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. |
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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. |
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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 |