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Improving Antiretroviral Medication Adherence Among HIV-infected Youth

13 april 2017 bijgewerkt door: Matthew Mimiaga, Fenway Community Health

Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II

HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment.

The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted form of the Life-Steps behavioral intervention) to improve medication adherence among HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to recruit, feasibility of intervention delivery with study counselors and all study procedures, and initial clinically significant improvement in medication adherence via MEMS caps. This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Aims:

  1. To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24. Feasibility of all study procedures and participant acceptability will be assessed.
  2. To explore whether the intervention leads to improved medication adherence among youth who receive the intervention, compared to a control group of youth who do not.

40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Children's Hospital Boston. Participants will be randomized into one of two arms (half and half). Randomization for all participants will occur after the beginning of the week 2 study visit. The duration of the study is 3 months

Randomization:

The investigators will conduct block randomization based on two categories of electronic adherence: 85% or above versus < 85%. All participants will have exhibited some non-adherence in order to be eligible for the study, although they may vary in the extent of non-adherence. Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points, the investigators may need to reconsider adherence categories over the course of the pilot study. The investigators will regularly examine the data to determine whether finer adherence categories are needed, and the investigators will adjust the categories if such a determination is made.

Intervention arm:

  • Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks).
  • Participants will receive motivational reminders to take medications sent via text message to their cell phones
  • Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.

Comparison condition arm:

• Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Children's Hospital Boston
      • Boston, Massachusetts, Verenigde Staten, 02215
        • The Fenway Institute, Fenway Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 24 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age 13 to 24 years
  • HIV-infected
  • Currently taking antiretroviral therapy or prescribed medication for HIV
  • Self-reported difficulties adhering to HIV medications in the past 3 months (i.e., <95% compliant)
  • If 18-24: Willing and able to provide informed consent
  • If 13-17: Parent/guardian willing and able to provide parental permission and participant willing and able to provide assent
  • Willing to attend all study visits

Exclusion Criteria:

  • If 18-24:Unwilling or unable to provide informed consent
  • If 13-17: Parent/guardian unwilling or unable to provide parental permission and participant willing and able to provide assent
  • Has severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit your ability to participate (e.g. dementia)
  • Has severe cognitive limitation that would limit your ability to comprehend the informed consent or assent (see Decisional Capacity Determination SOP)
  • Unwilling to attend all study visits

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Condition
In the comparison condition, participants will receive MEMS only.
Experimenteel: Positive STEPS
  • Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks).
  • Participants will receive motivational reminders to take medications sent via text message to their cell phones.
  • Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
Gedragsmatig: Positive STEPS
This intervention is given to patients in the experimental condition only. The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy. Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor. The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants. Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Electronically monitored (MEMS) antiretroviral medication adherence
Tijdsspanne: 3 months
The primary outcome will be antiretroviral medication adherence. Adherence will be measured through the medication event monitoring device(MEMS).
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fenway Community Health

Medewerkers

Harvard Medical School (HMS and HSDM)
Massachusetts General Hospital
Boston Children's Hospital

Onderzoekers

  • Hoofdonderzoeker: Matthew J Mimiaga, ScD, MPH, Massachusetts General Hospital and Fenway Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2011

Primaire voltooiing (Werkelijk)

1 januari 2013

Studie voltooiing (Werkelijk)

6 maart 2013

Studieregistratiedata

Eerst ingediend

4 april 2011

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2011

Eerst geplaatst (Schatting)

4 mei 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 april 2017

Laatste update ingediend die voldeed aan QC-criteria

13 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CFAR Adherence HIV Youth:2

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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