Brown 2011.
Methods |
Setting: 2 hospitals in Malawi, outpatient STI clinics Enrolment: participants enrolled from 2 October 2008 to 2 September 2009 Follow up: 2 weeks after initial diagnosis follow‐up was scheduled but authors did not report number of index patients returning for follow‐up |
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Participants | 240 newly diagnosed HIV‐positive men (n = 100) and women (n = 140) from 2 Malawian hospitals were randomised Inclusion criteria
Exclusion criteria
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Interventions | All index patients were provided with referral cards, all counselled on importance of safe sex behaviour, staged according to WHO, blood drawn for CD4 count Simple patient referral (n = 77) Index patients notify partners themselves Contract referral (n = 82) Index patients were given 7 days to notify their partners after which a healthcare provider contacted partners, who had not reported to the clinic, for counselling and testing Provider referral (n = 81) Notification of partners within 48 hours by community outreach workers who were trained HIV testing counsellors or nurses |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | Authors did not report the number of index patients who came for 2‐week follow‐up. Authors were contacted but data from Malawi on 2‐week follow‐up were not available Ethics approval from Institutional Review Board at the University of North Carolina, Chapel Hill and the National Health Sciences Research Committee in Malawi Power was set at 85% to detect an absolute difference of 25% between passive referral and the 2 active referral study arms ‐ therefore need 80 index patients in each arm ‐ respective arms had 77, 82, 81 therefore sufficient |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised using a permuted block design with randomly allocated block sizes of 6, 9 and 12 stratified by sex and study site |
Allocation concealment (selection bias) | Low risk | Was concealed in a sealed envelope until the end of the enrolment visit (after all partner data and locator information had been collected) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Clinic visit and test outcome data were available for each partner of every index patient who was randomised Harms ‐ number of index patients returning for 2‐week follow‐up was not given, therefore, loss to follow‐up cannot be calculated |
Selective reporting (reporting bias) | Low risk | Outcome for each partner of every index patient who was randomised was available. Protocol not available in 3 trial registries |
Other bias | Low risk | No other bias identified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Personnel not blinded to which group index patient or partner belonged ‐ partner identified if presented with a patient referral card or if their name was found on the log. Index patient returned 2 weeks after enrolment and were asked if partners were notified, how they were notified and what their behaviour was like (harms). HIV antibody‐negative or antibody‐indeterminate specimens were tested for the presence of HIV RNA using the ultrasensitive Roche Amplicor Monitor HIV RNA assay. Primary outcome low risk |