Social-Psychological Intervention to Improve Adherence to HAART

Not Applicable

• Conditions: AIDS; HIV Infections
• Interventions: Behavioral: Social-psycho intervention to improve adherence to HAART; Other: Usual care

• Registration Number: NCT00716040
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-15
• Last Update Submitted: 2008-07-15
• Study First Posted: 2008-07-16
• Last Update Posted: 2008-07-16
• Primary Completion: 2008-09
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Social-psycho intervention to improve adherence to HAART	The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
Control	Usual care	The control group will be submitted to the usual care of the health service.

Primary Outcome Measures

Name	Time	Method
Adherence to HAART	24 weeks

Secondary Outcome Measures

Name	Time	Method
Viral Load	12 and 24 weeks

Trial Locations

Locations (1)

Centro de Referência e Treinamento DST/AIDS; 🇧🇷 Sao Paulo, Brazil