Cervical CancerACT 2NCT05413811
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
A study testing 5 Fluorouracil (5 FU) Cream in people with Cervical Cancer and CIN2, run by UNC Lineberger Comprehensive Cancer Center at 1 site in South Africa.
Trial summary
The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, CIN2, CIN3
- What is being tested?
- 5 Fluorouracil (5 FU) Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Mar 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV-1 infection
- On antiretroviral therapy (ART), for at least 90 days prior to enrollment
- Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.
Who cannot join
- pregnancy,
- breastfeeding,
- intend to become pregnant within 180 days of enrollment
- have an active sexually transmitted infection (women may participate once treated)
- have a surgically absent cervix
- have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer
- have a medical comorbidity that would interfere with study participation.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, 2092
About this study
The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.
Read the detailed description
There are currently no medical therapies recommended to promote the clearance of human papillomavirus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV)-infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia [CIN2/3]), and invasive cervical cancer also occur more frequently in HIV infected women.
This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.
- Conditions
- Cervical Cancer, CIN2, CIN3, Human Immunodeficiency Virus, Human Papillomavirus
- Being tested
- 5 Fluorouracil (5 FU) Cream, Placebo
- Keywords
- 5-fluorouracil cream, Loop electrosurgical excision
- Medical subject headings
- Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Fluorouracil (5 FU) CreamDrug
Also called Fluoroplex, Efudex, Carac
Intravaginal topical chemotherapy, 5-fluorouracil cream
PlaceboDrug
Intravaginal topical placebo cream
| Study group | Role | What they receive |
|---|---|---|
| 5 Fluorouracil (5FU) Cream | Experimental | Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total). Receives: Drug: 5 Fluorouracil (5 FU) Cream |
| Placebo Cream | Placebo comparator | Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained in the Study Through Week 24
Retention was defined as the number of participants who remained in follow-up and completed the Week 24 study visit. The number and percentage of participants retained at Week 24 were reported for each study arm.
Measured: Baseline (Week 0) through Week 24
Number of Participants With ≥80% Acceptability Summary Score at Week 10
Acceptability was defined as a summary score ≥80% on a 7-item questionnaire administered at Week 10. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm.
Measured: Week 10
Number of Participants With ≥80% Acceptability Summary Score by Week 24
Acceptability was defined as a summary score ≥80% on the same 7-item questionnaire administered at Week 24. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm.
Measured: Week 24
Number of Participants Experiencing a Treatment-Related Grade ≥2 Adverse Event or Grade 1 Genital Lesion
A safety event was defined as any Grade 2 or higher adverse event (AE), or any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to the study drug. Adverse events were assessed from Week 4 (randomization) through Week 24. The number and percentage of participants experiencing at least one such event were reported for each study arm.
Measured: Week 4 (randomization) through Week 24
Number of Participants Unable or Unwilling to Apply ≥50% of Study Cream Doses Due to Dose-Limiting Toxicity
A tolerability event was defined as inability or unwillingness to apply ≥4 of 8 planned doses of the study treatment due to a dose-limiting toxicity (DLT). A DLT was defined as (1) any Grade 2 or higher AE, or (2) any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to study drug and resulted in an investigator decision to reduce the number of doses or discontinue study treatment. Tolerability was assessed from randomization through the dosing period (Week 18), with follow-up censored at the last tolerability assessment for participants who exited early without experiencing an event. The number and percentage of participants experiencing a tolerability event were reported for each study arm.
Measured: Week 4 (randomization) through Week 18
Number of Participants Adherent to ≥75% of Study Cream Doses Based on Ultraviolet Inspection
Adherence was defined as administration of at ≥6 of 8 planned doses of study treatment, as determined by ultraviolet inspection of returned applicators. Applicator collection occurred through Week 24, including for participants who completed dosing earlier, to allow complete ascertainment of dose use. Each applicator was independently assessed by ≥2 reviewers; in cases of disagreement, a third reviewer adjudicated the result. Participants were classified as adherent if ≥6 applicators showed evidence of use. Participants who did not meet this threshold, including those with missing or incomplete applicator data, were classified as non-adherent. The number and percentage of participants meeting this definition were reported for each study arm.
Measured: Week 4 (randomization) through Week 24
Secondary outcomes (2)
Percent of Participants With CIN2/3 at Baseline Who Regressed to CIN1 or Normal Histology at Week 24
The analysis population included all randomized participants, all of whom had CIN2 or CIN3 at baseline (Week 0) confirmed by loop electrosurgical excision procedure (LEEP) histology. The analysis population was restricted to participants who completed the Week 24 visit and had cervical biopsy results available. This included 89 participants in the placebo arm and 81 participants in the 5FU arm. Regression was defined as improvement from CIN2 or CIN3 at baseline to CIN1 or normal histology at Week 24, as assessed by cervical biopsy. Participants missing Week 24 data were not included and not considered to have experienced CIN2/3 regression. The number and percentage of participants meeting this definition were reported for each study arm. The Wilson score method was used to estimate 95% confidence intervals around percentages.
Measured: Baseline (Week 0) through Week 24
Percent of Participants With Baseline High-Risk HPV Who Achieved Genotype-Specific Clearance at Week 24
The analysis population was restricted to participants with at least one high-risk HPV (hrHPV) genotype detected at baseline and with hrHPV results available at Week 24. A total of 69 participants in the 5FU arm and 80 participants in the placebo arm met these criteria. High-risk HPV clearance was defined as absence at Week 24 of all hrHPV genotypes detected at baseline. Participants without baseline hrHPV infection or without Week 24 hrHPV results were excluded from this analysis. The number and percentage of participants meeting this definition were reported for each study arm. The Wilson score method was used to estimate 95% confidence intervals around percentages.
Measured: Baseline (Week 0) through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start22 Mar 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carla Chibwesha, MD, MSc, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413811
- Sponsor's protocol ID
- IGHID12046
- Other IDs
- 1R01CA250850-01
- Acronym
- ACT 2
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2022
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.
Publications
Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Mischell MA, Rahangdale L, Chibwesha CJ. Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Primary Outcomes from the ACT 2 Randomized Trial. medRxiv [Preprint]. 2026 Mar 16:2026.03.14.26348308. doi: 10.64898/2026.03.14.26348308.
PubMed 41891028Chibwesha CJ, Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Efficacy of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Secondary Outcomes from the ACT 2 Randomized Controlled Trial. medRxiv [Preprint]. 2026 Mar 22:2026.03.19.26348810. doi: 10.64898/2026.03.19.26348810.
PubMed 41890998Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2). Contemp Clin Trials. 2026 May;164:108272. doi: 10.1016/j.cct.2026.108272. Epub 2026 Mar 2.
PubMed 41780745Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. ACT 2 Clinical Trial Design: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV. medRxiv [Preprint]. 2025 Aug 14:2025.08.12.25333540. doi: 10.1101/2025.08.12.25333540.
PubMed 40832398
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
- ClinicalTrials.gov ID
- NCT05413811
- Acronym / sponsor ID
- ACT 2 / IGHID12046
- Conditions
- Cervical Cancer, CIN2, CIN3, Human Immunodeficiency Virus, Human Papillomavirus
- Keywords
- 5-fluorouracil cream, Loop electrosurgical excision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Posted 21 Aug 2026
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 explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.
Detailed description
There are currently no medical therapies recommended to promote the clearance of human papillomavirus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV)-infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia [CIN2/3]), and invasive cervical cancer also occur more frequently in HIV infected women.
This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 Fluorouracil (5FU) Cream | Experimental | Drug: 5 Fluorouracil (5 FU) CreamParticipants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total). |
| Placebo Cream | Placebo comparator | Drug: PlaceboParticipants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed HIV-1 infection
- On antiretroviral therapy (ART), for at least 90 days prior to enrollment
- Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.
Key exclusion criteria (7 listed)
- pregnancy,
- breastfeeding,
- intend to become pregnant within 180 days of enrollment
- have an active sexually transmitted infection (women may participate once treated)
- have a surgically absent cervix
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 |
|---|---|---|
| 5 Fluorouracil (5 FU) CreamAlso: Fluoroplex, Efudex, CaracIntravaginal topical chemotherapy, 5-fluorouracil cream | Drug | 5 Fluorouracil (5FU) Cream |
| PlaceboIntravaginal topical placebo cream | Drug | Placebo Cream |
Primary outcome
Number of Participants Retained in the Study Through Week 24
Time frame: Baseline (Week 0) through Week 24
Retention was defined as the number of participants who remained in follow-up and completed the Week 24 study visit. The number and percentage of participants retained at Week 24 were reported for each study arm.
Number of Participants With ≥80% Acceptability Summary Score at Week 10
Time frame: Week 10
Acceptability was defined as a summary score ≥80% on a 7-item questionnaire administered at Week 10. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm.
Number of Participants With ≥80% Acceptability Summary Score by Week 24
Time frame: Week 24
Acceptability was defined as a summary score ≥80% on the same 7-item questionnaire administered at Week 24. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm.
Number of Participants Experiencing a Treatment-Related Grade ≥2 Adverse Event or Grade 1 Genital Lesion
Time frame: Week 4 (randomization) through Week 24
A safety event was defined as any Grade 2 or higher adverse event (AE), or any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to the study drug. Adverse events were assessed from Week 4 (randomization) through Week 24. The number and percentage of participants experiencing at least one such event were reported for each study arm.
Number of Participants Unable or Unwilling to Apply ≥50% of Study Cream Doses Due to Dose-Limiting Toxicity
Time frame: Week 4 (randomization) through Week 18
A tolerability event was defined as inability or unwillingness to apply ≥4 of 8 planned doses of the study treatment due to a dose-limiting toxicity (DLT). A DLT was defined as (1) any Grade 2 or higher AE, or (2) any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to study drug and resulted in an investigator decision to reduce the number of doses or discontinue study treatment. Tolerability was assessed from randomization through the dosing period (Week 18), with follow-up censored at the last tolerability assessment for participants who exited early without experiencing an event. The number and percentage of participants experiencing a tolerability event were reported for each study arm.
Number of Participants Adherent to ≥75% of Study Cream Doses Based on Ultraviolet Inspection
Time frame: Week 4 (randomization) through Week 24
Adherence was defined as administration of at ≥6 of 8 planned doses of study treatment, as determined by ultraviolet inspection of returned applicators. Applicator collection occurred through Week 24, including for participants who completed dosing earlier, to allow complete ascertainment of dose use. Each applicator was independently assessed by ≥2 reviewers; in cases of disagreement, a third reviewer adjudicated the result. Participants were classified as adherent if ≥6 applicators showed evidence of use. Participants who did not meet this threshold, including those with missing or incomplete applicator data, were classified as non-adherent. The number and percentage of participants meeting this definition were reported for each study arm.
2 secondary outcomes
Percent of Participants With CIN2/3 at Baseline Who Regressed to CIN1 or Normal Histology at Week 24
Time frame: Baseline (Week 0) through Week 24
Percent of Participants With Baseline High-Risk HPV Who Achieved Genotype-Specific Clearance at Week 24
Time frame: Baseline (Week 0) through Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41891028Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Mischell MA, Rahangdale L, Chibwesha CJ. Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Primary Outcomes from the ACT 2 Randomized Trial. medRxiv [Preprint]. 2026 Mar 16:2026.03.14.26348308. doi: 10.64898/2026.03.14.26348308.
- Derived from this study: PubMed 41890998Chibwesha CJ, Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Efficacy of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Secondary Outcomes from the ACT 2 Randomized Controlled Trial. medRxiv [Preprint]. 2026 Mar 22:2026.03.19.26348810. doi: 10.64898/2026.03.19.26348810.
- Derived from this study: PubMed 41780745Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2). Contemp Clin Trials. 2026 May;164:108272. doi: 10.1016/j.cct.2026.108272. Epub 2026 Mar 2.
- Derived from this study: PubMed 40832398Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. ACT 2 Clinical Trial Design: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV. medRxiv [Preprint]. 2025 Aug 14:2025.08.12.25333540. doi: 10.1101/2025.08.12.25333540.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.
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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.
Carla Chibwesha, MD, MSc principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 Fluorouracil (5 FU) Cream in people with Cervical Cancer and CIN2, run by UNC Lineberger Comprehensive Cancer Center 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 3 inclusion and 7 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 21 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Retained in the Study Through Week 24 (time frame: Baseline (Week 0) through Week 24). The study lists 6 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 NCT05413811, 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 21 Aug 2026.