Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01904994
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2013-07-16
Brief Title:
Link4Health A Combination Strategy for Linkage and Retention Swaziland
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
LINK4HEALTH A Combination Approach to Linkage and Retention for HIV Human Immunodeficiency Virus Infected Individuals in Swaziland
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
L4H
Brief Summary:
Despite increased HIV Human Immunodeficiency Virus infection testing in Africa many patients never enroll in subsequent HIV care after testing or remain in care after an initial enrollment This studys aim is to improve linkage to HIV care and retention in HIV care through the use of feasible evidence-based and practical interventions The study takes place in Swaziland the country with the highest HIV prevalence 24 in sub-Saharan Africa The study will randomize groups of HIV testing sites and affiliated clinics to either standard of care or a combined intervention strategy CIS which consists of point-of care CD4 cluster differentiation 4 CD4 testing at time of HIV testing fast-track HIV medications for those who are eligible for treatmentmobile phone appointment reminders care bags filled with health prevention materials and financial incentives The study outcomes are linkage to and retention in care as well as cost effectiveness feasibility of interventions and patient acceptability of interventions
Detailed Description:
Linkage of patients from HIV testing to HIV care programs and their retention once enrolled in care are essential to HIV program effectiveness in terms of prevention of HIVrelated morbidity and mortality and prevention of HIV transmission Linkage and retention rates in HIV programs in sub-Saharan Africa SSA are suboptimal with less than half of patients who test positive successfully linking and remaining in care at 1 year This study is a two-arm cluster siterandomized trial to compare the effectiveness of a novel combination package of evidencebased interventions the combination intervention strategy CIS compared to standard of care SOC on linkage and retention of HIVpositive patients from point of testing to retention in care CIS will include 1 point of care CD4 count assays at HIV testing sites 2 accelerated antiretroviral therapy ART initiation for eligible patients 3 provision of a basic care and prevention package BCPP 4 short message service SMS reminders for clinic appointments and 5 financial incentives for linkage and retention The primary aim is to evaluate the effectiveness of CIS as compared to SOC on the combined outcome of rapid linkage to HIV care within 1 month and retention in care at 12 months among adults testing positive for HIV Secondary aims include evaluation of the effectiveness of CIS compared to SOC on each of linkage to HIV retention in care time to ART initiation HIV disease progression and mortality patient acceptability association between baseline characteristics and outcomes and comparison of cost effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AI100059-02 | NIH | None | httpsreporternihgovquickSearch5R01AI100059-02 |