Link4Health: A Combination Strategy for Linkage and Retention, Swaziland (L4H)

Columbia University

Status: Completed

Conditions: HIV (Human Immunodeficiency Virus)

Treatments: Behavioral: Basic Care and Prevention Package; Behavioral: Cellular Appointment Reminders and Follow-Up; Procedure: Accelerated ART (antiretroviral therapy) Initiation; Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) Count; Other: Financial Incentive

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT01904994

5R01AI100059-02 (U.S. NIH Grant/Contract)

AAAL2708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,201 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Participants will be managed per standard of care following prevailing Swaziland Ministry of Health guidelines.

Combined Intervention Strategy

Experimental group

Description:

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

Treatment:

Other: Financial Incentive

Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) Count

Behavioral: Cellular Appointment Reminders and Follow-Up

Procedure: Accelerated ART (antiretroviral therapy) Initiation

Behavioral: Basic Care and Prevention Package