The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

Lester, Richard T; Mills, Edward J; Kariri, Antony; Ritvo, Paul; Chung, Michael; Jack, William; Habyarimana, James; Karanja, Sarah; Barasa, Samson; Nguti, Rosemary; Estambale, Benson; Ngugi, Elizabeth; Ball, T Blake; Thabane, Lehana; Kimani, Joshua; Gelmon, Lawrence; Ackers, Marta; Plummer, Francis A

doi:10.1186/1745-6215-10-87

Trials

Table 3 Variables, Measures and Methods of Analysis

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) 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:			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

IMPORTANT REMARKS:
• The GEE[11] is a technique that allows to specify the correlation structure between patients within a hospital and this approach produces unbiased estimates under the assumption that missing observations will be missing at random. An amended approach of weighted GEE will be employed if missingness is found not to be at random.[12]
• In all analyses results will be expressed as coefficient, standard errors, corresponding 95% and associated p-values.
• Goodness-of-fit will be assessed by examining the residuals for model assumptions and chi-squared test of goodness-of-fit.
Bonferroni method will be used to adjust the overall level of significance for multiple secondary outcomes.

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ISSN: 1745-6215

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