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- Klinische proef NCT01253850
Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I
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 first phase of the study is an intervention development phase, which includes conducting interviews with 40 HIV-infected youth for input on the adaptation of the approach. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
This phase of the protocol focuses on setting up the infrastructure necessary for conducting the study, including hiring and training activities with study staff. This time will be spent conducting interviews and using these data to inform the development of the intervention protocol and adaptation of all Life-Steps intervention materials, including study assessment instruments, for HIV-infected youth.
The interview is a one-time event and will last for 1.5-2 hours. It has two components: a quantitative assessment and a qualitative discussion. After all participants have completed the informed consent and assent (if under the age of 18) processes, the research staff will administer a brief quantitative assessment that will ask questions related to demographics, medication adherence, sexual risk, substance use, and psychosocial condition. The second part of the interview will be an open discussion. The interviews will be conducted by a trained member of the research staff. The interviews will be informed by a pre-determined qualitative topic guide.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Verenigde Staten, 02115
- Children's Hospital Boston
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Boston, Massachusetts, Verenigde Staten, 02215
- Fenway Community Health
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Phase I
Inclusion Criteria:
- Age 13 to 24 years
- HIV-infected and aware of HIV-infection status
- Currently taking antiretroviral therapy, has been prescribed antiretroviral therapy in the past 6 months, or a medical provider has recommended antiretroviral medications within the last 6 months
- Willing and able to provide informed consent or assent (if under the age of 18)
Exclusion Criteria:
- Not willing or able to provide informed consent or assent (if under the age of 18)
- Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
- Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
Phase II
Inclusion Criteria:
- Age 13-24 years
- HIV-infected and aware of HIV-infection status
- Currently taking antiretroviral therapy
- Self-reported difficulties adhering to HIV medications in the past 3 months
- Self-identify as heterosexual or LGB
- Willing and able to provide informed consent/consent of parent/guardian if under the age of 18
Exclusion Criteria:
- Not willing or able to provide informed consent or assent (if under the age of 18)
- Is dealing with a severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit a participant's ability to engage with study protocol (e.g. dementia)
- Has severe cognitive limitations that would limit a participant's ability to comprehend the informed consent or assent.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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perceived barriers and facilitators to adherence
Tijdsspanne: One-time qualitative interview
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We will code the qualitative interview data for key themes that emerge with respect to adherence and intervention needs.
The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.
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One-time qualitative interview
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Matthew J. Mimiaga, ScD MPH, Fenway Health and Massachusetts General Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- CFAR Adherence HIV Youth:1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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