HIV InfectionsTENDAI4PrEPNCT06226155
Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
A study testing TENDAI4PrEP and Enhanced treatment as usual in people with HIV Infections and Pregnancy Related, run by Massachusetts General Hospital at 1 site in Zimbabwe.
Trial summary
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- HIV Infections, Pregnancy Related, Depression, Anxiety
- What is being tested?
- TENDAI4PrEP and Enhanced treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteZimbabwe
- Study dates
- 21 Oct 2024to 31 Mar 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Across all aims participants must be
- Pregnant
- Presenting at the Chitungwiza Central Hospital ANC
- Aged 15+
- Willing to provide informed consent or assent
- Have HIV negative status
Show all 11Show fewer
- At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and/or recent condomless sexual activity)
- Score >5 on the Shona Symptom Questionnaire
- For the RCT, eligible participants must also be willing to
- Initiate PrEP prior to randomization
- Bring their pregnancy partner (if they are safe doing so).
Who cannot join
- Inability to provide informed consent/assent and/or complete procedures in Shona or English
- Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zimbabwe1 site, 1 recruiting
- Recruiting
University of Zimbabwe
Harare
Walter Mangezi, MD, +263712606560 ext. no ext, wmangezi@yahoo.co.uk
Walter Mangezi, MD
About this study
Official title: TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.
Read the detailed description
Zimbabwe's HIV prevalence rate is among the highest globally, and cisgender women of reproductive age are disproportionately affected. Considering the increased risk of HIV acquisition and transmission during pregnancy, there is an urgent public health need to develop interventions that increase the use of efficacious HIV prevention strategies like PrEP in the antenatal context. Oral pre-exposure prophylaxis (PrEP) is safe during pregnancy, effective in preventing HIV, and available in Zimbabwean antenatal care (ANC) clinics. However, PrEP use remains low among cisgender women of reproductive age. Individual-, interpersonal/community-, and provider-level barriers (e.g., psychological distress, stigma, low partner support, limited PrEP knowledge in providers) compromise use.
A multi-level, problem-solving intervention that addresses barriers to PrEP adherence and persistence during pregnancy and through the postpartum transition among patients, their partners, and antenatal care providers could improve the health of pregnant persons, ultimately decreasing HIV incidence in Zimbabwe.
The aims of this study are as follows:
Aim 1: Explore the impact of intersecting, multi-level barriers on PrEP uptake, adherence, and persistence during pregnancy (n=30), and explore barriers to PrEP provision among antenatal care providers (8-10). In individual interviews with HIV-negative pregnant women with psychological distress (15 PrEP naïve, 15 PrEP experienced), the investigators will probe individual, interpersonal/community, and structural barriers/facilitators. It is anticipated that barriers to uptake, adherence, and persistence may include distress linked to common mental health challenges (e.g., depressed mood, posttraumatic stress) at the individual level; lack of support from partners and providers, stigma, and low PrEP awareness at the interpersonal/community level; and limited access to PrEP care and food insecurity/poverty at the structural level. Among providers, interviews will explore PrEP knowledge, perspectives on HIV prevention during pregnancy, and barriers to prescribing PrEP.
Aim 2: Specify the manual and conduct a small proof-of-concept trial with patients (n=5), their partners (n=5), and providers (n=2). The new manual will teach skills to navigate resources and problem solve the multi-level barriers to PrEP use identified in Aim 1 and will include a group-based training for all providers (education on PrEP during pregnancy, negative PrEP attitudes/stigma, and other barriers to prescribing). Content of the manual will be interactively refined on five participants, their partners, and two providers.
Aim 3a: Evaluate the feasibility and acceptability of the patient-level intervention in a pilot RCT (n=70). PrEP eligible pregnant persons with motivation to initiate PrEP who are experiencing psychological distress will be randomized to either the intervention or to enhanced treatment as usual (mental health referral). Primary outcomes will be feasibility and acceptability; it is hypothesized that the intervention (4 sessions, including one dyadic session with a partner (n ~ 35), plus a postpartum booster) will be both feasible and acceptable. Secondary outcomes are self-reported PrEP adherence and psychological distress at the end of treatment as well as PrEP persistence (measured via urine) at 3-month follow-up. Though the study is not powered to detect secondary outcome effects, we anticipate clinically meaningful trends. Aim 3b: Evaluate the feasibility and acceptability of the provider training (1 session), which will be offered to all providers (n~10) in a nonrandomized pre/post design; it is hypothesized that the training will be feasible and acceptable. Aim 3c: Explore perceptions of key implementation outcomes among providers and other administrators (n ~ 25) through individual qualitative exit interviews. In individual qualitative exit interviews, we will explore reach, adoptability, and other key components of the RE-AIM framework to inform future implementation in the clinic. All providers and staff who completed the group-based session will be invited to participate.
- Conditions
- HIV Infections, Pregnancy Related, Depression, Anxiety
- Being tested
- TENDAI4PrEP, Enhanced treatment as usual
- Medical subject headings
- HIV Infections, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENDAI4PrEPBehavioural
An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
Enhanced treatment as usualOther
Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy.
safety during pregnancy/postpartum, and PrEP availability at the ANC.
| Study group | Role | What they receive |
|---|---|---|
| TENDAI4PrEP | Experimental | TENDAI4PrEP problem-solving intervention will likely entail 4-5 sessions, inclusive of the dyadic session with a partner, with an optional postpartum booster session. The intervention will involve PrEP education and psychoeducation, Nzira Itsva (a culturally adapted Life Steps intervention), and problem-solving therapy. Receives: Behavioral: TENDAI4PrEP |
| Enhanced Treatment as Usual (ETAU) | Active comparator | Participants randomized to ETAU will receive care as usual, which is monthly visits to the ANC, plus a pamphlet of information that describes PrEP efficacy, safety during pregnancy/postpartum, and PrEP availability at the ANC. Antenatal treatment as usual will also be enhanced at the clinic level through the provider-level training, which will be offered to all clinic staff in a nonrandomized design. ETAU participants will also be referred for psychological services at the hospital. Receives: Other: Enhanced treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (patient level)
Assessed by (1) 75% of the participants attended at least half of all treatment sessions (2) 80% of the reviewed treatment sessions addressed all key themes, and (3) 60% of the participants completed the assessments at T2 and T3.
Measured: T3 (within 5 months post-baseline)
Acceptability (patient level)
Assessed via the brief health care interventions framework questionnaire; on average, at least 75% of the participants rate four or more of the items on the postsession acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.
Measured: T3 (within 5 months post-baseline)
Feasibility (provider level)
Feasibility will be demonstrated if (1) at least 70% of the antenatal clinic providers attend the group sessions and (2) a review of the audio recording indicates that all key themes were addressed.
Measured: T3 (within 5 months post-baseline)
Acceptability (provider level)
Assessed via the brief health care interventions framework questionnaire; the sessions will be deemed acceptable if, on average, at least 75% of the providers rate four or more of the items on the post-session acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.
Measured: T3 (within 5 months post-baseline)
Secondary outcomes (5)
Self-reported PrEP adherence (patient level)
Assessed at T2 via an adapted version of the Wilson three-item self-report adherence scale.This is a 0-100 scale with 0 representing the lowest possible adherence and 100 representing the highest adherence.
Measured: T2 (2 months post-baseline)
Psychological distress (patient level)
Measured by the Shona Symptom Questionnaire. Scores from 0-14, with a higher score indicating greater psychological distress.
Measured: T2 (2 months post-baseline)
PrEP persistence (patient level)
PrEP persistence will be determined via urine tests and defined as tenofovir being detected in a validated point-of-care device with a level of detection of at least 1500 nanograms [ng] TFV/milliliter [mL], indicative of taking a dose of PrEP within the past 24 hours. The test is sensitive (96%), specific (100%), precise (coefficient of variation <15%), and quantitates tenofovir levels in urine as accurately as LC-MS/MS (correlation between TFV levels by both assays 0.96) in a study of HIV negative patients taking PrEP with TDF/FTC. This threshold may be adjusted pending new data; pregnancy appears to alter the pharmacokinetics of oral PrEP such that differences in TVF-DP levels may be as great as 30-40% between pregnant and postpartum women.
Measured: T3 (within 5 months post-baseline)
Change in PrEP knowledge (provider level)
Will be assessed in a PrEP-Related Knowledge Scale adapted from the Fenway Institute. Total scores may range from 0-8 with higher scores indicating greater PrEP knowledge. PrEP knowledge will be assessed at baseline and 5 months post-baseline to determine change in knowledge after the intervention.
Measured: Baseline, T3 (within 5 months post-baseline)
Change in PrEP stigma (provider level)
Will be assessed via an adapted version of the Community PrEP-Related Stigma Scale. Each item is measured on a 1-5 Likert Scale. Scores range from 16-80, with higher scores indicating greater stigma. PrEP stigma will be assessed at baseline and 5 months post-baseline to determine change in stigma after the intervention.
Measured: Baseline, T3 (within 5 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start21 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zimbabwe, Boston University
- Responsible party
- Principal investigator, Conall O'Cleirigh, Massachusetts General Hospital
- Investigators
- Amelia M Stanton, PhD, Principal investigator, Boston UniversityWalter Mangezi, MD, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226155
- Sponsor's protocol ID
- 2023P003607
- Acronym
- TENDAI4PrEP
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with our DMS plan, de-identified data will be deposited to NIMH Data Archive. This will be available to the research community free of charge. In addition to individual level data, the following materials and tools will be made available to interested individuals following achievement of the main aims of the project: qualitative interview guides, qualitative codebooks, and the TENDAI4PrEP intervention manual.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
- ClinicalTrials.gov ID
- NCT06226155
- Acronym / sponsor ID
- TENDAI4PrEP / 2023P003607
- Conditions
- HIV Infections, Pregnancy Related, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Zimbabwe, Boston University
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Jan 2024 (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 purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.
Detailed description
Zimbabwe's HIV prevalence rate is among the highest globally, and cisgender women of reproductive age are disproportionately affected. Considering the increased risk of HIV acquisition and transmission during pregnancy, there is an urgent public health need to develop interventions that increase the use of efficacious HIV prevention strategies like PrEP in the antenatal context. Oral pre-exposure prophylaxis (PrEP) is safe during pregnancy, effective in preventing HIV, and available in Zimbabwean antenatal care (ANC) clinics. However, PrEP use remains low among cisgender women of reproductive age. Individual-, interpersonal/community-, and provider-level barriers (e.g., psychological distress, stigma, low partner support, limited PrEP knowledge in providers) compromise use.
A multi-level, problem-solving intervention that addresses barriers to PrEP adherence and persistence during pregnancy and through the postpartum transition among patients, their partners, and antenatal care providers could improve the health of pregnant persons, ultimately decreasing HIV incidence in Zimbabwe.
The aims of this study are as follows:
Aim 1: Explore the impact of intersecting, multi-level barriers on PrEP uptake, adherence, and persistence during pregnancy (n=30), and explore barriers to PrEP provision among antenatal care providers (8-10). In individual interviews with HIV-negative pregnant women with psychological distress (15 PrEP naïve, 15 PrEP experienced), the investigators will probe individual, interpersonal/community, and structural barriers/facilitators. It is anticipated that barriers to uptake, adherence, and persistence may include distress linked to common mental health challenges (e.g., depressed mood, posttraumatic stress) at the individual level; lack of support from partners and providers, stigma, and low PrEP awareness at the interpersonal/community level; and limited access to PrEP care and food insecurity/poverty at the structural level. Among providers, interviews will explore PrEP knowledge, perspectives on HIV prevention during pregnancy, and barriers to prescribing PrEP.
Aim 2: Specify the manual and conduct a small proof-of-concept trial with patients (n=5), their partners (n=5), and providers (n=2). The new manual will teach skills to navigate resources and problem solve the multi-level barriers to PrEP use identified in Aim 1 and will include a group-based training for all providers (education on PrEP during pregnancy, negative PrEP attitudes/stigma, and other barriers to prescribing). Content of the manual will be interactively refined on five participants, their partners, and two providers.
Aim 3a: Evaluate the feasibility and acceptability of the patient-level intervention in a pilot RCT (n=70). PrEP eligible pregnant persons with motivation to initiate PrEP who are experiencing psychological distress will be randomized to either the intervention or to enhanced treatment as usual (mental health referral). Primary outcomes will be feasibility and acceptability; it is hypothesized that the intervention (4 sessions, including one dyadic session with a partner (n ~ 35), plus a postpartum booster) will be both feasible and acceptable. Secondary outcomes are self-reported PrEP adherence and psychological distress at the end of treatment as well as PrEP persistence (measured via urine) at 3-month follow-up. Though the study is not powered to detect secondary outcome effects, we anticipate clinically meaningful trends. Aim 3b: Evaluate the feasibility and acceptability of the provider training (1 session), which will be offered to all providers (n~10) in a nonrandomized pre/post design; it is hypothesized that the training will be feasible and acceptable. Aim 3c: Explore perceptions of key implementation outcomes among providers and other administrators (n ~ 25) through individual qualitative exit interviews. In individual qualitative exit interviews, we will explore reach, adoptability, and other key components of the RE-AIM framework to inform future implementation in the clinic. All providers and staff who completed the group-based session will be invited to participate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENDAI4PrEP | Experimental | Behavioral: TENDAI4PrEPTENDAI4PrEP problem-solving intervention will likely entail 4-5 sessions, inclusive of the dyadic session with a partner, with an optional postpartum booster session. The intervention will involve PrEP education and psychoeducation, Nzira Itsva (a culturally adapted Life Steps intervention), and problem-solving therapy. |
| Enhanced Treatment as Usual (ETAU) | Active comparator | Other: Enhanced treatment as usualParticipants randomized to ETAU will receive care as usual, which is monthly visits to the ANC, plus a pamphlet of information that describes PrEP efficacy, safety during pregnancy/postpartum, and PrEP availability at the ANC. Antenatal treatment as usual will also be enhanced at the clinic level through the provider-level training, which will be offered to all clinic staff in a nonrandomized design. ETAU participants will also be referred for psychological services at the hospital. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Across all aims participants must be
- Pregnant
- Presenting at the Chitungwiza Central Hospital ANC
- Aged 15+
- Willing to provide informed consent or assent
Key exclusion criteria (2 listed)
- Inability to provide informed consent/assent and/or complete procedures in Shona or English
- Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)
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 |
|---|---|---|
| TENDAI4PrEPAn adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers. | Behavioural | TENDAI4PrEP |
| Enhanced treatment as usualIncludes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy. safety during pregnancy/postpartum, and PrEP availability at the ANC. | Other | Enhanced Treatment as Usual (ETAU) |
Primary outcome
Feasibility (patient level)
Time frame: T3 (within 5 months post-baseline)
Assessed by (1) 75% of the participants attended at least half of all treatment sessions (2) 80% of the reviewed treatment sessions addressed all key themes, and (3) 60% of the participants completed the assessments at T2 and T3.
Acceptability (patient level)
Time frame: T3 (within 5 months post-baseline)
Assessed via the brief health care interventions framework questionnaire; on average, at least 75% of the participants rate four or more of the items on the postsession acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.
Feasibility (provider level)
Time frame: T3 (within 5 months post-baseline)
Feasibility will be demonstrated if (1) at least 70% of the antenatal clinic providers attend the group sessions and (2) a review of the audio recording indicates that all key themes were addressed.
Acceptability (provider level)
Time frame: T3 (within 5 months post-baseline)
Assessed via the brief health care interventions framework questionnaire; the sessions will be deemed acceptable if, on average, at least 75% of the providers rate four or more of the items on the post-session acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.
5 secondary outcomes
Self-reported PrEP adherence (patient level)
Time frame: T2 (2 months post-baseline)
Psychological distress (patient level)
Time frame: T2 (2 months post-baseline)
PrEP persistence (patient level)
Time frame: T3 (within 5 months post-baseline)
Change in PrEP knowledge (provider level)
Time frame: Baseline, T3 (within 5 months post-baseline)
Change in PrEP stigma (provider level)
Time frame: Baseline, T3 (within 5 months post-baseline)
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. In accordance with our DMS plan, de-identified data will be deposited to NIMH Data Archive. This will be available to the research community free of charge. In addition to individual level data, the following materials and tools will be made available to interested individuals following achievement of the main aims of the project: qualitative interview guides, qualitative codebooks, and the TENDAI4PrEP intervention manual.
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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.
Amelia M Stanton, PhD principal investigator
Boston University
Walter Mangezi, MD principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENDAI4PrEP and Enhanced treatment as usual in people with HIV Infections and Pregnancy Related, run by Massachusetts General Hospital at 1 site in Zimbabwe.
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 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 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 Zimbabwe. 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 Conall O'Cleirigh (617-643-0385, cocleirigh@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (patient level) (time frame: T3 (within 5 months post-baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.