HIVNCT02206906

Incentives to Promote Medication Adherence Among HIV-Infected Youth

An observational study of HIV, run by St. Jude Children's Research Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Medication adherence is one of the most salient predictors of patient outcomes in the era following development of effective treatment for HIV infection. Evolving strategies to improve adherence, specifically incentive interventions and real-time medication monitoring, have shown some success in limited studies. Read more about this study

Who is it for?: Ages 16 to 24 years
Conditions the study is for: HIV
What is being tested?: Incentive intervention model
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Jun 2016
Phase: Observational
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 16 to 24 years
All sexes
No healthy volunteers
Child, Adult

Study population: Youth with HIV who meet eligibility criteria.

Who may be able to join

≥16 and ≤ 24 years old
Documented diagnosis of HIV
Adolescent is aware of his/her HIV diagnosis
Adolescent understands either written or spoken English.
Adolescent is willing and able to provide informed consent or assent.
Adolescent has access to a phone and the internet at the time of enrollment.

Show all 10Show fewer

Adolescent meets the definition of inadequate ARV adherence, which is any of the following in the previous 12 months:
< 80% adherent to any ARV by pharmacy pill count
≥ 7 days delay in scheduled ARV prescription pick-up
Detectable viral load after being on ARVs for at least 12 weeks

Who cannot join

Adolescent has a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation.
Adolescent has a documented acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
Adolescent was diagnosed with HIV in the previous 6 months.
Adolescent has a planned transition to alternative care setting prior to study completion (e.g. relocation, pregnancy or planned pregnancy, transition to adult care).
Concurrent enrollment on a research study with an intervention targeted at increasing adherence to antiretroviral regimens.

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105

Other trials in United States

About this study

Official title: Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Youth on Antiretroviral Therapy

Read the detailed description

PRIMARY OBJECTIVE:

To describe the effects of a novel incentive intervention model on HIV-infected youths' patterns of antiretroviral medication adherence.

SECONDARY OBJECTIVES:

To evaluate the feasibility of an outpatient incentive intervention model.
To assess participant satisfaction with the incentive intervention model.
To evaluate the effect of an outpatient incentive intervention model on targeted health behaviors (numbers of missed appointments and STI diagnoses).
To measure the effect of the incentive intervention on HIV viral load and CD4+ count.
To determine the overall and per patient cost of the incentive intervention model.
To describe associations between adherence measures: real-time medication monitor data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report.

Upon enrollment, participants will receive education and a real-time medication monitor. Participants will be followed monthly in the clinic and will be prescribed thirty-day supplies of medication. During weeks 1-4 participants will establish a baseline with the real-time medication monitor. During weeks 5-28, participants will receive remote incentives based on their level of medication adherence as measured by the real-time medication monitor. Additional lottery-style incentives will occur at regular follow-up visits. No incentives will be applied during weeks 29-48. Participants will complete the protocol at the week 48 visit.

Conditions: HIV
Being tested: Incentive intervention model
Keywords: Medication Adherence, Incentives, Real-time Medication Monitoring
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Incentive intervention modelBehavioural
All participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.

Study groups in NCT02206906
Study group	Role	What they receive
Study Participants		All participants who meet eligibility requirements and who consent to participation will use an incentive intervention model. Receives: Behavioral: Incentive intervention model

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of dosages taken within 2 hours of prescribed time per month
Data collected by a real-time medication monitor that records pillbox opening times.
Measured: Monthly through week 48
Pharmacy pill count
Pharmacy pill count data is collected at each participant encounter, approximately once per month.
Measured: Monthly from 6 months prior to study start through week 48

Secondary outcomes (13)

Feasibility - Accrual percentage
Number of people enrolled in study/number approached for enrollment.
Measured: End of study (week 48)
Feasibility - Drop out rate
Number of people ending protocol early/ total enrollment
Measured: End of study (week 48)
Feasibility - Participant reported device concerns
Problems with the Wisepill devices as spontaneously reported by participants or as assessed at routine follow-up.
Measured: End of study (week 48)
Feasibility - Device replacement rate
Number of devices requiring replacement due to loss/theft/breakage
Measured: End of study (week 48)
Feasibility - Contact failure rate
Number of failed attempts to contact participants/total number of contact attempts made
Measured: End of study (week 48)
Feasibility - Staff hours per week
Hours spent providing remote incentives
Measured: End of study (week 48)
Feasibility - Adverse effects of incentives
Unexpected risks/harms of providing incentives as self-reported by participants.
Measured: End of study (week 48)
Percentage of participants who are satisfied with the incentive intervention
To assess participant satisfaction with the incentive intervention model. Patient satisfaction, assessed by ACASI survey, will be summarized and tabulated for baseline (week 0) and follow-up (week 48) measurements.
Measured: Enrollment (week 0) and end of study (week 48)
Effect of incentives on missed appointment rate
Descriptive statistics of numbers of missed appointments such as mean, interquartile range and median, during each study phase will be computed and compared
Measured: Enrollment (week 0) and end of study (week 48)
Effect of incentives on STI rates
Descriptive statistics of numbers of STI rates such as mean, interquartile range and median, during each study phase will be computed and compared
Measured: Enrollment (week 0) and end of study (week 48)
Change in biological parameters
To measure the effect of the incentive intervention on HIV viral load and CD4+ count. HIV viral load and CD4+ count measured at week 0, 12, 24, 36 and 48 will be summarized and plotted by descriptive statistics, such as mean and standard deviation. Mixed effects models will be applied to explore the effect of the intervention on HIV viral load and CD4+ count.
Measured: At weeks 0, 12, 24, 36 and 48
Overall cost of incentive intervention
To determine the overall and per patient cost of the incentive intervention model the accumulated overall and per patient cost till week 48 will be summarized and tabulated.
Measured: End of study (week 48)
Association between adherence measures
To describe associations between adherence measures: Wisepill data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report. Associations of Wisepill adherence rates with pill count and pick up rates will be described by Pearson or Spearman's correlation coefficients and intraclass correlation coefficients as appropriate.
Measured: End of study (week 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jun 2016

First posted1 Aug 2014 (estimated)
Study startJul 2014
Primary completionJun 2016
Study completionJun 2016

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.
More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02206906
Sponsor's protocol ID: INMED
Status last verified: Jun 2015
First submitted: 30 Jul 2014
Last updated: 21 Jun 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Youth on Antiretroviral Therapy
ClinicalTrials.gov ID: NCT02206906
Acronym / sponsor ID: INMED
Conditions: HIV
Keywords: Medication Adherence, Incentives, Real-time Medication Monitoring
Study type: Observational
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: St. Jude Children's Research HospitalUniversity, hospital or other
Study start: Jul 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 1 Aug 2014 (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.

Detailed description

PRIMARY OBJECTIVE:

To describe the effects of a novel incentive intervention model on HIV-infected youths' patterns of antiretroviral medication adherence.

SECONDARY OBJECTIVES:

To evaluate the feasibility of an outpatient incentive intervention model.
To assess participant satisfaction with the incentive intervention model.
To evaluate the effect of an outpatient incentive intervention model on targeted health behaviors (numbers of missed appointments and STI diagnoses).
To measure the effect of the incentive intervention on HIV viral load and CD4+ count.
To determine the overall and per patient cost of the incentive intervention model.
To describe associations between adherence measures: real-time medication monitor data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Study Participants	–	Behavioral: Incentive intervention modelAll participants who meet eligibility requirements and who consent to participation will use an incentive intervention model.

Who may qualify

Ages: 16 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Youth with HIV who meet eligibility criteria.

Key inclusion criteria (10 listed)

≥16 and ≤ 24 years old
Documented diagnosis of HIV
Adolescent is aware of his/her HIV diagnosis
Adolescent understands either written or spoken English.
Adolescent is willing and able to provide informed consent or assent.

Key exclusion criteria (5 listed)

Adolescent has a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation.
Adolescent has a documented acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
Adolescent was diagnosed with HIV in the previous 6 months.
Adolescent has a planned transition to alternative care setting prior to study completion (e.g. relocation, pregnancy or planned pregnancy, transition to adult care).
Concurrent enrollment on a research study with an intervention targeted at increasing adherence to antiretroviral regimens.

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
Incentive intervention modelAll participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.	Behavioural	Study Participants

Primary outcome

Percentage of dosages taken within 2 hours of prescribed time per month
Time frame: Monthly through week 48
Data collected by a real-time medication monitor that records pillbox opening times.
Pharmacy pill count
Time frame: Monthly from 6 months prior to study start through week 48
Pharmacy pill count data is collected at each participant encounter, approximately once per month.

13 secondary outcomes

Feasibility - Accrual percentage
Time frame: End of study (week 48)
Feasibility - Drop out rate
Time frame: End of study (week 48)
Feasibility - Participant reported device concerns
Time frame: End of study (week 48)
Feasibility - Device replacement rate
Time frame: End of study (week 48)
Feasibility - Contact failure rate
Time frame: End of study (week 48)
Feasibility - Staff hours per week
Time frame: End of study (week 48)
Feasibility - Adverse effects of incentives
Time frame: End of study (week 48)
Percentage of participants who are satisfied with the incentive intervention
Time frame: Enrollment (week 0) and end of study (week 48)
Effect of incentives on missed appointment rate
Time frame: Enrollment (week 0) and end of study (week 48)
Effect of incentives on STI rates
Time frame: Enrollment (week 0) and end of study (week 48)
Change in biological parameters
Time frame: At weeks 0, 12, 24, 36 and 48
Overall cost of incentive intervention
Time frame: End of study (week 48)
Association between adherence measures
Time frame: End of study (week 48)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
St. Jude Children's Research HospitalLink provided by the sponsor.
Clinical Trials Open at St. JudeLink provided by the sponsor.

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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.

Ronald Dallas, PhD principal investigator

St. Jude Children's Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by St. Jude Children's Research Hospital at 1 site in United States.

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 10 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jun 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of dosages taken within 2 hours of prescribed time per month (time frame: Monthly through week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02206906.

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 21 Jun 2016.