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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Columbia University
Sponsor:
Collaborators:
New York University
Information provided by (Responsible Party):
Wafaa Mahmoud El-Sadr, Columbia University
ClinicalTrials.gov Identifier:
NCT01904994
First received: July 16, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LINK4HEALTH: A Combination Approach to Linkage and Retention for HIV (Human Immunodeficiency Virus) Infected Individuals in Swaziland

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Combined outcome of linkage to HIV care within 1 month after testing HIV positive and retention in care 12 months after testing.

    Participants are considered to achieve this outcome if they successfully link to the HIV clinic at their SU (study unit) within 1 month of testing HIV positive and are retained in care at the HIV clinic at their SU 12 months after testing HIV positive, as measured from medical records.



Secondary Outcome Measures:
  • Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Linkage to care within 1 month of HIV testing (at any clinic within the assigned study unit).

  • Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis. [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Retention in care 12 months after HIV testing, independent of linkage at 1 month (at any clinic within the assigned study unit).

  • 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 ] [ Designated as safety issue: No ]
    Proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis

  • Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility [ Time Frame: 12-months after enrollment ] [ Designated as safety issue: No ]
    Time from linkage to ART eligibility assessment

  • Median time from HIV testing to ART eligibility [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Time from HIV testing to ART eligibility

  • Proportion of participants who consistently engage in care (attend > 75% of scheduled appointments) [ Time Frame: 12-months after enrollment ] [ Designated as safety issue: No ]
    Proportion of participants who consistently engage in care, defined as attend > 75% of scheduled appointments

  • 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 ] [ Designated as safety issue: No ]
    Proportion of participants with new WHO Stage III/IV event or hospitalization

  • Median CD4+ (cluster difference 4) count and viral load 12 months after HIV diagnosis [ Time Frame: 12 months after testing HIV-positive ] [ Designated as safety issue: No ]
    Median CD4+ cell count 12 months after HIV diagnosis, median viral load 12 months after HIV diagnosis

  • Change in Mortality rate [ Time Frame: 1 month after enrollment, 12 months after enrollment ] [ Designated as safety issue: No ]
    Mortality rate 12 months after HIV diagnosis

  • Change in proportion of participants reporting interventions were received [ Time Frame: 1 month after enrollment, 12 months after enrollment ] [ Designated as safety issue: No ]
    Proportion of participants, who are randomized to study units receiving CIS, reporting receipt of each intervention

  • Proportion of participants reporting that interventions were highly acceptable [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    Proportion of participants, who are randomized to study units receiving CIS, reporting that interventions were highly acceptable


Other Outcome Measures:
  • Change in adjusted risk ratio comparing proportion of participants who both link to care at assigned study unit within one month and are retained in care at designated study unit twelve months after HIV diagnosis [ Time Frame: at enrollment, one month after enrollment, 12 months after enrollment ] [ Designated as safety issue: No ]
    Adjusted risk ratio comparing proportion of participants who both link to care at assigned study unit within one month and are retained in care at designated study unit twelve months after HIV diagnosis, by strata of age, sex, and other socio-demographic variables


Estimated Enrollment: 2200
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
Participants will be managed per standard of care following prevailing Swaziland Ministry of Health guidelines.
Experimental: Combined Intervention Strategy
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
Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) Count
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 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.
Other Name: PIMA
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.
Other Name: BCPP
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 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.
Other Name: FI (Financial Incentive)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904994

Contacts
Contact: Wafaa M El-Sadr, MD MPH 2129392936 wme1@cumc.columbia.edu
Contact: Margaret McNairy, MD MPH 2123045483 mm3780@columbia.edu

Locations
Swaziland
Mkhuzweni Health Center Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Dvokolwako Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Good Shepherd Hospital Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Hlatikhulu Hospital Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa M El-Sadr, MD MPH         
Horo Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Kamfishane Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Lamvelase Withdrawn
Swaziland, Swaziland
Luyengo Clinic Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Mangweni Clinic Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Mankayane Hospital Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr, MD MPH         
Mashobneni Clinic Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Mbabane Government Hospital Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr, MD MPH         
Sithobeloa Rural Health Center Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Motshane Not yet recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Mpolenjeni Clinic Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Nhlangano Health Center Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr, MD MPH         
Piggs Peak Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr, MD MPH         
Raleigh Fitkin Memorial Hospital Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr, MD MPH         
Siphofaneni Clinc Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Bhalekane Clinic Recruiting
Swaziland, Swaziland
Contact: Yvonne Mavengere         
Principal Investigator: Wafaa El-Sadr         
Sponsors and Collaborators
Columbia University
New York University
Investigators
Principal Investigator: Wafaa El-Sadr, MD MPH ICAP Columbia University
Study Director: Charles Azih, MD MPH Swaziland MOH
Study Director: Scott Braithwaite, MD MSc New York University
Study Director: Batya Elul, PhD MD ICAP Columbia University
Study Director: Peter Ehrenkranz, MD MPH Centers for Disease Control and Prevention
Study Director: Matthew Lamb, PhD MPH ICAP Columbia University
Study Director: Margaret McNairy, MD MSc ICAP Columbia University
Study Director: Phumzile Mndzebele Swaziland MOH
Study Director: Ruben Sahabao, MD ICAP Swaziland
  More Information

No publications provided

Responsible Party: Wafaa Mahmoud El-Sadr, Professor of Epidemiology and Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01904994     History of Changes
Other Study ID Numbers: AAAL2708, 5R01AI100059-02
Study First Received: July 16, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board
Swaziland: Center for Disease Control and Prevention
Swaziland: Swaziland National AIDS Programme
Swaziland: Ministry of Health
Swaziland: Médecins Sans Frontières
Swaziland: Population Services International
Swaziland: University Research Co., LLC
Swaziland: Clinton Health Access Initiative
Swaziland: Swaziland Network of People Living with HIV/AIDS
Swaziland: Elizabeth Glaser Pediatric AIDS Foundation

Keywords provided by Columbia University:
HIV (Human Immunodeficiency Virus)
ART (antiretroviral therapy)
financial incentive
linkage
retention
SMS (Short Message Service) appointment reminder
accelerated ART
CD4+ count

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014