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

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
Participants 272 index patients (135 men and 137 women) with a syndromically diagnosed bacterial STI were randomised
Inclusion criteria
  • Over the age of 18 years

  • Syndromically diagnosed bacterial STI seen on their first visit for treatment


Exclusion criteria
  • No criteria specified

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
Outcomes Primary outcome
  • Notification and referral of partners for treatment (as reported by index patient at follow‐up interview 1 week after treatment)


Secondary outcome
  • Adverse events ‐ physical and verbal abuse (as reported by index patient at follow‐up interview 1 week after treatment)

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
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