Methods | Randomised controlled trial conducted between December 2009 and March 2010. | |
Participants | Self‐reported HIV‐positive people (n=100) over 45 years of age (mean age 54) who participated in risky sexual behaviour (had engaged in one or more occasions of unprotected anal or vaginal intercourse in the past 3 months). Participants were recruited from five metropolitan areas: New York City, Atlanta, Philadelphia, Cincinnati and Columbus The majority were black (87%), and the remainder white (13%). 46% were female. Participants did not differ on any baseline demographic or clinical variables across the three study conditions. | |
Interventions | Participants were randomised to four sessions of telephone delivered motivational interviewing (n= 38), one session of telephone delivered motivational interviewing (n=39) or a control group (n=23) in which they received no motivational interviewing sessions. Participants in the four session MI group received four sessions of MI, in which a therapist aimed to explore the participants’ relationship dynamics, increase readiness to engage in condom‐protected sex, discuss and overcome barriers to condom use and improve clients’ confidence to engage in condom‐protected sex. Exactly what was included depended on the patients’ readiness to change. Participants in the one‐session MI group received the same intervention as the four session group, with the exception of treatment dose (one session as opposed to four sessions). Participants in the control group did not receive any active intervention, but were encouraged to seek support from their local AIDS service organisations, HIV‐related and other support groups, information websites, and any other resources available to them. No formal referrals to these services were made. |
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Outcomes | Outcomes were: the number of self‐reported non‐condom protected anal and vaginal sex acts in the last three months; and readiness to engage in condom protected behaviours (assessed by asking participants to endorse one of five statements which most represented their willingness to change). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Study quote: 'Prior to initiating the study, off‐site personnel utilized a random numbers table and weighted simple random assignment to generate the allocation sequence, yielding a 2 (1‐session MI): 2 (4‐session MI): 1 (control) ratio.' |
Allocation concealment (selection bias) | Low risk | Study quote: 'Immediately following the baseline interview, participants were assigned to one of three parallel study conditions using concealment of allocation procedures. Sealed, consecutively numbered, opaque envelopes prepared by off‐site personnel contained the randomly allocation conditions.' |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study quote: 'All research personnel were blind to participant condition prior to, and during, the baseline interview.' Blinding of participants was unlikely to be feasible in this study, but we do not think this will have affected the results. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study quote: 'Interviewers were blind to participant condition when conducting all interviews.' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participants in the four session MI group, three participants in the one session MI group, and zero participants in the control group did not complete six month follow‐up. Reasons were: unable to locate (n=2); dropped out of study (n=1); deceased (n=1); and too sick (n=1). |
Selective reporting (reporting bias) | Unclear risk | Protocol was unavailable to us. |