From: The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol
Variable/Outcome | Hypothesis | Outcome Measure | Methods of Analysis |
---|---|---|---|
1) Primary | Intervention improved outcome from baseline to 6 months | Â | Â |
a) Adherence at 12 months | Â | Percent adherence in previous 30 days >95% [binary] | Chi-squared test |
b) Suppression of HIV viral load at 12 months |  | Viral load ≤400 copies/ml [binary] | Chi-squared test |
2) Secondary Adherence percentage at 12 months | improvement occurred | Adherence % (>95%) [binary] | Chi-squared test |
HIV viral load at 12 months | improvement occurred | Viral load (copies) | T-test |
Immune reconstitution (change in CD4 T cell count from baseline) | improvement occurred | Cd4 T-cells/mm3 (continuous) | T-test |
Time to virological failure | Improvement occurred | Virological failure after successful suppression | Kaplan-Meier survival analysis |
Weight gain [lbs] and BMI | improvement occurred | Change in weight (lbs) and BMI [continuous] | T-test |
Occurrence of opportunistic infections (OIs) | improvement occurred | Presence of AIDS defining opportunistic infection [binary] | Chi-squared test |
Time to reporting of adverse drug events (ADEs) | improvement occurred | Presence of drug-related adverse event [time to event] | Kaplan-Meier survival analysis |
Deaths (all cause) | improvement occurred | All-cause mortality [binary] | Chi-squared test and Kaplan-Meier survival analysis |
SF-12 | improvement occurred | Quality pf life questionnaire [continuous] | T-test |
Satisfaction with care provided | improvement occurred | Questionnaire [continuous] | T-test |
Level of disclosure of HIV status | improvement occurred | Disclosed to a family member [binary] | Chi-squared test |
Impression of stigma | improvement occurred | Questionnaire [continuous] | T-test |
Family dyamics | improvement occurred | Questionnaire [continuous] | T-test |
Employment attendance | improvement occurred | Questionnaire [continuous] | T-test |
Household member school attendance | improvement occurred | Questionnaire [continuous] | T-test |
Cell phones lost/stolen | improvement occurred | Presence of cellphone [binary] | Poisson regression |
Stopped taking HAART | improvement occurred | Self-report [binary] | Chi-squared test |
Required active tracing for 12 month follow-up | improvement occurred | Field officers [binary] | Chi-squared test |
3) Subgroup Analyses: | Â | Â | Regression methods with appropriate interaction term |
   Urban vs. rural | Distance affects adherence |  |  |
Female vs. male | Sex affects adherence | Â | Â |
Phone ownership (owned vs. shared) | Ownership affects adherence | Â | Â |
Level of education | Low education affects adherence | Â | Â |
4) Sensitivity Analyses: | improvement occurred | All outcomes | Â |
   a) Per protocol analysis |  |  |    a) Chi-squared/T-test test |
   b) Adjusting for baseline covariates |  |  |    b) Multivariable regression |
   c) clustering among individuals within a clinic |  |  | c) GEE |