Petersen 2014.

Study characteristics
Methods	Study design: cluster‐RCT  Duration of study: intervention was conducted in a 6‐month period between 2012 and 2013
Participants	Country: South Africa  Income classification: upper‐middle income between 2012 and 2014  Geographical scope: study was conducted at a public clinic in the KwaZuluNatal Province in a periurban area outside of Durban in the eThekwini District, situated on the eastern seaboard of South Africa  Healthcare setting: PC facility  Mental health condition: depression  Population   1. Age: ≥ 18 years  2. Gender: both  3. Socioeconomic background: 70% to 80% not working  4. Inclusion criteria    a. Participants attending the dedicated ART (HIV anti‐retroviral treatment) clinic for treatment  b. 18 years age or older   c. Not requiring urgent medical attention   d. No difficulty with hearing, speaking, or cognition that would make interviewing difficult  e. Screened ≥ 8 on the SRQ‐20   f. Diagnosis of major depressive disorder (MDD)  g. Structured clinical interview  5. Exclusion criteria: not mentioned
Interventions	Stated purpose: to conduct a pilot randomised controlled trial (RCT) to evaluate potential effectiveness of an adapted group‐based HIV counsellor‐delivered intervention for treating depression in people living with HIV/AIDS  INTERVENTION (n = 17) Name: group‐based counselling adapted from a local group‐based interpersonal therapy (IPT) intervention  Delivered by: LHW Title/name of PW and number: lay HIV counsellors ‐ 6  1. Selection: lay HIV counsellors, historically funded by US President's Emergency Plan for AIDS Relief (PEPFAR) to provide health counselling and testing (HCT); based in most primary healthcare (PHC) clinics in South Africa   2. Educational background: not mentioned  3. Training: training was conducted by a clinical psychologist and a clinical psychology trainees. It took place over 4 days. The first 2 days involved training in micro‐counselling skills as well as in different ways of helping, viz psychoeducation, problem management, health thinking, and getting active. The second 2 days involved training in group‐based sessions that drew on the techniques learned during the first 2 days   4. Supervision: adopting the apprenticeship model, which has been shown to be the most appropriate training model within a task‐shifting approach in LMIC (Murray et al, 2011), lay HIV counsellors were supported through via weekly supervision sessions with clinical psychology trainees for the first 2 months, then on a monthly basis. Exposure to the intervention was measured through an attendance register  5. Incentives/remuneration: not mentioned  Intervention details  1. Duration/frequency: weekly for 8 weeks (8 sessions)  2. Content of intervention: each session comprised a number of steps starting with introducing a common trigger or exacerbating factor using a vignette. The second step involved asking participants who identify with the story to share their problem. The third step drew on problem management to address the triggers of depression and cognitive‐behavioural techniques for exacerbating factors, promoting healthy thinking in the case of negative intrusive thoughts, and managing behavioural activation for social isolation. The fourth step involved getting participants to identify problems that they were going to work on in the next week  CONTROL: treatment as usual (n = 17) Non‐treatment group received normal standard of care, which included counselling services provided by HIV counsellors  CO‐INTERVENTIONS: nil
Outcomes	Patients  1. PHQ‐9 2. HSCL‐25 3. MSPSS   Carers  Nil  Process/health workers 1. Qualitative process evaluation, e.g. to explore poor uptake, dropout, and loss to follow‐up rates  Economic outcomes  Nil  Time points: baseline, 3 months *post baseline (*1 month post intervention, as the intervention was 8 weeks long)
Notes	Source of funding: Health Economics and HIV/AIDS Research Division (HEARD) at University of KwaZulu‐Natal, South Africa  Notes on validation of instruments (screening and outcomes): all validated, with resulting item reductions: PHQ‐9 item 8 removed, HSCL‐25 items 13,15, 23, 24 removed, and MSPSS items 8, 12 removed, but not sure how this impacted scoring and cutoffs  Additional information: declarations of interest ‐ study authors declared no conflicts of interest Handling the data: as per footnotes in data and analysis  Prospective trial registration number: none stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Following recruitment of the final sample, participants were allocated to an intervention and control arm using computer generated random allocation by the third author, who had no knowledge of the participant scores"
Allocation concealment (selection bias)	Low risk	Study author who performed random sequence generation did not have knowledge of participants' baseline scores
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Not possible to blind participants and personnel to the intervention; unlikely to affect outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	"Follow up outcome evaluation...was administered by 3 independent fieldworkers who were not informed whether the participants were fewer in the intervention or control arms"
Baseline outcome measurements similar	Low risk	Independent sample t‐tests showed no significant differences at baseline between intervention and control group mean scores on PHQ‐9, HSCL‐25, and MSPSS measures
Baseline characteristics similar?	Low risk	Chi‐square (χ2 ) analysis did not reveal any significant differences in demographic characteristics between intervention and control arms
Incomplete outcome data (attrition bias) Efficacy data	High risk	Around half of initial participants were lost to follow‐up
Protection against contamination	Unclear risk	Study takes place in 1 clinic
Selective reporting (reporting bias)	Unclear risk	No published clinical trial protocol available; outcomes declared at beginning of the study are reported at the end
Other bias	Unclear risk	This is a pilot study; the sample size is small