Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|HIV Adherence||Other: Text messaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
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.
- Acceptability of Intervention [ Time Frame: 30 days ]Acceptability of the intervention will be measured using the Technology Acceptance Model (TAM) scale.
- Feasibility of Intervention [ Time Frame: 30 days ]Feasibility of the intervention will be assessed focusing on study implementation, including recruitment and attrition rates.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02468544
|United States, New York|
|New York, New York, United States, 10457|
|Principal Investigator:||Jemima A. Frimpong, PhD., MPH||Columbia University|