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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 November 2021 |
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Main ID: |
NCT01904994 |
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Date of registration:
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16/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Link4Health: A Combination Strategy for Linkage and Retention, Swaziland
L4H |
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Scientific title:
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LINK4HEALTH: A Combination Approach to Linkage and Retention for HIV (Human Immunodeficiency Virus) Infected Individuals in Swaziland |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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2201 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01904994 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Swaziland
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Contacts
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Name:
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Peter Ehrenkranz, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centers for Disease Control and Prevention |
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Name:
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Batya Elul, PhD MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICAP Columbia University |
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Name:
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Margaret McNairy, MD MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICAP Columbia University |
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Name:
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Phumzile Mndzebele |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swaziland MOH |
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Name:
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Scott Braithwaite, MD MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York University |
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Name:
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Matthew Lamb, PhD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICAP Columbia University |
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Name:
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Ruben Sahabao, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICAP Swaziland |
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Name:
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Wafaa El-Sadr, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICAP Columbia University |
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Name:
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Charles Azih, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swaziland MOH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =18 years
- Testing HIV-positive at an HTC (HIV testing and counseling) site within a SU (study
unit)
- Willing to be referred to an HIV care clinic associated with the SU
- Willing to provide locator information
- Willing to adhere to study procedures, including a baseline interview, home-based
interviews at 1 and 12 months after study enrollment; home-based CD4+ count assessment
12 months after enrollment, and abstraction of data from their medical records.
- Able to provide informed consent
Exclusion Criteria:
- Planning on leaving the community where they currently reside in the next 12 months
for a period greater than 6 months
- Enrolled in HIV (Human immunodeficiency virus) care in the past 6 months at any HIV
care clinic
- Currently on ART (antiretroviral therapy)
- Initiated ART (for any duration) in the past 6 months at any HIV care clinic
- Does not speak or understand English or si-Swati
- Reports being currently pregnant at time of study enrollment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV (Human Immunodeficiency Virus)
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Intervention(s)
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Behavioral: Cellular Appointment Reminders and Follow-Up
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Behavioral: Basic Care and Prevention Package
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Other: Financial Incentive
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Procedure: Accelerated ART (antiretroviral therapy) Initiation
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Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) Count
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Primary Outcome(s)
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Change in proportion of participants who both link to care at assigned study unit within 1 month and are retained in care at the designated study unit 12 months after HIV (Human Immunodeficiency Virus) diagnosis
[Time Frame: one month after enrollment, 12 months after enrollment]
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Secondary Outcome(s)
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Median time from HIV testing to ART eligibility
[Time Frame: 12 months after enrollment]
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Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis.
[Time Frame: 12 months after enrollment]
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Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis
[Time Frame: 12 months after enrollment]
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Median CD4+ (cluster difference 4) count and viral load 12 months after HIV diagnosis
[Time Frame: 12 months after testing HIV-positive]
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Proportion of participants reporting that interventions were highly acceptable
[Time Frame: 12 months after enrollment]
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Change in proportion of participants reporting interventions were received
[Time Frame: 1 month after enrollment, 12 months after enrollment]
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Proportion of participants who consistently engage in care (attend > 75% of scheduled appointments)
[Time Frame: 12-months after enrollment]
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Change in proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis
[Time Frame: one month after enrollment, 12 months after enrollment]
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Change in proportion of participants with new World Health Organization (WHO) Stage III/IV event or hospitalization
[Time Frame: 1 month after enrollment,12 months after enrollment]
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Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility
[Time Frame: 12-months after enrollment]
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Change in Mortality rate
[Time Frame: 1 month after enrollment, 12 months after enrollment]
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Secondary ID(s)
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AAAL2708
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5R01AI100059-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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