Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial

University of Sao Paulo1 site in 1 country121 target enrollmentMarch 2008

ConditionsAIDS HIV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: AIDS
Sponsor: University of Sao Paulo
Enrollment: 121
Locations: 1
Primary Endpoint: Adherence to HAART
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

All eligible patients will be invited to use electronic monitoring of medication (MEMS) during the next six months. After two months with MEMS the enrolled patients will be randomized to intervention group or to control group. The intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. The control group will receive the usual care of the health service.

The study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. The duration of the study will be of six months. The analysis will be based on "intention-to-treat.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

November 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

•Patients aged more than 18 years old, with detectable viral load and more than six months under HAART

Exclusion Criteria

•Pregnant women
•Patients participating in other trials
•Patients in treatment for hepatitis and for active opportunistic infection
•Patients with mental or physical condition which do not allow their attendance to the health service