Social-Psychological Intervention to Improve Adherence to HAART - Full Text View

Sponsors and Collaborators:	University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00716040

Purpose

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.

Condition	Intervention
AIDS HIV Infections	Behavioral: Social-psycho intervention to improve adherence to HAART Other: Usual care

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Adherence to HAART [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Viral Load [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.	Behavioral: 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.
Control The control group will be submitted to the usual care of the health service.	Other: Usual care The control group will be submitted to the usual care of the health service

Arms

Assigned Interventions

Intervention: Experimental

The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.

Behavioral: 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.

Control

The control group will be submitted to the usual care of the health service.

Other: Usual care

The control group will be submitted to the usual care of the health service

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716040

Locations

Brazil
Centro de Referência e Treinamento DST/AIDS
Sao Paulo, Brazil, 04121-000

Sponsors and Collaborators

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Principal Investigator:	Maria Ines B Nemes, PhD	Faculty of Medicine -University of Sao Paulo
Study Director:	Ernani T Santa Helena, PhD	Regional University of Blumenau

More Information

No publications provided

Responsible Party:	Faculdade de Medicina da Universidade de São Paulo ( Maria Ines Battistella Nemes )
Study ID Numbers:	FAPESP 2006-61277-6
Study First Received:	July 14, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00716040 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

AIDS treatment
HAART adherence
intervention

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 10, 2009