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iLink (Incentives for Linkage to ART) Study: A Mixed-methods Study to Improve Linkage to HIV Care (iLink)

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ClinicalTrials.gov Identifier: NCT02440386
Recruitment Status : Unknown
Verified October 2016 by Brendan Maughan-Brown, University of Cape Town.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Brendan Maughan-Brown, University of Cape Town

Study Description
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Brief Summary:
The iLink Study examines whether a Conditional Economic Incentive (CEI) may be an effective tool for improving linkage to HIV treatment and care following referral for antiretroviral therapy (ART) services from a mobile health clinic in Cape Town, South Africa. The study examines the feasibility and acceptability of using a R300 (approximately $25 as of April 2015) voucher - that is exchanged for cash upon initiation of ART within 3 months - to increase the uptake of ART among men and women living in low-income areas. This pilot study (n=64) includes a randomised control trial, follow-up telephone calls and medical record reviews, and in-depth interviews.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Conditional economic incentive Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: iLink (Incentives for Linkage to ART) Study: A Mixed-methods Study to Improve Linkage to HIV Care
Study Start Date : April 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
The control arm receives standard of care. Standard of care involves referral for ART services and follow-up calls (maximum of 6) to assess whether linkage to care has occurred.
Experimental: Incentive
The incentive arm receives standard of care plus a R300 voucher. The R300 voucher can be exchanged for cash if the participant starts ART at any clinic of their choice within three months from study enrollment.
 Behavioral: Conditional economic incentive

Individuals in the intervention arm will receive the standard of care. In addition, individuals in the intervention arm receive a voucher worth R300. They are told that they will get this money if they:

  1. Initiate ART at any clinic within 3 months from the time of their CD4 count test at the Tutu Tester; and
  2. send a text message to the study team to let us know they have started ART;
  3. Schedule a meeting with a member of the study team to show their clinic card and ARVs to confirm ART initiation.
Other Name: CEI


Outcome Measures
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Primary Outcome Measures :
  1. ART initiation [ Time Frame: 3 months ]
    Commencement of antiretroviral therapy for HIV


Secondary Outcome Measures :
  1. Time to ART initiation [ Time Frame: 1-52 weeks ]
    Days between referral for ART and ART initiation

  2. Linkage to Care: first visit to clinic [ Time Frame: 3 months ]
    Self-reported attendance at an HIV/ART clinic within 3 months of study enrollment

  3. Time to linkage to care [ Time Frame: 1-52 weeks ]
    Days between referral for ART and attendance at an HIV/ART clinic

  4. ART retention [ Time Frame: 12 months ]
    Indicator of whether the participant collected his/her ART 1 year after starting treatment

  5. Feasibility - accrual percentage [ Time Frame: 6 months ]
    Number of people enrolled in study/number approached for enrollment

  6. Feasibility - participant tracking [ Time Frame: 3 and 6 months post enrolment ]
    Number of participants contact at 3 and 6 months/number of participants enrolled

  7. Acceptability - adverse events [ Time Frame: 6 months ]
    Unexpected risks/harms of providing incentives as self-reported by participants


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Referred for ART by the Tutu Tester Mobile Clinic (CD4 ≤ 500 or WHO stage 4)
  • Planning to live in the study area for the next 6 months
  • Willing and able to provide written informed consent for study participation
  • Willing to accept calls from the study staff

Exclusion Criteria:

  • Participated in the study previously
  • Previously been on ART
  • Intoxicated at the time of enrolment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440386


Locations
South Africa
Tutu Tester Mobile Clinic, Desmond Tutu HIV Foundation
Cape Town, Western Cape, South Africa, 7705
Sponsors and Collaborators
University of Cape Town
Brown University
Investigators
Principal Investigator: Brendan Maughan-Brown, PhD University of Cape Town
Principal Investigator: Omar Galarraga, PhD Brown University
More Information
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Responsible Party: Brendan Maughan-Brown, Dr, University of Cape Town
ClinicalTrials.gov Identifier: NCT02440386     History of Changes
Other Study ID Numbers: HRECREF:849/2014
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016