HIV (Human Immunodeficiency Virus)RKPK: Phase IINCT05373095
Rudi Kundini, Pamoja Kundini
A study testing PKC (adapted adherence counseling) and Conditional Cash Transfers in people with HIV (Human Immunodeficiency Virus), run by University of California, Berkeley at 4 sites in Tanzania.
Trial summary
This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- PKC (adapted adherence counseling) and Conditional Cash Transfers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 4 sitesTanzania
- Study dates
- 23 Oct 2023to 10 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PLHIV on ART;
- Age 18 years or older;
- Phone ownership OR consistent phone access;
- Not already enrolled in/currently attending enhanced adherence counseling sessions at the facility
- Living in Geita Region and intends to receive care at a study facility for the next 12 months;
- Classified as "high-risk" for loss to follow-up (LTFU) from HIV care, and
- Provides written informed consent for participation
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Tanzania4 sites
Geita Regional Referral Hospital
Geita
Geita Town Council Hospital
Geita
Nyankumbu Health Center
Geita
Katoro Health Center
Katoro
About this study
Official title: Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase II
This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).
Read the detailed description
This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at a participating health facility (Katoro Health Center, Geita Town Council Hospital, Geita Regional Referral Hospital, or Nyankumbu Health Center), and have provided informed consent to be part of the study will be randomized in a 1:1 ratio (n=346 PLHIV in each arm), stratified by site, to the control or intervention group. The investigators will use machine learning to finalize a predictive model based on routinely collected medical and pharmacy record data to identify and recruit PLHIV for participation at participating facilities who are at high-risk for disengaging from HIV care.
Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. Criteria for enrollment into enhanced adherence counseling sessions includes when client's viral load reaches a detectable level (>1000 copies/ml). Enhanced adherence counseling includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. Sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff, or in a group setting with a trained counselor who is on the clinical staff. A minimum of three sessions are required. Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. Due to the nature of the intervention, participants will not be blinded to intervention assignment. The primary endpoint is viral load suppression (<1000 copies/ml) at 12 months following study enrollment.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- PKC (adapted adherence counseling) and Conditional Cash Transfers
- Keywords
- Tanzania, Conditional Cash Transfers, People Living With HIV, Machine Learning
- 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.
PKC (adapted adherence counseling) and Conditional Cash TransfersBehavioural
The intervention includes up to 3 cash transfers of 22,500 Tanzanian Shillings (~$10) paired with attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first cash transfer will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining PKC sessions. The cash transfers will include extra funds for transaction fees, typically <$1.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Adherence Counseling (PKC) and Conditional Cash Transfers | Experimental | Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV clinical services according Tanzania's National Guidelines for the Management of HIV as the comparison arm, which includes provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions adapted for study purposes (PKC sessions). Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required. In addition to enhanced adherence counseling, intervention participants will receive the offer of a cash transfer paired with attendance at each of the three enhanced adherence counseling sessions. The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. Receives: Behavioral: PKC (adapted adherence counseling) and Conditional Cash Transfers |
| Enhanced Adherence Counseling only for those who qualify | No intervention | Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of a detectable viral load result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Viral Suppression
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 12 months after study enrollment.
Measured: 12 months
Secondary outcomes (19)
6-month retention in care
The proportion of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)
Measured: 6 months
12-month retention in care
The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)
Measured: 12 months
12-month durable viral load
Proportion with durable HIV viral suppression 12 months after enrollment: at least 2 viral load measurements taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment and all are undetectable (<1000 copies/ml) will have met criteria for durable viral suppression at 12 months.
Measured: 12 months
12-month Appointment Attendance
The proportion of scheduled visits that were completed during the 0-12 month period
Measured: 12 months
6-month Appointment Attendance
The proportion of scheduled visits that were completed during the 0-6 month period
Measured: 6 months
12-month Mortality
The cumulative incidence of mortality at 12 months after study enrollment
Measured: 12 months
6-month Predictive value positive (PVP) of machine learning algorithm
Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 6 months
Measured: 6 months
12-month Predictive value positive (PVP) of machine learning algorithm
Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 12 months
Measured: 12 months
6-month PVP of routine clinical criteria
PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 6 months
Measured: 6 months
12-month PVP of routine clinical criteria
PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 12 months
Measured: 12 months
6-month Predictive value negative (PVN) of the machine learning algorithm
Predictive value negative (PVN) of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 6 months
Measured: 6 months
12-month PVN of the machine learning algorithm
PVN of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 12 months
Measured: 12 months
6-month PVN of routine clinical criteria
PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 6 months
Measured: 6 months
12-month PVN of routine clinical criteria
PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 12 months
Measured: 12 months
Enhanced Adherence Counseling Session Attendance
Proportion of enhanced adherence counseling sessions completed among sessions scheduled
Measured: 6 months
Viral Suppression with enhanced adherence counseling completion
Proportion with HIV viral suppression after completion of enhanced adherence counseling sessions
Measured: 6 months
6-Month Viral Suppression (<1000 copies/ml)
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 6 months after study enrollment.
Measured: 6 months
6-Month Viral Suppression (<50 copies/ml)
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 6 months after study enrollment.
Measured: 6 months
12-Month Viral Suppression (<50 copies/ml)
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 12 months after study enrollment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start23 Oct 2023
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV (Human Immunodeficiency Virus)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Health for a Prosperous Nation, Rasello, Management and Development for Health, Ministry of Health, Tanzania, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jingshen Wang, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373095
- Sponsor's protocol ID
- R01MH125746 - Phase II
- Other IDs
- R01MH125746
- Acronym
- RKPK: Phase II
- Status last verified
- Aug 2026
- First submitted
- 9 May 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Trials. 2024 Feb 10;25(1):114. doi: 10.1186/s13063-024-07960-x.
PubMed 38336793Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.
PubMed 38196655
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase II
- ClinicalTrials.gov ID
- NCT05373095
- Acronym / sponsor ID
- RKPK: Phase II / R01MH125746 - Phase II
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- Tanzania, Conditional Cash Transfers, People Living With HIV, Machine Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Health for a Prosperous Nation, Rasello, Management and Development for Health, Ministry of Health, Tanzania, National Institute of Mental Health (NIMH)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 13 May 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.
This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).
Detailed description
This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at a participating health facility (Katoro Health Center, Geita Town Council Hospital, Geita Regional Referral Hospital, or Nyankumbu Health Center), and have provided informed consent to be part of the study will be randomized in a 1:1 ratio (n=346 PLHIV in each arm), stratified by site, to the control or intervention group. The investigators will use machine learning to finalize a predictive model based on routinely collected medical and pharmacy record data to identify and recruit PLHIV for participation at participating facilities who are at high-risk for disengaging from HIV care.
Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. Criteria for enrollment into enhanced adherence counseling sessions includes when client's viral load reaches a detectable level (>1000 copies/ml). Enhanced adherence counseling includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. Sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff, or in a group setting with a trained counselor who is on the clinical staff. A minimum of three sessions are required. Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. Due to the nature of the intervention, participants will not be blinded to intervention assignment. The primary endpoint is viral load suppression (<1000 copies/ml) at 12 months following study enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Adherence Counseling (PKC) and Conditional Cash Transfers | Experimental | Behavioral: PKC (adapted adherence counseling) and Conditional Cash TransfersEligible and consenting participants randomized to the intervention arm will receive the same standard HIV clinical services according Tanzania's National Guidelines for the Management of HIV as the comparison arm, which includes provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions adapted for study purposes (PKC sessions). Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required. In addition to enhanced adherence counseling, intervention participants will receive the offer of a cash transfer paired with attendance at each of the three enhanced adherence counseling sessions. The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. |
| Enhanced Adherence Counseling only for those who qualify | No intervention | –Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of a detectable viral load result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PLHIV on ART;
- Age 18 years or older;
- Phone ownership OR consistent phone access;
- Not already enrolled in/currently attending enhanced adherence counseling sessions at the facility
- Living in Geita Region and intends to receive care at a study facility for the next 12 months;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PKC (adapted adherence counseling) and Conditional Cash TransfersThe intervention includes up to 3 cash transfers of 22,500 Tanzanian Shillings (~$10) paired with attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first cash transfer will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining PKC sessions. The cash transfers will include extra funds for transaction fees, typically <$1. | Behavioural | Adapted Adherence Counseling (PKC) and Conditional Cash Transfers |
Primary outcome
12-Month Viral Suppression
Time frame: 12 months
The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 12 months after study enrollment.
19 secondary outcomes
6-month retention in care
Time frame: 6 months
12-month retention in care
Time frame: 12 months
12-month durable viral load
Time frame: 12 months
12-month Appointment Attendance
Time frame: 12 months
6-month Appointment Attendance
Time frame: 6 months
12-month Mortality
Time frame: 12 months
6-month Predictive value positive (PVP) of machine learning algorithm
Time frame: 6 months
12-month Predictive value positive (PVP) of machine learning algorithm
Time frame: 12 months
6-month PVP of routine clinical criteria
Time frame: 6 months
12-month PVP of routine clinical criteria
Time frame: 12 months
6-month Predictive value negative (PVN) of the machine learning algorithm
Time frame: 6 months
12-month PVN of the machine learning algorithm
Time frame: 12 months
6-month PVN of routine clinical criteria
Time frame: 6 months
12-month PVN of routine clinical criteria
Time frame: 12 months
Enhanced Adherence Counseling Session Attendance
Time frame: 6 months
Viral Suppression with enhanced adherence counseling completion
Time frame: 6 months
6-Month Viral Suppression (<1000 copies/ml)
Time frame: 6 months
6-Month Viral Suppression (<50 copies/ml)
Time frame: 6 months
12-Month Viral Suppression (<50 copies/ml)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 38336793Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Trials. 2024 Feb 10;25(1):114. doi: 10.1186/s13063-024-07960-x.
- Derived from this study: PubMed 38196655Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.
- Individual participant dataSharing planned: Yes
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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.
Jingshen Wang, PhD principal investigator
University of California, Berkeley
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PKC (adapted adherence counseling) and Conditional Cash Transfers in people with HIV (Human Immunodeficiency Virus), run by University of California, Berkeley at 4 sites in Tanzania.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 14 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 4 sites in Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Viral Suppression (time frame: 12 months). 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 NCT05373095, which also lists 2 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 14 Aug 2026.