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

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
Participants Inclusion criteria
  • Women 16 years and older

  • CT positive


Exclusion criteria
  • Pregnant or women trying to conceive

  • Women who are planning to move in the following 3 months

  • Currently living outside the study areas

  • Inability to understand spoken English adequately

  • Self‐reported HIV infection, other serious illnesses or disability

  • Self‐reported allergy to macrolide antibiotics such as azithromycin

  • Referrals from providers or clinics other than the STD or family planning clinics, unless women are re‐tested at the STD clinics and test positive for chlamydia


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
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
Outcomes
  • Rescreening 3 months after treatment (189/639)(120/653)

  • Reinfection (29/189)(27/120)

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
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