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Table 2 List of study instruments, data elements and source of information

From: Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes – a randomised controlled trial protocol

Data collection instruments

Time period

Data collected

Source

Screening questionnaire

Day of enrolment

Eligibility assessment

Self-report

Participant assessment

Baseline 3, 6, and 12 month follow up

Demographic information, alcohol consumption, social problem solving styles, motivation/readiness to change, antiretroviral therapy (ART) history, adherence to ART, psychosocial factors associated with ART adherence (disclosure, HIV/AIDS stigma, social support, adherence self-efficacy), alcohol and ART beliefs, HIV-related factors (e.g. degree of ill-health between HIV diagnosis and ART initiation), clinical/structural factors (e.g. length of time to doctor), physical functioning (e.g. limitations due to physical health, bodily pain, vitality), general physical well-being, mental well-being, drug and tobacco use

Self-report

Laboratory report form

Baseline, 3, 6, 12 month follow up

HIV-related outcomes: viral load (baseline and 12-month follow up assessments only) and CD4 counts

Laboratory report

Alcohol biomarkers: Posphatidylethanol (PEth)

Process evaluation interview schedule

12-months follow-up

A randomly selected 10% subsample will respond to a qualitative interview regarding impressions of the degree to which the intervention helped or hindered behaviour change

Self-report