Methods | DESIGN: Single centre RCT | |
LENGTH OF FOLLOW-UP: Immediately post-intervention and 2 months after intervention | ||
DATA ANALYSIS: Used an intention to treat analysis with last observations carried forward in lieu of missing data | ||
ATTRITION RATE: Not reported separately by group. Overall 70/78 participants attended the immediate post-intervention test (90%) and 67/78 participants completed 2 month follow up (86%) | ||
UNIT OF DATA ANALYSIS: Individuals; same as the unit of randomisation | ||
SAMPLE SIZE CALCULATION: Stated that power analyses using effect sizes from earlier work (reference provided) indicated that a sample size of 17 per group would provide ‘good’ (i.e. β > 0.80) power | ||
EQUIVALENT STUDY GROUPS AT BASELINE: Stated that the only difference between groups found was on decisional balance, where Group 3 scored higher (mean = 13.58) than Group 1 (mean = 12.91) and Group 2 (mean = 10.89); P = 0.05 | ||
Stated that, of 31 participants who reported exposure to other STD programmes (e.g. television), there were no differences between groups 1 and 2 (P = 0.21) or between groups 1 and 3 (P = 0.80) | ||
PROCESS EVALUATION: A 7-item group experience measure assessed participants’ perceptions of the session delivery and their comfort and enjoyment of the group (data presented but not extracted) | ||
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Participants | NUMBER RANDOMISED: 78 | |
AGE: Not reported separately by group. Overall mean = 20 years | ||
SOCIO-ECONOMIC STATUS: Not reported. | ||
ETHINCITY/RACE: Not reported separately by group. Overall 76% of participants were European-American | ||
LOCATION: USA; Syracuse, New York. | ||
PREVIOUS STI: Stated that only a small proportion of women reported a recent STD (no further details provided) | ||
SEXUAL RISK BEHAVIOUR: Not reported separately by group. Women had to be sexually active during the previous 2 months for inclusion in the trial, but were excluded if they used condoms at every episode of vaginal, oral and anal sex during the previous 2 months or if pregnant or trying to become pregnant. Overall, 48% reported ≥ 3 lifetime sexual partners; 65% reported unprotected vaginal sex in the previous 2 months; and 53% were in committed relationships and not using condoms | ||
OTHER: Participants were those who volunteered for a study of ‘College Women’s Health’ for either partial fulfilment of course requirements or for extra credit in undergraduate psychology courses (suggests the population was limited to psychology undergraduates) | ||
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Interventions | GROUP 1: Information-Motivation-Behavioural skills (1MB) group with motivational enhancement (n randomised not reported) | |
YEAR STARTED: Not reported. | ||
PROVIDER(S): Two facilitators who were advanced graduate students in clinical psychology with training in sexual health | ||
SETTING(S): Not explicitly stated but appears to be a university health and behaviour centre | ||
TYPE: Small-group intervention with approximately 8 participants per group in which sexual risk reduction was normative and supported and the threat of STIs and promotion of behaviour change was personalised. Comprised information/education about STI transmission, consequences, prevention and treatment. Also included practical skills development, based on sexual communication role playing, with a focus on assertive-ness skills. Facilitators followed detailed manuals to protect against facilitator drift and contamination of intervention components | ||
DURATION: One session lasting 150 minutes conducted 1 week after the baseline survey. The session was divided into six consecutive segments, of duration 10, 30, 20, 45,15 and 30 minutes, for each of which a detailed description is provided (information not extracted) | ||
THEORETICAL BASIS: Based on the Information-Motivation-Behavioural skills model (IMB) strengthened with a motivational enhancement approach to personalise the threat of STIs and promote behaviour change | ||
STIs COVERED: STIs in general. | ||
GROUP 2: Time-matched information provision group (INFO) (n randomised not reported) | ||
YEAR STARTED: Not reported. | ||
PROVIDER(S): As Group 1. | ||
SETTING(S): As Group 1. | ||
TYPE: Structured as Group 1 but based on information provision only (information/ education about STI transmission, consequences, prevention and treatment). Facilitators avoided personalising the threat of STIs | ||
DURATION: As Group 1. | ||
THEORETICAL BASIS: None specified; information provision only | ||
STIs COVERED: As Group 1. | ||
GROUP 3: Waiting list control group (n randomised not reported) | ||
Received an intervention identical to Group 2, but this occurred after Group 3’s follow-up survey | ||
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Outcomes | (Not stated which were primary): | |
Knowledge: about STI transmission, consequences, prevention and treatment; | ||
Attitudes towards condoms and perceptions of sexual risk (assessed with 3 instruments); | ||
Behavioural intentions (based on an 8-item instrument); | ||
Behavioural skills: sexual assertiveness scores; | ||
Self-reported sexual behaviour: vaginal sex without condom; vaginal sex with condom; oral sex without condom; oral sex with condom; number of sexual partners | ||
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Notes | COST DATA: None reported. | |
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Risk of bias | ||
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Bias | Authors’ judgement | Support for judgement |
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Adequate sequence generation? | Unclear risk | Stated only that participants were assigned randomly, with no explanation of the method used |
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Allocation concealment? | Unclear risk | Stated that participants generated code names to ensure confidentiality and reduce error from self-presentation bias. However, it is unclear whether this would have resulted in allocation concealment |
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Blinding? All outcomes |
Unclear risk | Stated that immediately post-intervention the survey was administered by a research assistant who was not present at the groups and who was masked to the study condition. But not stated whether the research assistants who administered the 2 month follow up survey were also blinded |
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Incomplete outcome data addressed? All outcomes |
Unclear risk | An intent to treat analysis was used, with last observations carried forward to account for missing data. Stated that the 67 completers at 2 month follow up did not differ from the dropouts (n = 11) as a function of group assignment (P = 0.44) and that no differences were found on the dependent measures between the completers and dropouts |
Note however that attrition was not reported separately by study group and no reasons were given for attrition | ||
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Free of selective reporting? | Low risk | All outcomes mentioned in the methods section were reported in the results section |
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Free of other bias? | Unclear risk | Unclear |