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Table 2 Primary and secondary outcomes

From: Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial

Outcome measures

Outcomes

Primary outcomes

HIV viral load (chart-abstracted HIV RNA)

Undetectable viral load (binary) (primary) Log change in viral load from baseline (continuous)

Dose-taking adherence (MEMS)

Took at least 85 % of prescribed doses (binary) (primary) Percentage of prescribed doses taken (continuous)

Secondary outcomes

Dose-timing adherence (MEMS)

Percentage of prescribed doses taken in correct time window (±2 h for twice-daily regimens and ±3 h for once-daily regimens) (continuous) Took at least 85 % of prescribed doses on time (binary)

Dose-taking adherence (self-report)

Percentage of prescribed doses taken in past 7 days (continuous) Took at least 85 % of prescribed doses (binary) Visual analogue scale rating from 0 % to 100 % adherence over past 30 days

Dose interruptions (MEMS data)

Number of >48-h interruptions

Clinic attendance (chart abstract; self-report)

Number of attended and missed clinic appointments in past 6 months

CD4 count (chart-abstracted)

Change from baseline

  1. MEMS Medication Event Monitoring System