Madhombiro 2019.
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Country: Zimbabwe Setting: tertiary HIV clinic Eligibility criteria: included were adults (18+ years) with problem drinking (AUDIT 6+ for females, 7+ for males) receiving HIV treatment. Excluded were individuals with cognitive impairment Informed consent: all participants provided informed consent Ethical approvals: Health Research Ethics Committee of the Stellenbosch University, the Medical Research Council of Zimbabwe, the Harare Hospital Ethics Committee |
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| Participants |
Sample size: 40 (20 motivational interviewing + CBT, 20 brief advice) Description of the target population: people living with HIV/AIDS Age: 39.5 (SD = 9.6) Sex: 42.5% female Race/Ethnicity: not reported Marital status: 52.5% married Harmful alcohol use (baseline): AUDIT=15.45 Co‐occurring disorders: 100% HIV‐positive |
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| Interventions |
Type: non‐pharmacologic Description: motivational interviewing + cognitive behavioral therapy: Personalized feedback, change talk, readiness to change, goal setting, dealing with cravings/cues, thinking errors, dealing with stress, and developing drinking refusal skills Duration and frequency: four sessions ranging from 30‐60 minutes each Delivery and provider: registered general nurses Comparison group: Brief advice (mhGAP) including an assessment of alcohol use history, brief advice on harmful alcohol use, and referral for probable alcohol dependence over a single session lasting approximately 60 minutes with a registered general nurse |
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| Outcomes |
Primary outcome(s): hazardous alcohol use Primary outcome measurement tool(s): AUDIT Secondary outcome(s): disability, Quality of life Secondary outcome measurement tool(s): WHODAS, WHOQOL Time points: 0, 3 months |
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| Notes |
Study funding and conflicts of interest: South African Research Chairs Initiative in PTSD, Department of Science and Technology; National Research Foundation; Partnership for Alcohol and AIDS Intervention Research, Stellenbosch University Linked study records: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A computer‐generated randomization schedule was used to assign participants to the two interventions." Pg. 3 |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel cannot be blinded for this type of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes reported by participant not blind to intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The retention rate was 77% at 3 months with no statistically significant group difference" |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |