|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201611001756166 |
|
Date of registration:
|
31/08/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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
|
|
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 |
|
Date of first enrolment:
|
19/09/2016 |
|
Target sample size:
|
4000 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1756 |
|
Study type:
|
Interventional |
|
Study design:
|
Single group: all participants receive same intervention throughout study,Non-randomised
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Uganda
| | | | | | | |
|
Contacts
|
|
Name:
|
Vennie
Nabitaka |
|
Address:
|
Plot 8 Moyo Close, Kololo
Kampala
United States of America |
|
Telephone:
|
+256 752 621092 |
|
Email:
|
vnabitaka@clintonhealthaccess.org |
|
Affiliation:
|
Senior Study Coordinator |
|
|
Name:
|
Vennie
Nabitaka |
|
Address:
|
Plot 8 Moyo Close, Kololo
Kampala
Uganda |
|
Telephone:
|
+256 752 621092 |
|
Email:
|
vnabitaka@clintonhealthaccess.org |
|
Affiliation:
|
Senior Study Coordinator |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 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.
Exclusion criteria: Study sites that are already part of a study that may impact retention will be excluded.
Age minimum:
0 Year(s)
Age maximum:
100 Year(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV/AIDS
|
HIV/AIDS
|
|
Intervention(s)
|
|
|
|
Strengthened management intervention
|
|
Pre-intervention group
|
|
Primary Outcome(s)
|
|
Retention in care
|
|
Linkage to ART care
|
|
Secondary Outcome(s)
|
|
Linkage to ART care and retention in care, separated by pediatric, adolescent, and adult patients
|
|
Median number of patient appointments
|
|
Linkage to ART care
|
|
Patient and provider satisfaction
|
|
Secondary ID(s)
|
|
#SHSREC REF:2016-032
|
|
Source(s) of Monetary Support
|
|
Department for International Development (DFID)
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Chesapeake IRB
|
Status: Approved
Approval date: 15/08/2016
Contact:
Makarere University School of Health Sciences Research and Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|