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

Not Applicable

Withdrawn

• Conditions: HIV; Adherence
• Interventions: Other: Text messaging

• Registration Number: NCT02468544
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-31
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Study Start: 2017-03
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Intervention Study	Text messaging	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy of the intervention	30 days	Preliminary efficacy of the intervention will be measured using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES) and the HIV appointment adherence questionnaire.

Trial Locations

Locations (1)

Acacia Network/Promesa; 🇺🇸 New York, New York, United States