Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women

May 19, 2017 updated by: Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston

Evaluation of Texting Intervention to Improve Adherence to Antiretroviral Therapy (ART) in Young Women Infected With Human Immunodeficiency Virus (HIV)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77009
        • Thomas Street Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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.
  2. Subjects must be 18 years or older.
  3. Subjects must have cell phones with texting capability.
  4. Ability to speak, read, or understand English or Spanish.
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMS (texting) Arm
texts received
Behavioral: cell phone SMS text messaging
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-14-0692

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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