Recruiting

mHealth Intervention

Sponsor:

University of Miami

Code:

NCT03738410

Conditions

HIV/AIDS

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mobile Health Messaging application

Standard of Care Treatment

Study Details

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. The intervention will also include patient navigation and motivational interviewing

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.

Conditions

HIV/AIDS

Study ID

NCT03738410

Start date

May 2, 2022

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jun 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Control Arm

The control arm will receive standard of care.

experimental: Mobile Health Messaging Arm

The Patient Navigation and Mobile Health Messaging Arm will receive standard of care, as well as patient navigation assistance and the mobile health intervention. The mHealth intervention includes psycho-educational messaging as well.

no intervention: Focus Group Arm

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

Interventions

Mobile Health Messaging application

Mobile messaging sent to participants over a 12-month period.

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.

Primary outcome measure

  • Rate of Enrollment [ Time Frame: Month 12 ]
  • Acceptability of the mHealth application [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Lunthita M Duthely, Ed.D.

305-243-5800lduthely@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

mCARES Lab

305-243-5800mCARES@miami.edu

Principal Investigator:

Lunthita M Duthely, Ed.D.

More Information

Sponsor

University of Miami

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • mHealth
  • mobile applications
  • culturally-competent
  • HIV stigma
  • Resilience

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-25.