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An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738410
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Lunthita M. Duthely, University of Miami

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 13, 2018
Last Update Posted Date November 15, 2021
Actual Study Start Date  ICMJE May 30, 2019
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Rate of Enrollment [ Time Frame: Month 12 ]
    The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.
  • Acceptability of the mHealth application [ Time Frame: Month 12 ]
    The proportion of messages opened, which were received
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Change in Clinic Attendance [ Time Frame: Baseline, Month 12 ]
    Change in attendance to HIV primary care visits within 12 months of randomization
  • Change in HIV Stigma [ Time Frame: Baseline, Month 12 ]
    Change in measured stigma (AIDS-related Stigma Scale) within 12 months of randomization (range 40=strongly disagree to 160=strongly agree).
  • Change in Medical Mistrust [ Time Frame: Baseline, Month 12 ]
    Change in measured medical mistrust (Group-based Medical Mistrust) within 12 months of randomization (range 12=does not agree at all to 60=completely agrees).
  • Change in Resilience [ Time Frame: Baseline, Month 12 ]
    Change in measured resiliency (Connor-Davidson Resiliency Scale) within 12 months of randomization (range 0=not true at all to 100=true nearly all of the time).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
Official Title  ICMJE A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)
Brief Summary

The purpose of this study is:

  1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).
  2. Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
This is a qualitative/quantitative trial that utilizes a Sequential to Parallel intervention study design model. The initial 15 participants (first 5 each that speak English, Spanish, or Haitain Creole) will participate in the Qualitative arm. These participants may also be eligible to roll over into the quantitative portion of the study and randomized to either the control group or the mHealth Intervention group.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • Behavioral: Mobile Health Messaging application
    Mobile messaging sent to participants over a 12-month period.
  • Other: Standard of Care Treatment
    Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat HIV/AIDS. SOC associated procedures and policies may vary across clinical settings.
Study Arms  ICMJE
  • Active Comparator: Control Arm
    The control arm will receive standard of care.
    Intervention: Other: Standard of Care Treatment
  • Experimental: Mobile Health Messaging Arm
    The Mobile Health Messaging Arm will receive standard of care, as well as the mobile health intervention. The mHealth intervention includes psycho-educational messaging as well.
    Interventions:
    • Behavioral: Mobile Health Messaging application
    • Other: Standard of Care Treatment
  • No Intervention: Focus Group Arm
    The results of the focus groups will contribute to the wording and design of the intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed HIV diagnosis as per the clinic standard
  • Female >= 18 years old at enrollment
  • Currently active or recently returned into care or newly enrolled
  • With two or more previously scheduled visits (12 months prior to study enrollment
  • in the 12 months prior to enrollment:
  • missed one or more visits or
  • viral load detectable (>20 mL) or
  • not taking prescribed HIV anti-retroviral medications

Exclusion Criteria:

  • men
  • women who are cognitively impaired or are not able to consent for themselves
  • non-working cell phone
  • adolescents < 18 years old at enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: self-identify
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lunthita M Duthely, Ed.D. 305-243-5800 lduthely@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03738410
Other Study ID Numbers  ICMJE 20170287
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lunthita M. Duthely, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lunthita M Duthely, Ed.D. University of Miami
PRS Account University of Miami
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP