Methods | DESIGN: Cluster RCT | |
LENGTH OF FOLLOW-UP: Post-campaign surveys (April-July 2005) were initiated immediately following the campaign period (September 2004 - March 2005) | ||
DATA ANALYSIS: Primary analysis (using permutation tests) was not stated explicitly as intention to treat but included all randomised units (neighbourhoods). There was evidence of contamination across neighbourhoods (see participants section below) whereas the primary analysis kept the neighbourhoods to their allotted intervention groups. The analysis thus appears to be equivalent to an intention to treat analysis. A secondary, post-hoc, analysis based on logistic regression was carried out to investigate the effect on outcomes of actual exposure to the intervention (data not extracted as not reported by study group) | ||
ATTRITION RATE: Attrition was not reported because pre-campaign and post-campaign outcomes were based on different groups of participants (cross-sectional samples nested within study groups at pre-intervention and post-intervention). Also, this was a cluster RCT and none of the clusters (neighbourhoods) were omitted. Of 16,478 and 12,183 women who appeared eligible at baseline and post-campaign respectively, 3407 and 3003 provided pre-campaign and post-campaign data | ||
UNIT OF DATA ANALYSIS: Neighbourhoods were the units randomised and also the units analysed statistically (permutation tests conducted on 12 neighbourhoods stratified by 4 regions and two study arms = 144 possible arrangements of groups to conditions) | ||
SAMPLE SIZE CALCULATION: Intraclass correlation coefficient assumed to be 0.02 from a pilot study in Denver. For adequate (unspecified) power it was assumed that data from 12 neighbourhoods with 300 women per neighbourhood would be required. It ws also assumed that inclusion of 250 women per neighbourhood would not substantially reduce power (actual sample sizes ranged 229 to 301 per neighbourhood) | ||
EQUIVALENT STUDY GROUPS AT BASELINE: Not reported in the results, but stated that following the baseline survey neighbourhoods were stratified within regions to ensure adequate comparability between campaign and comparison neighbourhoods | ||
PROCESS EVALUATION: Exposure of participants to the social marketing campaign was assessed and analysed (data not extracted) | ||
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Participants | NUMBER RANDOMISED: 12 neighbourhoods (comprising 3407 respondents to baseline survey; 3003 respondents to follow up survey) | |
AGE: (number (%) of 3407 respondents; not reported separately by study group): 15 to 17 years = 1428 (41.9); 18 to 19 years = 663 (19.5); 20 to 25 years = 1299 (38.1); missing data: 17 (0.5) | ||
SOCIO-ECONOMIC STATUS: Not reported. | ||
ETHINCITY/RACE: (number (%) of 3407 respondents; not reported separately by study group): African American = 1124 (33.0); Latina = 1420 (41.7); Other = 788 (23. | ||
1); missing data = 75 (2.2) | ||
LOCATION: USA; 12 urban neighbourhoods: 10 in California (4 in San Francisco Bay area, 4 in Los Angeles, 2 in San Diego) and 2 in Nevada (Las Vegas) | ||
PREVIOUS STI: Not reported. Stated that the neighbourhoods were selected as they had the highest rates of chlamydia, gonorrhoea and teen births for 15 to 25 year old | ||
women in the campaign area | ||
SEXUAL RISK BEHAVIOUR: (number (%) of 3407 respondents; not reported separately by study group): Ever had sex, answer yes = 2342 (68.7); Ever had sex, answer no = 1014 (29.8); missing data = 51 (1.5); had sex in past 90 days = 1853 (54.4) | ||
OTHER: Cross-contamination ofrandomised groups (exposure to intervention assessed by self-report questionnaire): Women in comparison (control) neighbourhoods were able to define unique elements of the POWER campaign intervention. Of 87 women who said they received a silk purse (provided only in intervention neighbourhoods), 39% were from control neighbourhoods | ||
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Interventions | GROUP 1: POWER (Prevention Options for Women Equals Rights) Reproductive Health social marketing campaign (n = 6 neighbourhoods) | |
YEAR STARTED: September 2004 to March 2005. | ||
PROVIDER(S): Not stated but appears to be that participants self-accessed intervention materials which were placed at community venues | ||
SETTING(S): Urban neighbourhood community venues (unspecified) (n = 400 sites) that were frequented by the target population of adolescent women (mentioned only bathrooms, stalls and bulletin boards) | ||
TYPE: Information/Education about condom efficacy and use; Resource provision (included take-away information cards and coupons redeemable for male and female condoms in a silk carrying case with lubricant and instructions for use). Described as social marketing | ||
DURATION: Not reported. The intervention was implemented during September 2004 to March 2005 but it is unclear whether implementation in the different neighbourhoods was simultaneous or staggered within this period | ||
THEORETICAL BASIS: Based on social marketing principles. Stated only that a theoretical framework to affect attitudes, knowledge and beliefs about female as well as male condoms guided the campaign | ||
STIs COVERED: STIs in general. | ||
GROUP 2: Comparison group (n = 6 neighbourhoods) | ||
YEAR STARTED: As Group 1. | ||
PROVIDERS: None (no intervention). | ||
SETTINGS: As Group 1. | ||
TYPE: None (no intervention). | ||
DURATION: None (no intervention). | ||
THEORETICAL BASIS: None (no intervention). | ||
STIs COVERED: None (no intervention). | ||
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Outcomes | Several outcomes were reported in different places on page 74 to be the primary outcomes: | |
Attitudes to condom use | ||
Intentions to use condoms | ||
Behaviour: | ||
- Ever having used male or female condoms for vaginal or anal sex; | ||
- Having used male or female condoms at last vaginal or anal sex; | ||
- The proportion of protected vaginal or anal sex acts in the past 90 days (No secondary outcomes were explicitly defined.) |
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Notes | COST DATA: Stated only that women were offered a $10 coupon to a local store for participation | |
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Risk of bias | ||
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Bias | Authors’ judgement | Support for judgement |
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Adequate sequence generation? | Low risk | Stated that the six campaign neighbourhoods were selected at random using a computer-generated program (no other details provided) |
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Allocation concealment? | Unclear risk | No information provided. |
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Blinding? All outcomes |
Unclear risk | No information provided. |
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Incomplete outcome data addressed? All outcomes |
Unclear risk | All randomised units were analysed. However, within the randomised units there were missing data and it is not stated whether or how, these were accounted for in the primary analysis (permutation tests) . (Stated that missing data were imputed in a secondary regression-based analysis; however data were not extracted as not reported separately by study groups). In summary, it is unclear whether there was imbalance within the study groups and, if present, whether this would lead to risk of bias |
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Free of selective reporting? | High risk | Results are presented only for ever using a female condom (no information provided on male condom use or condom use for last sex or for last 90 days) |
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Free of other bias? | High risk | There was contamination between intervention and comparison neighbourhoods which may have biased the results (see ‘Methods’ and ‘Participants’ above) |