mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV
- Conditions
- HIVMedication AdherenceTelemedicine
- Interventions
- Behavioral: Face-to-Face ART Adherence InterventionBehavioral: Carium Mobile Health Platform
- Registration Number
- NCT05046392
- Lead Sponsor
- Rhode Island Hospital
- Brief Summary
HIV medications can be very effective at helping patients have longer, healthier lives. However, many patients do not take their HIV medications as prescribed. This study aims to test a promising HIV medication adherence health coaching intervention delivered primarily via a smartphone application. N = 400 persons living with HIV will be enrolled across two sites (Providence, RI \& Atlanta, GA). Participants will be randomly assigned, with a 2:1 ratio, to receive a 1) health coaching session with access to a smartphone application that provides medication reminders and remote access to the health coach or a 2) health coaching session only. Participants will complete interviews at baseline, 1, 3, 6, and 12 months after baseline. Some participants will also complete interviews at 18 and 24 months after baseline. Data analysis will examine the extent to which the intervention improves ART medication adherence, as well as other factors, compared to the control condition, which approximates standard of care.
- Detailed Description
There are more than a million persons living with HIV in the United States. Despite the effectiveness of antiretroviral therapy (ART), viral suppression, particularly durable viral suppression, can be difficult to achieve. Suboptimal ART adherence plays a significant role in unsuccessful viral suppression, which increases the risk of disease progression, a shortened lifespan, transmission to others, and the development of treatment resistant strains of HIV. As a result, interventions targeting adherence have been developed. There have been some signs of success, particularly with more intensive interventions. However, there is a need to develop efficacious ART adherence interventions that are readily disseminable and make efficient use of available resources. To that end, PI Ramsey developed and tested an mHealth facilitated ART adherence intervention that includes a single face-to-face ART adherence session delivered by a health coach, followed by 12 months of access to an app and health coaching delivered via the app. The app generates a push notification medication reminder, and adherence data are available to the health coach via a "dashboard," allowing the health coach to monitor adherence in real time and provide support. The health coach uses a two-way secure messaging feature on the app to message participants and to provide support, encouragement, and resources, including links and attachments, in response to adherence lapses and in response to participant-generated messages. The combination of a face-to-face intervention component followed by app facilitated health coaching represents a novel combination that affords participants with a personal connection to a health coach while minimizing the resources needed to deliver the intervention and maximizing timely responsiveness to adherence lapses and other participant needs. A preliminary randomized controlled trial (RCT) compared the intervention to a control condition in which participants received the single face-to-face ART adherence session alone. Based on pilot data, the protocol and intervention are highly feasible and acceptable, and results are consistent with preliminary efficacy of the intervention on objective measures of ART adherence. This study will expand on this preliminary test of the intervention using a fully powered RCT (n=400) across two sites (Providence, RI and Atlanta, GA). The long-term goal of this line of research is to disseminate an efficacious, mHealth facilitated ART adherence intervention that can be readily integrated into clinical care. This study will examine the impact of the intervention, relative to control, on electronic pillbox ART adherence and viral load data. In addition, the role of theoretically supported variables in the mediation and moderation of intervention effects will be explored. Interviews will be conducted at baseline, 1, 3, 6, and 12 months. A subset of participants will also complete interviews at 18 and 24 months to explore sustained intervention effects. If found efficacious, the intervention could be broadly integrated into clinical care for HIV, reducing morbidity and mortality among PLWH in a manner that makes efficient use of available resources.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- at least 18 years of age
- prescribed ART
- diagnosed with HIV
- detectable viral load (>20 copies/mL) in past 6 months
- less than 100% self-reported medication adherence
- physical impairments that would prevent completion of the intervention
- cognitive impairments that jeopardize informed consent and/or intervention comprehension
- active psychosis
- not fluent in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHealth Facilitated Adherence Coaching Carium Mobile Health Platform - mHealth Facilitated Adherence Coaching Face-to-Face ART Adherence Intervention - Control Face-to-Face ART Adherence Intervention -
- Primary Outcome Measures
Name Time Method HIV Viral Load 12 Months HIV viral load data will be extracted from participants' medical record if it was performed as a part of clinical care prior to the study visit. Otherwise, viral load will be collected from laboratories at the study sites. All laboratories will use assays with sensitivity to detect viral load \> 20 copies/mL. For the 18- and 24-month follow-up, VL data will only be collected via medical record extraction.
Electronic Pillbox ART Adherence 12 Months ART adherence will be measured objectively with an electronic pillbox. In this study, the electronic pillbox will be a MEMS Cap. The MEMS Cap is a battery operated electronic bottle cap that is affixed to a pill bottle and records the date and time a patient opens their bottle but provides no feedback or reminders. Participants will be given a MEMS Cap and instructions on how to use it at the baseline interview. Data will be downloaded from the MEMS Cap at all proceeding study visits.
- Secondary Outcome Measures
Name Time Method HIV Treatment Adherence Self-Efficacy Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews. Self-efficacy for adherence to HIV medication will be assessed using HIV-ASES. The HIV-ASES is a 12-item scale of patient confidence in their ability to carry out behaviors related to adherence to medication regimens.
Substance Use Baseline, 1-, 3-, 6-, & 12-month follow-up interviews. The Timeline Followback (TLFB_ interview will be used to assess daily substance use. At baseline, it will be administered for the three months prior to the interview. At follow-up interviews, the TLFB will be used to assess the period of time since the previous interview. The TLFB will provide data on the number of standard drinks consumed per day and types of drug classes used each day.
Depressive Symptoms Baseline, 1-, 3-, 6-, & 12-month follow-up interviews. The Center for Epidemiologic Studies Depression Scale (CESD) will be used to measure level of depressive symptoms. Scores range from 0 - 60, with higher scores representing higher depressive symptomology.
ART Adherence Barriers Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews. Barriers to adherence will be assessed with the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire.
HIV Stigma Baseline, 1-, 3-, 6-, & 12-month follow-up interviews. The HIV Stigma Scale will be used to assess perceived stigma related to HIV. Scores range from 40 - 160, with higher scores representing higher perceived HIV stigma.
Trial Locations
- Locations (2)
Emory University
🇺🇸Atlanta, Georgia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States