Shrier 2001.

Methods	DESIGN: RCT (not specifically stated, but appears to be single‐centre) LENGTH OF FOLLOW‐UP: 1, 3, 6 and 12 months DATA ANALYSIS: not reported ATTRITION RATE: 34% for month 1, 41% for months 3 and 48% for 12 months (33% attended all 4 follow up visits, 11% participants did not return for any follow ups). Attrition rates generally balanced between the study groups. No reasons for attrition specified. UNIT OF DATA ANALYSIS: Individuals. SAMPLE SIZE CALCULATION: Not stated if statistically powered for primary outcome, but states that study had limited power (35%) to detect a significant difference in condom use between groups, as only 35% of adolescents at 1 month follow‐up reported a non‐main partner in the previous 6 months. Also states that low participation rates threatened the external validity of results. EQUIVALENT STUDY GROUPS AT BASELINE: States no significant difference between groups at baseline (no p values reported) and that percentage reported may not add up to 100% due to missing values. Group 1 had a 10% higher rate of motherhood than Group 2 (23% versus 13%) and the same higher rate for ‘another partner in the last 6 months’ (40% versus 30%), as well as 9% higher in condom used with last sexual encounter (47% versus 38%). Cervicitis participants had higher baseline knowledge (P = 0.03) and negotiation (P = 0.008) than PID patients. PROCESS EVALUATION: not reported
Participants	NUMBER RANDOMISED: 123 AGE: median 17.2 years (Group1 17.0 median years, range 14.1 to 22.0; Group 2 17.5 median years,  range 13.9 to 21.9) Gender: female SOCIO‐ECONOMIC STATUS: not reported ETHINCITY/RACE: Non‐Hispanic black 49% (Group 1 48%, Group 2 49%); Hispanic 18% (Group 1 20%, Group 2 16%); Non‐Hispanic white 14% (Group 1 17%, Group 2 11%); Other 17% (Group 1 13%, Group 2 21%). LOCATION: USA (Boston, Massachusetts ‐ urban) PREVIOUS STI: history of previous STI/ PID 44% (Group 1 42%, Group 2 46%). SEXUAL RISK BEHAVIOUR: <50% reported using condom at last intercourse and sexual risk behaviours described as prevalent, with 48% young women needing treatment for cervicitis (n = 59) or 52% for PID (n = 64). OTHER: 3 randomised participants with cervicitis did not receive intervention or return for any follow up visits. Participants were paid $10 for each follow up visit. Group 1 received free condoms and written material about safer sex, condoms and spermicide and an opportunity to view ‘Time Out: The Truth About AIDS, HIV and You’ videotape again. Group 2 were offered free condoms at the end of the visit. States that 82 eligible adolescent were not included in the study as no research assistant was available to approach them for study participation at the time of treatment and this might have introduced a bias.
Interventions	NAME OF INTERVENTION: none reported GROUP 1: Safer sex education (n = 60) YEAR STARTED: 1996 to 1998 PROVIDER(S): female health educators SETTING(S): children’s hospital adolescent clinic and inpatient service TYPE: Information/Education (increased awareness of sexual risk behaviour,dangers of unsafe sex, STI transmission, abstinence, correct condom use and use of female condom) and practical skill development (correct condom use and condom‐use negotiating skills if appropriate). DURATION: 1 individual session lasting approximately 37 minutes (7 minutes videotape and around 30 minutes on intervention topics), with 3 booster sessions (month 1, 3 and 6). THEORETICAL BASIS: Social cognitive theory, the Transtheoretical Model of behaviour change and Motivational interviewing STIs COVERED: AIDS/HIV and STIs (no specific STIs reported) Group 2: Standard care/STD education (n = 63) NAME OF INTERVENTION: PROVIDER(S): STD education provided at the discretion of the treating clinician SETTING(S): children’s hospital adolescent clinic and inpatient service TYPE: Information/education (e.g. increased awareness of STD transmission, importance of consistent condom use) DURATION: not reported. THEORETICAL BASIS: none reported.
Outcomes	PRIMARY: not specifically stated but would appear to be self‐reported condom use and recurrence of STD. SECONDARY: Attitudes (attitudes toward condoms) Behaviour (self‐reported behaviours) Knowledge (sexual risk knowledge) Practical skill (condom use negotiation skills)
Notes	COST DATA: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Randomisation was stratified by presenting diagnosis (cervicitis or PID) using 2 separate random numbers lists.
Allocation concealment?	Unclear risk	No details reported.
Blinding? All outcomes	Unclear risk	Not reported
Incomplete outcome data addressed? All outcomes	Unclear risk	Not reported, but follow‐up data appears to be based only on those who received the intervention. Attrition rates were similar between groups, but no reasons were given and it is therefore not clear whether reasons for attrition differed between trial groups.
Free of selective reporting?	Unclear risk	The baseline stage of change scale could not be scored due to 73% of responders not following instructions. No results for 3 months follow‐up reported. Selective reporting difficult to evaluate as not all reported outcome measures are explained in the methods section.
Free of other bias?	Unclear risk	Uncertain