Ploem 1997.
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. |
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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. |
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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 |
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Outcomes | Knowledge of AIDS Perceived social norms Attitudes towards condoms Behaviour (condom use) Not stated which outcomes were primary/secondary |
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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 |