title: Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections.
abstract: BACKGROUND
  Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most frequent causes of bacterial sexually transmitted infections (STIs). Management strategies that reduce losses in the clinical pathway from infection to cure might improve STI control and reduce complications resulting from lack of, or inadequate, treatment.
  
  
  OBJECTIVE
  To assess the effectiveness and safety of home-based specimen collection as part of the management strategy for Chlamydia trachomatis and Neisseria gonorrhoeae infections compared with clinic-based specimen collection in sexually-active people.
  
  
  METHODS
  We searched the Cochrane Sexually Transmitted Infections Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS on 27 May 2015, together with the World Health Organization International Clinical Trials Registry (ICTRP) and ClinicalTrials.gov. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
  
  
  METHODS
  Randomized controlled trials (RCTs) of home-based compared with clinic-based specimen collection in the management of C. trachomatis and N. gonorrhoeae infections.
  
  
  METHODS
  Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We contacted study authors for additional information. We resolved any disagreements through consensus. We used standard methodological procedures recommended by Cochrane. The primary outcome was index case management, defined as the number of participants tested, diagnosed and treated, if test positive.
  
  
  RESULTS
  Ten trials involving 10,479 participants were included. There was inconclusive evidence of an effect on the proportion of participants with index case management (defined as individuals tested, diagnosed and treated for CT or NG, or both) in the group with home-based (45/778, 5.8%) compared with clinic-based (51/788, 6.5%) specimen collection (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.29; 3 trials, I² = 0%, 1566 participants, moderate quality). Harms of home-based specimen collection were not evaluated in any trial. All 10 trials compared the proportions of individuals tested. The results for the proportion of participants completing testing had high heterogeneity (I² = 100%) and were not pooled. We could not combine data from individual studies looking at the number of participants tested because the proportions varied widely across the studies, ranging from 30% to 96% in home group and 6% to 97% in clinic group (low-quality evidence). The number of participants with positive test was lower in the home-based specimen collection group (240/2074, 11.6%) compared with the clinic-based group (179/967, 18.5%) (RR 0.72, 95% CI 0.61 to 0.86; 9 trials, I² = 0%, 3041 participants, moderate quality).
  
  
  CONCLUSIONS
  Home-based specimen collection could result in similar levels of index case management for CT or NG infection when compared with clinic-based specimen collection. Increases in the proportion of individuals tested as a result of home-based, compared with clinic-based, specimen collection are offset by a lower proportion of positive results. The harms of home-based specimen collection compared with clinic-based specimen collection have not been evaluated. Future RCTs to assess the effectiveness of home-based specimen collection should be designed to measure biological outcomes of STI case management, such as proportion of participants with negative tests for the relevant STI at follow-up.
authors.affiliation: Clinical Research Institute, Faculty of Medicine, Universidad Nacional de Colombia, KR 30 45 03, Bogota, Colombia.
authors.forename: Luisa
authors.initials: L
authors.lastname: Fajardo-Bernal
authors.forename: Johanna
authors.initials: J
authors.lastname: Aponte-Gonzalez
authors.forename: Patrick
authors.initials: P
authors.lastname: Vigil
authors.forename: Edith
authors.initials: E
authors.lastname: Angel-Müller
authors.forename: Carlos
authors.initials: C
authors.lastname: Rincon
authors.forename: Hernando G
authors.initials: HG
authors.lastname: Gaitán
authors.forename: Nicola
authors.initials: N
authors.lastname: Low
mesh_terms: D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000302:isolation & purification*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification*; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D012648:Self Care / Q000379:methods / Q000706:statistics & numerical data; D013048:Specimen Handling / Q000379:methods* / Q000706:statistics & numerical data