This study will use a longitudinal, experimental design. Participants will be randomized to either the intervention or the control group. The intervention will involve cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Control group participants will participate in all on-study evaluations, except the intervention exit interviews.
Forty participants, non-adherent to HAART at study start, will be randomly assigned to either a 1) "Cell Phone Adherence Facilitator" group (intervention group) or a 2) control group. In the intervention group, a Cell Phone Adherence Facilitator will initiate a short (typically five minutes or less) contact Monday through Friday (excluding major holidays) with each participant to enhance their adherence to HAART. Occasionally, calls may be longer if crises arise that can be addressed by the Adherence Facilitator. Calls from the Adherence Facilitator will occur once or twice a day (depending on dosing schedule) and go on for 24 weeks in the intervention group. Calls will occur at a time soon after the prescribed dose is supposed to be taken, but also one convenient to the participant and the Adherence Facilitator. All participants regardless of condition will be followed for 48 weeks. This intervention will be examined as a tool to address participant-specific, healthcare systems and participant-provider relationship barriers to ARV adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization.
Childrens Hospital of Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
To examine the content of the Adherence Facilitator's conversation; including reported stressful life circumstances, what solutions were offered, and acceptability of the intervention among intervention participants.
Time frame: 1 year
To examine the trends of therapeutic success at 6 and 12 months, as measured by lowered viral load, and self-reported adherence among intervention versus control group participants.
Time frame: 1 year
To examine the trends of self-reported and chart-documented service utilization among intervention versus control participants.
Time frame: 1 year
To identify the characteristics of youth who may require longer-term adherence support with cell phone conversations based on their self-reported scores of depression, life stressors, substance use, and their utilization of services.
Time frame: 1 year
To track the costs of implementation of cell phone contacts with Adherence Facilitators in the adolescent clinical setting by collecting the monthly cost of youths' cell phones.
Time frame: 1 year
To evaluate barriers to and promoters of implementation of cell phone support through qualitative interviews with intervention participants and Adherence Facilitators.
Time frame: 1 year
To examine the trends for self-reported adherence self-efficacy, perceived stress, and problem-solving orientation towards medication among intervention versus control group participants.
Time frame: 1 year
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Tulane University Health Sciences Center
New Orleans, Louisiana, United States