2,201
Participants
Start Date
August 31, 2013
Primary Completion Date
May 31, 2016
Study Completion Date
October 12, 2021
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.
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"
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.
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."
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.
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
National Institutes of Health (NIH)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Centers for Disease Control and Prevention
FED
New York University
OTHER
Columbia University
OTHER