mHealth Intervention Supporting HIV Treatment Adherence and Retention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01951092
First received: September 18, 2013
Last updated: September 24, 2014
Last verified: September 2014

September 18, 2013
September 24, 2014
February 2013
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01951092 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Exploratory end point of PVL <200 copies at the end of the study
Same as current
Not Provided
Not Provided
 
mHealth Intervention Supporting HIV Treatment Adherence and Retention
mHealth Intervention Supporting HIV Treatment Adherence and Retention

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV
  • Adherence
  • mHealth
  • Retention
Other: Text messaging
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.
Intervention: Other: Text messaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2014
June 2014   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01951092
Lifespan Dev Grant Rana-2012
Yes
Aadia Rana, The Miriam Hospital
The Miriam Hospital
Not Provided
Not Provided
The Miriam Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP