Link4Health: A Combination Strategy for Linkage and Retention, Swaziland
- Conditions
- HIV (Human Immunodeficiency Virus)
- Interventions
- Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) CountProcedure: Accelerated ART (antiretroviral therapy) InitiationBehavioral: Basic Care and Prevention PackageBehavioral: Cellular Appointment Reminders and Follow-UpOther: Financial Incentive
- Registration Number
- NCT01904994
- Lead Sponsor
- Columbia University
- 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 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.
- 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 HIV;related 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 site;randomized trial to compare the effectiveness of a novel combination package of evidence;based interventions, the combination intervention strategy (CIS), compared to standard of care (SOC) on linkage and retention of HIV;positive 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2201
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined Intervention Strategy Cellular Appointment Reminders and Follow-Up Point-of-care (POC) 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 Combined Intervention Strategy POC (point-of-care) CD4+ (cluster of differentiation 4) Count Point-of-care (POC) 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 Combined Intervention Strategy Basic Care and Prevention Package Point-of-care (POC) 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 Combined Intervention Strategy Accelerated ART (antiretroviral therapy) Initiation Point-of-care (POC) 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 Combined Intervention Strategy Financial Incentive Point-of-care (POC) 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
- Primary Outcome Measures
Name Time Method 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 one month after enrollment, 12 months after enrollment Combined outcome of linkage to HIV care within 1 month after testing HIV positive and retention in care 12 months after testing.
Participants are considered to achieve this outcome if they successfully link to the HIV clinic at their study unit (SU) within 1 month of testing HIV positive and are retained in care at the HIV clinic at their SU 12 months after testing HIV positive, as measured from medical records.
- Secondary Outcome Measures
Name Time Method Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis. 12 months after enrollment Retention in care 12 months after HIV testing, independent of linkage at 1 month (at any clinic within the assigned study unit).
Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility 12-months after enrollment Time from linkage to ART eligibility assessment
Change in proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis one month after enrollment, 12 months after enrollment Proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis
Change in proportion of participants with new World Health Organization (WHO) Stage III/IV event or hospitalization 1 month after enrollment,12 months after enrollment Proportion of participants with new WHO Stage III/IV event or hospitalization
Change in Mortality rate 1 month after enrollment, 12 months after enrollment Mortality rate 12 months after HIV diagnosis
Change in proportion of participants reporting interventions were received 1 month after enrollment, 12 months after enrollment Proportion of participants, who are randomized to study units receiving CIS, reporting receipt of each intervention
Proportion of participants reporting that interventions were highly acceptable 12 months after enrollment Proportion of participants, who are randomized to study units receiving CIS, reporting that interventions were highly acceptable
Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis 12 months after enrollment Linkage to care within 1 month of HIV testing (at any clinic within the assigned study unit).
Median time from HIV testing to ART eligibility 12 months after enrollment Time from HIV testing to ART eligibility
Median CD4+ (cluster difference 4) count and viral load 12 months after HIV diagnosis 12 months after testing HIV-positive Median CD4+ cell count 12 months after HIV diagnosis, median viral load 12 months after HIV diagnosis
Proportion of participants who consistently engage in care (attend > 75% of scheduled appointments) 12-months after enrollment Proportion of participants who consistently engage in care, defined as attend \> 75% of scheduled appointments
Trial Locations
- Locations (20)
Good Shepherd Hospital
🇸🇿Swaziland, Swaziland
Lamvelase
🇸🇿Swaziland, Swaziland
Mangweni Clinic
🇸🇿Swaziland, Swaziland
Mankayane Hospital
🇸🇿Swaziland, Swaziland
Dvokolwako
🇸🇿Swaziland, Swaziland
Mashobneni Clinic
🇸🇿Swaziland, Swaziland
Mpolenjeni Clinic
🇸🇿Swaziland, Swaziland
Nhlangano Health Center
🇸🇿Swaziland, Swaziland
Kamfishane
🇸🇿Swaziland, Swaziland
Hlatikhulu Hospital
🇸🇿Swaziland, Swaziland
Horo
🇸🇿Swaziland, Swaziland
Bhalekane Clinic
🇸🇿Swaziland, Swaziland
Mbabane Government Hospital
🇸🇿Swaziland, Swaziland
Luyengo Clinic
🇸🇿Swaziland, Swaziland
Mkhuzweni Health Center
🇸🇿Swaziland, Swaziland
Motshane
🇸🇿Swaziland, Swaziland
Piggs Peak
🇸🇿Swaziland, Swaziland
Siphofaneni Clinc
🇸🇿Swaziland, Swaziland
Sithobeloa Rural Health Center
🇸🇿Swaziland, Swaziland
Raleigh Fitkin Memorial Hospital
🇸🇿Swaziland, Swaziland