Condition category
Infections and Infestations
Date applied
01/06/2010
Date assigned
13/07/2010
Last edited
17/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sida.se

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

  1. 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.

  2. 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.

  3. 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 .

Additional files

Editorial Notes