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 | ||

a) Adherence at 12 months | 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) SecondaryAdherence 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/mm^{3} (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:
| Regression methods with appropriate interaction term | ||

Urban vs. rural | Distance affects adherence | ||

Female vs. male | Sex affects adherence | ||

Phone ownership (owned vs. shared) | Ownership affects adherence | ||

Level of education | Low education affects adherence | ||

4) Sensitivity Analyses: | improvement occurred | All outcomes | |

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 |