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. 2015 Sep 29;2015(9):CD011317. doi: 10.1002/14651858.CD011317.pub2

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
  • Women, aged 18 to 40 years

  • Ability to read and to follow collection and testing instructions


Exclusion criteria
  • Not specified


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
  • Test completed (393/410)(394/408)

  • Feasibility and acceptability of testing

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