Counselling and entry into HIV care
| ISRCTN | ISRCTN94133652 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94133652 |
| Protocol serial number | MUSPH 06012009 |
| Sponsor | Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden) |
| Funder | Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden) |
- Submission date
- 01/06/2010
- Registration date
- 13/07/2010
- Last edited
- 17/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Fred Wabwire-Mangeni
Scientific
Scientific
Makerere University
School of Public Health
PO BOX 7072
Kampala
256
Uganda
| fwabwire@musph.ac.ug |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Longitudinal double-blind multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Assessing the effect of extended counselling on uptake and adherence to pre- antiretroviral care: A longitudinal, randomised controlled trial |
| Study acronym | pre-ARV |
| Study objectives | Extended counselling is associated with increased uptake and adherence to pre-antiretroviral therapy (ART) |
| Ethics approval(s) | 1. Makerere University School of Public Health Higher Degrees Research and Ethics Committee, 06/01/2009 2. Uganda National Council for Science and Technology |
| Health condition(s) or problem(s) studied | Pre-ARV care adherence |
| Intervention | Newly screened HIV positive persons will be followed and monitored for uptake and adherence to the pre-ART care for a period of 5 months depending on the frequency of enrolment of eligible subjects. The HIV positive persons from three centres will be classified into two arms. 1. Control arm: HIV positive persons will receive the current format and text of counselling 2. Intervention arm: HIV positive persons will receive a specially packaged continuum of extended counselling |
| Intervention type | Other |
| Primary outcome measure(s) |
Proportion of HIV positive persons with extended counselling who adhere to pre-ART care |
| Key secondary outcome measure(s) |
Proportion of HIV positive persons not lost to follow up during subsequent HIV care |
| Completion date | 02/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | Adult patients (>18 years) who test HIV positive at the ART centres at the start of the study (November 2009) |
| Key exclusion criteria | 1. Patients undergoing Prevention of Mother-To-Child Transmission (PMTCT) therapy 2. Patients who are not of sound mental status 3. Those who are expected to leave the district during the period of follow-up |
| Date of first enrolment | 02/12/2009 |
| Date of final enrolment | 02/06/2010 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Makerere University
Kampala
256
Uganda
256
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No | |
| Results article | results | 27/07/2011 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
