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. Author manuscript; available in PMC: 2014 Jun 2.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Apr 13;(4):CD001035. doi: 10.1002/14651858.CD001035.pub2
Methods DESIGN: Single-centre RCT
LENGTH OF FOLLOW-UP: One month
DATA ANALYSIS: Unclear. Appears to be based on participants who completed follow-up but stated that as dropout was random, missing data were imputed based on group means
ATTRITION RATE: 14.3% for overall study population. Attrition rates not given for randomised groups but stated to not to differ between groups
UNIT OF DATA ANALYSIS: Individual
SAMPLE SIZE CALCULATION: Not reported. It is stated that the size of the control group was limited in order to maximize the size of the experimental groups
EQUIVALENT STUDY GROUPS AT BASELINE: Authors report no statistically significant differences betwen groups on the basis of pre-test scores or social/sexual behaviour characteristics, using discriminant function analysis
PROCESS EVALUATION: Not reported.

Participants NUMBER RANDOMISED: 112
AGE: 18 to 32 years (mode =18 years)
SOCIO-ECONOMIC STATUS: Not reported, though all were University undergraduates
ETHINCITY/RACE: described as largely Caucasian and native to the unspecified Canadian province in which this study was conducted
LOCATION: Canada (exact location not specified, though possibly New Brunswick)
PREVIOUS STI: Almost 5% had been tested for HIV, but none reported a positive result. 9% of the coitally experienced participants reported having had one or more STD
SEXUAL RISK BEHAVIOUR: 80% had engaged in vaginal intercourse. On average they had been coitally experienced for 2.5 years. Coitally experienced women reported a mean of 3.7 partners (range 1 to 30 partners). 48% of coitally experienced participants reported never having used condoms consistently with any of their partners; 84% of those coitally active in past year had engaged in unprotected intercourse
OTHER: The majority of participants were enrolled in a Faculty of Arts (59.8%) and were in their first year of University (79.5%). The sample was described as heterosexual

Interventions NAME OF STUDY: Not reported
GROUP 1 Information, condom eroticisation/normalization and communication skills combination intervention (n = 49)
YEAR STARTED: Not stated
PROVIDER(S): Researcher SETTING(S): University
TYPE: Information/Education. Information about AIDS disseminated through a 15 minute videotape as well as through several information-orientated pamphlets and handouts. Information was provided on the definition, etiology, epidemiology, transmission, prevention and ‘treatment’ of AIDS, as well as on effective condom use.
Practical skill development. Fifteen minute segment of the audiotape ‘How to talk with your partner about smart sex’. This audiotape models the communication skills required for negotiating safer sex and condom use with a partner
Condom eroticisation, condom normalisation.Ten minute audiotape erotic account of a heterosexual college couple integrating condom use into their sexual script. Addresses a a number of negative beliefs about condoms
DURATION: 40 minutes
THEORETICAL BASIS: Social Learning Theory. The Theory of Reasoned Action.
Sexual Behaviour Sequence Theory (theories or erotophobia-erotophilia)
STIs COVERED: HIV/AIDS
GROUP 2 Information only intervention (n = 44)
YEAR STARTED: Not stated
PROVIDER(S): As Group 1
SETTING(S): As Group 1
TYPE: As Group 1 but only the Information/Education component
DURATION: 15 minutes
THEORETICAL BASIS: As Group 1
STIs COVERED: As Group 1
GROUP 3 No-intervention control group (n = 19)
No information provided

Outcomes Knowledge of AIDS
Perceived social norms
Attitudes towards condoms
Behaviour (condom use)
Not stated which outcomes were primary/secondary

Notes COST DATA: None reported.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk No information given on randomisation procedure.

Allocation concealment? Unclear risk Not reported

Blinding?
All outcomes
Unclear risk Not reported

Incomplete outcome data addressed?
All outcomes
Unclear risk States that the attrition rates did not differ between randomised groups (though does not give reasons). No mention of whether an ITI analysis was done though they do report using the respective group means for knowledge, attitudes and norms (though not behaviour) for the missing cases

Free of selective reporting? Low risk Results for all outcomes specified in the methods section of the trial publication are reported

Free of other bias? Unclear risk Unclear