Xu 2011.
Methods |
Setting: STI clinics and family planning clinics in New Orleans, Louisiana, St Louis, Missouri, and Jackson, Mississippi, United States
Study design: Parallel two arms. Enrollment between 2005 and 2007 Sample size estimation a priori: Yes |
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Participants |
Inclusion criteria
Exclusion criteria
Population Mean age 22 years. 1292 women with C. trachomatis infection were randomized to rescreening, 639 to home‐based strategy and 653 to clinic‐based strategy |
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Interventions |
Home‐based specimen collection (n = 639) Participants in home group were mailed a vaginal swab kit for self collection at home and they returned the sample via mail Clinical‐based specimen collection (n = 653) Participants in clinic group were given an appointment to return to clinics for rescreening for CT infection |
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Outcomes |
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Notes |
Funding sources: "Funded by Centers for Disease Control and Prevention" Role of funder: Not reported Declarations of interest: None declared It is unclear if all participants with positive test and their sexual partners were treated. Ethical approval was obtained from ethical committees of Louisiana State University Health Sciences Center, Washington University, University of Mississippi State Department of Health, and the CDC. All participants provided informed consent Number of identifier register: ClinicalTrials.gov NCT00132457 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "Women were randomly assigned... according to a random number generator... with a block size of 12" |
Allocation concealment (selection bias) | Low risk | Group allocation was concealed using sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding, the outcomes are likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | No subjective outcomes reported |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | It is not reported if the laboratory personnel or assessors were blinded |
Incomplete outcome data (attrition bias) Short‐term outcomes | High risk | In home‐based group 189/639 participants were tested and in clinic‐based group 120/653 were tested. More than 20% participants were not tested and the missing data were not balanced in the group |
Incomplete outcome data (attrition bias) Long‐term outcomes | Unclear risk | Only number of individuals not tested reported; however clearly information was not available to make a judgement |
Selective reporting (reporting bias) | Low risk | Protocol was available from trial registry. Primary outcome in protocol same as in trial |
Other bias | High risk | Reminders added to management strategy, also this study evaluated re‐testing |
CT = Chlamydia trachomatis
NG = Neisseria gonorrhoeae