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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02468544
Recruitment Status : Suspended (Updating mobile phone platform in preparation for round two of testing.)
First Posted : June 11, 2015
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
Jemima Frimpong, 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.

Condition or disease Intervention/treatment Phase
HIV Adherence Other: Text messaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

Primary Outcome Measures :
  1. Acceptability of Intervention [ Time Frame: 30 days ]
    Acceptability of the intervention will be measured using the Technology Acceptance Model (TAM) scale.

  2. Feasibility of Intervention [ Time Frame: 30 days ]
    Feasibility of the intervention will be assessed focusing on study implementation, including recruitment and attrition rates.

Secondary Outcome Measures :
  1. Efficacy of the intervention [ Time Frame: 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.

Other Outcome Measures:
  1. Self-efficacy to self-manage HIV infection [ Time Frame: 30 days ]
    Changes in self-efficacy to self-manage HIV infection will be measured using the self-management scale applied to persons with HIV/AIDS.

  2. Improvements in HIV knowledge [ Time Frame: 30 days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02468544

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United States, New York
Acacia Network/Promesa
New York, New York, United States, 10457
Sponsors and Collaborators
Columbia University
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Principal Investigator: Jemima A. Frimpong, PhD., MPH Columbia University
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Responsible Party: Jemima Frimpong, Assistant Professor of Health Policy and Management, Columbia University Identifier: NCT02468544    
Other Study ID Numbers: AAAO7902
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jemima Frimpong, Columbia University:
Engagement in care