Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I
Recruitment status was: Active, not recruiting
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.
|Study Design:||Observational Model: Cohort|
|Official Title:||Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I|
- perceived barriers and facilitators to adherence [ Time Frame: One-time qualitative interview ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253850
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Fenway Community Health|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Matthew J. Mimiaga, ScD MPH||Fenway Health and Massachusetts General Hospital|