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
Scientific
Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil
| Phone | +55 51 32688919 |
|---|---|
| rsk@via-rs.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DOT-AIDS |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | HIV/AIDS |
| Intervention | Intervention 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 type | Other |
| Primary outcome measure | 1. 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 measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. HIV-1 infected individuals 2. 18 years old or older 3. Starting antiretroviral therapy in three AIDS clinics in Porto Alegre (Brazil) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil
91920-150
Brazil
Sponsor information
Ministry of Health (Brazil)
Government
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 |
|---|---|
| aids@aids.gov.br | |
| Website | http://portal.saude.gov.br/portal/saude/default.cfm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
