HIVNCT05481294
Supportive Coaching Intervention in PLWHA
A study testing Transpersonal Supportive Coaching and Standard Support in people with HIV, run by Muh. Yusuf Tahir at 1 site in Indonesia.
Trial summary
Introduction: Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support. Read more about this study
- Who is it for?
- Ages 17 to 45 years
- Conditions the study is for
- HIV
- What is being tested?
- Transpersonal Supportive Coaching and Standard Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Dec 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- newly diagnosed with HIV maximum 2 months
- Stadium I, II
Who cannot join
- Stadium III and IV
- Opportunistic infection
- Drop Out (DO) criteria:
- Not participating in Supportive Coaching for consecutive 3 times
- Not taking ARV for 1 week
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Yayasan Kelompok Dukungan Sebaya (Peer Support Group Foundation)
Makassar, South Sulawesi, 90231
Rahman Rahim, +6281342122955
Muh.Yusuf Tahir, PhD (Cand.)
About this study
Official title: The Effectivity of Transpersonal Supportive Coaching Intervention on Serotonin Level and Quality of Life in People Living With HIV/AIDS (PLWHA)
Introduction:
Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support.
Read more
Objective:
To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA.
Method:
This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses.
Alternative hypothesis:
- There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA.
- There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA
Read the detailed description
Sampling technique: Purposive sampling
Sample Size :
The estimation of sample size was calculated using the Slovin formula:
n = N / (1 + (N x e²))
n = sample N = population e = margin error (0.05)
n = 100/(1+100 x 0.0025) = 80
The sample will be divided into 3 groups (each group = 26.67 or 27).
Detailed Intervention:
- Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy.
- Control group I: A group was given only basic support for 4 months and taking ARV therapy.
- Control group II: A group only taking ARV therapy without any support was given.
Statistical analysis:
- Qualitative analysis using thematic and content analysis with N-Vivo software
- Quantitative analysis:
- Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval
- Bivariate analysis using Anova or Kruskal Wallis tests.
- Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method
- Data will analysis using SPSS version 26
- Conditions
- HIV
- Being tested
- Transpersonal Supportive Coaching, Standard Support
- Keywords
- Serotonin, Quality of Life, Supportive Coaching, PLWHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpersonal Supportive CoachingOther
Coaching is given for four months (two times a month) with a 45-minute duration per coaching by a professional coach
Standard SupportOther
Standard support is given for four months using a support system provided by Peer Support Foundation
| Study group | Role | What they receive |
|---|---|---|
| Intervention with Transpersonal Supportive Coaching | Experimental | PLWHA is given coaching using standard operating procedures (SOP) for Transpersonal Supportive Coaching to encourage or guide patients in obtaining support. The necessary tool is a representative room for two people with two chairs. Receives: Other: Transpersonal Supportive Coaching |
| Intervention with Standard Support | Active comparator | PLWHA is given standard support provided by peer support foundations Receives: Other: Standard Support |
| No Support | No intervention | PLWHA is not given any kind of support |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in blood serotonin level
Serotonin (5-hydroxytryptamine, 5-HT) is one of the main neurotransmitters in the human brain that could be affected by psychotherapy (i.e., change the serotonin levels). Total serotonin levels in the blood are measured using the Enzyme-linked Immunoassay (ELISA) method with a standard curve range of 70 ng/L-270 ng/L. The change in serotonin level (i.e., mean score) before and after intervention will be statistically assessed.
Measured: The baseline level of serotonin in blood is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention)
The change in Quality of life (QoL) of PLWHA
Quality of life is defined as individuals' perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concern which measure using the modified World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) questionnaire in Indonesian version to measure the QoL patients with HIV/AIDS. it is a 31-item instrument consisting of six domains: physical health (4 items), psychological/emotional well-being (5 items), functional/independence (4 items), social (4 items), environmental (8 items) and spiritual satisfaction (4 items). Further, it also contains overall quality of life and general health perception (2 items). Each item's scores range between 1 (very bad) and 5 (very good). A total score and total of each domain at baseline and after the intervention will be statistically assessed. A positive score change indicates good QoL, while a negative indicates worse QoL.
Measured: The baseline score of total and each domain of Quality of Life on PLWHA is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start16 Dec 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group was given transpersonal supportive coaching and ARV therapy. Meanwhile, comparison group 1 was given basic support and ARV therapy, and comparison group 2 was only given ARV therapy without any support.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muh. Yusuf Tahir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muh. Yusuf Tahir, Hasanuddin University
- Investigators
- Yusuf Tahir, PhD (Cand.), Principal investigator, Hasanudddin UniversityFirdaus Hamid, PhD, Study chair, Hasanudddin UniversityRisna Halim, PhD, Study chair, Hasanudddin UniversityKusrini S. Kadar, PhD, Study chair, Hasanudddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481294
- Sponsor's protocol ID
- 683/UN4.6.4.5.31./PP36/2021
- Status last verified
- Dec 2022
- First submitted
- 28 Jul 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ajisegiri WS, Abubakar AA, Gobir AA, Balogun MS, Sabitu K. Palliative care for people living with HIV/AIDS: Factors influencing healthcare workers' knowledge, attitude and practice in public health facilities, Abuja, Nigeria. PLoS One. 2019 Dec 31;14(12):e0207499. doi: 10.1371/journal.pone.0207499. eCollection 2019.
PubMed 31891577Bradley PJ, Fureder T, Eckel HE. Systemic Therapy, Palliation and Supportive Care of Patients with Hypopharyngeal Cancer. Adv Otorhinolaryngol. 2019;83:148-158. doi: 10.1159/000492359. Epub 2019 Feb 12.
PubMed 30943508Burgess MJ, Zeuli JD, Kasten MJ. Management of HIV/AIDS in older patients-drug/drug interactions and adherence to antiretroviral therapy. HIV AIDS (Auckl). 2015 Oct 27;7:251-64. doi: 10.2147/HIV.S39655. eCollection 2015.
PubMed 26604826Bush SH, Tierney S, Lawlor PG. Clinical Assessment and Management of Delirium in the Palliative Care Setting. Drugs. 2017 Oct;77(15):1623-1643. doi: 10.1007/s40265-017-0804-3.
PubMed 28864877Busolo D, Woodgate R. Palliative care experiences of adult cancer patients from ethnocultural groups: a qualitative systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):99-111. doi: 10.11124/jbisrir-2015-1809.
PubMed 26447011Collins AB, Parashar S, Hogg RS, Fernando S, Worthington C, McDougall P, Turje RB, McNeil R. Integrated HIV care and service engagement among people living with HIV who use drugs in a setting with a community-wide treatment as prevention initiative: a qualitative study in Vancouver, Canada. J Int AIDS Soc. 2017 Mar 3;20(1):21407. doi: 10.7448/IAS.20.1.21407.
PubMed 28426185Gomes B, Calanzani N, Curiale V, McCrone P, Higginson IJ. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD007760. doi: 10.1002/14651858.CD007760.pub2.
PubMed 23744578Harding R, Selman L, Powell RA, Namisango E, Downing J, Merriman A, Ali Z, Gikaara N, Gwyther L, Higginson I. Research into palliative care in sub-Saharan Africa. Lancet Oncol. 2013 Apr;14(4):e183-8. doi: 10.1016/S1470-2045(12)70396-0.
PubMed 23561750Harding R, Simms V, Alexander C, Collins K, Combo E, Memiah P, Patrick G, Sigalla G, Loy G. Can palliative care integrated within HIV outpatient settings improve pain and symptom control in a low-income country? A prospective, longitudinal, controlled intervention evaluation. AIDS Care. 2013;25(7):795-804. doi: 10.1080/09540121.2012.736608. Epub 2012 Oct 31.
PubMed 23113572Head BA, Cantrell M, Pfeifer M. Mark's journey: a study in medicaid palliative care case management. Prof Case Manag. 2009 Jan-Feb;14(1):39-45. doi: 10.1097/01.PCAMA.0000343146.81635.38.
PubMed 19092600Hui D. Definition of supportive care: does the semantic matter? Curr Opin Oncol. 2014 Jul;26(4):372-9. doi: 10.1097/CCO.0000000000000086.
PubMed 24825016Krakauer EL, Ngoc NT, Green K, Van Kham L, Khue LN. Vietnam: integrating palliative care into HIV/AIDS and cancer care. J Pain Symptom Manage. 2007 May;33(5):578-83. doi: 10.1016/j.jpainsymman.2007.02.004.
PubMed 17482051Kristanti MS, Setiyarini S, Effendy C. Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training. BMC Palliat Care. 2017 Jan 17;16(1):4. doi: 10.1186/s12904-016-0178-4.
PubMed 28095837McNeil R, Dilley LB, Guirguis-Younger M, Hwang SW, Small W. Impact of supervised drug consumption services on access to and engagement with care at a palliative and supportive care facility for people living with HIV/AIDS: a qualitative study. J Int AIDS Soc. 2014 Mar 13;17(1):18855. doi: 10.7448/IAS.17.1.18855. eCollection 2014.
PubMed 24629844Medeiros RCDSC, Medeiros JA, Silva TALD, Andrade RD, Medeiros DC, Araujo JS, Oliveira AMG, Costa MAA, Dantas PMS. Quality of life, socioeconomic and clinical factors, and physical exercise in persons living with HIV/AIDS. Rev Saude Publica. 2017 Jul 20;51:66. doi: 10.1590/S1518-8787.2017051006266.
PubMed 28746573
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity of Transpersonal Supportive Coaching Intervention on Serotonin Level and Quality of Life in People Living With HIV/AIDS (PLWHA)
- ClinicalTrials.gov ID
- NCT05481294
- Acronym / sponsor ID
- 683/UN4.6.4.5.31./PP36/2021
- Conditions
- HIV
- Keywords
- Serotonin, Quality of Life, Supportive Coaching, PLWHA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Muh. Yusuf TahirUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Aug 2022 (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.
Introduction:
Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support.
Objective:
To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA.
Method:
This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses.
Alternative hypothesis:
- There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA.
- There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA
Detailed description
Sampling technique: Purposive sampling
Sample Size :
The estimation of sample size was calculated using the Slovin formula:
n = N / (1 + (N x e²))
n = sample N = population e = margin error (0.05)
n = 100/(1+100 x 0.0025) = 80
The sample will be divided into 3 groups (each group = 26.67 or 27).
Detailed Intervention:
- Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy.
- Control group I: A group was given only basic support for 4 months and taking ARV therapy.
- Control group II: A group only taking ARV therapy without any support was given.
Statistical analysis:
- Qualitative analysis using thematic and content analysis with N-Vivo software
- Quantitative analysis:
- Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval
- Bivariate analysis using Anova or Kruskal Wallis tests.
- Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method
- Data will analysis using SPSS version 26
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention group was given transpersonal supportive coaching and ARV therapy. Meanwhile, comparison group 1 was given basic support and ARV therapy, and comparison group 2 was only given ARV therapy without any support.
| Arm | Type | Receives |
|---|---|---|
| Intervention with Transpersonal Supportive Coaching | Experimental | Other: Transpersonal Supportive CoachingPLWHA is given coaching using standard operating procedures (SOP) for Transpersonal Supportive Coaching to encourage or guide patients in obtaining support. The necessary tool is a representative room for two people with two chairs. |
| Intervention with Standard Support | Active comparator | Other: Standard SupportPLWHA is given standard support provided by peer support foundations |
| No Support | No intervention | –PLWHA is not given any kind of support |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- newly diagnosed with HIV maximum 2 months
- Stadium I, II
Key exclusion criteria (5 listed)
- Stadium III and IV
- Opportunistic infection
- Not participating in Supportive Coaching for consecutive 3 times
- Not taking ARV for 1 week
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 |
|---|---|---|
| Transpersonal Supportive CoachingCoaching is given for four months (two times a month) with a 45-minute duration per coaching by a professional coach | Other | Intervention with Transpersonal Supportive Coaching |
| Standard SupportStandard support is given for four months using a support system provided by Peer Support Foundation | Other | Intervention with Standard Support |
Primary outcome
The change in blood serotonin level
Time frame: The baseline level of serotonin in blood is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention)
Serotonin (5-hydroxytryptamine, 5-HT) is one of the main neurotransmitters in the human brain that could be affected by psychotherapy (i.e., change the serotonin levels). Total serotonin levels in the blood are measured using the Enzyme-linked Immunoassay (ELISA) method with a standard curve range of 70 ng/L-270 ng/L. The change in serotonin level (i.e., mean score) before and after intervention will be statistically assessed.
The change in Quality of life (QoL) of PLWHA
Time frame: The baseline score of total and each domain of Quality of Life on PLWHA is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention).
Quality of life is defined as individuals' perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concern which measure using the modified World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) questionnaire in Indonesian version to measure the QoL patients with HIV/AIDS. it is a 31-item instrument consisting of six domains: physical health (4 items), psychological/emotional well-being (5 items), functional/independence (4 items), social (4 items), environmental (8 items) and spiritual satisfaction (4 items). Further, it also contains overall quality of life and general health perception (2 items). Each item's scores range between 1 (very bad) and 5 (very good). A total score and total of each domain at baseline and after the intervention will be statistically assessed. A positive score change indicates good QoL, while a negative indicates worse QoL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 31891577Ajisegiri WS, Abubakar AA, Gobir AA, Balogun MS, Sabitu K. Palliative care for people living with HIV/AIDS: Factors influencing healthcare workers' knowledge, attitude and practice in public health facilities, Abuja, Nigeria. PLoS One. 2019 Dec 31;14(12):e0207499. doi: 10.1371/journal.pone.0207499. eCollection 2019.
- Background: PubMed 30943508Bradley PJ, Fureder T, Eckel HE. Systemic Therapy, Palliation and Supportive Care of Patients with Hypopharyngeal Cancer. Adv Otorhinolaryngol. 2019;83:148-158. doi: 10.1159/000492359. Epub 2019 Feb 12.
- Background: PubMed 26604826Burgess MJ, Zeuli JD, Kasten MJ. Management of HIV/AIDS in older patients-drug/drug interactions and adherence to antiretroviral therapy. HIV AIDS (Auckl). 2015 Oct 27;7:251-64. doi: 10.2147/HIV.S39655. eCollection 2015.
- Background: PubMed 28864877Bush SH, Tierney S, Lawlor PG. Clinical Assessment and Management of Delirium in the Palliative Care Setting. Drugs. 2017 Oct;77(15):1623-1643. doi: 10.1007/s40265-017-0804-3.
- Background: PubMed 26447011Busolo D, Woodgate R. Palliative care experiences of adult cancer patients from ethnocultural groups: a qualitative systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):99-111. doi: 10.11124/jbisrir-2015-1809.
- Background: PubMed 28426185Collins AB, Parashar S, Hogg RS, Fernando S, Worthington C, McDougall P, Turje RB, McNeil R. Integrated HIV care and service engagement among people living with HIV who use drugs in a setting with a community-wide treatment as prevention initiative: a qualitative study in Vancouver, Canada. J Int AIDS Soc. 2017 Mar 3;20(1):21407. doi: 10.7448/IAS.20.1.21407.
- Background: PubMed 23744578Gomes B, Calanzani N, Curiale V, McCrone P, Higginson IJ. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD007760. doi: 10.1002/14651858.CD007760.pub2.
- Background: PubMed 23561750Harding R, Selman L, Powell RA, Namisango E, Downing J, Merriman A, Ali Z, Gikaara N, Gwyther L, Higginson I. Research into palliative care in sub-Saharan Africa. Lancet Oncol. 2013 Apr;14(4):e183-8. doi: 10.1016/S1470-2045(12)70396-0.
- Background: PubMed 23113572Harding R, Simms V, Alexander C, Collins K, Combo E, Memiah P, Patrick G, Sigalla G, Loy G. Can palliative care integrated within HIV outpatient settings improve pain and symptom control in a low-income country? A prospective, longitudinal, controlled intervention evaluation. AIDS Care. 2013;25(7):795-804. doi: 10.1080/09540121.2012.736608. Epub 2012 Oct 31.
- Background: PubMed 19092600Head BA, Cantrell M, Pfeifer M. Mark's journey: a study in medicaid palliative care case management. Prof Case Manag. 2009 Jan-Feb;14(1):39-45. doi: 10.1097/01.PCAMA.0000343146.81635.38.
- Background: PubMed 24825016Hui D. Definition of supportive care: does the semantic matter? Curr Opin Oncol. 2014 Jul;26(4):372-9. doi: 10.1097/CCO.0000000000000086.
- Background: PubMed 17482051Krakauer EL, Ngoc NT, Green K, Van Kham L, Khue LN. Vietnam: integrating palliative care into HIV/AIDS and cancer care. J Pain Symptom Manage. 2007 May;33(5):578-83. doi: 10.1016/j.jpainsymman.2007.02.004.
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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. This study is not recruiting at the moment.
Yusuf Tahir, PhD (Cand.) principal investigator
Hasanudddin University
Firdaus Hamid, PhD study chair
Hasanudddin University
Risna Halim, PhD study chair
Hasanudddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpersonal Supportive Coaching and Standard Support in people with HIV, run by Muh. Yusuf Tahir at 1 site in Indonesia.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muh. Yusuf Tahir, PhD (Cand.) (+628111885522, yusuf_0101@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in blood serotonin level (time frame: The baseline level of serotonin in blood is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention)). 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 NCT05481294, which also lists 19 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 28 Dec 2022.