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

NCT02440386 | Unknown

• 1 other identifier: HRECREF:849/2014
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• ART initiation

  Commencement of antiretroviral therapy for HIV

  3 months

Secondary Outcomes (7)

• Time to ART initiation

  1-52 weeks

• Linkage to Care: first visit to clinic

  3 months

• Time to linkage to care

  1-52 weeks

• ART retention

  12 months

• Feasibility - accrual percentage

  6 months

Study Arms (2)

Control

NO INTERVENTION

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.

Incentive

EXPERIMENTAL

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

Interventions

Conditional economic incentive BEHAVIORAL

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.

Also known as: CEI

Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participated in the study previously
• Previously been on ART
• Intoxicated at the time of enrolment

Sponsors & Collaborators

• University of Cape Town: lead
• Brown University: collaborator

Study Sites (1)

Tutu Tester Mobile Clinic, Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7705, South Africa

Location

Study Officials

• Brendan Maughan-Brown, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Omar Galarraga, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 12, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

ZA (1)