Link4Health: A Combination Strategy for Linkage and Retention, Swaziland

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.

Conditions

• HIV (Human Immunodeficiency Virus)

Interventions

PROCEDURE

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

Each HIV testing and counseling (HTC) site will be equipped with POC CD4+ testing using PIMA™ Analyser (Inverness), test strips, and reagents. Study staff will obtain 25 microliters of blood via finger prick and process the POC (point-of-care) CD4+ (cluster of differentiation 4) Count' test immediately following the baseline interview. Test results will be recorded on study forms including a referral form that has multiple copies, one copy to be given to the participant, the second sent to the affiliated HIV (Human immunodeficiency virus)care clinic in the study unit, and the third kept by study staff in a locked cabinet with other confidential material. All participants, regardless of the CD4+ result, will be encouraged to enroll in HIV care as soon as they can.

PROCEDURE

Accelerated ART (antiretroviral therapy) Initiation

Accelerated ART initiation for patients with POC CD4+ \< 350 cells/uL (micro-liter) within 1 week from testing. 2 counseling sessions (one at time of HTC and other at first HIV clinic visit), and collection of blood for other baseline lab tests, but initiation prior to return of results for patients who do not meet criteria for waiting

BEHAVIORAL

Basic Care and Prevention Package

Basic care and prevention package (BCPP) provided approximately every three months that includes: condoms; soap, pill box and pictorial education about use of materials and HIV, such as family testing tools and information. Information on BCPP contents and review the educational materials will be provided. An example of educational materials is a family-testing tool to encourage the participant to have all family members tested for HIV. All BCPP items will be replenished every 3 months for all participants, regardless of ART status, beginning at linkage to HIV care.

BEHAVIORAL

Cellular Appointment Reminders and Follow-Up

SMS (short messaging service) appointment reminders for follow-up appointments. Telephone call within 7 days of missed appointment for all patients.

OTHER

Financial Incentive

Participants will receive a series of financial incentives to support linkage into care within 1 month and retention in care at 6 months and 12 months after testing HIV positive. The value of the financial incentive (FI) will be 80 Swaziland Rand, calculated based on the associated financial costs of traveling to clinic. These incentives will be distributed by through mobile airtime. Participants without mobile phones will be given an alternative incentive of equal value, such as a store voucher.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Centers for Disease Control and Prevention

  collaborator FED

• New York University

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Wafaa El-Sadr, MD MPH · ICAP Columbia University

• Charles Azih, MD MPH · Swaziland MOH

• Scott Braithwaite, MD MSc · New York University

• Batya Elul, PhD MD · ICAP Columbia University

• Peter Ehrenkranz, MD MPH · Centers for Disease Control and Prevention

• Matthew Lamb, PhD MPH · ICAP Columbia University

• Margaret McNairy, MD MSc · ICAP Columbia University

• Phumzile Mndzebele · Swaziland MOH

• Ruben Sahabao, MD · ICAP Swaziland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2016-05-31

Completion

2021-10-12

Countries

• Eswatini