Social-Psychological Intervention to Improve Adherence to HAART
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Adherence to HAART
time frame: 24 weeks
time frame: 12 and 24 weeks
Male or female participants at least 18 years old.
- Patients aged more than 18 years old, with detectable viral load and more than six months under HAART
- 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
|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|
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