Link4Health: A Combination Strategy for Linkage and Retention, Swaziland

NACompletedINTERVENTIONAL
Enrollment

2,201

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

October 12, 2021

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.

Trial Locations (20)

Unknown

Bhalekane Clinic, Swaziland

Dvokolwako, Swaziland

Good Shepherd Hospital, Swaziland

Hlatikhulu Hospital, Swaziland

Horo, Swaziland

Kamfishane, Swaziland

Lamvelase, Swaziland

Luyengo Clinic, Swaziland

Mangweni Clinic, Swaziland

Mankayane Hospital, Swaziland

Mashobneni Clinic, Swaziland

Mbabane Government Hospital, Swaziland

Mkhuzweni Health Center, Swaziland

Motshane, Swaziland

Mpolenjeni Clinic, Swaziland

Nhlangano Health Center, Swaziland

Piggs Peak, Swaziland

Raleigh Fitkin Memorial Hospital, Swaziland

Siphofaneni Clinc, Swaziland

Sithobeloa Rural Health Center, Swaziland

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Centers for Disease Control and Prevention

FED

collaborator

New York University

OTHER

lead

Columbia University

OTHER

NCT01904994 - Link4Health: A Combination Strategy for Linkage and Retention, Swaziland | Biotech Hunter | Biotech Hunter