Clinical trial NCT03738410: 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
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: mHealth
mobile applications
culturally-competent
HIV stigma
Resilience
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-11-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Rate of Enrollment
timeFrame: Month 12
measure: Acceptability of the mHealth application
timeFrame: Month 12
Secondary outcomes:
measure: Change in Clinic Attendance
timeFrame: Baseline, Month 12
measure: Change in HIV Stigma
timeFrame: Baseline, Month 12
measure: Change in Medical Mistrust
timeFrame: Baseline, Month 12
measure: Change in Resilience
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lunthita M Duthely, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.