Skip to main content
. 2013 Oct 3;2013(10):CD002843. doi: 10.1002/14651858.CD002843.pub2

Schwebke 2010.

Methods Setting: Jefferson County Department of Health in Birmingham, AL, US
Enrolment: participants were enrolled between February 2003 and June 2008
Follow‐up: index patients were asked to return to clinic 5‐9 days after enrolment for a "test of cure". Follow‐up visits to detect repeat infections were performed at the clinic, 1 and 3 months after "test‐of‐cure". At these visits an examination was performed, including culture for Trichomonas vaginalis and a follow‐up questionnaire completed
Participants 484 index patients with Trichomonas vaginalis were randomised
Inclusion criteria
  • Women

  • Aged 19 years and older

  • Culture or wet prep positive for trichomonas


Exclusion criteria
  • Infection with other STI pathogens

  • Pregnancy

  • Currently breast feeding

  • Recent (8 hours) ingestion of alcoholic beverages or intention to do so in next 24 hours

  • Allergy to metronidazole

  • Presence of sexual partner in the clinic during enrolment

  • History of referral by a partner already treated for trichomoniasis

  • Report of more than 4 sexual partners in the preceding 30 days

Interventions Simple patient referral (n = 160)
Simple patient referral: usual care ‐ index patient were given a standard message on the importance of PN and asked to tell partners to come for treatment. If the partner did present to the clinic they were offered participation in the male substudy
Contract referral (n = 162)
Index patients were interviewed by a DIS who took the details of partners of previous 60 days, then entered in to a verbal contract with DIS to refer their partners to the clinic for treatment, partners were telephoned within 1‐2 days of index patient's enrolment. The partners were informed that they will be eligible for remuneration if participate in male study. If treatment of partner could not be verified within 2 working days the DIS attempted to notify partner by telephone or field visits
EPT (n = 162)
Index patients were given medication for up to 4 partners. The index patients were also given a list of contraindications of the medication and a 24‐hour phone number for partners if they had any questions regarding medication, indications for therapy and further evaluation of symptoms
Outcomes
  • Re‐infection rates 1 and 3 months post‐treatment (In clinic follow‐up visit where examination and culture were performed)

Notes Ethical approval by the Institutional Review Boards of the University of Alabama and the Jefferson County Department of Health
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details given
Allocation concealment (selection bias) Unclear risk No details given
Incomplete outcome data (attrition bias) 
 All outcomes High risk There were data available on 296/484 (61%) index patients at 1‐month follow‐up and 194/484 (40%) participants completed the study
Selective reporting (reporting bias) Low risk Protocol available from trial registries. In the protocol, the only outcome was the recurrence of trichomonas in index patient at 6 weeks. In the trial, the authors reported re‐infection in index patient at 1 and 3 months post treatment
Other bias Low risk Study authors planned to recruit 330 participants in each arm but after 4 years were only able to recruit about 50%. Early stopping due to lower than expected recruitment rate are not considered to be prone to bias
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participant and personnel not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No blinding. The primary outcome was repeat infection in index patient ‐ an objective outcome measure (positive culture or presence of motile trichomonads microscopically)