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Recruiting

NCT Number: NCT03738410

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Lunthita M Duthely, Ed.D.

PRINCIPAL_INVESTIGATOR

mCARES Lab

CONTACT

[email protected]

305-243-5800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Health Messaging application

Behavioral

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

Standard of Care Treatment

Other

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 outcomes

  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 outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lunthita M Duthely, Ed.D.

CONTACT

[email protected]

305-243-5800

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2018
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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