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OpenTrials
Completed

NCT Number: NCT01951092

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital Immunology Center

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Text Messaging

Other

Primary outcomes

  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 outcomes

  1. Efficacy

    Time frame: 6 months

    Exploratory end point of PVL <200 copies at the end of the study

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2013
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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