Counselling and entry into HIV care

ISRCTN ISRCTN94133652
DOI https://doi.org/10.1186/ISRCTN94133652
Secondary identifying numbers MUSPH 06012009
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

Makerere University
School of Public Health
PO BOX 7072
Kampala
256
Uganda

fwabwire@musph.ac.ug

Study information

Study designLongitudinal double-blind multicentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Please contact Dr Muhamadi Lubega [dlmuhamadi@yahoo.co.uk] to request a patient information sheet
Scientific titleAssessing the effect of extended counselling on uptake and adherence to pre- antiretroviral care: A longitudinal, randomised controlled trial
Study acronympre-ARV
Study objectivesExtended 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) studiedPre-ARV care adherence
InterventionNewly 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 typeOther
Primary outcome measureProportion of HIV positive persons with extended counselling who adhere to pre-ART care
Secondary outcome measuresProportion of HIV positive persons not lost to follow up during subsequent HIV care
Overall study start date02/12/2009
Completion date02/06/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants400
Key inclusion criteriaAdult patients (>18 years) who test HIV positive at the ART centres at the start of the study (November 2009)
Key exclusion criteria1. 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 enrolment02/12/2009
Date of final enrolment02/06/2010

Locations

Countries of recruitment

  • Uganda

Study participating centre

Makerere University
Kampala
256
Uganda

Sponsor information

Funders

Funder type

Government

Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden)

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

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
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