Contact information
Type
Scientific
Primary contact
Prof Fred Wabwire-Mangeni
ORCID ID
Contact details
Makerere University
School of Public Health
PO BOX 7072
Kampala
256
Uganda
-
fwabwire@musph.ac.ug
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MUSPH 06012009
Study information
Scientific title
Assessing the effect of extended counselling on uptake and adherence to pre- antiretroviral care: A longitudinal, randomised controlled trial
Acronym
pre-ARV
Study hypothesis
Extended counselling is associated with increased uptake and adherence to pre-antiretroviral therapy (ART)
Ethics approval
1. Makerere University School of Public Health Higher Degrees Research and Ethics Committee, 06/01/2009
2. Uganda National Council for Science and Technology
Study design
Longitudinal double-blind multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Please contact Dr Muhamadi Lubega [dlmuhamadi@yahoo.co.uk] to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Proportion of HIV positive persons with extended counselling who adhere to pre-ART care
Secondary outcome measures
Proportion of HIV positive persons not lost to follow up during subsequent HIV care
Overall trial start date
02/12/2009
Overall trial end date
02/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients (>18 years) who test HIV positive at the ART centres at the start of the study (November 2009)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
02/12/2009
Recruitment end date
02/06/2010
Locations
Countries of recruitment
Uganda
Trial participating centre
Makerere University
Kampala
256
Uganda
Sponsor information
Organisation
Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden)
Sponsor details
Karolinska institutet
Stockholm
c/o Makerere University
PO BOX 7072
Kampala
256
Uganda
-
stefan.peterson@ki.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swedish International Development Authority - Department for Research Cooperation (SIDA/SAREC) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20022131
2. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21794162
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26079842
Publication citations
-
Results
Muhamadi L, Tumwesigye NM, Kadobera D, Marrone G, Wabwire-Mangen F, Pariyo G, Peterson S, Ekström AM, A single-blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in Eastern Uganda., Trials, 2011, 12, 184, doi: 10.1186/1745-6215-12-184.
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Lubega M, Nsabagasani X, Tumwesigye NM, Wabwire-Mangen F, Ekström AM, Pariyo G, Peterson S, Policy and practice, lost in transition: Reasons for high drop-out from pre-antiretroviral care in a resource-poor setting of eastern Uganda., Health Policy, 2010, 95, 2-3, 153-158, doi: 10.1016/j.healthpol.2009.11.021.
-
Results
Muhamadi L, Mbona Nazarius T, Daniel K, Gaetano M, Fred WM, Stefan P, Steven James R, Anna Mia E, The effect of community support agents on retention of people living with HIV in pre-antiretroviral care - A randomized controlled trial in Eastern Uganda, J Acquir Immune Defic Syndr, 2015 .