Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201508001149239 Date of Approval: 26/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of Family Clinic Days on Pediatric and Adolescent Retention in ART
Official scientific title Impact of Family Clinic Days on Pediatric and Adolescent Retention in ART
Brief summary describing the background and objectives of the trial In April 2014, revised national healthcare guidelines were being implemented in Uganda, including new antiretroviral (ARV) treatment regimens for pediatric patients and a test-and-treat policy regardless of CD4 count for all HIV-positive pediatric and adolescent patients less than 15 years of age. Revised ART guidelines will increase the number of individuals eligible for treatment but will also introduce challenges to the health care system. Since 2009, a test-and treat policy has been in place for children under-two years of age. The new test-and-treat guidelines will expand the eligible patient pool and authorize approximately 21,000 patients currently active in pre-ART care for immediate initiation on ART. With the release of revised national guidelines, health care workers (HCWs) will encounter more adolescents and pediatric patients in ART than ever before. This study seeks to evaluate an intervention ¿ the family clinic day (FCD) ¿ that aims to increase pediatric and adolescent retention and adherence rates in ART.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 31/03/2018
Actual Last follow-up date 31/03/2015
Anticipated target sample size (number of participants) 3450
Actual target sample size (number of participants) 4902
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation (stratification by implementing partner, region, and health facility level) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Family Clinic Day 6 months scheduling and counselling 23
Control Group Standard Care 6 months No intervention 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Health facility being supported by one of the participating IPs, Having 30 or more patients less than 15 years of age active on pre-ART or ART care as of September 2013 MEEPP data Registered as private not-for-profit Already implementing one of the key components of the FCD intervention 2 Year(s) 19 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/03/2015 MildMay Uganda
Ethics Committee Address
Street address City Postal code Country
Plot 129 Naziba Hill, Entebbe Road Entebbe Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of pediatric and adolescent patients in sample retained in care by end of study Endline
Primary Outcome Proportion of patients who were non-adherent to the dosing treatment regimen Endline
Primary Outcome Proportion of patients in each adherence category (good, fair, and poor) as recorded by HCWs in the ART care cards endline
Primary Outcome Rate of pediatric and adolescent patient ARV adherence within (+/- 7) days of pill dosing treatment regimen Endline
Secondary Outcome Perceptions of staff Endline
Secondary Outcome Perceptions of patients Endline
Secondary Outcome Proportion of FCD ineligible patients retained in care Endline
Secondary Outcome Proportion of FCD ineligible patients who are non-adherent to the dosing treatment regimen Endline
Secondary Outcome Proportion of FCD ineligible patients in each adherence category ( good, fair, and poor) as recorded by HCWs in the ART care cards Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bukuya HCIII Bukuya Uganda
Kassanda HCIV Kassanda Uganda
Nakasongola HCIV Nakasongola Uganda
Nyimbwa HCIV Nyimbwa Uganda
Buhehe HCIII Buhehe Uganda
Bukigai HCIII Bukigai Uganda
Busolwe Hospital Busolwe Uganda
Kapchorwa Hospital Kapchorwa Uganda
Kibuku HCIV Kibuku Uganda
Aboke HCIV Aboke Uganda
Agulurude HCIII Agulurude Uganda
Akokoro HCIII Akokoro Uganda
Amolatar HCIV Amolatar Uganda
Anaka Hospital Anaka Uganda
Apac Hospital Apac Uganda
Atiak HCIV Atiak Uganda
Bata HCIII Bata Uganda
Etam HCIII Etam Uganda
Koch Goma HCIII Koch Goma Uganda
Naam Okora HCIV Naam Okora Uganda
Otwal HCIII Otwal Uganda
Padibe HCIV Padibe HCIV Uganda
Butenga HCIV Butenga Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development 22 Whiltehall London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinton Health Access Initiative Plot 8 Moyo Close Kololo, Kampala Uganda Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
AIDS Control Program, Ministry of Health Plot 6 Lourdel Rd Nakasero, Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Moberley smoberley@clintonhealthaccess.org +61 491108157
City Postal code Country Position/Affiliation
Australia
Role Name Email Phone Street address
Principal Investigator Sarah Moberley smoberley@clintonhealthaccess.org +61 491108157
City Postal code Country Position/Affiliation
Melbourne Australia Senior Technical Advisor
Role Name Email Phone Street address
Public Enquiries CJ Schellack cschellack@clintonhealthaccess.org +256 773 919 258 Plot 8 Moyo Close
City Postal code Country Position/Affiliation
Kololo, Kampala Uganda Research Coordinator
Role Name Email Phone Street address
Scientific Enquiries Elizabeth McCarthy emccarthy@clintonhealthaccess.org +26 0211 267 985/987 Plot 175 Kudu Road
City Postal code Country Position/Affiliation
Kabulonga , Lusaka Zambia Director, Applied Analytics Team
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information