Smith 1993.

Methods	DESIGN: Cluster RCT (single centre). LENGTH OF FOLLOW‐UP: Up to 3 months, Time 1 (immediately post intervention) and Time 2 (2 months) later for Group 1 (intervention) and Time 3 only for Group 2 (control). DATA ANALYSIS: Analysis is at a different level to randomisation and is based on intervention received. ATTRITION RATE: Overall 56% based on number randomised (42% group 1; 74% group 2). Full compliers had more previous condom use (Time 0 ‐ baseline) than those who dropped out (52.38 versus 11.11%, P < 0.05). UNIT OF DATA ANALYSIS: randomised by floors, but analysis by individuals. SAMPLE SIZE CALCULATION: none reported. EQUIVALENT STUDY GROUPS AT BASELINE: Baseline questionnaire completed by 80.9% of Group 1 and 72.8% of Group 2. Baseline data only reported for participants completing follow‐up at 2 months (34% Group 1; 54% Group 2). No difference in age, age at menarche, dating status, percent experienced sexual intercourse ever, age at first sexual intercourse, number of sexual partners ever, percent ever used condoms and percent condom use in last month. Group 2 had more sexual partners in the last year (1.36 versus 1.00, P < 0.01). The rate of condom use in the two months prior to baseline was higher in Group 2 (control) (61.29) than Group 1 (intervention) (49.75) but stated not statistically significant. PROCESS EVALUATION: none reported.
Participants	NUMBER RANDOMISED: 380 AGE: Group 1 ‐ intervention 18.80 years, Group 2 ‐ control 18.82 years. Gender: 100% female. SOCIO‐ECONOMIC STATUS: not reported (university students) ETHINCITY/RACE: not reported. LOCATION: Canada (Ontariouniversity) PREVIOUS STI: not reported. SEXUAL RISK BEHAVIOUR: Only just under a third in the intervention group and around half of the control group were sexually active. STI history not reported. OTHER: the number of floors used for randomisation could be insufficient in number to ensure even distribution of socio‐demographic and outcome related characteristics (and unknown mediating factors) of participants, however, participants were randomised to floors upon entry to the University. This may have ensured balanced distribution.
Interventions	NAME OF INTERVENTION: none reported GROUP 1: Condom desensitisation and AIDS education (n = 199) YEAR STARTED: not reported. PROVIDER(S): Two female programme providers, approximately five years older than participating students SETTING(S): Educational Institution ‐ tertiary education (University dormitory meetings, site could be considered to be 'home’). TYPE: Information/education (e.g. relevance of AIDS to the female university population, risk factors and transmission of AIDS, misconceptions about condoms, desensitisation to condoms, increasing positive attitudes towards condom use, increasing condom use); practical skill development (e.g. correct condom use, communication skills in negotiating condom use, strategies of preventing condom failure). NUMBER OF SESSIONS: 1 DURATION: Approximately 45 minutes THEORETICAL BASIS: Theory of Reasoned Action and its extension the Theory of Planned Behaviour STIs COVERED: HIV/AIDS Group 2: Control group (n = 181) TYPE: no intervention NUMBER OF SESSIONS: 0
Outcomes	PRIMARY: None explicitly stated, but would appear to be behaviour (i.e. condom use) SECONDARY: Awareness/Beliefs: subjective norms towards safer sex Behaviour: condoms use Self‐efficacy/self‐esteem/self‐confidence: perceived control over safer sex behaviours, motivation to comply with safer sex.
Notes	COST DATA: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Researchers randomised by dormitory quadrant (dormitory had 6 floors, each quadrant 2 floors). 4 quadrants used to receive an experimental session or no session (control) by floor (4 floors assigned to experimental group and 4 to control group).
Allocation concealment?	Unclear risk	No details reported.
Blinding? All outcomes	Unclear risk	Not stated. Data collected by trained female data collectors, remaining with participant during completion of questionnaire (to answer questions and collect completed questionnaires).
Incomplete outcome data addressed? All outcomes	High risk	Participants with more previous condom use at baseline were less likely to drop out before completing the programme session (P < 0.05) the authors acknowledge that the fully compliant sample may have been biased through self selection. Attrition was higher in Group 2 (control) (74%) compared to Group 1 (intervention) (42%). No reaons were given for attrition.
Free of selective reporting?	Unclear risk	In order to avoid re‐test bias, not all planned behaviour questions were used at baseline for the intervention group, only at Time 1 (immediate post intervention).
Free of other bias?	High risk	Cluster RCT with analysis at the level of the individual. Baseline data only reported for those completing 2 month follow‐up (see 'Methods' above). Statistically significant trial group differences at baseline on at least one relevant variable.

* Slight disagreement between reported and actual percentages