mHealth Intervention Supporting HIV Treatment Adherence and Retention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01951092
First received: September 18, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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 Intervention
HIV
Adherence
mHealth
Retention
Other: Text messaging

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: mHealth Intervention Supporting HIV Treatment Adherence and Retention

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Feasibility and Acceptability of Intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Exploratory end point of PVL <200 copies at the end of the study


Enrollment: 32
Study Start Date: February 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951092

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

No publications provided

Responsible Party: Aadia Rana, Assistant Professor of Medicine, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01951092     History of Changes
Other Study ID Numbers: Lifespan Dev Grant Rana-2012
Study First Received: September 18, 2013
Last Updated: September 23, 2013
Health Authority: United States: The Miriam Hospital Institutional Review Board
United States: mHealth study Data Safety Monitoring Board

Keywords provided by The Miriam Hospital:
HIV
mHealth
adherence
retention
texting

ClinicalTrials.gov processed this record on July 22, 2014