Directly Observed Antiretroviral Therapy for Injection Drug Users With HIV Infection

Directly Observed Therapy Regimen

Patients were enrolled over a 3-month period and followed for 1 year after enrollment. After this time, they continued to attend the HIV clinic and receive HAART.

Patients eligible for directly observed therapy (DOT) were enrolled at a DTC, where their opioid dependence was stabilized and DOT was started. Patients were to attend the DTC daily and to be given their morning antiretroviral drugs under supervision, before receiving methadone. Patients were given a single dose of their evening medications to take at home. Over the initial 3-month period of DOT, patients were to attend on a daily basis. Once a patient was considered to be stable regarding methadone maintenance therapy and antiretroviral therapy, his or her daily visits to the DTC were tapered from once daily to 5 times weekly, 3 times weekly, twice weekly, and finally once weekly. On each visit, patients were given sufficient methadone and antiretroviral medication to last until their next appointment.

Baseline demographics of age; sex; CDC classification for HIV disease; previous antiretroviral therapies; and baseline, 3-month, 6-month, and 12-month CD4⁺ cell counts and HIV RNA levels (measured by polymerase chain reaction) were documented. The antiretroviral regimen prescribed and any adverse events deemed attributable to the regimen were noted.

Patients

All patients were active IDUs (injecting heroin at least once daily) and fulfilled standard criteria for commencing antiretroviral therapy. All enrolled patients provided informed consent.

Statistical Analysis

A Kruskal-Wallis test, followed by a Dunn multiple comparison test, was used to determine the statistical significance of the changes observed in CD4⁺ cell counts and HIV RNA levels. A P value of less than .05 was considered to be significant. Data were calculated using an intent-to-treat analysis (with all participants included in the group to which they were assigned, whether or not they completed the intervention given to the group) and an on-treatment analysis (with only those still participating in the group to which they were assigned included in the data analysis).

Methods
	Directly Observed Antiretroviral Therapy for Injection Drug Users With HIV Infection from The AIDS Reader ^® Susan Clarke, MD, MRCPI, Eamon Keenan, MD, MRCPsych, Mairin Ryan, PhD, Michael Barry, MD, PhD, Fiona Mulcahy, MD, FRCPI
	09/04/2002
	Methods Directly Observed Therapy Regimen Patients were enrolled over a 3-month period and followed for 1 year after enrollment. After this time, they continued to attend the HIV clinic and receive HAART. Patients eligible for directly observed therapy (DOT) were enrolled at a DTC, where their opioid dependence was stabilized and DOT was started. Patients were to attend the DTC daily and to be given their morning antiretroviral drugs under supervision, before receiving methadone. Patients were given a single dose of their evening medications to take at home. Over the initial 3-month period of DOT, patients were to attend on a daily basis. Once a patient was considered to be stable regarding methadone maintenance therapy and antiretroviral therapy, his or her daily visits to the DTC were tapered from once daily to 5 times weekly, 3 times weekly, twice weekly, and finally once weekly. On each visit, patients were given sufficient methadone and antiretroviral medication to last until their next appointment. Baseline demographics of age; sex; CDC classification for HIV disease; previous antiretroviral therapies; and baseline, 3-month, 6-month, and 12-month CD4⁺ cell counts and HIV RNA levels (measured by polymerase chain reaction) were documented. The antiretroviral regimen prescribed and any adverse events deemed attributable to the regimen were noted. Patients All patients were active IDUs (injecting heroin at least once daily) and fulfilled standard criteria for commencing antiretroviral therapy. All enrolled patients provided informed consent. Statistical Analysis A Kruskal-Wallis test, followed by a Dunn multiple comparison test, was used to determine the statistical significance of the changes observed in CD4⁺ cell counts and HIV RNA levels. A P value of less than .05 was considered to be significant. Data were calculated using an intent-to-treat analysis (with all participants included in the group to which they were assigned, whether or not they completed the intervention given to the group) and an on-treatment analysis (with only those still participating in the group to which they were assigned included in the data analysis).



Abstract and Introduction / Methods / Results / Discussion / Editorial Comment / Figures / Tables / References

Methods

Directly Observed Therapy Regimen

Patients

Statistical Analysis