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

Kissinger 2006.

Methods Setting: the Orleans Women's Health Clinic in New Orleans, US
Enrolment: participants enrolled from December 2001 to August 2004
Follow‐up: participants were asked to return 4 weeks after the initial visit (with a window of 2‐8 weeks)
Participants 463 index patients with a culture‐confirmed diagnosis of Trichomonas vaginalis were randomised
Inclusion criteria
  • Women

  • Culture‐confirmed Trichomonas vaginalis diagnoses

  • Not in first trimester of pregnancy

  • No medical contraindication to take metronidazole or bringing metronidazole to partner

  • At least 1 male sexual partner in the last 60 days


Exclusion criteria
  • No criteria specified

Interventions Study staff counselled women in all study arms about T. vaginalis and the importance of partner treatment before randomisation
Simple patient referral (n = 155)
Index patients were instructed to tell their partners that they need to go to a clinic for STI evaluation and treatment
Booklet enhanced partner referral (n = 154)
Index patients were given a wallet‐sized booklet containing tear‐out cards with information for the partner and treatment guidelines for providers
EPT (n = 154)
Index patients were given packages for their partners, containing medicine, written instructions on how to take medicine, warnings about side effects and nurse's pager number for enquiries
Outcomes
  • Re‐infection rate of index patient (T. vaginalis culture)

  • PN (self report index patient ‐ interview)

  • Partner treatment (self report index patient)

  • Having unprotected sex before partner took medication (self report index patient)

  • Re‐initiated sex with baseline partner (self report index patient)

  • Unprotected sex with any partner (self report index patient)

  • Cost effectiveness

Notes Ethical approval from Institutional review board from Tulane University Health Sciences Center, CDC and the Louisiana Office of Public Health
Author was contacted and provided details on consent (oral) and exact numbers of how many women returned for follow‐up and testing. Details to what intervention arm the woman with re‐infection belonged to was also provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Blocked scheme of 3 or 6 units using Microsoft Excel
Allocation concealment (selection bias) Unclear risk Previously prepared envelopes. Not specified if these were sealed or identical
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 412/463 (89%) index patients were re‐interviewed (some interviews done by telephone, and, therefore, no sample submitted) but only 376/463 (81%) index patients were retested and re‐interviewed (data from author directly)
Selective reporting (reporting bias) Unclear risk Protocol available from trial registries
Outcomes stated in the protocol:
Primary ‐ Index patient report of partner taking medicine at 6‐8 weeks
Secondary ‐ Index patient re‐infection at 6‐8 weeks, cost‐effectiveness outcomes
Outcome reported in actual study:
Outcomes were not reported as primary and secondary. Additional sexual and behavioural outcomes reported Re‐interview scheduled for 4 weeks after treatment (window of 2‐8 weeks)
Outcome in method section same as results section but differs from protocol
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 No blinding
Although some outcomes were subjective, the outcome of interest in the telephone interview was the response to this question: "Did partner tell you that he took the medicine?" Different methods were used for outcome assessment (i.e. telephone or computer‐assisted self interview) that may have introduced detection bias, outcomes assessors were unlikely blinded
Assessment of T. vaginalis culture result was not blinded but is an objective outcome