Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women
Primary Purpose
HIV Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cell phone SMS text messaging
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infection
Eligibility Criteria
Inclusion Criteria:
- HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
- Subjects must be 18 years or older.
- Subjects must have cell phones with texting capability.
- Ability to speak, read, or understand English or Spanish.
- Must be willing and able to respond to text messages.
Exclusion Criteria:
1. Women who are unable to speak, read, or understand English or Spanish
Sites / Locations
- Thomas Street Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMS (texting) Arm
Arm Description
texts received
Outcomes
Primary Outcome Measures
Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments.
Secondary Outcome Measures
assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.
Full Information
NCT ID
NCT02301507
First Posted
November 18, 2014
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02301507
Brief Title
Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women
Official Title
Evaluation of Texting Intervention to Improve Adherence to Antiretroviral Therapy (ART) in Young Women Infected With Human Immunodeficiency Virus (HIV)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. In the present era, cell phones have become part of daily life for most people even among those in lower economic groups. There have also been several studies looking at cell phone text messaging services to improve adherence to ART among HIV infected subjects but no studies have so far been done in HIV infected young women to help retention and adherence to care. The overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in HIV infected young women.
Study Hypothesis:
Text message intervention will improve adherence to ART in HIV infected young women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS (texting) Arm
Arm Type
Experimental
Arm Description
texts received
Intervention Type
Behavioral
Intervention Name(s)
cell phone SMS text messaging
Intervention Description
This study will utilize mobile texting services to send text messages to enrolled subjects on a weekly basis. The text would convey messages that promote better awareness and knowledge on HIV and its treatment, reminders for medication adherence and clinic appointments. The text content would also be customized based on individual subject requirements. English will be used in texting. We would also assess the subjects for traditional demographic items (e.g., age, marital status, education, number/age of other children, employment, and religion), and potential environmental barriers (e.g., transportation and childcare).
Primary Outcome Measure Information:
Title
Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
Subjects must be 18 years or older.
Subjects must have cell phones with texting capability.
Ability to speak, read, or understand English or Spanish.
Must be willing and able to respond to text messages.
Exclusion Criteria:
1. Women who are unable to speak, read, or understand English or Spanish
Facility Information:
Facility Name
Thomas Street Health Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women
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