An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile Health Messaging application, Standard of Care Treatment.
- Who it may be relevant to
- Registry conditions: HIV/AIDS. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Behavioral Mobile Health Messaging application
Mobile messaging sent to participants over a 12-month period. - Other 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 measures
- Rate of Enrollment [Time frame: Month 12]
- Acceptability of the mHealth application [Time frame: Month 12]
Secondary outcome measures (4)
- Change in Clinic Attendance [Time frame: Baseline, Month 12]
- Change in HIV Stigma [Time frame: Baseline, Month 12]
- Change in Medical Mistrust [Time frame: Baseline, Month 12]
- Change in Resilience [Time frame: Baseline, Month 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Miami — Miami
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT03738410 · 20170287 · 5R34DA057150