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

• ClinicalTrials.gov Identifier: NCT03738410
• Recruitment Status: Recruiting
• First Posted: November 13, 2018
• Last Update Posted: May 2, 2022
• Sponsor: University of Miami
• Information provided by (Responsible Party): Lunthita M. Duthely, University of Miami

Study Description

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

Study Design

• 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)
• Actual Study Start Date: May 30, 2019
• Estimated Primary Completion Date: November 30, 2022
• Estimated Study Completion Date: November 30, 2022

Arms and Interventions

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.

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Lunthita M Duthely, Ed.D.; 305-243-5800; lduthely@med.miami.edu

Locations

United States, Florida

University of Miami; 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

• Principal Investigator: Lunthita M Duthely, Ed.D.; University of Miami

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Duthely LM, Sanchez-Covarrubias AP, Prabhakar V, Brown MR, Thomas TES, Montgomerie EK, Potter JE. Medical Mistrust and Adherence to Care Among a Heterogeneous Cohort of Women Living with HIV, Followed in a Large, U.S. Safety Net Clinic. Health Equity. 2021 Sep 24;5(1):681-687. doi: 10.1089/heq.2020.0105. eCollection 2021.

Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fønhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8:CD013680. doi: 10.1002/14651858.CD013680.

Duthely LM, Sanchez-Covarrubias AP, Mohamed AB, Potter JE. A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 19;9(6):e17656. doi: 10.2196/17656.

• Responsible Party: Lunthita M. Duthely, Research Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03738410
• Other Study ID Numbers: 20170287
• First Posted: November 13, 2018
• Last Update Posted: May 2, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases