HIV InfectionsPhase 3AXISNCT06138600
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa
A Phase 3 study testing Cabotegravir Injection [Apretude] and Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) in people with HIV Infections, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial summary
This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC[3TC]), or… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabotegravir Injection [Apretude] and Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Nov 2023to 31 Jan 2026
- Phase
- Phase 3
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- Each participant must meet all of the following criteria to be enrolled in this study:
- Adult male or female (≥18 and ≤ 35 years old)
- Is self-reported sexually active
- HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1)
- Body weight ≥ 35 kilograms.
- Creatinine clearance ≥ 60 mL/min.
- Willingness to sign informed consent.
Who cannot join
- -
- Participants meeting the following criteria will be excluded from participating in the study:
- Symptoms of HIV seroconversion (see Table 1).
- Pregnant (participant must have a negative beta human chorionic gonadotrophin (b-hCG) urine test at screening) or lactating women, or women intending to become pregnant or breastfeed during the study.
- Is in good health, with no surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history. This including, but not limited to, the following: a. History of severe hepatic impairment, history of liver cirrhosis with or without viral hepatitis co-infection.
- Unstable or poorly controlled seizure disorder. c. History of coagulopathies, or current or anticipated need for chronic anticoagulation.
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- Presence of a tattoo or other dermatological condition overlying the gluteus region which would realistically obstruct administration of an intramuscular injection.
- Known hypersensitivity to or specific contraindications to the use of TDF or FTC/3TC or CABLA.
- Hep B surface antigen positive or known active Hep B infection.
- Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:
- tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin)
- anticoagulation agents;
- anti-convulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
- herbal products (e.g. St John's Wort).
- Concurrent use of PrEP from a different medical provider, other than the study site
- Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
- Inability or unwillingness to be followed up for the study period, including plans to move out the study geographical area in the next 12 months or otherwise unable to participate in the study visits as determined by the PI.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Ezintsha, a division of Wits Health Consortium
Johannesburg, Gauteng, 2193
About this study
This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC[3TC]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum of 9 visits is possible.
Read the detailed description
In the ATLAS study participants were asked, after they had transitioned back to conventional oral antiretroviral therapy, whether they preferred injectable or oral treatment. Their feedback on their preference overwhelming favoured injectables9. Women and men will be recruited from existing Ezintsha programs operating within the pharmacies, using current government criteria for Pre-exposure Prophylaxis initiation. Pre-exposure Prophylaxis will be initiated and monitored according to these and the Pharmacist-Initiated Management of Antiretroviral Therapy guidelines. Pre-exposure Prophylaxis, through these programs, will be offered free of charge. The study is designed to be as "real-world" as possible. Adaptations to routine Pre-exposure Prophylaxis guidelines have been made to accommodate visit-based HIV testing (based on the injectable regimens, which require more frequent access to the clinic). Participant reimbursement will therefore be for the baseline, mid and end-of-study interviews in participants consenting to these interviews. The maximum amount of time a participant in the study can be on either Cabotegravir Long-Acting Injectable or oral Pre-exposure Prophylaxis, or a combination, or, indeed, on neither drug, is therefore 15 months (and an additional three months on oral Pre-exposure Prophylaxis during the transition, as standard of care).
The Investigator anticipates that participants will favour Cabotegravir Long-Acting Injectable, but also anticipates that there may be interesting patterns of use when they learn that they may defer access to Cabotegravir Long-Acting Injectable or oral Pre-exposure Prophylaxis. Participants may favour Pre-exposure Prophylaxis, as they may prefer three monthly visits over the two monthly injection requirements. The Investigator may see participants initially choosing oral Pre-exposure Prophylaxis, and then moving to Cabotegravir Long-Acting Injectable, or even vice versa. The Investigator is unclear on what men may favour versus women. The Investigator will endeavor to recruit at least 20 men in the study, appreciating that not much is known about this group in the sub-Saharan Africa context. One of the most important analyses that will flow from information collected when assessing for Pre-exposure Prophylaxis eligibility is the risk profile of the participants taking up Pre-exposure Prophylaxis, a key issue when assessing cost-effectiveness. Finally, the investigator is not excluding women or men who defer Pre-exposure Prophylaxis initially. These various combinations will provide interesting quantitative, but more importantly, qualitative data on preferences, and on how services may be improved to accommodate participants' choices.
- Conditions
- HIV Infections
- Being tested
- Cabotegravir Injection [Apretude], Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Long Acting Injectable, Cabotegravir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir Injection [Apretude]Drug
Also called Apretude
White to slightly pink free flowing suspension suspension for injection contained in a brown coloured vial. Each vial is for single use and does not require dilution prior to administration.
Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)Drug
Also called Tenemine
TDF/FTC is currently available as standard of care for PrEP in the public sector as per the department of health guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Cabotegravir Long Acting Injectable | Active comparator | Investigational Product: Cabotegravir Dosage Formulation: 600 mg suspension for injection Route of Administration: Intra-muscular injection Dosing Instructions: 1 vial (600 mg) injected monthly for the initial visit (Month 1 and 2), then every 2 months thereafter (from Month 2 onwards) Receives: Drug: Cabotegravir Injection [Apretude] |
| Tenofovir disoproxil fumarate + Emtricitabine/Lamivudine (TDF/FTC[3TC]) | Active comparator | Investigational Product: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) Dosage Formulation: 300 mg / 200 mg (300mg) fixed dose combination tablet Route of Administration: Oral Dosing Instructions: 1 tablet (300/200/ TDF/FTC) daily or (300/300/TDF/3TC) daily Receives: Drug: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Acceptability of CAB-LA (Long-Acting Cabotegravir) as determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability. (Quantitative data will be expressed as ratios)
Measured: 15 Months
To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Acceptability of Intervention Measure (AIM)/ Intervention Appropriateness Measure/ (IAM), at 12 months and end of study. (Expressed as ratios where applicable)
Measured: 12 Months
Secondary outcomes (10)
To describe feasibility of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Feasibility of CAB-LA (Long-Acting Cabotegravir) as determined by qualitative and quantitative assessment using piloted or validated semi-structured questionnaires and on feasibility conducted with participants and healthcare workers.
Measured: 15 Months
To describe feasibility of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Feasibility of Intervention Measure (FIM) completed by healthcare workers at exit and participants at 12 months and end of study.
Measured: 12 Months
To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.
Tests of association between PrEP choice and selected predictor variables.
Measured: 15 Months
To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.
Proportion of individuals who are using each type of PrEP collected at study start, month 12 and end of study.
Measured: 12 Months
To describe the uptake, persistence and patterns of transition on each form of PrEP.
Attending all study visits/retention extracted from participant EDC (Electronic Data Capture) visit forms.
Measured: 15 Months
To describe a risk profile of those taking up both PrEP regimens, as well as those deferring PrEP.
Willingness to take CAB-LA (Long-Acting Cabotegravir) for the entire study duration extracted from participant EDC forms
Measured: 15 Months
To describe a risk profile of those taking up both PrEP regimens, as well as those deferring PrEP.
Willingness to take CAB-LA post study stop collected at end of study using semi-structured interviews.
Measured: 15 Months
To describe operational suggestions from the participants regarding how health services could be improved regarding better/more comfortable/faster/cheaper/other add-on sexual reproductive services.
Extent to which the study staff could easily administer CAB-LA (Long-Acting Cabotegravir).
Measured: 15 Months
To describe the provider experiences and perceptions of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Healthcare worker perspectives on maintenance, demand creation and service delivery post study completion collected during a focus group discussion conducted at the end of the study.
Measured: 15 Months
To describe participant willingness-to-pay for PrEP services at the end of the study.
Willingness to pay for CAB-LA (Long-Acting Cabotegravir) collected at the end of the study using semi-structured interviews.
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Jan 2026 (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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Adult (≥18 and ≤ 35 years old) male or female willing to access PrEP at the same pharmacy for up to 2 years
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Francois WD Venter, MBBCh, Study director, Ezintsha, a division of Wits Health ConsortiumSimiso M Sokhela, MBBCh, Principal investigator, Ezintsha, a division of Wits Health ConsortiumNonkululeko M Mashabane, BPharm, Study chair, Ezintsha, a division of Wits Health Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138600
- Sponsor's protocol ID
- EZ-FV-035
- Acronym
- AXIS
- Status last verified
- Jun 2024
- First submitted
- 17 Oct 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa
- ClinicalTrials.gov ID
- NCT06138600
- Acronym / sponsor ID
- AXIS / EZ-FV-035
- Conditions
- HIV Infections
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Long Acting Injectable, Cabotegravir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 18 Nov 2023 (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 is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC[3TC]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum of 9 visits is possible.
Detailed description
In the ATLAS study participants were asked, after they had transitioned back to conventional oral antiretroviral therapy, whether they preferred injectable or oral treatment. Their feedback on their preference overwhelming favoured injectables9. Women and men will be recruited from existing Ezintsha programs operating within the pharmacies, using current government criteria for Pre-exposure Prophylaxis initiation. Pre-exposure Prophylaxis will be initiated and monitored according to these and the Pharmacist-Initiated Management of Antiretroviral Therapy guidelines. Pre-exposure Prophylaxis, through these programs, will be offered free of charge. The study is designed to be as "real-world" as possible. Adaptations to routine Pre-exposure Prophylaxis guidelines have been made to accommodate visit-based HIV testing (based on the injectable regimens, which require more frequent access to the clinic). Participant reimbursement will therefore be for the baseline, mid and end-of-study interviews in participants consenting to these interviews. The maximum amount of time a participant in the study can be on either Cabotegravir Long-Acting Injectable or oral Pre-exposure Prophylaxis, or a combination, or, indeed, on neither drug, is therefore 15 months (and an additional three months on oral Pre-exposure Prophylaxis during the transition, as standard of care).
The Investigator anticipates that participants will favour Cabotegravir Long-Acting Injectable, but also anticipates that there may be interesting patterns of use when they learn that they may defer access to Cabotegravir Long-Acting Injectable or oral Pre-exposure Prophylaxis. Participants may favour Pre-exposure Prophylaxis, as they may prefer three monthly visits over the two monthly injection requirements. The Investigator may see participants initially choosing oral Pre-exposure Prophylaxis, and then moving to Cabotegravir Long-Acting Injectable, or even vice versa. The Investigator is unclear on what men may favour versus women. The Investigator will endeavor to recruit at least 20 men in the study, appreciating that not much is known about this group in the sub-Saharan Africa context. One of the most important analyses that will flow from information collected when assessing for Pre-exposure Prophylaxis eligibility is the risk profile of the participants taking up Pre-exposure Prophylaxis, a key issue when assessing cost-effectiveness. Finally, the investigator is not excluding women or men who defer Pre-exposure Prophylaxis initially. These various combinations will provide interesting quantitative, but more importantly, qualitative data on preferences, and on how services may be improved to accommodate participants' choices.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adult (≥18 and ≤ 35 years old) male or female willing to access PrEP at the same pharmacy for up to 2 years
| Arm | Type | Receives |
|---|---|---|
| Cabotegravir Long Acting Injectable | Active comparator | Drug: Cabotegravir Injection [Apretude]Investigational Product: Cabotegravir Dosage Formulation: 600 mg suspension for injection Route of Administration: Intra-muscular injection Dosing Instructions: 1 vial (600 mg) injected monthly for the initial visit (Month 1 and 2), then every 2 months thereafter (from Month 2 onwards) |
| Tenofovir disoproxil fumarate + Emtricitabine/Lamivudine (TDF/FTC[3TC]) | Active comparator | Drug: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)Investigational Product: Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) Dosage Formulation: 300 mg / 200 mg (300mg) fixed dose combination tablet Route of Administration: Oral Dosing Instructions: 1 tablet (300/200/ TDF/FTC) daily or (300/300/TDF/3TC) daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- -
- Adult male or female (≥18 and ≤ 35 years old)
- Is self-reported sexually active
- HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1)
- Body weight ≥ 35 kilograms.
Key exclusion criteria (17 listed)
- -
- Participants meeting the following criteria will be excluded from participating in the study:
- Symptoms of HIV seroconversion (see Table 1).
- Pregnant (participant must have a negative beta human chorionic gonadotrophin (b-hCG) urine test at screening) or lactating women, or women intending to become pregnant or breastfeed during the study.
- Is in good health, with no surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history. This including, but not limited to, the following: a. History of severe hepatic impairment, history of liver cirrhosis with or without viral hepatitis co-infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir Injection [Apretude]Also: ApretudeWhite to slightly pink free flowing suspension suspension for injection contained in a brown coloured vial. Each vial is for single use and does not require dilution prior to administration. | Drug | Cabotegravir Long Acting Injectable |
| Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)Also: TenemineTDF/FTC is currently available as standard of care for PrEP in the public sector as per the department of health guidelines. | Drug | Tenofovir disoproxil fumarate + Emtricitabine/Lamivudine (TDF/FTC[3TC]) |
Primary outcome
To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Time frame: 15 Months
Acceptability of CAB-LA (Long-Acting Cabotegravir) as determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability. (Quantitative data will be expressed as ratios)
To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Time frame: 12 Months
Acceptability of Intervention Measure (AIM)/ Intervention Appropriateness Measure/ (IAM), at 12 months and end of study. (Expressed as ratios where applicable)
10 secondary outcomes
To describe feasibility of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Time frame: 15 Months
To describe feasibility of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Time frame: 12 Months
To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.
Time frame: 15 Months
To describe the association of socio-demographic factors, reported sexual behaviour, PrEP knowledge and previous PrEP use on PrEP choice.
Time frame: 12 Months
To describe the uptake, persistence and patterns of transition on each form of PrEP.
Time frame: 15 Months
To describe a risk profile of those taking up both PrEP regimens, as well as those deferring PrEP.
Time frame: 15 Months
To describe a risk profile of those taking up both PrEP regimens, as well as those deferring PrEP.
Time frame: 15 Months
To describe operational suggestions from the participants regarding how health services could be improved regarding better/more comfortable/faster/cheaper/other add-on sexual reproductive services.
Time frame: 15 Months
To describe the provider experiences and perceptions of CAB-LA (Long-Acting Cabotegravir) PrEP implementation, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.
Time frame: 15 Months
To describe participant willingness-to-pay for PrEP services at the end of the study.
Time frame: 15 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
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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.
Francois WD Venter, MBBCh study director
Ezintsha, a division of Wits Health Consortium
Simiso M Sokhela, MBBCh principal investigator
Ezintsha, a division of Wits Health Consortium
Nonkululeko M Mashabane, BPharm study chair
Ezintsha, a division of Wits Health Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cabotegravir Injection [Apretude] and Tenofovir disoproxil fumarate / emtricitabine (or lamivudine) in people with HIV Infections, run by University of Witwatersrand, South Africa 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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women. (time frame: 15 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2024.