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

Email	fwabwire@musph.ac.ug

Study information

Study design	Longitudinal double-blind multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Please contact Dr Muhamadi Lubega [dlmuhamadi@yahoo.co.uk] to request a patient 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	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 study start date	02/12/2009
Completion date	02/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

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

Karolinska institutet
Stockholm
c/o Makerere University
PO BOX 7072
Kampala
256
Uganda

Email	stefan.peterson@ki.se
Website	http://www.sida.se
"ROR"	https://ror.org/01fn7me06

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 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

Study outputs

Output type	Details	Date created	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