Clinical trial NCT02206906: Incentives to Promote Medication Adherence Among HIV-Infected Youth
Official title: Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Youth on Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Medication Adherence
Incentives
Real-time Medication Monitoring
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth with HIV who meet eligibility criteria.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of dosages taken within 2 hours of prescribed time per month
timeFrame: Monthly through week 48
measure: Pharmacy pill count
timeFrame: Monthly from 6 months prior to study start through week 48
Secondary outcomes:
measure: Feasibility - Accrual percentage
timeFrame: End of study (week 48)
measure: Feasibility - Drop out rate
timeFrame: End of study (week 48)
measure: Feasibility - Participant reported device concerns
timeFrame: End of study (week 48)
measure: Feasibility - Device replacement rate
timeFrame: End of study (week 48)
measure: Feasibility - Contact failure rate
timeFrame: End of study (week 48)
measure: Feasibility - Staff hours per week
timeFrame: End of study (week 48)
measure: Feasibility - Adverse effects of incentives
timeFrame: End of study (week 48)
measure: Percentage of participants who are satisfied with the incentive intervention
timeFrame: Enrollment (week 0) and end of study (week 48)
measure: Effect of incentives on missed appointment rate
timeFrame: Enrollment (week 0) and end of study (week 48)
measure: Effect of incentives on STI rates
timeFrame: Enrollment (week 0) and end of study (week 48)
measure: Change in biological parameters
timeFrame: At weeks 0, 12, 24, 36 and 48
measure: Overall cost of incentive intervention
timeFrame: End of study (week 48)
measure: Association between adherence measures
timeFrame: End of study (week 48)
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Ronald Dallas, PhD
role: PRINCIPAL_INVESTIGATOR
References: