Koniak‐Griffin 2003.

Methods	DESIGN: Cluster RCT LENGTH OF FOLLOW‐UP: 3, 6 and 12 months DATA ANALYSIS: Stated that an intention to treat procedure was used with participants remaining in the analyses regardless of the number of sessions attended. However, results were only presented for 497 participants (87%) who provided data for 'all five time points' (unclear what the five time points equate to, as baseline, 3, 6 and 12 months equates to 4 time points). ATTRITION RATE: Attrition was reported as 525/572 participants (8%) at 12 months. Not reported separately by study group but stated that differential attrition was not observed across the groups. No reasons given for attrition. UNIT OF DATA ANALYSIS: Stated that data from all sites were analysed collectively because the same curriculum was offered at each site (=school) and the questionnaires administered were identical across sites. The unit of analysis appears to be individuals (data reported as numbers and proportions of the population) whereas the unit of randomisation was schools. SAMPLE SIZE CALCULATION: Not reported. No intra‐cluster correlation coefficient mentioned. EQUIVALENT STUDY GROUPS AT BASELINE: Stated that the study groups were nearly equivalent in terms of socio‐demographics and that there were no differences between the groups in scores from the social desirability scale. Statistically significant group differences at baseline were: Proportion pregnant: Group 1=70%; Group 2=58%; P < 0.01. Intention to use condoms score: stated lower in Group 1 (no data provided); P < 0.05. AIDS knowledge score: stated lower in Group 1 (no data provided); P < 0.01. Hedonistic beliefs about condom use score: stated lower in Group 1 (no data provided); P < 0.05. PROCESS EVALUATION: Observations on a sub‐sample of classes (number not specified) were done to maintain quality assurance of the curriculum. Intervention and control were rated by participants on a 5‐point Likert‐type scale (e.g. 'average', 'outstanding'). Stated that participants' reactions did not differ between the two groups (data not extracted).
Participants	NUMBER RANDOMISED: 572 (of which 497 analysed) AGE: mean (SD), years: Group 1=16.64 (1.16); Group 2=16.74 (1.04) SOCIO‐ECONOMIC STATUS: Mean (SD) Hollingshead 4‐factor score: Group 1=30.06 (10.64); Group 2=30.97 (10.63). Mean (SD) grade level (range 7 to 12): Group 1=10.43 (1.14); Group 2=10.63 (1.09). Mean (SD) acculturation score (Latinas only; range 1 to 5): Group 1=3.43 (0.84); Group 2=3.52 (0.85). Marital status, n (%): Group 1: single=247 (73%*); married=19 (6%*); living together=72 (21%). Group 2: single=110 (73%); married=6 (4%); living together=31 (21%). ETHINCITY/RACE, n (%): Group 1: Latina=266 (77.8%*); African‐American = 60 (17.5%*); Asian = 9 (2.6%); White=6 (1.8%); Other=1 (0.3%). Group 2: Latina=114 (77.6%*); African‐American = 29 (19.7%*); Asian = 0; White=3 (2.0%); Other=1 (0.7%). LOCATION: USA; California; 4 school districts in LA County. PREVIOUS STI: Not reported. SEXUAL RISK BEHAVIOUR, baseline data: Sexually active during past 3 months, n (%): Group 1=264 (76%); Group 2=109 (73%). Steady partner=yes, n (%): Group 1=304 (88%); Group 2=131 (87%). Steady partner=no, n (%): Group 1=41 (12%); Group 2=19 (13%). Pregnant=yes, n (%): Group 1=241 (70%); Group 2=87 (58%). Pregnant=no, n (%): Group 1=105 (30%); Group 2=63 (42%).
Interventions	NAME OF STUDY: Project CHARM (Children's Health And Responsible Mothering) GROUP 1: HIV prevention programme (CHARM 1) (n = 347 analysed; number randomised not reported by group) YEAR STARTED: Not reported. PROVIDER(S): Trained nurse facilitators delivered content. Questionnaires were read to small groups by specially trained research staff. SETTING(S): Schools with pregnant minor or young parents' programmes. TYPE: Information/Education about the impact of HIV and AIDS on pregnant women and their children, prevention of HIV, sexual risk reduction and sexual responsibility. Practical skills development (unspecified skill‐building activities). Resource provision: Participants were given coupons to be redeemed for free condoms throughout the study. DURATION: Four 2‐hour sessions. Completion of questionnaires took 45 to 90 minutes (not stated whether this was per questionnaire or in total). THEORETICAL BASIS: Social Cognitive Theory and the Theory of Reasoned Action; based on the 'Be Proud! Be Responsible!' programme. STIs COVERED: HIV/AIDS. GROUP 2: Health promotion programme (CHARM 2) (n = 150 analysed; number randomised not reported by group) YEAR STARTED: Not reported. PROVIDER(S): Trained nurse facilitator who was not involved in group 1 delivered the content. Questionnaires were read to small groups by specially trained research staff. SETTING(S): As group 1. TYPE: Information/Education about healthy living parenting. Practical skills development (unspecified skill‐building activities, e.g. coping and communications). Resource provision: As group 1. DURATION: As group 1. THEORETICAL BASIS: None stated. STIs COVERED: None stated.
Outcomes	Not reported whether primary or secondary: Knowledge of: AIDS; condom use. Behavioural intentions for: Condom use. Behaviour (reported) for: Number of episodes of unprotected sex in the past 3 months; number of sex partners in the past 3 months; condom use. Awareness/Beliefs: Self‐efficacy beliefs (reported as beliefs rather than self‐efficacy per se); condom use beliefs (hedonistic and prevention); partner reaction beliefs; perceived behavioural control.
Notes	COST DATA: Stated only that participants received: $15 on completion of each set of questionnaires as partial compensation for their time and expenses; $10 per class attended; and, upon completion of the study, a charm with the birthstone of their baby.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	No information provided
Allocation concealment?	Unclear risk	No information provided
Blinding? All outcomes	Low risk	Stated that the specially trained research staff who read questionnaires to women were blind to the experimental conditions. However, no details of the blinding method were reported and it is unclear whether other outcome assessors, e.g. data analysts, were also blinded.
Incomplete outcome data addressed? All outcomes	Unclear risk	Although an intention to treat analysis was stated, the analysis was performed only on those participants who completed all follow‐up sessions. Attrition rates were not reported separately by trial group, though the authors state that no differential attrition was found. No reasons were given for attrition and it is therefore not clear whether reasons for attrition differed between trial groups.
Free of selective reporting?	Low risk	Results were presented for all outcomes mentioned in the methods section (note that condom use was also reported in the results, although not mentioned in the methods section).
Free of other bias?	Unclear risk	The unit of analysis appears to be individuals (data reported as numbers and proportions of the population) whereas the unit of randomisation was schools (see 'Methods' above).