AIDSSPIAH-QNCT00716040
Social-Psychological Intervention to Improve Adherence to HAART
A study testing Social-psycho intervention to improve adherence to HAART in people with AIDS and HIV Infections, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS, HIV Infections
- What is being tested?
- Social-psycho intervention to improve adherence to HAART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 18 years old, with detectable viral load and more than six months under HAART
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Referência e Treinamento DST/AIDS
São Paulo, São Paulo, 04121-000
About this study
Official title: Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial
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
- Being tested
- Social-psycho intervention to improve adherence to HAART, Usual care
- Keywords
- AIDS treatment, HAART adherence, intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social-psycho intervention to improve adherence to HAARTBehavioural
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.
Usual careOther
The control group will be submitted to the usual care of the health service
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to HAART
Measured: 24 weeks
Secondary outcomes (1)
Viral Load
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Maria Ines B Nemes, PhD, Principal investigator, Faculty of Medicine -University of Sao PauloErnani T Santa Helena, PhD, Study director, Regional University of Blumenau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716040
- Sponsor's protocol ID
- FAPESP 2006-61277-6
- Acronym
- SPIAH-Q
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2008
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22527264
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00716040
- Acronym / sponsor ID
- SPIAH-Q / FAPESP 2006-61277-6
- Conditions
- AIDS, HIV Infections
- Keywords
- AIDS treatment, HAART adherence, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Social-psycho intervention to improve adherence to HAARTThe intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional. |
| Control | Other | Other: Usual careThe control group will be submitted to the usual care of the health service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged more than 18 years old, with detectable viral load and more than six months under HAART
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social-psycho intervention to improve adherence to HAARTThe 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. | Behavioural | Intervention |
| Usual careThe control group will be submitted to the usual care of the health service | Other | Control |
Primary outcome
Adherence to HAART
Time frame: 24 weeks
1 secondary outcome
Viral Load
Time frame: 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
- Derived from this study: PubMed 22527264Basso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Ines B Nemes, PhD principal investigator
Faculty of Medicine -University of Sao Paulo
Ernani T Santa Helena, PhD study director
Regional University of Blumenau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social-psycho intervention to improve adherence to HAART in people with AIDS and HIV Infections, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to HAART (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00716040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2008.