Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 2, 2020
Open Peer Review Period: Dec 31, 2019 - Feb 25, 2020
(currently open for review)
A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Improve Treatment Adherence for Women Living with HIV/AIDS: A Feasibility Study Protocol
This paper describes a protocol to investigate the feasibility of a mobile health (mHealth) intervention to improve adherence among women living with HIV. This is two-phase, mixed-methods, pilot, randomized controlled trial that begins with patient qualitative interviews to inform the application design. Participants will be randomized to one of two study arms. Study Population: Women (>=18 years of age) followed at an academic medical center women’s HIV clinic, with a recent history of non-adherence to HIV care (missed appointments, unsuppressed viral load, not taking medications as prescribed) will be enrolled. Intervention and Control: The experimental arm will receive the intervention, which includes health reminders and psycho-educational messaging, plus clinic standard of care reminders. The psycho-educational messaging will target patient-level barriers of HIV stigma and medical mistrust, and resiliency as a patient-level strength. The control arm will receive the standard of care reminders only—namely, mailed appointments and automated telephone calls. All aspects of the study and intervention, i.e. data measures, regulatory forms, and messaging, will be offered in participants’ preferred language (English, Spanish, or Haitian Creole). Outcome Measures: Primary outcome is study feasibility/acceptability. Secondary outcomes are changes in self-reported medication adherence, depressive symptoms (PHQ-9), HIV stigma (HSS), medical mistrust (GBMMS), and resiliency (CDRISC-25), and clinic attendance and viral suppression, extracted from participants’ medical records. Data will be assessed at baseline (T0), and two subsequent clinic visits--approximately 3-4 months post-baseline (T1); 6-9 months post-baseline (T2). Analysis: Audio recordings of qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by study group (chi-square, odds ratios, t-tests). Exploratory analyses using analysis of variance will be constructed for each outcome variable—T1 and T2 values will be compared to T0, by study group. Trial Registration: NCT03738410
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