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mHealth Intervention Supporting HIV Treatment Adherence and Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01951092
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital

Brief Summary:

Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected individuals inconsistently engaged with care are less likely to receive ART which is associated with correspondingly adverse clinical outcomes in the long term and increased risk of transmission. Mobile health (mHealth) strategies including cell phone and text messaging have shown success in the developing world for medication adherence, yet mHealth interventions have not been developed to improve retention in HIV care. This strategy needs to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in supporting HIV treatment adherence in Rhode Island.

The Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic in Rhode Island with patients also referred from eastern Connecticut and southern Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed within 1 year of entering care. In this environment, we propose a pilot study with the following specific aims:

Specific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in HIV care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the Immunology Center at TMH will be recruited to participate in a bidirectional mHealth intervention that delivers automated, regularly scheduled appointment and medication adherence reminders in an individualized format, and also allows individuals to request motivational enhancement and problem-solving support to address barriers to care.

Specific Aim 2: To assess the impact and acceptability of the pilot intervention through qualitative interviews. All participants will also be invited to complete individual in-depth interviews which will assess acceptability and effectiveness of the pilot mHealth intervention, such as content and frequency of automatic messages, for retention and medication adherence for HIV-infected individuals in RI.

The results of this study will provide preliminary data to inform an R21 or R34 application to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for loss to follow-up.

Condition or disease Intervention/treatment Phase
HIV Adherence Retention Other: Text messaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: mHealth Intervention Supporting HIV Treatment Adherence and Retention
Study Start Date : February 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Single Arm intervention study
All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
Other: Text messaging

Primary Outcome Measures :
  1. Number of Particpatns Who Considered the Intervention Feasible and Acceptable [ Time Frame: 6 months ]
    A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 6 months ]
    Exploratory end point of PVL <200 copies at the end of the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infected
  • age >/= 18
  • patient at The Miriam Hospital Immunology Center
  • has cell phone that can send and receive text messages
  • English speaking only

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01951092

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United States, Rhode Island
The Miriam Hospital Immunology Center
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital

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Responsible Party: Aadia Rana, Assistant Professor of Medicine, The Miriam Hospital Identifier: NCT01951092    
Other Study ID Numbers: Lifespan Dev Grant Rana-2012
First Posted: September 26, 2013    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: April 2016
Keywords provided by Aadia Rana, The Miriam Hospital: