Lippman 2007.
Methods |
Setting: Low‐income clinic population in São Paulo, Brazil
Study design: Parallel two arms. Enrollment between April and November 2004 Sample size estimation a priori: No |
|
Participants |
Inclusion criteria
Exclusion criteria
Population Mean age 27.6 years 818 women were randomized, 410 to home‐based strategy and 408 to clinic‐based strategy for CT, TV and NG detection |
|
Interventions |
Home‐based specimen collection (n = 410)
Participants in home group received a kit to take the CT, NG and TV test at home, then in the following 7 days they had to return the sample to study clinic. They also had a questionnaire on acceptability.
Clinical‐based specimen collection (n = 408) Participants in clinic group received an identical kit with STI information and an appointment card for testing at the study clinic. Additionally during the appointment a pelvic examination was performed and two endocervical samples collected. Afterwards they answered a questionnaire on acceptability. |
|
Outcomes |
|
|
Notes |
Funding sources: "this study was funded by the Office of Population and Reproductive Health, Bureau for Global Health, U.S. Agency for International Development" Declarations of interest: Not reported Role of funder: Not reported Ethical approval was obtained from ethical committees of the Irmandade Santa Casa de Misericórdia de São Paulo, the Brazilian National Ethics Committee and the Population Council. All participants provided informed consent Number of identifier register: Not found |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "identification numbers were randomized before study commencement in blocks of 16" |
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 | There is not sufficient information to permit judgement |
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 | Low risk | Participants tested in home‐based group were 393/410 and 394/408 in clinic‐based group |
Incomplete outcome data (attrition bias) Long‐term outcomes | Unclear risk | Only one long‐term outcome was evaluated, number of individuals not tested; however clearly information was not available to make a judgement |
Selective reporting (reporting bias) | Unclear risk | Protocol was not available from 3 trial registries. No information available in methods section to make a judgement |
Other bias | High risk | Reminders added to management strategy |