likely to have sexual debut during study than control Control 11.2%; Intervention 14.3%; (15.0% and 15.8% in exposed and highly exposed groups) No significant differences in frequency of sex, condom use and carrying condoms

+ IPV theoretical mediatorsITT>/=1>10 Attitudes coerced sexns + Attitudes physical IPV A (pros)ns + Attitudes physical IPV B (pros)ns Attitudes physical IPV C (cons)ns Social norms coerced sexns Social norms physical IPVns Self efficacy coerced sexns + Self-efficacy physical IPVns Action planning coerced sexns Action Plan physical IPV perpetrationns Action Plan physical IPV victns +

+ IPV and bullying behavioural outcomes ITT>/=1>10 IPV victimisationns IPV perpetrationns Bullying victimisation+++ Bullying perpetrationns

+ Summary: IPV theoretical mediators and behaviours ITT analysis: no significant impact on mediators. But, in the highly exposed group, we had a significant impact on 4/11 mediators Ignoring statistical significance, for most mediators, there was a favorable difference between arms, with some indication of dose response No evidence of an impact on IPV behaviours Bullying victimisation was lower in intervention arm: chance finding?

+ Effects at 6 months: Conclusions Intervention exposure was not intense enough to change most mediators and behaviours in a ITT analysis. Will programme effects have dissipated or intensified over the last 6 months follow-up? How likely was it that the intervention to change the school environment was sustained? Stratification for effects by sex? Publication of interim findings?

+ What did participants say about the intervention? It made me feel good about myself. Come again! Prepare helped a lot of people in personal life Thank you for questions not normally asked You helped me find solution to my private problems Made me feel release about my secrets. I feel better about myself and more confident Thank you for getting rid of some of my problems This is the best study of our lives