Methods	DESIGN: Multi-centre RCT
	LENGTH OF FOLLOW-UP: 3 and 6 months post-intervention
	DATA ANALYSIS: Not reported whether data analysis was ITI or intervention received. It is not clear from the results whether the analysis is based on all randomised participants or only those remaining at follow-up (no n’s reported only %)
	ATTRITION RATE: Retention rates were 85% at both 3 and 6 month follow-up. Rates for each study group are not reported. However it is mentioned that there were no significant group difference in retention rates at 3 (P = 0.195) or 6 months (P = 0.148)
	UNIT OF DATA ANALYSIS: Appears to be individual.
	SAMPLE SIZE CALCULATION: Not reported
	EQUIVALENT STUDY GROUPS AT BASELINE: Authors state they found no differences in demographics, sexual behaviours or condom use between groups at baseline. From data presented they appear reasonably balanced
	PROCESS EVALUATION: Not reported
Participants	NUMBER RANDOMISED: 409
	AGE: Mean age 22 years, 77% were aged between 18 to 24 years
	Group 1: 18 to 19 years = 49 (23%); 20 to 24 years = 114 (54%); 25 to 29 years = 29 (14%); 30 to 34 years = 14 (7%); 35 to 39 years = 7 (3%). Group 2: 18 to 19 years = 45 (23%); 20 to 24 years = 97 (49%); 25 to 29 years = 36 (18%); 30 to 34 years = 12 (6%); 35 to 39 years = 6 (3%)
	SOCIO-ECONOMIC STATUS: Group 1: Less than high school education = 94 (44%) ; High school education = 82 (38%); Some college education or college graduate = 37 (17%). Group 2: Less than high school education = 80 (41%); High school education = 88 (45%); Some college education or college graduate = 28 (14%)
	ETHINCITY/RACE: Group 1: African American = 27 (13%); Asian =14 (7%); Latina = 33 (15%); White = 139 (65%). Group 2: African American = 17 (9%); Asian = *10 (10%); Latina = 35 (18%); White = 122 (63%)
	*appears to be a mistake in the trial publication. It should be 20 not 10, though the total number would only sum to 194, rather than the 196 randomised
	LOCATION: 4 named San Fransisco Bay Area Cities, US.
	PREVIOUS STI: Group 1: 75 (35%); Group 2: 63 (32%)
	SEXUAL RISK BEHAVIOUR:
	Number of sexual partners in past 3 months. Group 1: 0 partners = 7 (3%); 1 partner = 119 (56%); 2 partners = 52 (24%); ≥ 3 partners = 35 (16%). Group 2: 0 partners = 6 (3%); 1 partner = 109 (56%); 2 partners = 51 (26%); ≥ 3 partners = 30 (15%)
	Used a male condom at least once during past 3 months. Group 1: 146 (68%). Group 2: 126 (64%)
	Ever used female condom. Group 1:10 (5%); Group 2: 7 (4%)
Interventions	NAME OF STUDY: Not reported
	GROUP 1: Female condom skills training intervention (n = 213)
	YEAR STARTED: 2003/4
	PROVIDER(S): Health Educators
	SETTING(S): Family planning clinics where the participants were originally attendees
	TYPE: Information/Education about HIV/STIs and safer sexual practices and assessment of personal risk. Practical skill development to learn how to use female condoms and how to communicate with sexual partners and negotiate the use offemale condoms. Examination ofpersonal barriers to using female condoms. Condoms (male and female) were supplied throughout and beyond the intervention period. Intervention was deliv-
	ered individually except session 3 which was in small groups of 6 to 10 participants
	DURATION: 4 sessions over an unspecified period of time. First 2 sessions lasted 2 hours each, the third lasted 2.5 hours and the 4th session lasted 30 minutes
	THEORETICAL BASIS: Social Learning Theory.
	STIs COVERED: HIV and STIs
	GROUP 2: General health promotion intervention (n = 196)
	YEAR STARTED: 2003/4
	PROVIDER(S): As Group 1
	SETTING(S): As Group 1
	TYPE: Information/Education about general health issues such as cancer and heart disease, to improve motivation to change health risk behaviours. Condoms supplied as per Group 1
	DURATION: As Group 1.
	THEORETICAL BASIS: Not stated
	STIs COVERED: N/A
Outcomes	PRIMARY: Not explicitly stated that these were their primary outcomes but behavioural outcomes appear to be the focus of the evaluation. Measures included: use of male or female condoms at least once during vaginal and anal intercourse in the past 3 months; percentage of vaginal and anal sexual acts protected by female condoms, by male condoms or by any (female or male) condom in the last 3 months. These measures were repeated for each sexual partner the participants had reported (up to 10 times as necessary) SECONDARY: Not explicitly stated that these were their secondary outcomes, but they measured impact on knowledge about female condoms, attitudes to female condoms and female condom use self-efficacy
Notes	COST DATA: All participants received monetary incentives after completing each session (i.e. $20 each at sessions 1 and 2, $30 at session 3 and $10 gift card at session 4)
Risk of bias
Bias	Authors’ judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Reports that randomisation was stratified by site and race/ethnicity. Prior to the study stratum-specific sequential identification numbers were generated and randomly pre-assigned to intervention groups in blocks of4 (i.e. 2 intervention and 2 control participants per block). No detail given on the actual method of random sequence generation
Allocation concealment?	Unclear risk	Not stated
Blinding? All outcomes	Unclear risk	Not stated
Incomplete outcome data addressed? All outcomes	Unclear risk	Authors report that there were no statistically significant differences between study groups in attrition (note though that they don’t actually provide the numbers, only an overall figure for the study population as a whole (85% retention)). No reasons for attrition are given. It is not clear whether the reasons for attrition differed between the groups
Free of selective reporting?	Low risk	All outcomes specified in the methods of the study appear to be reported on in the results
Free of other bias?	Unclear risk	Unclear