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. 2016 Nov 23;2016(11):CD007249. doi: 10.1002/14651858.CD007249.pub5

Boyer 2005.

Methods Cluster randomized trial: platoons were assigned to study groups. Number of platoons not specified (likely about 30, given 50 to 75 recruits in each platoon and overall sample size)
Location: most likely California and South Carolina (USA)
Time frame: recruitment June 1999 to June 2000
 Sample size calculation (and outcome of focus): originally 477 per group to assess decreasing STI by 6%. Increased to 568 per group to address cluster effect, then increased to 1000 per group since half of participants would be stationed where STI and pregnancy screening not be possible at follow‐up.
Participants General with N: 2157 women
 Inclusion criteria: female Marine recruits in training
 Exclusion criteria: no mention
Interventions Study focus: preventing STI and unplanned pregnancy
Theory or model: Information‐motivation‐behavioral (IMB) skills model
  1. Treatment: 4 group sessions (2 hours each) at weeks 1, 2, 4, and 12 of 13‐week recruit training

  2. Comparison: same format; content addressed nutrition and physical performance, risk of sports or training injuries, risk and prevention of cervical and breast cancer


Duration: 12‐week intervention
Outcomes Primary: unplanned pregnancy (tested); frequency of condom use; frequency of contraceptive use
 Secondary: NA
Follow‐up: 14 months after baseline
Notes Additional data from investigator: number of events and group size for pregnancy and condom use
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers table established before study start
Allocation concealment (selection bias) Low risk Platoons identified prior to randomization; female Marine recruits in platoons eligible
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Platoons informed of group assignment after enrollment and baseline assessment; blinding not feasible due to type of intervention
Blinding of outcome assessment (detection bias) Unclear risk No mention
Outcome measures Unclear risk Unplanned pregnancy by test; contraceptive use by self‐report
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up: 38% loss for questionnaire data and 59% loss for pregnancy data (due to deployments); study groups were similar.
Other bias Low risk Analysis for cluster randomized trial: robust standard errors using Huber‐White sandwich estimator in regression models. Independent variables were intervention group, sexual history, and time between assessments.