Social-Psychological Intervention to Improve Adherence to HAART

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial

Conditions
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AIDS, HIV Infections

Intervention / Treatment
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* Behavioral: Social-psycho intervention to improve adherence to HAART
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Other: Control<br>The control group will be submitted to the usual care of the health service. | Other: Usual care<br>* The control group will be submitted to the usual care of the health service<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to HAART |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load |  | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS treatment, HAART adherence, intervention