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Completed Not applicable Interventional Results available

mHealth Intervention Supporting HIV Treatment Adherence and Retention

ClinicalTrials.gov ID: NCT01951092

Public ClinicalTrials.gov record NCT01951092. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01951092
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
The Miriam Hospital
Other
Enrollment
32 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2013
Primary completion
May 31, 2014
Completion
May 31, 2014
Last update posted
Apr 21, 2016

2013 – 2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Miriam Hospital Immunology Center Providence Rhode Island 02906

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01951092, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 21, 2016 · Synced Sep 1, 2026

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