Outcomes, measures and methods of analysis
| Outcome/variable | Hypothesis | Outcome measure | Method of analysis |
|---|---|---|---|
| Primary outcome | |||
| 12-month retention in care | Intervention>control | Attends12-month clinic appointment (10–14-month time frame) | χ2 test |
| Key secondary outcomes | |||
| Retention in stage 1 HIV care | Intervention>control | Attends clinic to receive CD4 results (within 3 weeks of positive HIV test) | χ2 test |
| Incremental cost-effectiveness ratio | Intervention>control | Cost per disability-adjusted life-year averted | Decision analytic model |
| Additional secondary outcomes | |||
| Timely initiation of ART | Intervention>control | Starts ART within 3 months of eligibility (for those eligible at baseline) | χ2 test |
| Time to ART initiation | Intervention>control | ART initiation after eligible (at baseline) | Kaplan-Meier survival analysis |
| 6-month retention in care | Intervention>control | Attends 6-month clinic appointment (5–7-month time frame) | χ2 test |
| Level of engagement | Intervention>control | ||
| Proportion of scheduled appointments kept | Intervention>control | Mean proportion of scheduled appointments attended | T-test |
| Satisfaction with care | Intervention>control | 5-point Likert scale item | Kruskal-Wallis test |
| Level of social support | Intervention>control | 5-point Likert scale item | Kruskal-Wallis test |
| Quality of life | Intervention>control | SF-12 PCS and MCS scores | T test |
| Death (all-cause) | Intervention>control | All-cause mortality (binary) | χ2 test |
| Subgroup analyses | Regression methods with appropriate interaction term | ||
| Female vs male | Female>male | ||
| Age | Younger>older | ||
| Shared vs own phone | Own phone>shared phone | ||
| Distance from clinic | ≤1 h > >1 h | ||
| ART-eligible vs ineligible | ART eligible>ineligible | ||
ART, antiretroviral therapy.