HIV/AIDS
Conditions
Keywords
mHealth, mobile applications, culturally-competent, HIV stigma, Resilience
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.
Interventions
BEHAVIORALMobile Health Messaging application
Mobile messaging sent to participants over a 12-month period.
OTHERStandard 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.
Sponsors
University of Miami
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Enrollment | Month 12 | The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached. |
| Acceptability of the mHealth application | Month 12 | The proportion of messages opened, which were received |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinic Attendance | Baseline, Month 12 | Change in attendance to HIV primary care visits within 12 months of randomization |
| Change in HIV Stigma | Baseline, Month 12 | Change in measured stigma (AIDS-related Stigma Scale) within 12 months of randomization (range 40=strongly disagree to 160=strongly agree). |
| Change in Medical Mistrust | 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). |
| Change in Resilience | 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). |
Countries
United States
Contacts
CONTACTLunthita M Duthely, Ed.D.
PRINCIPAL_INVESTIGATORLunthita M Duthely, Ed.D.
University of Miami
Outcome results
None listed