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 |
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Participants | 484 index patients with Trichomonas vaginalis were randomised Inclusion criteria
Exclusion criteria
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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 |
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Outcomes |
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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) |