HIViLinkNCT02440386
iLink (Incentives for Linkage to ART) Study: A Mixed-methods Study to Improve Linkage to HIV Care
A study testing Conditional economic incentive in people with HIV, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Conditional economic incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participated in the study previously
- Previously been on ART
- Intoxicated at the time of enrolment
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Tutu Tester Mobile Clinic, Desmond Tutu HIV Foundation
Cape Town, Western Cape, 7705
About this study
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.
Read the detailed description
The initiation of combination antiretroviral therapy (ART) remains a serious challenge globally, and particularly in South Africa, the country with the largest population of people living with HIV worldwide (UNAIDS 2012). South Africa has the largest ART programme globally, yet only half of those needing ART in South Africa were receiving treatment in 2011 (Johnson 2012). Early initiation of ART improves treatment outcomes and reduces AIDS-related morbidity and mortality. Recent studies have demonstrated a secondary benefit of ART in preventing HIV transmission by reducing viral load and thus transmissibility (Cohen et al. 2011; Montaner et al. 2010; Tanser et al. 2013). Despite the personal and public health benefits of ART, South African studies have shown large loss to follow-up at each of the stages required for ART initiation: (1) initial CD4 count testing and returning for results; (2) attending ART readiness counselling; and (3) returning to initiate ART (April et al. 2009; Bassett et al. 2010; Kranzer et al. 2010; Larson et al. 2010; Losina et al. 2010).
Novel interventions are urgently needed to improve linkage to HIV treatment and care post-diagnosis, as increased ART coverage will reduce AIDS-related morbidity and mortality, and HIV incidence. Improving ART coverage is therefore a priority in many regions of the world, and particularly in sub-Saharan Africa, where AIDS remains a key development challenge. Interventions based on theories from the field of behavioural economics, a hybrid of principles from psychology and economics (Bickel et al. 1995), have great potential to help strengthen the contributions of psychology to improving ART outcomes. Conditional economic incentives (CEIs), a financial incentive given upon completion of an outcome that can be objectively measured (i.e. ART initiation), has the potential to leverage two theoretical principles from behavioural economics to improve ART initiation. First, instead of being completely rational and accurate, decision-making is viewed as inherently biased due to a multitude of social-cognitive and affective factors that play a role in cost-benefit analysis, such as emotions, personal beliefs, and contextual factors (Fiske \& Taylor 2008). In other words, people's preferred outcomes are largely determined by salient contextual needs (Operario et al. 2013). Second, people have a tendency to give greater value to rewards in the present or near future than those in the more distant future (a phenomenon economists term temporal discounting) and therefore decision-making favours immediate rewards and heavily discounts future outcomes. This poses a challenge for ART initiation as the future benefits of ART may be valued less than an individual's more immediate needs, especially for individuals who currently perceive themselves to be relatively healthy.
A CEI may help overcome this challenge for ART initiation by increasing its immediate benefits. A CEI may therefore help 'nudge' individuals to initiate ART by altering the cost-benefit ratio so that the benefits of ART (i.e. the immediate financial reward and the future health reward) outweigh the immediate costs of ART initiation, such as transport, time off work, long waiting lines and the fear of stigma. The application of CEIs to address HIV prevention and treatment problems is still in its infancy, but they have been successfully employed to improve adherence to ART (Rosen et al. 2007; Sorensen et al. 2007; Javanbakht et al. 2010), increase HIV testing uptake and the collection of HIV tests results (Thornton 2008), and reduce risky sexual behaviours (Baird et al. 2012). This evidence indicates that small incentives-based interventions can 'nudge' individuals towards adopting healthier behaviours.
The proposed research will make a significant contribution to our knowledge about demand creation for HIV treatment and prevention services by examining whether CEIs may also be an effective tool for improving linkage to HIV treatment and care following referral for ART services. The proposed research will examine the feasibility and acceptability of using CEIs to increase the uptake of ART among men and women who are referred for ART services. Our long-term collaborative goal is to utilize the results from this pilot study to prepare a grant application for a fully-powered RCT examining whether CEIs can increase ART initiation.
Objectives To examine the acceptability and feasibility of an incentive intervention aimed at increasing uptake of ART among men and women who are referred for ART (CD4 < 500 or WHO stage 4) by a mobile health clinic.
Acceptability
- Did participants find the randomization process fair and acceptable?
- Was the intervention an incentive that motivated or encouraged uptake of ART?
- Was the incentive amount and type acceptable?
- Were individuals in the control arm discouraged from ART initiation because they felt that their linkage to care efforts were not rewarded?
- Were there cases of patients who were unsatisfied or disappointed as a consequence of the study (eg. they did not receive the incentive, yet they thought they should)?
Feasibility
- Is it possible to recruit men and women into the study on the day of being referred for ART?
- Is it possible to track individuals and recruit individuals for in-depth interviews?
- Is it possible to implement the study as planned:
- Did the randomization process work?
- Did participants understand the incentive system?
- Did participants believe that they would actually receive the incentive?
- Did the incentive delivery method work?
- What is the potential for individuals to game the incentive system? Did any individuals find a method of receiving the money without starting ART?
Potential Efficacy
- Is ART initiation more likely among men and women who are offered the incentive compared to men and women who are not offered the incentive?
- Is early ART initiation more likely among men and women who are offered the incentive compared to men and women who are not offered the incentive?
- Does retention in care after ART initiation differ among men and women who are offered the incentive compared to men and women not offered the incentive?
- What is the potential for incentives to improve ART initiation given participants behavioural intentions regarding ART initiation and barriers to ART initiation?
- Conditions
- HIV
- Being tested
- Conditional economic incentive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditional economic incentiveBehavioural
Also called CEI
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:
- Initiate ART at any clinic within 3 months from the time of their CD4 count test at the Tutu Tester; and
- send a text message to the study team to let us know they have started ART;
- Schedule a meeting with a member of the study team to show their clinic card and ARVs to confirm ART initiation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Conditional economic incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART initiation
Commencement of antiretroviral therapy for HIV
Measured: 3 months
Secondary outcomes (7)
Time to ART initiation
Days between referral for ART and ART initiation
Measured: 1-52 weeks
Linkage to Care: first visit to clinic
Self-reported attendance at an HIV/ART clinic within 3 months of study enrollment
Measured: 3 months
Time to linkage to care
Days between referral for ART and attendance at an HIV/ART clinic
Measured: 1-52 weeks
ART retention
Indicator of whether the participant collected his/her ART 1 year after starting treatment
Measured: 12 months
Feasibility - accrual percentage
Number of people enrolled in study/number approached for enrollment
Measured: 6 months
Feasibility - participant tracking
Number of participants contact at 3 and 6 months/number of participants enrolled
Measured: 3 and 6 months post enrolment
Acceptability - adverse events
Unexpected risks/harms of providing incentives as self-reported by participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Brendan Maughan-Brown, University of Cape Town
- Investigators
- Brendan Maughan-Brown, PhD, Principal investigator, University of Cape TownOmar Galarraga, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440386
- Sponsor's protocol ID
- HRECREF:849/2014
- Acronym
- iLink
- Status last verified
- Oct 2016
- First submitted
- 24 Apr 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iLink (Incentives for Linkage to ART) Study: A Mixed-methods Study to Improve Linkage to HIV Care
- ClinicalTrials.gov ID
- NCT02440386
- Acronym / sponsor ID
- iLink / HRECREF:849/2014
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The initiation of combination antiretroviral therapy (ART) remains a serious challenge globally, and particularly in South Africa, the country with the largest population of people living with HIV worldwide (UNAIDS 2012). South Africa has the largest ART programme globally, yet only half of those needing ART in South Africa were receiving treatment in 2011 (Johnson 2012). Early initiation of ART improves treatment outcomes and reduces AIDS-related morbidity and mortality. Recent studies have demonstrated a secondary benefit of ART in preventing HIV transmission by reducing viral load and thus transmissibility (Cohen et al. 2011; Montaner et al. 2010; Tanser et al. 2013). Despite the personal and public health benefits of ART, South African studies have shown large loss to follow-up at each of the stages required for ART initiation: (1) initial CD4 count testing and returning for results; (2) attending ART readiness counselling; and (3) returning to initiate ART (April et al. 2009; Bassett et al. 2010; Kranzer et al. 2010; Larson et al. 2010; Losina et al. 2010).
Novel interventions are urgently needed to improve linkage to HIV treatment and care post-diagnosis, as increased ART coverage will reduce AIDS-related morbidity and mortality, and HIV incidence. Improving ART coverage is therefore a priority in many regions of the world, and particularly in sub-Saharan Africa, where AIDS remains a key development challenge. Interventions based on theories from the field of behavioural economics, a hybrid of principles from psychology and economics (Bickel et al. 1995), have great potential to help strengthen the contributions of psychology to improving ART outcomes. Conditional economic incentives (CEIs), a financial incentive given upon completion of an outcome that can be objectively measured (i.e. ART initiation), has the potential to leverage two theoretical principles from behavioural economics to improve ART initiation. First, instead of being completely rational and accurate, decision-making is viewed as inherently biased due to a multitude of social-cognitive and affective factors that play a role in cost-benefit analysis, such as emotions, personal beliefs, and contextual factors (Fiske \& Taylor 2008). In other words, people's preferred outcomes are largely determined by salient contextual needs (Operario et al. 2013). Second, people have a tendency to give greater value to rewards in the present or near future than those in the more distant future (a phenomenon economists term temporal discounting) and therefore decision-making favours immediate rewards and heavily discounts future outcomes. This poses a challenge for ART initiation as the future benefits of ART may be valued less than an individual's more immediate needs, especially for individuals who currently perceive themselves to be relatively healthy.
A CEI may help overcome this challenge for ART initiation by increasing its immediate benefits. A CEI may therefore help 'nudge' individuals to initiate ART by altering the cost-benefit ratio so that the benefits of ART (i.e. the immediate financial reward and the future health reward) outweigh the immediate costs of ART initiation, such as transport, time off work, long waiting lines and the fear of stigma. The application of CEIs to address HIV prevention and treatment problems is still in its infancy, but they have been successfully employed to improve adherence to ART (Rosen et al. 2007; Sorensen et al. 2007; Javanbakht et al. 2010), increase HIV testing uptake and the collection of HIV tests results (Thornton 2008), and reduce risky sexual behaviours (Baird et al. 2012). This evidence indicates that small incentives-based interventions can 'nudge' individuals towards adopting healthier behaviours.
The proposed research will make a significant contribution to our knowledge about demand creation for HIV treatment and prevention services by examining whether CEIs may also be an effective tool for improving linkage to HIV treatment and care following referral for ART services. The proposed research will examine the feasibility and acceptability of using CEIs to increase the uptake of ART among men and women who are referred for ART services. Our long-term collaborative goal is to utilize the results from this pilot study to prepare a grant application for a fully-powered RCT examining whether CEIs can increase ART initiation.
Objectives To examine the acceptability and feasibility of an incentive intervention aimed at increasing uptake of ART among men and women who are referred for ART (CD4 < 500 or WHO stage 4) by a mobile health clinic.
Acceptability
- Did participants find the randomization process fair and acceptable?
- Was the intervention an incentive that motivated or encouraged uptake of ART?
- Was the incentive amount and type acceptable?
- Were individuals in the control arm discouraged from ART initiation because they felt that their linkage to care efforts were not rewarded?
- Were there cases of patients who were unsatisfied or disappointed as a consequence of the study (eg. they did not receive the incentive, yet they thought they should)?
Feasibility
- Is it possible to recruit men and women into the study on the day of being referred for ART?
- Is it possible to track individuals and recruit individuals for in-depth interviews?
- Is it possible to implement the study as planned:
- Did the randomization process work?
- Did participants understand the incentive system?
- Did participants believe that they would actually receive the incentive?
- Did the incentive delivery method work?
- What is the potential for individuals to game the incentive system? Did any individuals find a method of receiving the money without starting ART?
Potential Efficacy
- Is ART initiation more likely among men and women who are offered the incentive compared to men and women who are not offered the incentive?
- Is early ART initiation more likely among men and women who are offered the incentive compared to men and women who are not offered the incentive?
- Does retention in care after ART initiation differ among men and women who are offered the incentive compared to men and women not offered the incentive?
- What is the potential for incentives to improve ART initiation given participants behavioural intentions regarding ART initiation and barriers to ART initiation?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Conditional economic incentiveThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Participated in the study previously
- Previously been on ART
- Intoxicated at the time of enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional economic incentiveAlso: CEIIndividuals 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. | Behavioural | Incentive |
Primary outcome
ART initiation
Time frame: 3 months
Commencement of antiretroviral therapy for HIV
7 secondary outcomes
Time to ART initiation
Time frame: 1-52 weeks
Linkage to Care: first visit to clinic
Time frame: 3 months
Time to linkage to care
Time frame: 1-52 weeks
ART retention
Time frame: 12 months
Feasibility - accrual percentage
Time frame: 6 months
Feasibility - participant tracking
Time frame: 3 and 6 months post enrolment
Acceptability - adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Maughan-Brown, PhD principal investigator
University of Cape Town
Omar Galarraga, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditional economic incentive in people with HIV, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ART initiation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.