Ellison undated.
Methods |
Setting: Alexandra Health Centre and University Clinic, a community health clinic and principle provider of health care to the township of Alexandra, South Africa Enrolment: participants enrolled from 23 June to 12 September 1997 Follow‐up: no follow‐up of index patient scheduled |
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Participants | 1719 index patients, 811 men and 908 females, with any STI syndromically diagnosed were enrolled Inclusion criteria
Exclusion criteria
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Interventions |
Simple patient referral (n = 433) Index patient received a standard clinical consultation given by a nurse and received a contact card to be given to partner Patient referral and health education message (n = 431) Index patient received a standard clinical consultation, contact card and standardised verbal health education message given by nurse Patient referral and counselling (n = 430) Index patient received a standard clinical consultation, contact card and patient‐centred counselling in a private room, conducted by trained lay‐counsellors of same gender Patient referral with health education message and counselling (n = 425) Index patient received a standard clinical consultation, contact card and both interventions (health education by the nurse and counselling by lay‐counsellors) |
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Outcomes |
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Notes | Ethical approval from Committee for Research on Human Subjects of the University of the Witwatersrand in Johannesburg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Each consecutive patient received an anonymous consecutive number ‐ no specific details on how these numbers were delivered |
Allocation concealment (selection bias) | High risk | Research nurse allocated alternate patients to 1 of 4 groups. Research nurse allocated alternate interventions to each consecutive patient according to a printed schedule (drawn up by project co‐ordinator). Authors acknowledge that research nurse could unwittingly or deliberately influence which patient received each intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low risk for main outcome, partner treated |
Selective reporting (reporting bias) | Low risk | Outcomes reported in methods section were reported in results section |
Other bias | Low risk | No other risk of bias identified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Personnel and participant not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The research personnel at the pharmacy and casualty unit who collected the PN slips were masked to which intervention the participant received Masked bivariate analysis, unmasked multivariate statistical analysis took place |