HIV InfectionPtCNCT06807736
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
An observational study of HIV Infection and Sexual and Reproductive Health, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
Trial summary
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Sexual and Reproductive Health
- What is being tested?
- Cabotegravir long-acting, Tenofovir emtricitabine and Dapivirine containing vaginal ring
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,800 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Feb 2024to 31 Mar 2026
- Phase
- Observational
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be recruited from the Klipfontein-Mitchells Plain Health sub-district (a peri-urban, high-density, low socio-economic setting) in Cape Town, South Africa. Participants can access the study through the mobile clinic (which rotates through the study area on a fixed schedule) or a local government primary healthcare facility. The target study population includes adolescent girls and young women (aged 15 -29 years) and their intimate male partners (>15 years). Gender and sexually diverse populations, including men who have sex with men, transgender women, and transgender men, are eligible for study enrollment.
Who may be able to join
- All participants must be HIV negative at baseline
- All participants must have a body weight ¬> 35kg at baseline
- All participants must be older than 15 years. Specific age criteria will be applied to certain population groups.
- All participants must be currently resident in the study area
- All participants must be able to provide written, informed voluntary consent to partake in the study and willing and able to receive an injectable pre-exposure prophylaxis (PrEP) product
Who cannot join
- Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection
- Clinical conditions contraindicated for the chosen PrEP product as per SAHPRA regulations, including use of known contraindicated medications.
- Allergy to any of the study products
- Do not spend a reasonable amount of time in the study area as residents, for school, or work, or are otherwise unable to participate in clinical or study visits for geographical reasons, according to the site investigator
- Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
- Current enrolment in another HIV prevention clinical trial that in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (as verified by registration on the South African Medical Research Council biometric co-enrolment prevention system).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Desmond Tutu Health Foundation
Cape Town, Western Province, 7925
Carey T Pike, BSc(Hon), MSc, +27844532928, Carey.Pike@hiv-research.org.za
Philippa Macdonald, MBChB, MRCP, +27216505869, pippa.macdonald@hiv-research.org.za
About this study
Official title: PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.
Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.
The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.
Read the detailed description
The PrEPared to Choose (PtC) study seeks to describe patterns of persistence on HIV pre-exposure prophylaxis (PrEP) products, individually and overall, amongst a cohort of South African adolescents and youth when offered a choice between PrEP products in real-world public health facility and mobile clinic settings. The study will further seek to understand implementation barriers and enablers in PrEP adoption (decision to use any PrEP product), initiation (first dose of any PrEP product), and persistence amongst both PrEP users (adolescents and youth) and PrEP providers (healthcare providers).
This study will utilise a prospective cohort design that recruits 1800 adolescents and young people, specifically adolescent girls and young women, including pregnant and lacting women (15-29 years), young male key populations including men who have sex with men and male sex workers (15-29 years), and their collective intimate male partners (any age).
Participants will be invited to choose to initiate on one of three types of PrEP (injectable, oral, or vaginal ring PrEP). Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point. Participants will be followed for 7 months to meet the primary outcome of short-term persistence and for a further 18 months to meet the secondary outcome of long-term persistence. Persistence will be defined as the continuous use of the selected product as intended with (a) <7 day gap and (b) <28 day gap in PrEP availability for daily dosing (oral PrEP), vaginal ring insertion, or subsequent injection. The 7-day window aligns with previous trial definitions of on-time dosing while the 28-day window aligns with pragmatic definitions of on-time dosing for PrEP in the South African context.
The three products available will include: (1) a Tenofovir-based oral tablet that needs to be taken daily and is provided as a 30-day supply of oral tablets; (2) a intra-vaginal silicone ring containing slow-release Dapivirine that provides HIV protection for up to 28 days; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. The study will aim to recruit up to 900 participants that initiate on injectable PrEP, up to 600 participants that initiate on oral PrEP, and up to 300 participants that initiate on vaginal ring PrEP.
PrEP choice counselling will be co-created with PrEP providers and young PrEP users (members of an existing PrEP-orientated youth reference group) and delivered by trained, adolescent-friendly HIV counsellors. PrEP will be administered by NIMART trained (Nurse Initiated Management of Anti-Retroviral Therapy) nurses at two clinical sites: a stationary government primary health care facility and a mobile clinic service that rotates on a fixed schedule through the study area. Participants will initiate at a single site but remain eligible to receive subsequent product refills/doses at the other site if desired.
- Conditions
- HIV Infection, Sexual and Reproductive Health
- Being tested
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Keywords
- HIV prevention, Pre-exposure prophylaxis, Injectable PrEP, Adolescents and young people, South Africa, Cabotegravir long-acting, PrEP Choice
- Medical subject headings
- HIV Infections, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir long-actingDrug
Also called Apretude
3ml intramuscular injection containing 600mg of Cabotegravir
Tenofovir emtricitabineDrug
Oral tablet taken daily to PrEP HIV infection.
Dapivirine containing vaginal ringDrug
Intra-vaginal silicone ring containing slow-release Dapivirine, replaced every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Injectable PrEP User | Participants that select to use injectable PrEP (Cabotegravir long-acting) at baseline. Receives: Drug: Cabotegravir long-acting | |
| Oral PrEP user | Participants that select to use oral PrEP at baseline. Receives: Drug: Tenofovir emtricitabine | |
| Ring User | Participants that select to use vaginal ring PrEP (DapiRing) at baseline. Receives: Drug: Dapivirine containing vaginal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term persistence
Persistence (return for PrEP product within a scheduled visit window) over the short-term (7 months) will be measured and reported as persistent vs non-persistent continuation on each specific PrEP product (oral, injectable, ring) and on PrEP overall (accounting for continuation after switching to a different PrEP product). Non-persistence will be defined as failure to return for PrEP within (a) 7 days of the scheduled visit and (b) 28 days of the scheduled visit.
Measured: 7 months
Primary implementation aim.
The combination of implementation strategies best achieve pre-exposure prophylaxis (PrEP) adoption, active implementation (initiation), and persistence (sustainment) outcomes over the short term (7 months) and the long term (18 months) will be collected and reported within a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. This will include implementation strategies that describe PrEP choice counselling, the integration of injectable PrEP into standard of care clinical practise, and the differentiating practises required for the effective delivery of PrEP from community based and healthcare facility based settings.
Measured: 7 months; 18 months
Secondary outcomes (6)
Durable persistence
Persistence (return for PrEP product within a scheduled visit window) over the long-term (18 months) will be measured and reported as persistent vs non-persistent continuation on each specific PrEP product (oral, injectable, ring) and on PrEP overall (accounting for continuation after switching to a different PrEP product). Non-persistence will be defined as failure to return for PrEP within (a) 7 days of the scheduled visit and (b) 28 days of the scheduled visit.
Measured: 18 months
Time on PrEP
Time on PrEP based on expected (e.g. injections given; product collections as logged in dispency records) vs actual (e.g. self-reported patterns of use by the oral and ring PrEP user) PrEP coverage.
Measured: 18 months
Safety of PrEP products
Reported frequency, timing, and nature of self reported and/or clinically identified adverse events (including clinical events, intimate partner violence, and pregnancy and infant outcomes).
Measured: 18 months
Tolerability of PrEP products
Descriptive reports of product tolerability as per the frequency, timing, and nature of self-reported adverse side effect records. Side effects are asked about by HIV counsellors and research nurses at each study visit and rention officers during retention communications.
Measured: 18 months
Acceptability of PrEP products
Descriptive quantitative and qualitative summaries of reasons for pre-exposure prophylaxis (PrEP) pause or discontinuation. Qualitative questionnaires and in-depth interviews that include questions on PrEP product and PrEP service acceptability are held every 6 months with a sub-set of PrEP users.
Measured: 18 months
HIV testing in a context of PrEP choice
Sensitivity and specificity of counsellor-administered 3rd and 4th generation rapid Antigen/Antibody (Ag/Ab) HIV test compared to laboratory-based NAAT (Nucleic Acid Amplification Tests) testing results in injectable pre-exposure prophylaxis-using (Cabotegrvair long-acting initiated) participants as measured at discreet timepoints (baseline, month 1, month 7, and month 18) throughout the study.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start13 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, ViiV Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807736
- Sponsor's protocol ID
- PrEPared to Choose
- Acronym
- PtC
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pike C, Rousseau E, Macdonald P, Mapukata P, Lebelo K, Joseph-Davey D, Little F, Bekker LG. PrEPared to choose: the protocol for an implementation study of the delivery of cabotegravir long-acting injectable pre-exposure prophylaxis (PrEP) as an HIV prevention product option within a real world PrEP choice context in cape town. BMC Public Health. 2025 Sep 24;25(1):3109. doi: 10.1186/s12889-025-24370-z.
PubMed 40993613
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.
- ClinicalTrials.gov ID
- NCT06807736
- Acronym / sponsor ID
- PtC / PrEPared to Choose
- Conditions
- HIV Infection, Sexual and Reproductive Health
- Keywords
- HIV prevention, Pre-exposure prophylaxis, Injectable PrEP, Adolescents and young people, South Africa, Cabotegravir long-acting, PrEP Choice
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Desmond Tutu HIV FoundationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, ViiV Healthcare
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 4 Feb 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 goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.
Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.
The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.
Detailed description
The PrEPared to Choose (PtC) study seeks to describe patterns of persistence on HIV pre-exposure prophylaxis (PrEP) products, individually and overall, amongst a cohort of South African adolescents and youth when offered a choice between PrEP products in real-world public health facility and mobile clinic settings. The study will further seek to understand implementation barriers and enablers in PrEP adoption (decision to use any PrEP product), initiation (first dose of any PrEP product), and persistence amongst both PrEP users (adolescents and youth) and PrEP providers (healthcare providers).
This study will utilise a prospective cohort design that recruits 1800 adolescents and young people, specifically adolescent girls and young women, including pregnant and lacting women (15-29 years), young male key populations including men who have sex with men and male sex workers (15-29 years), and their collective intimate male partners (any age).
Participants will be invited to choose to initiate on one of three types of PrEP (injectable, oral, or vaginal ring PrEP). Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point. Participants will be followed for 7 months to meet the primary outcome of short-term persistence and for a further 18 months to meet the secondary outcome of long-term persistence. Persistence will be defined as the continuous use of the selected product as intended with (a) <7 day gap and (b) <28 day gap in PrEP availability for daily dosing (oral PrEP), vaginal ring insertion, or subsequent injection. The 7-day window aligns with previous trial definitions of on-time dosing while the 28-day window aligns with pragmatic definitions of on-time dosing for PrEP in the South African context.
The three products available will include: (1) a Tenofovir-based oral tablet that needs to be taken daily and is provided as a 30-day supply of oral tablets; (2) a intra-vaginal silicone ring containing slow-release Dapivirine that provides HIV protection for up to 28 days; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. The study will aim to recruit up to 900 participants that initiate on injectable PrEP, up to 600 participants that initiate on oral PrEP, and up to 300 participants that initiate on vaginal ring PrEP.
PrEP choice counselling will be co-created with PrEP providers and young PrEP users (members of an existing PrEP-orientated youth reference group) and delivered by trained, adolescent-friendly HIV counsellors. PrEP will be administered by NIMART trained (Nurse Initiated Management of Anti-Retroviral Therapy) nurses at two clinical sites: a stationary government primary health care facility and a mobile clinic service that rotates on a fixed schedule through the study area. Participants will initiate at a single site but remain eligible to receive subsequent product refills/doses at the other site if desired.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injectable PrEP User | – | Drug: Cabotegravir long-actingParticipants that select to use injectable PrEP (Cabotegravir long-acting) at baseline. |
| Oral PrEP user | – | Drug: Tenofovir emtricitabineParticipants that select to use oral PrEP at baseline. |
| Ring User | – | Drug: Dapivirine containing vaginal ringParticipants that select to use vaginal ring PrEP (DapiRing) at baseline. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from the Klipfontein-Mitchells Plain Health sub-district (a peri-urban, high-density, low socio-economic setting) in Cape Town, South Africa. Participants can access the study through the mobile clinic (which rotates through the study area on a fixed schedule) or a local government primary healthcare facility. The target study population includes adolescent girls and young women (aged 15 -29 years) and their intimate male partners (>15 years). Gender and sexually diverse populations, including men who have sex with men, transgender women, and transgender men, are eligible for study enrollment.
Key inclusion criteria (5 listed)
- All participants must be HIV negative at baseline
- All participants must have a body weight ¬> 35kg at baseline
- All participants must be older than 15 years. Specific age criteria will be applied to certain population groups.
- All participants must be currently resident in the study area
- All participants must be able to provide written, informed voluntary consent to partake in the study and willing and able to receive an injectable pre-exposure prophylaxis (PrEP) product
Key exclusion criteria (6 listed)
- Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection
- Clinical conditions contraindicated for the chosen PrEP product as per SAHPRA regulations, including use of known contraindicated medications.
- Allergy to any of the study products
- Do not spend a reasonable amount of time in the study area as residents, for school, or work, or are otherwise unable to participate in clinical or study visits for geographical reasons, according to the site investigator
- Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
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 |
|---|---|---|
| Cabotegravir long-actingAlso: Apretude3ml intramuscular injection containing 600mg of Cabotegravir | Drug | Injectable PrEP User |
| Tenofovir emtricitabineOral tablet taken daily to PrEP HIV infection. | Drug | Oral PrEP user |
| Dapivirine containing vaginal ringIntra-vaginal silicone ring containing slow-release Dapivirine, replaced every 28 days | Drug | Ring User |
Primary outcome
Short-term persistence
Time frame: 7 months
Persistence (return for PrEP product within a scheduled visit window) over the short-term (7 months) will be measured and reported as persistent vs non-persistent continuation on each specific PrEP product (oral, injectable, ring) and on PrEP overall (accounting for continuation after switching to a different PrEP product). Non-persistence will be defined as failure to return for PrEP within (a) 7 days of the scheduled visit and (b) 28 days of the scheduled visit.
Primary implementation aim.
Time frame: 7 months; 18 months
The combination of implementation strategies best achieve pre-exposure prophylaxis (PrEP) adoption, active implementation (initiation), and persistence (sustainment) outcomes over the short term (7 months) and the long term (18 months) will be collected and reported within a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. This will include implementation strategies that describe PrEP choice counselling, the integration of injectable PrEP into standard of care clinical practise, and the differentiating practises required for the effective delivery of PrEP from community based and healthcare facility based settings.
6 secondary outcomes
Durable persistence
Time frame: 18 months
Time on PrEP
Time frame: 18 months
Safety of PrEP products
Time frame: 18 months
Tolerability of PrEP products
Time frame: 18 months
Acceptability of PrEP products
Time frame: 18 months
HIV testing in a context of PrEP choice
Time frame: 18 months
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 4 Feb 2025.
- Derived from this study: PubMed 40993613Pike C, Rousseau E, Macdonald P, Mapukata P, Lebelo K, Joseph-Davey D, Little F, Bekker LG. PrEPared to choose: the protocol for an implementation study of the delivery of cabotegravir long-acting injectable pre-exposure prophylaxis (PrEP) as an HIV prevention product option within a real world PrEP choice context in cape town. BMC Public Health. 2025 Sep 24;25(1):3109. doi: 10.1186/s12889-025-24370-z.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of HIV Infection and Sexual and Reproductive Health, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
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 6 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 4 Feb 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 South Africa. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term persistence (time frame: 7 months). 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 NCT06807736, which also lists 1 linked publication.
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 4 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.