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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
Official Code
Related Publications
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