HIV/AIDSNCT03738410
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
A study testing Mobile Health Messaging application in people with HIV/AIDS, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Mobile Health Messaging application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- men
- women who are cognitively impaired or are not able to consent for themselves
- non-working cell phone
- adolescents < 18 years old at enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
mCARES Lab, 305-243-5800, mCARES@miami.edu
Lunthita M Duthely, Ed.D.
About this study
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)
The purpose of this study is:
- 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).
- The intervention will also include patient navigation and motivational interviewing
- Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.
- Conditions
- HIV/AIDS
- Being tested
- Mobile Health Messaging application, Standard of Care Treatment
- Keywords
- mHealth, mobile applications, culturally-competent, HIV stigma, Resilience
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Messaging applicationBehavioural
Mobile messaging sent to participants over a 12-month period.
Standard of Care TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | The control arm will receive standard of care. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Enrollment
The proportion of participants enrolled and proportion of participants declined enrollment or screen failed out of total number of participants approached.
Measured: Month 12
Acceptability of the mHealth application
The proportion of messages opened, which were received
Measured: Month 12
Secondary outcomes (4)
Change in Clinic Attendance
Change in attendance to HIV primary care visits within 12 months of randomization
Measured: Baseline, Month 12
Change in HIV Stigma
Change in measured stigma (AIDS-related Stigma Scale) within 12 months of randomization (range 40=strongly disagree to 160=strongly agree).
Measured: Baseline, Month 12
Change in Medical Mistrust
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).
Measured: Baseline, Month 12
Change in Resilience
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).
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start2 May 2022
- Primary completion27 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lunthita M. Duthely, University of Miami
- Investigators
- Lunthita M Duthely, Ed.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738410
- Sponsor's protocol ID
- 20170287
- Other IDs
- 5R34DA057150
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2018
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34909537Palmer 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.
PubMed 32779730Duthely 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.
PubMed 32438338
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03738410
- Acronym / sponsor ID
- 20170287
- Conditions
- HIV/AIDS
- Keywords
- mHealth, mobile applications, culturally-competent, HIV stigma, Resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- 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).
- The intervention will also include patient navigation and motivational interviewing
- Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Standard of Care TreatmentThe control arm will receive standard of care. |
| Mobile Health Messaging Arm | Experimental | Behavioral: Mobile Health Messaging application, Other: Standard of Care TreatmentThe 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. |
| Focus Group Arm | No intervention | –The results of the focus groups will contribute to the wording and design of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- men
- women who are cognitively impaired or are not able to consent for themselves
- non-working cell phone
- adolescents < 18 years old at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health Messaging applicationMobile messaging sent to participants over a 12-month period. | Behavioural | Mobile Health Messaging Arm |
| Standard of Care TreatmentStandard 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. | Other | Control Arm, Mobile Health Messaging Arm |
Primary outcome
Rate of Enrollment
Time frame: 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
Time frame: Month 12
The proportion of messages opened, which were received
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 34909537Duthely 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.
- Derived from this study: PubMed 32779730Palmer 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.
- Derived from this study: PubMed 32438338Duthely 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lunthita M Duthely, Ed.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Messaging application in people with HIV/AIDS, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lunthita M Duthely, Ed.D. (305-243-5800, lduthely@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Enrollment (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738410, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.