Overview

This trial is active, not recruiting.

Conditions aids, hiv infections
Treatments social-psycho intervention to improve adherence to haart, usual care
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date March 2008
End date September 2008
Trial size 121 participants
Trial identifier NCT00716040, FAPESP 2006-61277-6

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
social-psycho intervention to improve adherence to haart
The intervention focus on the notion of scenes and scenarios to examine and discussing the experience of taking ARV medicines. In principle, such an approach provides a tool for conscientization, action and the invention of novel group and individual repertoires that may result in individual mobilization for improving adherence to treatment and reducing his/her vulnerability.
(Other)
The control group will be submitted to the usual care of the health service.
usual care
The control group will be submitted to the usual care of the health service

Primary Outcomes

Measure
Adherence to HAART
time frame: 24 weeks

Secondary Outcomes

Measure
Viral Load
time frame: 12 and 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial
Principal investigator Maria Ines B Nemes, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by University of Sao Paulo.