Overview

This trial is active, not recruiting.

Condition hiv (human immunodeficiency virus)
Treatments poc (point-of-care) cd4+ (cluster of differentiation 4) count, accelerated art (antiretroviral therapy) initiation, basic care and prevention package, cellular appointment reminders and follow-up, financial incentive
Sponsor Columbia University
Collaborator National Institutes of Health (NIH)
Start date August 2013
End date May 2016
Trial size 2201 participants
Trial identifier NCT01904994, 5R01AI100059-02, AAAL2708

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 difference 4)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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Participants will be managed per standard of care following prevailing Swaziland Ministry of Health guidelines.
(Experimental)
POC (point-of-care) 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
poc (point-of-care) cd4+ (cluster of differentiation 4) count PIMA
Each HTC (HIV testing and counseling) 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 BCPP
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 FI (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 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.

Primary Outcomes

Measure
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
time frame: one month after enrollment, 12 months after enrollment

Secondary Outcomes

Measure
Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis
time frame: 12 months after enrollment
Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis.
time frame: 12 months after enrollment
Change in proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis
time frame: one month after enrollment, 12 months after enrollment
Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility
time frame: 12-months after enrollment
Median time from HIV testing to ART eligibility
time frame: 12 months after enrollment
Proportion of participants who consistently engage in care (attend > 75% of scheduled appointments)
time frame: 12-months after enrollment
Change in proportion of participants with new WHO (World Health Organization) Stage III/IV event or hospitalization
time frame: 1 month after enrollment,12 months after enrollment
Median CD4+ (cluster difference 4) count and viral load 12 months after HIV diagnosis
time frame: 12 months after testing HIV-positive
Change in Mortality rate
time frame: 1 month after enrollment, 12 months after enrollment
Change in proportion of participants reporting interventions were received
time frame: 1 month after enrollment, 12 months after enrollment
Proportion of participants reporting that interventions were highly acceptable
time frame: 12 months after enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title LINK4HEALTH: A Combination Approach to Linkage and Retention for HIV (Human Immunodeficiency Virus) Infected Individuals in Swaziland
Principal investigator Wafaa El-Sadr, MD MPH
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Columbia University.