HIVPHASESNCT07829133
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
A study testing Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing in people with HIV and Syphilis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial summary
The goal of this clinical trial is to find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
FSW Inclusion Criteria:
- Born biologically female
- Identifies as a woman
- Aged 18 years or older
- Exchanged sex for money, goods, or services in the last 6 months
- Lived and/or worked in Lusaka for at least the last 3 months
- Planning to remain in Lusaka for at least the next 3 months
- Willing and able to provide contact information, including a reachable telephone number
- Willing and able to provide informed consent in Nyanja, Bemba, or English
FSW Exclusion Criteria:
- Under the age of 18 years
- Does not identify as a woman
- Unable and/or unwilling to provide contact information
- Unable and/or unwilling to provide informed consent
Queen Mother Eligibility Criteria:
- Aged 18 years or older
- Currently engaged as a sex work manager ("queen mother")
- Lived and/or worked in Lusaka for at least the last 3 months
- Planning to remain in Lusaka for at least the next 6 months
- Willing and able to provide contact information, including a reachable telephone number
- Willing and able to provide informed consent in Nyanja, Bemba, or English
Implementer Focus Group Discussion Eligibility Criteria:
- Aged 18 years old or older
- Working as a queen mother OR civil society organization/Ministry of Health/non-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW
- Willing and able to provide verbal informed consent in English, Nyanja, or Bemba
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site
Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office
Lusaka, Lusaka Province, 10101
Stephanie Sweitzer, MSPH, MD, +260572003688, Stephanie.Sweitzer@unchealth.unc.edu
About this study
Official title: Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)
The goal of this clinical trial is to find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are:
- Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services?
- Can this approach increase STI diagnosis and connection to STI treatment services?
- Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach?
Read more
Researchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services.
FSW participants will:
- Complete questionnaires when they join the study and again about three months later.
- Complete HIV self-testing and self-collected STI testing when they join the study and again about three months later (at intervention sites), with the help of queen mothers.
- Agree to have their medical records reviewed.
Queen mother participants will:
- Complete questionnaires when they join the study and again about three months later.
- Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again three months later (at intervention sites).
Additionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.
- Being tested
- Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing
- Keywords
- Sexually transmitted infections, Female sex workers, Implementation science, HIV
- Medical subject headings
- Syphilis, Gonorrhea, Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testingOther
Sex work managers, known as "queen mothers", will act as peer champions and will store, distribute, and collect HIV self-tests and self-collected STI test kits at venues where sex is sold on-site. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health (MOH) health facilities based on participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues or DICs or health facilities based on participant preference.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | At intervention sites, the investigators will consecutively enroll 50 female sex workers (FSW) per site and follow them for 3 months, with questionnaire administration, HIV self-testing (HIVST), and self-collected STI testing performed at enrollment and 3 months post-enrollment. At enrollment, participants will complete a one-time questionnaire on sociodemographic data, sexual history, medical history, and strategy acceptability and appropriateness, as well as HIVST and self-collected STI testing, with the assistance of queen mothers. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health facilities per participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues/DICs/health facilities per participant preference. HIVST and self-collected STI testing and questionnaires repeated 3 months after enrollment. Receives: Other: Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing |
| Standard-of-Care Arm | No intervention | At standard-of-care (SOC) sites, the investigators will enroll 50 FSW at each site for completion of study questionnaires at enrolment and at 3-month follow up. These FSW will continue receiving routine syndromic STI management and HIV screening and treatment as recommended by Zambian guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of HIV/STI testing through the strategy
Completion of HIV self-testing and self-collected STI testing among those offered HIV self-testing and self-collected STI testing through the strategy.
Measured: From enrollment to study follow up at 3 months post-enrollment.
Uptake of HIV testing
Completion of HIV testing among those not known to be living with HIV at enrollment.
Measured: From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing
Completion of confirmatory HIV testing among those with positive HIV self tests.
Measured: From enrollment to study follow up at 3 months post-enrollment.
HIV diagnosis
New diagnosis of HIV among those not known to be living with HIV at enrollment.
Measured: From enrollment to study follow up at 3 months post-enrollment.
HIV treatment linkage
Registered in the Zambian national HIV program (of those with HIV).
Measured: From enrollment to study follow up at 3 months post-enrollment.
HIV prevention linkage
Registered in the national HIV program (of those not living with HIV).
Measured: From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected STI testing
Completed self-collected STI testing (of those offered testing through the strategy).
Measured: From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected syphilis testing
Completed self-collected syphilis testing (of those offered testing through the strategy).
Measured: From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected gonorrhea/chlamydia testing
Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).
Measured: From enrollment to study follow up at 3 months post-enrollment.
STI diagnosis
Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).
Measured: From enrollment to study follow up at 3 months post-enrollment.
STI syndromic diagnosis
Diagnosed with one or more STI syndromes (of those participating at SOC sites)
Measured: From enrollment to study follow up at 3 months post-enrollment.
STI treatment linkage
Received STI treatment (of those diagnosed with STIs and/or STI syndromes).
Measured: From enrollment to study follow up at 3 months post-enrollment.
Strategy acceptability
Acceptability of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers, using the Acceptability of Intervention Measure.
Measured: At enrollment and at study follow up 3 months post-enrollment.
Strategy appropriateness
Appropriateness of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers using the Intervention Appropriateness Measure.
Measured: At enrollment and at study follow up 3 months post-enrollment.
Strategy feasibility
Feasibility of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among implementers using the Feasibility of Intervention Measure.
Measured: At enrollment and at study follow up 3 months post-enrollment.
Strategy costs
Variable and fixed costs associated with the strategy and expressed per participant.
Measured: From enrollment to study follow up at 3 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will utilize a parallel pilot cohort study design to pilot the strategy at two purposively selected venues (i.e., sites where FSW socialize and meet new sex partners) in Lusaka, Zambia, and compare to standard of care (SOC, syndromic treatment for symptomatic FSW) at two SOC sites.
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie F Sweitzer, MSPH, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829133
- Sponsor's protocol ID
- 26-1772
- Other IDs
- D43TW009340
- Acronym
- PHASES
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the concern that sharing identifiable data could violate participant privacy around potentially stigmatizing information, this data will not be shared outside of the study team.
Publications
Guidelines for the management of symptomatic sexually transmitted infections [Internet]. Geneva: World Health Organization; 2021 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK572659/
PubMed 34370424Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Wall KM, Kilembe W, Inambao M, Chen YN, Mchoongo M, Kimaru L, Hammond YT, Sharkey T, Malama K, Fulton TR, Tran A, Halumamba H, Anderson S, Kishore N, Sarwar S, Finnegan T, Mark D, Allen SA. Implementation of an electronic fingerprint-linked data collection system: a feasibility and acceptability study among Zambian female sex workers. Global Health. 2015 Jun 27;11:27. doi: 10.1186/s12992-015-0114-z.
PubMed 26115656Evens E, Munthali T, Mangunje F, Kotaka ML, Burke HM, Musonda B, Musonda M, Todd CS. Qualitative focus group discussions exploring PrEP method and service delivery preferences among female sex workers and their managers in four Zambian provinces. BMJ Public Health. 2024 Feb 22;2(1):e000483. doi: 10.1136/bmjph-2023-000483. eCollection 2024 Jun.
PubMed 40018231
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)
- ClinicalTrials.gov ID
- NCT07829133
- Acronym / sponsor ID
- PHASES / 26-1772
- Keywords
- Sexually transmitted infections, Female sex workers, Implementation science, HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Sep 2026 (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 find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are:
- Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services?
- Can this approach increase STI diagnosis and connection to STI treatment services?
- Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach?
Researchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services.
FSW participants will:
- Complete questionnaires when they join the study and again about three months later.
- Complete HIV self-testing and self-collected STI testing when they join the study and again about three months later (at intervention sites), with the help of queen mothers.
- Agree to have their medical records reviewed.
Queen mother participants will:
- Complete questionnaires when they join the study and again about three months later.
- Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again three months later (at intervention sites).
Additionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will utilize a parallel pilot cohort study design to pilot the strategy at two purposively selected venues (i.e., sites where FSW socialize and meet new sex partners) in Lusaka, Zambia, and compare to standard of care (SOC, syndromic treatment for symptomatic FSW) at two SOC sites.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testingAt intervention sites, the investigators will consecutively enroll 50 female sex workers (FSW) per site and follow them for 3 months, with questionnaire administration, HIV self-testing (HIVST), and self-collected STI testing performed at enrollment and 3 months post-enrollment. At enrollment, participants will complete a one-time questionnaire on sociodemographic data, sexual history, medical history, and strategy acceptability and appropriateness, as well as HIVST and self-collected STI testing, with the assistance of queen mothers. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health facilities per participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues/DICs/health facilities per participant preference. HIVST and self-collected STI testing and questionnaires repeated 3 months after enrollment. |
| Standard-of-Care Arm | No intervention | –At standard-of-care (SOC) sites, the investigators will enroll 50 FSW at each site for completion of study questionnaires at enrolment and at 3-month follow up. These FSW will continue receiving routine syndromic STI management and HIV screening and treatment as recommended by Zambian guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testingSex work managers, known as "queen mothers", will act as peer champions and will store, distribute, and collect HIV self-tests and self-collected STI test kits at venues where sex is sold on-site. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health (MOH) health facilities based on participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues or DICs or health facilities based on participant preference. | Other | Intervention Arm |
Primary outcome
Uptake of HIV/STI testing through the strategy
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completion of HIV self-testing and self-collected STI testing among those offered HIV self-testing and self-collected STI testing through the strategy.
Uptake of HIV testing
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completion of HIV testing among those not known to be living with HIV at enrollment.
Completion of confirmatory HIV testing
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing among those with positive HIV self tests.
HIV diagnosis
Time frame: From enrollment to study follow up at 3 months post-enrollment.
New diagnosis of HIV among those not known to be living with HIV at enrollment.
HIV treatment linkage
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Registered in the Zambian national HIV program (of those with HIV).
HIV prevention linkage
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Registered in the national HIV program (of those not living with HIV).
Uptake of self-collected STI testing
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected STI testing (of those offered testing through the strategy).
Uptake of self-collected syphilis testing
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected syphilis testing (of those offered testing through the strategy).
Uptake of self-collected gonorrhea/chlamydia testing
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).
STI diagnosis
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).
STI syndromic diagnosis
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Diagnosed with one or more STI syndromes (of those participating at SOC sites)
STI treatment linkage
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Received STI treatment (of those diagnosed with STIs and/or STI syndromes).
Strategy acceptability
Time frame: At enrollment and at study follow up 3 months post-enrollment.
Acceptability of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers, using the Acceptability of Intervention Measure.
Strategy appropriateness
Time frame: At enrollment and at study follow up 3 months post-enrollment.
Appropriateness of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers using the Intervention Appropriateness Measure.
Strategy feasibility
Time frame: At enrollment and at study follow up 3 months post-enrollment.
Feasibility of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among implementers using the Feasibility of Intervention Measure.
Strategy costs
Time frame: From enrollment to study follow up at 3 months post-enrollment.
Variable and fixed costs associated with the strategy and expressed per participant.
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 18 Sep 2026.
- Background: PubMed 34370424Guidelines for the management of symptomatic sexually transmitted infections [Internet]. Geneva: World Health Organization; 2021 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK572659/
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 26115656Wall KM, Kilembe W, Inambao M, Chen YN, Mchoongo M, Kimaru L, Hammond YT, Sharkey T, Malama K, Fulton TR, Tran A, Halumamba H, Anderson S, Kishore N, Sarwar S, Finnegan T, Mark D, Allen SA. Implementation of an electronic fingerprint-linked data collection system: a feasibility and acceptability study among Zambian female sex workers. Global Health. 2015 Jun 27;11:27. doi: 10.1186/s12992-015-0114-z.
- Background: PubMed 40018231Evens E, Munthali T, Mangunje F, Kotaka ML, Burke HM, Musonda B, Musonda M, Todd CS. Qualitative focus group discussions exploring PrEP method and service delivery preferences among female sex workers and their managers in four Zambian provinces. BMJ Public Health. 2024 Feb 22;2(1):e000483. doi: 10.1136/bmjph-2023-000483. eCollection 2024 Jun.
- Individual participant dataSharing planned: No. Given the concern that sharing identifiable data could violate participant privacy around potentially stigmatizing information, this data will not be shared outside of the study team.
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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.
Stephanie F Sweitzer, MSPH, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing in people with HIV and Syphilis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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 Stephanie F Sweitzer, MSPH, MD (+260572003688, Stephanie.Sweitzer@unchealth.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of HIV/STI testing through the strategy (time frame: From enrollment to study follow up at 3 months post-enrollment.). The study lists 16 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 NCT07829133, which also lists 4 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 18 Sep 2026.