Berenson 2012.
Methods | Multisite, three‐arm, parallel group, RCT Location: Southeast Texas, USA Time frame: July 2006 to January 2010 Sample size calculation (and outcome of focus): N = 190 in each group (570 total) for 90% power to detect OR of 2.0 for OC continuation after 12 months |
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Participants | General with N: 1155 women, 16 to 24 years of age Source: 5 public clinics for reproductive health serving low‐income women Inclusion criteria:
Exclusion criteria:
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Interventions | Study focus: increasing contraceptive adherence and dual‐method use to prevent STI and pregnancy Intervention:
Comparison:
Duration: 6 months |
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Outcomes | OC adherence (consistent OC use), pregnancy (self‐report and medical record review) Follow‐up: 3, 6, 12 months |
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Notes | Trial registration: ClinicalTrials.gov NCT00584038 Funding: Trial was supported by grants from Maternal and Child Health Bureau, Health Resources and Services Administration, and Eunice Kennedy Shriver National Institute of Child Health & Human Development, National Institute of Health. Declaration of interest: no details provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization scheme (PLAN procedure, SAS Institute) |
Allocation concealment (selection bias) | High risk | When asked about concealment before assignment, investigator communicated that they did not conceal it from the researchers but did conceal it from the patient. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants due to nature of interventions |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Staff who made assessment telephone calls blinded to intervention group |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: by 12 months, counseling 44%, counseling + telephone 43%, and standard care 45% |
Selective reporting (reporting bias) | High risk | The secondary outcomes of measurement of contraceptive side effects and of sexual activity specified in the protocol registered with ClinicalTrials.gov were not reported in the published manuscript. |
Other bias | Low risk | Appeared free of other sources of bias |