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

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Messaging application
Standard of Care Treatment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring mHealth, mobile applications, culturally-competent, HIV stigma, Resilience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Control Arm

Mobile Health Messaging Arm

Focus Group Arm

Arm Description

The control arm will receive standard of care.

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.

The results of the focus groups will contribute to the wording and design of the intervention.

Outcomes

Primary Outcome Measures

Rate of Enrollment
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
The proportion of messages opened, which were received

Secondary Outcome Measures

Change in Clinic Attendance
Change in attendance to HIV primary care visits within 12 months of randomization
Change in HIV Stigma
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
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
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).

Full Information

First Posted
November 8, 2018
Last Updated
June 14, 2023
Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03738410
Brief Title
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is: 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). Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
mHealth, mobile applications, culturally-competent, HIV stigma, Resilience

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
The control arm will receive standard of care.
Arm Title
Mobile Health Messaging Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Focus Group Arm
Arm Type
No Intervention
Arm Description
The results of the focus groups will contribute to the wording and design of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health Messaging application
Intervention Description
Mobile messaging sent to participants over a 12-month period.
Intervention Type
Other
Intervention Name(s)
Standard of Care Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Enrollment
Description
The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.
Time Frame
Month 12
Title
Acceptability of the mHealth application
Description
The proportion of messages opened, which were received
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Change in Clinic Attendance
Description
Change in attendance to HIV primary care visits within 12 months of randomization
Time Frame
Baseline, Month 12
Title
Change in HIV Stigma
Description
Change in measured stigma (AIDS-related Stigma Scale) within 12 months of randomization (range 40=strongly disagree to 160=strongly agree).
Time Frame
Baseline, Month 12
Title
Change in Medical Mistrust
Description
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).
Time Frame
Baseline, Month 12
Title
Change in Resilience
Description
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).
Time Frame
Baseline, Month 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-identify
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lunthita M Duthely, Ed.D.
Phone
305-243-5800
Email
lduthely@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lunthita M Duthely, Ed.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latoya D Johnson, MBA
Phone
305-243-2170
Email
ldj32@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Lunthita M Duthely, Ed.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34909537
Citation
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.
Results Reference
derived
PubMed Identifier
32779730
Citation
Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus 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(8):CD013680. doi: 10.1002/14651858.CD013680.
Results Reference
derived
PubMed Identifier
32438338
Citation
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.
Results Reference
derived

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

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