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. 2013 Oct 3;2013(10):CD002843. doi: 10.1002/14651858.CD002843.pub2

Kissinger 2005.

Methods Setting: public STI clinic in New Orleans, US
Enrolment: participants enrolled from December 2001 to March 2004
Follow‐up: index patients were asked to return 4 weeks after the initial clinic visit (with a window of 2‐8 weeks) for a follow‐up interview and a urine specimen
Participants 977 index patients with diagnosis of urethritis were randomised
Inclusion criteria
  • Male

  • Diagnosis of urethritis

  • Test positive for Chlamydia trachomatis or Neisseria gonorrhoeae

  • 16‐44 years old

  • At least 1 female sexual partner who did not accompany them to clinic


Exclusion criteria
  • No criteria specified

Interventions Simple patient referral (n = 285)
Index patients were instructed to tell their partners that they needed to go to either the public STI clinic or the clinic of their choice for STI evaluation and treatment
Patient referral booklet enhanced (n = 348)
Index patients were given a wallet‐sized booklet that contained 4 tear‐out cards with information for the partner and treatment guidelines for professionals. If they had more than 4 partners they were given additional booklets
EPT (n = 344)
Index patients were given packages containing medication, written instructions about how to take medication, warning about adverse effects, 24‐h nurse's pager number to call if any enquiries and asked to give package to each of their partners
Outcomes Primary outcome
  • Proportion of partners who received antibiotic treatment (self report by index patient)


Secondary outcome
  • Recurrence of C. trachomatis and N. gonorrhoeae in index patient (urine sample or urethral swab collected at follow‐up interview)

  • Behavioural outcome ‐ partners treated (self report)

  • Sexual outcome ‐ unprotected sex before partner treatment, re‐initiated sex with baseline partner, unprotected sex with any partner (self report)

Notes Institutional review board approval was obtained from all participating institutions
Authors were contacted for statistical analysis (sample size calculations, power) details and exact numbers, authors replied that sample size calculations were performed, but could not provide exact details
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by month in which they attended the clinic to 1 of 3 study arms. Randomisation of months was conducted using a blocked scheme of 3 to 6 units using Microsoft Excel software
Allocation concealment (selection bias) Unclear risk No information given
Incomplete outcome data (attrition bias) 
 All outcomes High risk 770/977 (79%) participants returned for follow‐up interview but only 37.5% were retested. At follow‐up interview, index patients were asked outcome questions for each partner. Outcome of interest was the response to the question: "Did baseline partner tell you that he or she took the medicine?"
Selective reporting (reporting bias) Unclear risk Same outcomes in the methods section (re‐infection index patient and partners treated) were reported in the results section. With additional sexual outcomes (unprotected sex before partner treatment, re‐initiated sex with baseline partner, unprotected sex with any partner) not stated in the methods section. Protocol not available from 3 trial registries
Other bias Low risk No other bias identified
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participant and personnel not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The 1‐month interview was performed either by computer‐assisted self interview or study staff
The outcomes were assessed by an interview either computer‐assisted self interview (24.3%), telephonic (35.4%) or face‐to‐face (40.2%). The interviewer was not blinded. An in‐person interview has the potential for information bias.
No details given whether laboratory personnel were blinded but outcome measure was objective