Directly Observed antiretroviral Therapy for people living with Human Immunodeficiency Virus (HIV) and Acquired ImmunDeficiency Syndrome (AIDS): a randomised controlled trial

ISRCTN ISRCTN48682427
DOI https://doi.org/10.1186/ISRCTN48682427
Secondary identifying numbers N/A
Submission date
01/01/2004
Registration date
02/03/2004
Last edited
06/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ricardo Kuchenbecker
Scientific

Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil

Phone +55 51 32688919
Email rsk@via-rs.net

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymDOT-AIDS
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHIV/AIDS
InterventionIntervention group:
Twice-weekly home visits performed by community-peer educators over a two month period. Thereafter, patients were visited once a week for four months. The purpose of the peer educators was to assist the patients in taking medication and provide information and support related to adherence, the importance of following physician recommendations and information related to healthy behaviour (e.g. safe sex, supportive measures related to stigma, and adherence strategies).

Control group:
Usual care provided by the outpatient clinics.
Intervention typeOther
Primary outcome measure1. Adherence to highly active antiretroviral therapy (HAART) at the end of the study (6 months)
2. Diseases progression
3. Occurence of AIDS-related disease/opportunistic infections
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2004
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. HIV-1 infected individuals
2. 18 years old or older
3. Starting antiretroviral therapy in three AIDS clinics in Porto Alegre (Brazil)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2004
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Brazil

Study participating centre

Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil

Sponsor information

Ministry of Health (Brazil)
Government

Ministério da Saúde
Secretaria de Políticas de Saúde
Coordenação Nacional de DST e Aids
Grupo Matricial de Pesquisa e Vacinas
W3 Norte - SEPN 511 - Bloco C
Brasilia
70750-537
Brazil

Phone +55-51-4488121
Email aids@aids.gov.br
Website http://portal.saude.gov.br/portal/saude/default.cfm
ROR logo "ROR" https://ror.org/02y7p0749

Funders

Funder type

Government

Ministry of Health (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan