HypertensionCoPILOTNCT07076134
Community-and Primary Care-based Intervention Linked With mObile Technology for HTN Control in Nepal
A study testing FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology in people with Hypertension, run by Duke Kunshan University at 1 site in Nepal.
Trial summary
The clinical trial aims to evaluate whether a community and primary care-based intervention linked with mobile technology (CoPILOT) is acceptable, effective, cost-effective, sustainable, and scalable in improving hypertension (HTN) control among individuals aged 30 to 70 in Nepal. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteNepal
- Study dates
- 15 Aug 2025to 31 Dec 2025
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patient's should be in the range of 30 to 70 years old living in selected communities with HTN (systolic BP ≥ 130 mmHg or diastolic ≥ 85 mmHg or taking antihypertensive medication)
- They should have been diagnosed previously and under medication.
- They should agree to the informed consent
- FCHVs should be working for the selected communities and agree to the informed consent
- FLHWs should work for the health facilities in selected communities and agree to the informed consent.
Who cannot join
- Participants who are not able to respond during the data collection period.
- Participants who are out of municipality during the data collection period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site
Namobuddha municipality
Namobuddha, Kavrepalanchowk, 45200
Karma Lama, 9851255760 ext. +977, namobuddhahs@gmail.com
About this study
Official title: A Pilot Trial of a Community-and Primary Care-based Intervention Linked With mObile Technology for Hypertension Control in Nepal (CoPILOT Trial)
The clinical trial aims to evaluate whether a community and primary care-based intervention linked with mobile technology (CoPILOT) is acceptable, effective, cost-effective, sustainable, and scalable in improving hypertension (HTN) control among individuals aged 30 to 70 in Nepal. The primary research questions include:
Is the use of the application by Frontline Health Workers (FLHWs) and Female Community Health Volunteers (FCHVs) feasible and acceptable? Can FCHVs equipped with mHealth technology effectively increase the linkage of individuals with elevated blood pressure (BP) to health facilities? Does a mobile-based lifestyle intervention reduce or control BP? Can adherence to prescribed HTN treatments be improved among patients through this intervention?
Read the detailed description
The researcher will compare the intervention and control groups to assess changes in BP, quality of life (QoL), body mass index (BMI), medication adherence, and linkage to care.
Participants in the intervention group will:
Attend bi-monthly meetings conducted by FCHVs for BP measurement, facilitated through the mobile application.
Receive healthy lifestyle awareness guidance provided by FCHVs via the mobile app and supplemented with text message reminders.
Visit nearby health facilities for monthly follow up.
- Conditions
- Hypertension
- Being tested
- FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technologyOther
Our intervention utilizes FCHVs as a bridge between the community and health facilities to improve HTN care. FCHVs and FLHWs will receive 2 days of training to use an Android app. The app provides prompts for BP measurement and educational content on healthy lifestyles. For 3 months, FCHVs will conduct bimonthly meetings, measure BP, height, and weight, provide awareness and enter sociodemographic details of participants into the app. Participants with BP ≥130/85 mmHg (unmedicated) or ≥120/80 mmHg (on medication) will be referred to a nearby health facility by FCHVs. The data entered by FCHVs will be linked to FLHWs' terminals. FLHWs will enter required information about medication use, referrals, and follow-ups into the app and take necessary actions for the treatment of referred patients. The intervention includes 795 participants from 10 clusters with BP ≥130/85 mmHg. Data on BP, medication adherence, quality of life, and physical activity will be collected at baseline and endline.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | FCHVs and FLHWs will be given 2 days training on Android mobile-based application usage. The app includes prompts regarding patients' current BP measurements and educational content on dietary habits, the importance of physical activity, and the harmful effects of smoking and alcohol consumption. FCHVs will conduct bimonthly meetings with groups of hypertensive patients. They will measure BP, enter it in the app, provide awareness and refer to nearby health facilities if needed. Data entered by FCHVs will be synchronized with FLHWs' accounts, allowing them to view the data entered by FCHVs. After a patient visits a health facility, the FLHW will take action as needed and record it in the app, thereby creating a linkage between the community and the health facility. Patients registered in the app will also receive weekly health education text messages on their mobile phones. Receives: Other: FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology |
| Usual care | No intervention | Usual care refers to the standard treatment that participants receive as part of their regular routine, without the research introducing any new interventions. The FCHVs and FLHWs in the usual care group will not receive training on application usage, and the participants will not receive text messages on their mobile phones. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure (mmHg)
Change in systolic and diastolic blood pressure (mmHg) among hypertensive patients in the intervention group will be measured using a validated digital blood pressure monitor at baseline and endline. The outcome will be reported as the mean change in systolic and diastolic blood pressure.
Measured: Three months intervention
Secondary outcomes (6)
Change in body weight(kg)
Weight will be measured in kilograms using a weighing scale at health posts by healthcare providers or by FCHVs during group meetings. The measurements will be recorded in the application and later analyzed to assess changes in body weight.
Measured: During baseline and endline (3 months intervention period)
Height (meters)
FLHWs will measure the height (in meters) by using stadiometer at health posts. They will enter the data in the application.
Measured: At baseline or endline (3 months intervention period)
Change in body mass index (BMI) (kg/m²)
Body Mass Index (BMI) will be calculated using the formula BMI = weight (kg) / height² (m²). The BMI values will be derived from the collected data and analyzed to assess changes.
Measured: Three months intervention period
Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS)
Quality of life will be assessed using the EuroQol Visual Analogue Scale (EQ VAS), administered by the study team at baseline and endline. Participants will rate their overall health on a vertical visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), and changes in these scores will be used to evaluate improvements in health-related quality of life.
Measured: Three months intervention period
Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS)
Medication adherence will be assessed using the Morisky Green Levine Medication Adherence Scale (MGLS), administered by the study team at baseline and endline. The MGLS is a 4-item self-report scale that assesses medication-taking behavior, with each item scored 1 for "No" and 0 for "Yes." Total scores range from 0 to 4, with higher scores indicating better adherence. The outcome will be reported as the change in MGLS total score over the 3-month intervention period.
Measured: Three months intervention period
Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews
Empowerment will be assessed through qualitative semi-structured interviews conducted with FCHVs and FLHWs at both baseline and endline. Interview questions will explore changes in core dimensions of empowerment, including knowledge, confidence, and role perception, in relation to the hypertension mHealth intervention. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. The outcome will be reported as a summary of key themes and illustrative quotes that reflect perceived changes in empowerment over the 3-month intervention period.
Measured: Three months intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke Kunshan University
- Sponsor type
- University, hospital or other
- Collaborators
- Dhulikhel Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076134
- Sponsor's protocol ID
- 437_2024
- Other IDs
- DGHI pilot grant
- Acronym
- CoPILOT
- Status last verified
- Aug 2025
- First submitted
- 19 Nov 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, Chen CS, Gibbons L, Krousel-Wood M, Bazzano LA, Nejamis A, Gulayin P, Santero M, Augustovski F, Chen J, Rubinstein A; HCPIA Investigators. Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1016-1025. doi: 10.1001/jama.2017.11358.
PubMed 28975305Lloyd-Sherlock P, Beard J, Minicuci N, Ebrahim S, Chatterji S. Hypertension among older adults in low- and middle-income countries: prevalence, awareness and control. Int J Epidemiol. 2014 Feb;43(1):116-28. doi: 10.1093/ije/dyt215. Epub 2014 Feb 6.
PubMed 24505082Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.
PubMed 26187183Yan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.
PubMed 33909607Ni Z, Atluri N, Shaw RJ, Tan J, Khan K, Merk H, Ge Y, Shrestha S, Shrestha A, Vasudevan L, Karmacharya B, Yan LL. Evaluating the Feasibility and Acceptability of a Mobile Health-Based Female Community Health Volunteer Program for Hypertension Control in Rural Nepal: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Mar 9;8(3):e15419. doi: 10.2196/15419.
PubMed 32149712Tan J, Xu H, Fan Q, Neely O, Doma R, Gundi R, Shrestha B, Shrestha A, Shrestha S, Karmacharya B, Gu W, Ostbye T, Yan LL. Hypertension Care Coordination and Feasibility of Involving Female Community Health Volunteers in Hypertension Management in Kavre District, Nepal: A Qualitative Study. Glob Heart. 2020 Oct 23;15(1):73. doi: 10.5334/gh.872.
PubMed 33150138Bhattarai P, Shrestha A, Xiong S, Peoples N, Ramakrishnan C, Shrestha S, Yin R, Karmacharya B, Yan LL, Jafar TH. Strengthening urban primary healthcare service delivery using electronic health technologies: A qualitative study in urban Nepal. Digit Health. 2022 Jul 21;8:20552076221114182. doi: 10.1177/20552076221114182. eCollection 2022 Jan-Dec.
PubMed 35898291
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Community-and Primary Care-based Intervention Linked With mObile Technology for Hypertension Control in Nepal (CoPILOT Trial)
- ClinicalTrials.gov ID
- NCT07076134
- Acronym / sponsor ID
- CoPILOT / 437_2024
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Duke Kunshan UniversityUniversity, hospital or other
- Collaborators
- Dhulikhel Hospital
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jul 2025 (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 clinical trial aims to evaluate whether a community and primary care-based intervention linked with mobile technology (CoPILOT) is acceptable, effective, cost-effective, sustainable, and scalable in improving hypertension (HTN) control among individuals aged 30 to 70 in Nepal. The primary research questions include:
Is the use of the application by Frontline Health Workers (FLHWs) and Female Community Health Volunteers (FCHVs) feasible and acceptable? Can FCHVs equipped with mHealth technology effectively increase the linkage of individuals with elevated blood pressure (BP) to health facilities? Does a mobile-based lifestyle intervention reduce or control BP? Can adherence to prescribed HTN treatments be improved among patients through this intervention?
Detailed description
The researcher will compare the intervention and control groups to assess changes in BP, quality of life (QoL), body mass index (BMI), medication adherence, and linkage to care.
Participants in the intervention group will:
Attend bi-monthly meetings conducted by FCHVs for BP measurement, facilitated through the mobile application.
Receive healthy lifestyle awareness guidance provided by FCHVs via the mobile app and supplemented with text message reminders.
Visit nearby health facilities for monthly follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technologyFCHVs and FLHWs will be given 2 days training on Android mobile-based application usage. The app includes prompts regarding patients' current BP measurements and educational content on dietary habits, the importance of physical activity, and the harmful effects of smoking and alcohol consumption. FCHVs will conduct bimonthly meetings with groups of hypertensive patients. They will measure BP, enter it in the app, provide awareness and refer to nearby health facilities if needed. Data entered by FCHVs will be synchronized with FLHWs' accounts, allowing them to view the data entered by FCHVs. After a patient visits a health facility, the FLHW will take action as needed and record it in the app, thereby creating a linkage between the community and the health facility. Patients registered in the app will also receive weekly health education text messages on their mobile phones. |
| Usual care | No intervention | –Usual care refers to the standard treatment that participants receive as part of their regular routine, without the research introducing any new interventions. The FCHVs and FLHWs in the usual care group will not receive training on application usage, and the participants will not receive text messages on their mobile phones. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hypertensive patient's should be in the range of 30 to 70 years old living in selected communities with HTN (systolic BP ≥ 130 mmHg or diastolic ≥ 85 mmHg or taking antihypertensive medication)
- They should have been diagnosed previously and under medication.
- They should agree to the informed consent
- FCHVs should be working for the selected communities and agree to the informed consent
- FLHWs should work for the health facilities in selected communities and agree to the informed consent.
Key exclusion criteria (2 listed)
- Participants who are not able to respond during the data collection period.
- Participants who are out of municipality during the data collection period.
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 |
|---|---|---|
| FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technologyOur intervention utilizes FCHVs as a bridge between the community and health facilities to improve HTN care. FCHVs and FLHWs will receive 2 days of training to use an Android app. The app provides prompts for BP measurement and educational content on healthy lifestyles. For 3 months, FCHVs will conduct bimonthly meetings, measure BP, height, and weight, provide awareness and enter sociodemographic details of participants into the app. Participants with BP ≥130/85 mmHg (unmedicated) or ≥120/80 mmHg (on medication) will be referred to a nearby health facility by FCHVs. The data entered by FCHVs will be linked to FLHWs' terminals. FLHWs will enter required information about medication use, referrals, and follow-ups into the app and take necessary actions for the treatment of referred patients. The intervention includes 795 participants from 10 clusters with BP ≥130/85 mmHg. Data on BP, medication adherence, quality of life, and physical activity will be collected at baseline and endline. | Other | Intervention group |
Primary outcome
Change in blood pressure (mmHg)
Time frame: Three months intervention
Change in systolic and diastolic blood pressure (mmHg) among hypertensive patients in the intervention group will be measured using a validated digital blood pressure monitor at baseline and endline. The outcome will be reported as the mean change in systolic and diastolic blood pressure.
6 secondary outcomes
Change in body weight(kg)
Time frame: During baseline and endline (3 months intervention period)
Height (meters)
Time frame: At baseline or endline (3 months intervention period)
Change in body mass index (BMI) (kg/m²)
Time frame: Three months intervention period
Change in quality of life as measured by EuroQol Visual Analogue Scale (EQ VAS)
Time frame: Three months intervention period
Change in antihypertensive medication adherence as measured by the Morisky Green Levine Medication Adherence Scale (MGLS)
Time frame: Three months intervention period
Change in perceived empowerment among FCHVs and FLHWs as assessed through structured qualitative interviews
Time frame: Three months intervention period
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 17 Aug 2025.
- Results publication: PubMed 28975305He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, Chen CS, Gibbons L, Krousel-Wood M, Bazzano LA, Nejamis A, Gulayin P, Santero M, Augustovski F, Chen J, Rubinstein A; HCPIA Investigators. Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1016-1025. doi: 10.1001/jama.2017.11358.
- Results publication: PubMed 24505082Lloyd-Sherlock P, Beard J, Minicuci N, Ebrahim S, Chatterji S. Hypertension among older adults in low- and middle-income countries: prevalence, awareness and control. Int J Epidemiol. 2014 Feb;43(1):116-28. doi: 10.1093/ije/dyt215. Epub 2014 Feb 6.
- Results publication: PubMed 26187183Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.
- Results publication: PubMed 33909607Yan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.
- Results publication: PubMed 32149712Ni Z, Atluri N, Shaw RJ, Tan J, Khan K, Merk H, Ge Y, Shrestha S, Shrestha A, Vasudevan L, Karmacharya B, Yan LL. Evaluating the Feasibility and Acceptability of a Mobile Health-Based Female Community Health Volunteer Program for Hypertension Control in Rural Nepal: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Mar 9;8(3):e15419. doi: 10.2196/15419.
- Results publication: PubMed 33150138Tan J, Xu H, Fan Q, Neely O, Doma R, Gundi R, Shrestha B, Shrestha A, Shrestha S, Karmacharya B, Gu W, Ostbye T, Yan LL. Hypertension Care Coordination and Feasibility of Involving Female Community Health Volunteers in Hypertension Management in Kavre District, Nepal: A Qualitative Study. Glob Heart. 2020 Oct 23;15(1):73. doi: 10.5334/gh.872.
- Results publication: PubMed 35898291Bhattarai P, Shrestha A, Xiong S, Peoples N, Ramakrishnan C, Shrestha S, Yin R, Karmacharya B, Yan LL, Jafar TH. Strengthening urban primary healthcare service delivery using electronic health technologies: A qualitative study in urban Nepal. Digit Health. 2022 Jul 21;8:20552076221114182. doi: 10.1177/20552076221114182. eCollection 2022 Jan-Dec.
- The WHO Nepal launched the Hypertension Care Cascade Initiative on May 17, 2023, aiming to improve hypertension prevention and treatment across the country. This initiative focuses on strengthening healthcare systems and enhancing community-based careLink provided by the sponsor.
- The clinical trial NCT06163859 focuses on evaluating the effectiveness of a new intervention for managing hypertension. The study aims to improve patient outcomes and refine treatment strategiesLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCHVs and FLHWs in a community managing HTN using primary care based approach and mobile health technology in people with Hypertension, run by Duke Kunshan University at 1 site in Nepal.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Aug 2025. 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 Nepal. 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 Lijing Prof. Lijing Yan (86 186 1038 3698, lijing.yan@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (mmHg) (time frame: Three months intervention). 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 NCT07076134, which also lists 7 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 17 Aug 2025; AzTrials last refreshed its copy on 5 Nov 2026.