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

NCT02468544 | Withdrawn

• 1 other identifier: AAAO7902
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Adherence

Keywords

Engagement in care; mHealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Efficacy of the intervention

  30 days

Other Outcomes (2)

• Self-efficacy to self-manage HIV infection

  30 days

• Improvements in HIV knowledge

  30 days

Study Arms (1)

Single Arm Intervention Study

EXPERIMENTAL

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

Interventions

Text messaging OTHER

Text messaging mHealth intervention to improve HIV Primary Care Engagement among clients of methadone maintenance treatment programs who are living with HIV.

Single Arm Intervention Study

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Acacia Network/Promesa

New York, New York, 10457, United States

Location

Study Officials

• Jemima A. Frimpong, PhD., MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 11, 2015
• Study Start: March 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

US (1)