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. 2014 Mar 30;2014(3):CD010915. doi: 10.1002/14651858.CD010915.pub2

Peipert 2008.

Methods Design: randomized controlled trial
Location: Rhode Island (USA); recruitment Oct 1999 to Oct 2003
 Sample size calculation (and outcome of focus): N=250 in each group to detect two‐fold increase in dual method use and 50% difference in unintended pregnancy.
Participants General with N: 542 women
 Source: primary care and family planning clinics
 Inclusion criteria: 13 to 35 years old, sex with man in past 6 months, desire to avoid pregnancy for 24 months; if age 25 to 35 years, then high‐risk history (unplanned pregnancy, STIs, inconsistent contraception use, > 1 sex partner in past 6 months, drug or alcohol abuse).
 Exclusion criteria: currently using dual methods of contraception consistently and correctly.
Interventions Study focus: STI and pregnancy prevention
 Theory or model: transtheoretical model
 Treatment: 3 sessions over 80 days; individually‐tailored, computer‐delivered; designed to move toward action and maintenance for dual‐method use and recycling through relapse.
 Comparison or control: 1 session, computer‐delivered, standard contraception and STI prevention information.
 Duration: return visits at 12 and 24 months.
Outcomes Dual‐method use (hormonal + barrier; male condoms + female condoms; condoms + spermicide; intrauterine device + barrier), initiated or sustained (reported at 2 or more interviews); consistent condom use; unplanned pregnancy (tested); STIs.
Notes Investigator communicated that the code book did not contain data on attitudes about dual‐method use as the report indicated; the manuscript must have contained an error.
An investigator noted that they assessed self‐efficacy for condom use and non‐condom contraceptive use separately.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer program; stratified by site and contraceptive use
Allocation concealment (selection bias) Unclear risk Computer allocated women after collecting baseline information; separate from executor of assignment (phone interviewer and nurse doing exams)
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No mention; presume none since blinding is not usually feasible for educational interventions.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Follow‐up evaluators were 'masked' to allocation as far as possible
Incomplete outcome data (attrition bias) 
 All outcomes High risk Losses to follow up: 26% by 24 months (groups had similar losses)
2011 paper: N=463; 15% had no follow‐up data
 Exclusions after randomization: no;
intent‐to‐treat analysis
Selective reporting (reporting bias) Low risk Not apparent