Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : November 12, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Lunthita M. Duthely, University of Miami

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Mobile Health Messaging application Other: Standard of Care Treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Official Title: A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)
Estimated Study Start Date : April 22, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Control Arm
The control arm will receive standard of care.
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.

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.
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.

No Intervention: Focus Group Arm
The results of the focus groups will contribute to the wording and design of the intervention.



Primary Outcome Measures :
  1. 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.

  2. Acceptability of the mHealth application [ Time Frame: Month 12 ]
    The proportion of messages opened, which were received


Secondary Outcome Measures :
  1. Change in Clinic Attendance [ Time Frame: Baseline, Month 12 ]
    Change in attendance to HIV primary care visits within 12 months of randomization

  2. 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).

  3. 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).

  4. 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).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-identify
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03738410


Contacts
Layout table for location contacts
Contact: Adi B Mohamed, MEd 305-243-5800 adi.mohamed@med.miami.edu

Locations
Layout table for location information
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Adi B Mohamed, MEd    305-243-5800    adi.mohamed@med.miami.edu   
Principal Investigator: Lunthita M Duthely, Ed.D.         
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Lunthita M Duthely, Ed.D. University of Miami

Layout table for additonal information
Responsible Party: Lunthita M. Duthely, Research Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03738410     History of Changes
Other Study ID Numbers: 20170287
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lunthita M. Duthely, University of Miami:
mHealth
mobile applications
culturally-competent
HIV stigma
Resilience