Effect of directly observed therapy for highly active antiretroviral therapy on virologic, immunologic, and adherence outcomes: a meta-analysis and systematic review.
BACKGROUND
Directly observed therapy of highly active antiretroviral therapy (DOT-HAART) is a feasible adherence intervention. Prospective DOT-HAART studies have shown mixed results, and optimal target groups have yet to be defined. We performed a meta-analysis and systematic review to assess the effect of DOT-HAART on adherence and virologic and immunologic response.


METHODS
We performed a comprehensive search through August 2009 to identify peer-reviewed controlled studies that involved outpatient DOT-HAART among adults and reported at least 1 outcome assessed in this meta-analysis. Random-effects meta-analyses were performed; differences in effect on virologic suppression were examined using stratified meta-analyses and meta-regression on several study characteristics.


RESULTS
Seventeen studies met inclusion criteria. Compared with control groups, DOT-HAART recipients were more likely to achieve an undetectable viral load (random effects risk ratio 1.24, 95% confidence interval (CI): 1.08 to 1.41), a greater increase in CD4 cell count (random effects weighted mean difference 43 cells/microL, 95% CI: 12 to 74 cells/microL), and HAART adherence of > or =95% (random effects risk ratio 1.17, 95% CI: 1.03 to 1.32). Results varied with respect to virologic response. DOT-HAART did not have a significant effect on virologic suppression when restricted to randomized controlled studies. Post-treatment effect was not observed in a limited number of studies.


CONCLUSIONS
DOT-HAART had a significant effect on virologic, immunologic, and adherence outcomes, although its efficacy was not supported when restricting analysis to randomized controlled trials. DOT-HAART shows greatest treatment effect when targeting individuals with greater risk of nonadherence and when delivering the intervention that maximizes participant convenience and provides enhanced adherence support. Further investigation is needed to assess the postintervention effect and cost-effectiveness of DOT-HAART.
Hart
Jessica E
JE
The Warren Alpert Medical School of Brown University, Providence, RI, USA.
Jeon
Christie Y
CY
Ivers
Louise C
LC
Behforouz
Heidi L
HL
Caldas
Adolfo
A
Drobac
Peter C
PC
Shin
Sonya S
SS
D023241:Antiretroviral Therapy, Highly Active / Q000379:methods / Q000523:psychology*; D018791:CD4 Lymphocyte Count; D016001:Confidence Intervals; D023801:Directly Observed Therapy / Q000379:methods / Q000523:psychology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000523:psychology / Q000821:virology; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D016017:Odds Ratio; D012307:Risk Factors; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects