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: www.pactr.org
Trial no.: PACTR201611001756166 Date registered: 31/08/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Strengthened Management Intervention for Proactive Follow-up and Enhanced Counseling to Improve Linkage to and Retention in Care among HIV Patients in Uganda
Official scientific title A Strengthened Management Intervention for Proactive Follow-up and Enhanced Counseling to Improve Linkage to and Retention in Care among HIV Patients in Uganda
Brief summary describing the background and objectives of the trial The Ministry of Health, in collaboration with CHAI plans to conduct a study with the objective to measure the impact of a strengthened management intervention for proactive follow-up and enhanced counselling on HIV patient linkage to care and six-month retention in care. The study will evaluate a facility-level intervention that involves: 1. Expert client training and accountability. 2. Facility in-charge training and empowerment. 3. Strengthened district oversight. To evaluate how much patient linkage to care and retention in care changes upon implementation of this program, a nine-month pre-/post-study will be conducted. 20 facilities in Central Uganda with low baseline retention and high antiretroviral (ART) patient volume will be selected for inclusion in the study. In addition to collecting information on linkage to care and retention through patient records, we will be collecting qualitative information on challenges and successes of the program through interviews with healthcare workers and focus group discussions with patients.
Type of trial CCT
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 19/09/2016
Actual trial start date
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 4000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
#SHSREC REF:2016-032 Makarere University School of Health Sciences Research and Ethics Committee
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Strengthened management intervention N/A 9 months 1. Expert client training and accountability. 2. Facility in-charge training and empowerment. 3. Strengthened district oversight 2000
Control Group Pre-intervention group N/A 9 months Data will be collected from this group before the intervention implementation 2000 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For inclusion into this study, facilities must: ¿ Be located in Central Uganda ¿ Not be a private clinic ¿ Have offered ART to pediatric and adult patients since January 1, 2015 or earlier ¿ Have a high volume of ART patients (¿120 patients enrolled per year) ¿ Have low retention (35-75%, as estimated with MOH data on total ART patients in 2014 and 2015 in each facility and new ART patients in 2015) In addition, any implementing partners at facilities must be willing to integrate any existing follow-up activities into this intervention. From eligible study sites, sites will be randomly selected for inclusion. Within study sites, a random sample of patients who tested positive in the appropriate time windows will be included in the assessment of linkage to care and all patients who initiated in the appropriate time windows will be included in the assessment of retention. Study sites that are already part of a study that may impact retention will be excluded. 0 Year(s) 100 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 15/08/2016 Makarere University School of Health Sciences Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 7072 Kampala Uganda
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 31/08/2016 Chesapeake IRB
Ethics Committee Address
Street address City Postal code Country
6940 Columbia Gateway Dr, #110 Columbia 21046 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Linkage to ART care Within one month of testing
Primary Outcome Retention in care At six months after ART initiation
Secondary Outcome Linkage to ART care Within three months of testing
Secondary Outcome Median number of patient appointments Within six months of ART initiation
Secondary Outcome Linkage to ART care and retention in care, separated by pediatric, adolescent, and adult patients Same as for primary outcomes
Secondary Outcome Patient and provider satisfaction Nine months after implementation of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lugasa Kayunga District Uganda
Busana Kayunga District Uganda
Kikonda Kyankwanzi District Uganda
Katikamu Luwero District Uganda
Lwengo Lwengo District Uganda
Bukeeri Makasa District Uganda
Kyanamukaaka Makasa District Uganda
Butoolo Mpigi District Uganda
Kiganda Mubende District Uganda
Goma Mukono District Uganda
Kojja Mukono District Uganda
Mpunge Mukono District Uganda
Ngoma Nakaseke District Uganda
Maddu Gomba District Uganda
Bbaale Kayunga District Uganda
Kyantungo Mityana District Uganda
Ntuusi Sembabule District Uganda
Sembabule Sembabule District Uganda
Kiziba Wakiso District Uganda
Butenga Bukomansimbi District Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development (DFID) 22 Whitehall London SW1A 2EG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CHAI Plot 8 Moyo Close, Kololo Kampala Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Cordelia Katureebe Mboijana Ministry of Health, STI/AIDS Control Program, P.O. Box 7272 Kampala Uganda
Andrew Musoke Plot 8 Moyo Close, Kololo Kampala Uganda
Vennie Nabitaka Plot 8 Moyo Close, Kololo Kampala Uganda
Caroline Boeke 383 Dorchester Avenue Boston 02127 United States of America
Katherine Guerra 383 Dorchester Avenue Boston 02127 United States of America
Victor Bigira Plot 8 Moyo Close, Kololo Kampala Uganda
Betty Mirembe Plot 8 Moyo Close, Kololo Kampala Uganda
Arnold Kabbale Plot 8 Moyo Close, Kololo Kampala Uganda
Andrea Rowan Plot 8 Moyo Close, Kololo Kampala Uganda
Vivienne Mulema Plot 8 Moyo Close, Kololo Kampala Uganda
Pamela Nawaggi Plot 8 Moyo Close, Kololo Kampala Uganda
Barbara Asire Ministry of Health, STI/AIDS Control Program, P.O. Box 7272 Kampala Uganda
Eleanor Namusoke Magongo Ministry of Health, STI/AIDS Control Program, P.O. Box 7272 Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cordelia Katureebe Mboijana katureebecordelia@gmail.com +256772372411 Ministry of Health, STI/AIDS Control Program, P.O. Box 7272
City Postal code Country Position/Affiliation
Kampala Uganda
Role Name Email Phone Street address
Public Enquiries Vennie Nabitaka vnabitaka@clintonhealthaccess.org +256 752 621092 Plot 8 Moyo Close, Kololo
City Postal code Country Position/Affiliation
Kampala Uganda Senior Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Vennie Nabitaka vnabitaka@clintonhealthaccess.org +256 752 621092 Plot 8 Moyo Close, Kololo
City Postal code Country Position/Affiliation
Kampala United States of America Senior Study Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 12/10/2016 This sample size includes the pre-intervention and post-intervention participants. 2000 4000
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 06/09/2016 Modified Others CCT
Section Name Field Name Date Reason Old Value Updated Value
Intervention InterventionTypeID 06/09/2016 This is a pre-/post- study of a single group of 15-18 facilities that will all be exposed to the intervention. The % linked to care and retained in care will be compared before vs. after implementation of the intervention to calculate a % change after implementation of the intervention. Experimental group Experimental group
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 26/04/2017 Updated with final number of sites. The Ministry of Health, in collaboration with CHAI plans to conduct a study with the objective to measure the impact of a strengthened management intervention for proactive follow-up and enhanced counselling on HIV patient linkage to care and six-month retention in care. The study will evaluate a facility-level intervention that involves: 1. Expert client training and accountability. 2. Facility in-charge training and empowerment. 3. Strengthened district oversight. To evaluate how much patient linkage to care and retention in care changes upon implementation of this program, a nine-month pre-/post-study will be conducted. Approximately 15 facilities in Central Uganda with low baseline retention and high antiretroviral (ART) patient volume will be selected for inclusion in the study. In addition to collecting information on linkage to care and retention through patient records, we will be collecting qualitative information on challenges and successes of the program through interviews with healthcare workers and focus group discussions with patients. The Ministry of Health, in collaboration with CHAI plans to conduct a study with the objective to measure the impact of a strengthened management intervention for proactive follow-up and enhanced counselling on HIV patient linkage to care and six-month retention in care. The study will evaluate a facility-level intervention that involves: 1. Expert client training and accountability. 2. Facility in-charge training and empowerment. 3. Strengthened district oversight. To evaluate how much patient linkage to care and retention in care changes upon implementation of this program, a nine-month pre-/post-study will be conducted. 20 facilities in Central Uganda with low baseline retention and high antiretroviral (ART) patient volume will be selected for inclusion in the study. In addition to collecting information on linkage to care and retention through patient records, we will be collecting qualitative information on challenges and successes of the program through interviews with healthcare workers and focus group discussions with patients.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/04/2017 Modified Not yet recruiting Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/04/2017 Modified Open to recruitment: actively recruiting participants Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 06/09/2016 The committee approved the ethics approval. false true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 26/04/2017 Updated with final number of facilities. The Ministry of Health, in collaboration with CHAI plans to conduct a study with the objective to measure the impact of a strengthened management intervention for proactive follow-up and enhanced counselling on HIV patient linkage to care and six-month retention in care. The study will evaluate a facility-level intervention that involves: 1. Expert client training and accountability. 2. Facility in-charge training and empowerment. 3. Strengthened district oversight. To evaluate how much patient linkage to care and retention in care changes upon implementation of this program, a nine-month pre-/post-study will be conducted. Approximately 15 facilities in Central Uganda with low baseline retention and high antiretroviral (ART) patient volume will be selected for inclusion in the study. In addition to collecting information on linkage to care and retention through patient records, we will be collecting qualitative information on challenges and successes of the program through interviews with healthcare workers and focus group discussions with patients. The Ministry of Health, in collaboration with CHAI plans to conduct a study with the objective to measure the impact of a strengthened management intervention for proactive follow-up and enhanced counselling on HIV patient linkage to care and six-month retention in care. The study will evaluate a facility-level intervention that involves: 1. Expert client training and accountability. 2. Facility in-charge training and empowerment. 3. Strengthened district oversight. To evaluate how much patient linkage to care and retention in care changes upon implementation of this program, a nine-month pre-/post-study will be conducted. 20 facilities in Central Uganda with low baseline retention and high antiretroviral (ART) patient volume will be selected for inclusion in the study. In addition to collecting information on linkage to care and retention through patient records, we will be collecting qualitative information on challenges and successes of the program through interviews with healthcare workers and focus group discussions with patients.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 12/10/2016 Updated to include numbers for both pre-intervention group and post-intervention group. 2000 4000
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 10/07/2018 pactr update A Strengthened Management Intervention for Proactive Follow-up and Enhanced Counseling to Improve Linkage to and Retention in Care among HIV Patients A Strengthened Management Intervention for Proactive Follow-up and Enhanced Counseling to Improve Linkage to and Retention in Care among HIV Patients in Uganda
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 10/07/2018 pactr update Not Applicable