Social-Psychological Intervention to Improve Adherence to HAART

NCT00716040 | Unknown

• 1 other identifier: FAPESP 2006-61277-6
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS; HIV Infections

Keywords

AIDS treatment; HAART adherence; intervention

Outcome Measures

Primary Outcomes (1)

• Adherence to HAART

  24 weeks

Secondary Outcomes (1)

• Viral Load

  12 and 24 weeks

Study Arms (2)

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

Control

OTHER

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

Other: Usual care

Interventions

Social-psycho intervention to improve adherence to HAART BEHAVIORAL

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.

Intervention

Usual care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Centro de Referência e Treinamento DST/AIDS

São Paulo, São Paulo, 04121-000, Brazil

Location

Related Publications (1)

• Basso CR, Helena ET, Caraciolo JM, Paiva V, Nemes MI. Exploring ART intake scenes in a human rights-based intervention to improve adherence: a randomized controlled trial. AIDS Behav. 2013 Jan;17(1):181-92. doi: 10.1007/s10461-012-0175-4.

  PMID: 22527264 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Maria Ines B Nemes, PhD

  Faculty of Medicine -University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Ernani T Santa Helena, PhD

  Regional University of Blumenau

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 16, 2008

Record last verified: 2008-07

Locations

BR (1)