Moyo 2002.
Methods |
Setting: 2 large public STI clinics in Harare, Zimbabwe Enrolment: index patients were consecutively recruited from July to September 2000. Follow‐up: index patient was interviewed for 15 minutes at the routine 1‐week clinic follow‐up visit |
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Participants | 272 index patients (135 men and 137 women) with a syndromically diagnosed bacterial STI were randomised Inclusion criteria
Exclusion criteria
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Interventions | All index patients completed a standard STI treatment and counselling consultation, a clinic nurse or doctor explained the objectives and procedure. The same gender counsellor explained the basic procedure to all, then conducted the 30‐minute baseline interview with each patient. All participants were given reminder cards to visit the study counsellor for a 15‐minute follow‐up interview when returning for routine 1‐week clinic follow‐up visit Patient referral with additional counselling session (n = 131) Counsellor conducted an additional individualised session with the index patient lasting approximately 30 minutes. Session included identification of likely sources and spread of STI, approaches to notification, role playing, motivating factors, barriers and domestic violence. Session also include health education. Index patients were also allocated coupons to give to partners for free treatment at the study clinic Simple patient referral (n = 141) Counsellor did a 30‐minute baseline interview with index patient. No coupons were given for partners free treatment |
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Outcomes |
Primary outcome
Secondary outcome
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Notes | Ethics approved by the Committee on Human Research at the University of California, San Francisco, and by the Medical Research Council of Zimbabwe Authors were contacted without success regarding discrepancies in numbers reported and distribution of harms in intervention arms |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation process not described |
Allocation concealment (selection bias) | Unclear risk | The nurse or doctor selected a sealed, opaque envelope from a box that randomly assigned the patient to intervention or control. Envelopes were constructed prior to any recruitment. An equal number of the allocation slips with the words 'intervention' or 'control' were placed in the box and manually mixed. All participants brought the envelope to the study counsellor, whereupon it was opened in the presence of both study counsellor and patient. Unclear whether these envelopes were sequentially numbered |
Incomplete outcome data (attrition bias) All outcomes | High risk | Self reported notification and referral of partners to treatment were assessed at follow‐up interview. 137/272 (50%) participants completed the follow‐up interview. ITT analyses were performed. However, the high loss to follow‐up is potentially a source of bias |
Selective reporting (reporting bias) | Low risk | Outcomes reported in methods section were reported in results section. No protocol available from trial registries |
Other bias | Low risk | No other bias identified The randomisation scheme produced approximately equivalent numbers in the intervention and control groups for men and women. Of note, people randomly allocated to the intervention arm were slightly older, more likely to be working in the formal economy, and more likely to be currently married or co‐habiting. These findings may indicate a problem with randomisation It may also be due to the small sample size that baseline differences occurred by chance |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. Index patient reports about PN can introduce bias The same study counsellor who did the counselling session did the 1‐week follow‐up interview ‐ this might have introduced detection bias |