Morrison‐Beedy 2005.

Methods	DESIGN: Single‐centre RCT (pilot study) LENGTH OF FOLLOW‐UP: 3 months (after last intervention group session) DATA ANALYSIS: Stated that although only 48 of 62 randomised participants had completed the post‐treatment assessment, data from all 62 were used in the analyses to provide estimates of effect. Also stated that generalised estimating equations (GEE) were used to handle missing data, so that all available data can be used in the analyses. But did not explain the method for imputing missing data. ATTRITION RATE: Not reported separately by study group. Overall, 62/62 participants (100%) completed all intervention sessions and 48/62 participants (77.4%) (reported as 78%) completed the 3‐month follow up. UNIT OF DATA ANALYSIS: Individuals; same as the unit of randomisation. SAMPLE SIZE CALCULATION: Not reported. Stated that sample size was intentionally small (pilot study) and that because sample size was small, effect sizes were calculated using post‐treatment data (effect sizes calculated with post‐treatment data from randomised trials are unbiased, even in the presence of significant baseline differences; reference cited). EQUIVALENT STUDY GROUPS AT BASELINE: Stated there were no observed pre‐intervention differences between the study groups with respect to demographics, HIV‐related knowledge or motivation. However, girls in the HIV intervention had higher levels of confidence in condom use (mean (SD) score from 5‐item confidence scale: Group 1=4.0 (1.0); Group 2=3.2 (1.1); P < 0.01). PROCESS EVALUATION: None reported.
Participants	NUMBER RANDOMISED: 62 AGE: Not reported separately by study group. Overall: mean = 17.3 years (SD 1.4; range 15 to 19). SOCIO‐ECONOMIC STATUS: Not reported separately by study group. Overall: low income (received free school lunch programme)=28%; worked outside their home=53% (mean 15.6 hours/week; SD 9.1). ETHINCITY/RACE: Not reported separately by study group. Overall: White=59%; Black=29%; Hispanic=10%; Asian = 2%. LOCATION: USA; Central New York State; urban. PREVIOUS STI: Not reported separately by study group. Overall: Reported a history of STIs=15%. SEXUAL RISK BEHAVIOUR: Not reported separately by study group. Overall: Sexually active with male partner in past 3 months=62/62 (100%) (an inclusion criterion). Had ≥2 sex partners in past year=53% Reported previous pregnancy=21% Reported having a sex partner who injected drugs=11% Reported having drunk alcohol before sex in past 3 months=39% Reported having taken drugs before sex in past 3 months=15% Reported anal sex=<5% (therefore anal sex data not considered further in the study report).
Interventions	GROUP 1: HIV risk reduction group (n = 33) YEAR STARTED: Not reported. PROVIDER(S): Two trained female interventionists who were nurses; one aged mid‐20s and African‐American; the other aged mid‐40s and Caucasian. Trained research assistants also helped with some administrative tasks (participant recruitment and assistance if required with participants' self‐report survey questionnaires). SETTING: Urban family planning clinic that provided services to economically disadvantaged teens. Sessions were held in the community education rooms of the clinic. TYPE: Information/education: provision of information about HIV, transmission, risk reduction and prevention; increasing motivation to reduce risky behaviour. Practical skills development: provision of behavioural skills training that is ultimately necessary to reduce HIV risk, comprising: sexual assertiveness skills; negotiating condom use or other safer sex practices with partner; identifying high‐risk situations. Delivered to groups of 6 to 8 participants. Each session included (unspecified) take‐home activities for participants to complete for the following session. Refreshments (unspecified) were provided to participants. DURATION: Four 2‐hour sessions (interval not stated) held after school hours. THEORETICAL BASIS: Information‐Motivation‐Behavioural Skills (IMB) Model. STIs COVERED: HIV GROUP 2: Health promotion control group (n = 29) YEAR STARTED: Not reported. PROVIDER(S): As Group 1 (the same personnel delivered both). SETTING(S): As Group 1. TYPE: Followed the same structure as Group 1 (i.e. participants had equivalent professional attention, time and group support), but did not target sexual or HIV‐related behaviours. Instead, addressed anger management, caffeine use and nutrition (topics not addressed in Group 1). Comprised information/education, but unclear whether also practical skills development (not explicitly stated). DURATION: As Group 1. THEORETICAL BASIS: None reported. STIs COVERED: None (not applicable).
Outcomes	Not stated whether primary or secondary outcomes: Knowledge about HIV Risk perception (beliefs) Readiness to change risky behaviours (motivation) Behavioural intentions to reduce risk Pros and cons of condom use (perceptions/beliefs) Confidence in condom use (self‐efficacy) Self‐reported sexual risk behaviours in past 3 months: frequency of protected vaginal or anal sex; frequency of unprotected vaginal or anal sex; frequency of giving oral sex; frequency of receiving oral sex; number of male and female sex partners; communication frequency with partner about safer sex; frequency of drug use before sex; frequency of alcohol use before sex.
Notes	COST DATA: Mentioned only that participants received the following financial incentives: $10 for completion of the pre‐randomisation survey; $15 per intervention session attended to offset travel, babysitting and lost wages; and $15 for attending the follow‐up assessment.
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	Unclear risk	No information provided.
Incomplete outcome data addressed? All outcomes	Unclear risk	The description of analysis implies that data for all randomised participants were included in the analyses but the method used in the generalised estimating equations was not explained. Attrition rates were not reported separately by trial group. 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	The outcomes listed in the methods section are all reported in the results section.
Free of other bias?	Unclear risk	Unclear