Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention

Study Overview
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Brief Summary
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This is an open-trial pilot study in which adult methadone maintenance treatment patients who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments, non-adherence to medication) will be recruited to participate in a HIV primary care engagement study. The purpose of this study is to develop and test the feasibility and acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve engagement in HIV primary care among substance abusing populations with HIV.

Official Title
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Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention

Conditions
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HIV, Adherence

Intervention / Treatment
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* Other: Text messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Client of a methadone maintenance treatment program HIV positive (status confirmed by medical records) At least 18 years of age English speaking Comfortable using a mobile phone (to send and receive text messages) Lives in New York City Willingness to attend at least two design sessions Willingness to attend one usability testing session, and participate in a post-usability survey and exit interview.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Intervention Study<br>All participants will receive individualized text messages based on a schedule determined during the development and refinement of the mHealth text messaging intervention (i.e., once or twice a week). All participants will receive text messages for: 1) medication reminders, 2) appointment reminders, and 3) text messages addressing barriers (educational information to improve HIV knowledge) or promoting facilitators (e.g., routinizing taking of HIV antiretroviral medication) of care engagement. Each participant will complete baseline assessments, and will select their preferences for personalized messages on the day of baseline assessments. Text messages will be deployed for the duration of the 30-day trial. Participants will be followed-up at the completion of the 30-day intervention. Each participant will be asked to complete a follow-up survey, including questions on the acceptability of the mHealth intervention. | Other: Text messaging<br>* Text messaging mHealth intervention to improve HIV Primary Care Engagement among clients of methadone maintenance treatment programs who are living with HIV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention | Acceptability of the intervention will be measured using the Technology Acceptance Model (TAM) scale. | 30 days | 
| Feasibility of Intervention | Feasibility of the intervention will be assessed focusing on study implementation, including recruitment and attrition rates. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the intervention | Preliminary efficacy of the intervention will be measured using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES) and the HIV appointment adherence questionnaire. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Engagement in care, mHealth