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

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV; Adherence
• Intervention / Treatment: Other: Text messaging

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10457
      • Acacia Network/Promesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm Intervention Study; 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; Text messaging mHealth intervention to improve HIV Primary Care Engagement among clients of methadone maintenance treatment programs who are living with HIV.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy to self-manage HIV infection	Changes in self-efficacy to self-manage HIV infection will be measured using the self-management scale applied to persons with HIV/AIDS.	30 days
Improvements in HIV knowledge	Improvements in HIV knowledge will be measured by changes in HIV knowledge. We will use the HIV Knowledge Questionnaire (HIV-KQ-18) at baseline and at 30 days post baseline assessments to measure changes in HIV knowledge.	30 days

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Jemima A. Frimpong, PhD., MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: May 31, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: mHealth; Engagement in care
• Other Study ID Numbers: AAAO7902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No