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. 2016 Nov 23;2016(11):CD007249. doi: 10.1002/14651858.CD007249.pub5

Taylor 2014.

Methods Design: cluster randomized trial; 16 high schools (urban and rural) allocated to conditions
Location: KwaZulu‐Natal, South Africa
Time frame: 2009
Sample size estimation and outcome of focus: no information
Participants General with N: 16 high schools; 816 students
Inclusion criteria: 2 of 11 districts (1 urban and 1 rural); 16 of 1580 high schools on Department of Education list; randomly selected grade 8 classes (1st year high school)
Exclusion criteria: no information
Interventions Study focus: teenage pregnancy prevention
Theory or model: I‐Change model from 2005 (DeVries 2013); integration of ideas from Theory of Planned Behavior, Social Cognitive Theory, Transtheoretical Model, Health Belief Model, and goal setting theories
  1. Intervention: interactive program with 12 weekly sessions addressing choice, body development, contraception (role play included visiting clinic for contraception), parenthood; compulsory program (below)

  2. Control: compulsory Lifeskills program + media messages regarding teen pregnancy; had experimental program at trial end

Outcomes Primary: been pregnant or caused pregnancy; condom use (any); condom use consistency as 4‐point scale from 1 (never) to 4 (always)
Secondary: attitudes to teen pregnancy (pro and con scales); intent to prevent pregnancy and to use condoms
Follow‐up: 4 months postprogram (8 months after baseline)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No specifics on sequence generation: 16 of 1580 schools selected; geographical stratification; randomly allocated schools to groups
Allocation concealment (selection bias) Unclear risk Students invited from 1 randomly selected grade 8 class
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Presume no blinding of participants or providers; not feasible due to type of intervention
Blinding of outcome assessment (detection bias) Unclear risk No mention
Outcome measures High risk Contraceptive use and pregnancy by self‐report
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up: intervention 11% (48/431); control 23% (89/385); differential losses
Other bias High risk Analysis for cluster randomized trial: multivariate linear and logistic regression models included covariates of age, gender, socioeconomic status, sexual experience, and baseline scores.
Analysis of behavioral outcomes based on who had sex (could be affected by intervention), rather than all randomized (high risk)