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LINK4HEALTH

Status
Completed
Phase
Open Label
Principal Investigator(s)
Wafaa M El-Sadr & Margaret McNairy
Objective


This study's 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 treatment,mobile 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.

Last updated September 8, 2022

Prevention Option(s)
Treatment
Study Design
Controlled
Randomized
Open label
Arms and Assigned Interventions
Description
No Intervention: Standard of Care Participants will be managed per standard of care following prevailing Swaziland Ministry of Health guidelines.
ARMs
Placebo Comparator
Description
Experimental: Combined Intervention Strategy POC (point-of-care) CD4+ (cluster of differentiation 4) Count Accelerated ART initiation for ART eligible participants Basic care and prevention package Cellular Appointment Reminders and Follow-Up Financial Incentives
ARMs
Experimental
Trial Sponsors
Columbia University, NIH, NIAID, CDC, & New York University
August 2013
October 2021
Enrollment
2 201
18
Years
Population
HIV positive
Men
Women
Sites

Hlatikhulu Hospital

Swaziland

Mankayane Hospital

Swaziland

Nhlangano Health Center

Swaziland

Mbabane Government Hospital

Swaziland

Raleigh Fitkin Memorial Hospital

Swaziland

Piggs Peak

Swaziland

Horo

Swaziland

Mkhuzweni Health Center

Swaziland

Mangweni Clinic

Swaziland

Sithobeloa Rural Health Center

Swaziland

Siphofaneni Clinc

Swaziland

Good Shepherd Hospital

Swaziland

Kamfishane

Swaziland

Mashobneni Clinic

Swaziland

Luyengo Clinic

Swaziland

Mpolenjeni Clinic

Swaziland

Dvokolwako

Swaziland

Bhalekane Clinic

Swaziland

Lamvelase

Swaziland

Motshane

Swaziland