Nuwaha 2001.
Methods |
Setting: Mulago Hospital STI clinic in Kampala, Uganda treats patients free of charge. Clinic is the main STI reference centre, mainly serves as a walk‐in primary care STI treatment centre Enrolment: consecutive patients with STI symptoms enrolled between November 1999 and January 2000 Follow‐up: index patients were asked to return to the clinic within 2 weeks |
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Participants | 383 index patients (196 men, 187 women) with STI symptoms were randomised Inclusion criteria:
Exclusion criteria
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Interventions | All index patients were given information, education and communication for 5‐10 minutes. Trained research assistants performed interviews using a pre‐tested questionnaire Simple patient referral (n = 191) Index patients were given contact slips to take to sexual partners. Index patient asked to return 2 weeks later EPT (n = 192) Index patients were given medications to take to sexual partners. Index patient were asked to return after 2 weeks. Index patients were request to return medication if their partners refused them or if they could not trace the partner |
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Outcomes |
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Notes | Ethics approval by Mbarara University, the Faculty of Medicine Research Committee, the Uganda AIDS Committee, the Uganda National Council for Science and Technology, and the Ethics Research Committee at Karolinska Institute (Stockholm, Sweden). Permission to conduct the study was obtained from the Mulago Hospital administration | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number between 0 and 999; even numbers to EPT group, and odd numbers were assigned to the patient‐based partner referral group. Stratified randomisation according to the sex of the index patient was used |
Allocation concealment (selection bias) | Unclear risk | No detail of allocation concealment given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis was used. In EPT, 187/192 (97%) index patients returned after 2 weeks and in simple patient referral 117/191 (61%) returned. On return, participants reported on partner treatment and partner reaction. Attrition bias in the simple patient referral arm |
Selective reporting (reporting bias) | Low risk | Outcomes reported in methods section were reported in results section. Protocol not available from 3 trial registries |
Other bias | Unclear risk | Partners of participants in simple patient referral group could have been treated elsewhere leading to misclassification bias |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Partners in simple patient referral group returned coded slips. Clinic workers checked clinic records for all patients who said they had been referred by a partner to attempt to link them to an index patient. In addition, they collected reports from index patients on partner referral (not analysed in this review) In the EPT participants, the outcome was index patient reports whether partner took medication. This can introduce detection bias |