Incentives to Promote Medication Adherence Among HIV-Infected Youth

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206906
• Other study ID #: INMED
• Status: Completed
• Phase: N/A
• First received: July 30, 2014
• Last updated: June 20, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. Further investigation into incentive interventions for HIV-infected adolescents with poor medication adherence is necessary.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• =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.

• 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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Incentive intervention model
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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Monthly through week 48	No
Primary	Pharmacy pill count	Pharmacy pill count data is collected at each participant encounter, approximately once per month.	Monthly from 6 months prior to study start through week 48	No
Secondary	Feasibility - Accrual percentage	Number of people enrolled in study/number approached for enrollment.	End of study (week 48)	No
Secondary	Feasibility - Drop out rate	Number of people ending protocol early/ total enrollment	End of study (week 48)	No
Secondary	Feasibility - Participant reported device concerns	Problems with the Wisepill devices as spontaneously reported by participants or as assessed at routine follow-up.	End of study (week 48)	No
Secondary	Feasibility - Device replacement rate	Number of devices requiring replacement due to loss/theft/breakage	End of study (week 48)	No
Secondary	Feasibility - Contact failure rate	Number of failed attempts to contact participants/total number of contact attempts made	End of study (week 48)	No
Secondary	Feasibility - Staff hours per week	Hours spent providing remote incentives	End of study (week 48)	No
Secondary	Feasibility - Adverse effects of incentives	Unexpected risks/harms of providing incentives as self-reported by participants.	End of study (week 48)	No
Secondary	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.	Enrollment (week 0) and end of study (week 48)	No
Secondary	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	Enrollment (week 0) and end of study (week 48)	No
Secondary	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	Enrollment (week 0) and end of study (week 48)	No
Secondary	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.	At weeks 0, 12, 24, 36 and 48	No
Secondary	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.	End of study (week 48)	No
Secondary	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.	End of study (week 48)	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital