Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents - Full Text View

Purpose

The primary objective of this project is to assess the study population's acceptance of two medication adherence support strategies: incentive-based programs and electronic medication monitoring. The study population is adolescents (ages 16 - 24) positive for human immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be 10-20 minutes. Patient identifiers will not be attached the survey.

Condition	Intervention
Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome (AIDS)	Other: Questionnaire


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Incentives and Technology Survey 2013: Evaluation of Acceptance of Incentive-Based Adherence Programs and Electronic Medication Monitoring Among HIV-Positive Adolescents

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

Reported perceptions about incentive-based adherence programs and electronic medication monitoring [ Time Frame: Once, at enrollment ] [ Designated as safety issue: No ]
Participants will complete a survey/questionnaire on the computer describing their disease state, the frequency and amount of medication taken daily, and how well they comply with taking their medications and attending their clinic appointments. They will also note their perceptions about how incentive-based adherence programs and electronic medication monitoring. Descriptive statistics will be prepared from survey results.


Enrollment:	100
Study Start Date:	June 2013
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Study Population Participants must meet the eligibility requirements will complete a questionnaire on the computer.	Other: Questionnaire Participants who consent to participate in this study will complete a short questionnaire. The survey will be completely anonymous (not matched with the participant's name). Estimated time to complete the survey is 10-20 minutes. Other Name: Survey

Detailed Description:

Whether or not patients take their medications is one of the most noticeable and important predictors of treatment success or failure for HIV infection. Ways to improve compliance, specifically rewards-based programs and electronic medication monitoring, have shown some success in limited clinical research studies focused on adult subjects. Because the social and developmental factors in adolescents are different from adults, adolescents may not respond to these interventions in the same way as adults. This study will investigate adolescent acceptance and the effectiveness of these programs.

Eligibility


Ages Eligible for Study:	16 Years to 24 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV-positive adolescents between the ages of 16 and 24 years who are currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic.

Criteria

Inclusion Criteria:

HIV positive
Ages 16-24 years.
Participants must understand written or spoken English, because the ACASI used in the study can only be administered in English.

Exclusion Criteria:

Adolescents with a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849393

Locations


United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators


Principal Investigator:	Mary Westfall, MD	St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site


Responsible Party:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT01849393 History of Changes
Other Study ID Numbers:	INTECH
Study First Received:	May 6, 2013
Last Updated:	December 12, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:


Adolescents Medication Compliance Rewards-Based Incentive Programs

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections HIV Seropositivity Immune System Diseases Lentivirus Infections	Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2016