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

NCT03738410 | Recruiting

• 2 other identifiers: 201702875R34DA057150
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 2.The intervention will also include patient navigation and motivational interviewing

Conditions

HIV/AIDS

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of Enrollment

  The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.

  Month 12

• Acceptability of the mHealth application

  The proportion of messages opened, which were received

  Month 12

Secondary Outcomes (4)

• Change in Clinic Attendance

  Baseline, Month 12

• Change in HIV Stigma

  Baseline, Month 12

• Change in Medical Mistrust

  Baseline, Month 12

• Change in Resilience

  Baseline, Month 12

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

The control arm will receive standard of care.

Other: Standard of Care Treatment

Mobile Health Messaging Arm

EXPERIMENTAL

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.

Behavioral: Mobile Health Messaging application; Other: Standard of Care Treatment

Focus Group Arm

NO INTERVENTION

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

Interventions

Mobile Health Messaging application BEHAVIORAL

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

Mobile Health Messaging Arm

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.

Control Arm; Mobile Health Messaging Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-identify
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• men
• women who are cognitively impaired or are not able to consent for themselves
• non-working cell phone
• adolescents \< 18 years old at enrollment

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 34909537 DERIVED

• 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.

  PMID: 32779730 DERIVED

• 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.

  PMID: 32438338 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lunthita M Duthely, Ed.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lunthita M Duthely, Ed.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: May 2, 2022
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)