Incentives to Promote Medication Adherence Among HIV-Infected Youth

NCT02206906 | Completed

• 1 other identifier: INMED
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Medication Adherence; Incentives; Real-time Medication Monitoring

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (13)

• Feasibility - Accrual percentage

  End of study (week 48)

• Feasibility - Drop out rate

  End of study (week 48)

• Feasibility - Participant reported device concerns

  End of study (week 48)

• Feasibility - Device replacement rate

  End of study (week 48)

• Feasibility - Contact failure rate

  End of study (week 48)

Study Arms (1)

Study Participants

All participants who meet eligibility requirements and who consent to participation will use an incentive intervention model.

Behavioral: Incentive intervention model

Interventions

Incentive intervention model BEHAVIORAL

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 Participants

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Youth with HIV who meet eligibility criteria.

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ronald Dallas, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2015-06

Locations

US (1)