Cell Phone Reminders Intervention



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:15 - 24
Updated:3/1/2017
Start Date:October 2009
End Date:November 2010

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A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral Therapy Due to Non-Adherence

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.

Inclusion Criteria:

Documented HIV-positive infected either behaviorally or perinatally as determined by
medical record review or verbal verification from referring professional.

Age 15 and 0 days to 24 years and 364 days. Enrolled in care at an AMTU or affiliated
site.

History of non-adherence to one or more components of antiretroviral therapy, defined as
meeting one of the following criteria:

- Currently prescribed HAART and reports to care provider less than 90% adherence in
previous month and has viral load greater than 1000 copies/ml when last evaluated
(within the last four weeks);

- Discontinued HAART in the past while documented to be less than 90% adherent during
the most recent antiretroviral treatment; and

- Agreed to initiate antiretroviral treatment in the past, but never initiated. Able to
speak and understand English. Willing to provide informed consent or assent.

Exclusion Criteria:

Evidence of cognitive impairment or other mental condition (including substance abuse)
that limits his/her ability to complete intervention and assessments (per PI or designee
discretion). Participants with stable and treated mental health/substance abuse disorders
are acceptable for inclusion with protocol team approval.

Any condition, including active substance abuse that is expected to limit the likelihood
that the participant may maintain involvement for the entire year on-study (per PI or
designee discretion with protocol team approval).

No participant consent, parental permission or youth assent (as appropriate). Minors
unable to acquire parental/guardian consent, even if not living at home, will not be able
to participate as a change in housing status during the study might require premature
discontinuation.

Current participation in another behavioral interventional trial.
We found this trial at
5
sites
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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1401 South Federal Highway
Fort Lauderdale, Florida 33301
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Fort Lauderdale, FL
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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San Francisco, California 94143
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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