HIVPhase 4ASCENDNCT07199335
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
A Phase 4 study testing APRETUDE (cabotegravir) in people with HIV and Substance Use Disorder (SUD), run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- What is being tested?
- APRETUDE (cabotegravir)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2026to Dec 2028
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV Ab/Ag test (lab-based or rapid) negative at time of enrollment
- ≥18 years old
- Able to provide informed consent
- Have injected non-prescribed drugs within the past 6 months
- No prior history of receiving cabotegravir (Note: prior or active use of non-CAB PrEP ([FTC/TDF or FTC/TAF]) at screening is allowed, but participant will need to indicate that they prefer to switch to injectable PrEP).
- PrEP provider deems cabotegravir use to be appropriate per the applicable prescribing information prior to enrollment in the study.
Who cannot join
- Pregnant or breastfeeding people. Should a participant become pregnant, the treating physician will discuss with the participant whether to continue study medication, taking into consideration the risks and benefits of continuing cabotegravir compared with the risk of switching to an alternative recommended PrEP regimen.
- Has not had vaginal or anal sex in the past 6 months
- HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
- Already diagnosed with HIV
- Taking any of the following medications: Carbamazepine, Rifampin, Oxcarbazepine, Rifapentine, Phenobarbital, Phenytoin
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Suzanne McCluskey, MD, MSc, 617-726-9488, SMCCLUSKEY@MGH.HARVARD.EDU
Suzanne McCluskey, MD, MSc
- Recruiting
Fenway Health
Boston, Massachusetts, 02215
Julia Fleming, MD, MHS, 857-313-6984, JFleming@fenwayhealth.org
Julia Fleming, MD, MHS
About this study
Official title: A Multi-Center Assessment of an Intervention to Provide Long-Acting Cabotegravir Injectable Pre-Exposure Prophylaxis to People Who Inject Drugs
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk.
Read the detailed description
This is a Phase IV open-label single arm implementation study of the on-label use of an FDA approved drug, cabotegravir, as long-acting, injectable HIV pre-exposure prophylaxis (CAB-LA) among people who inject drugs. All enrollees will be prescribed CAB-LA based on CAB-LA's FDA approved indication, which is sexual risk of HIV transmission. Investigators will recruit participants from two sites in Boston, Massachusetts. The target study sample size is 100 participants.
Recruitment will be primarily by clinician referrals and medical records review at each site.
The study team will screen potential participants at both sites and assess their initial eligibility. Participants will be eligible to participate if they meet the inclusion and exclusion criteria. If an individual consents to participation, a 4th generation antibody/antigen (Ab/Ag) screening test (rapid or lab-based) and a confirmatory HIV-1 RNA test will be sent. If the HIV Ab/Ag screening test is negative, individuals will be enrolled.
Once a participant is enrolled, the participant will return 0-7 days later to complete a medical evaluation by a medical provider who will prescribe CAB-LA, and the participant will complete an enrollment survey. After the enrollment survey, participants will receive the first CAB-LA injection according to label instructions. The second injection visit will occur 1 month after the first injection. Thereafter, CAB-LA will be administered every 2 months for three additional doses. Thus, participants will remain in the study for seven months. CAB-LA for the study is supplied by ViiV Healthcare Ltd.
At each CAB-LA injection visit after the first one, participants will be asked to complete a short survey. A longer survey will be administered at the final study visit for each participant regarding acceptability of the intervention.
At each follow-up study visit prior to CAB-LA injection, HIV testing will be performed using both a screening Ag/Ab test and a confirmatory HIV-1 RNA test (if a blood sample for RNA testing can be obtained). If the screening HIV Ag/Ab test is positive, the CAB-LA injection will not be administered, and the participant will be withdrawn from the study and referred for HIV treatment. If the confirmatory HIV-1 RNA test returns positive from any study visit, including from the pre-enrollment sample, the participant will be withdrawn from the study and referred for HIV treatment. For any participant who is diagnosed with HIV during the study period, additional testing for antiretroviral drug resistance, including integrase strand transfer inhibitor resistance, will be collected, and the patient will be referred to HIV care.
Participants will also be screened for STIs (gonorrhea, chlamydia, and syphilis), HBV, and HCV at enrollment and at the time of the 3rd and 5th injections.
In addition to receiving CAB-LA, each participant will also receive support services while participating in the study. Specifically, participants will be connected with a PrEP Navigator who will work with participants between visits to provide support, education, and coordinate visits. The PrEP navigator will be a trained non-provider who can provide counseling about the risks and benefits of PrEP, discuss participant concerns, assist in coordinating clinic visits, and facilitate connections to medical care if needed. In addition, incentives for phlebotomy ($20) and appointment attendance ($20) will be provided to all participants. Transportation assistance for study appointments will also be provided.
After the study, participants will transition from study-supplied CAB-LA to commercially-available CAB-LA.
- Conditions
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- Being tested
- APRETUDE (cabotegravir)
- Keywords
- HIV, Substance use, pre-exposure prophylaxis, cabotegravir, long-acting cabotegravir, PrEP, implementation science, PrEP navigator
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APRETUDE (cabotegravir)Drug
All participants will be prescribed APRETUDE based on APRETUDE's FDA approved indication, which is sexual risk of HIV transmission.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will receive long-acting injectable cabotegravir and a suite of support services, including PrEP navigation, transportation assistance, and financial incentives. Receives: Drug: APRETUDE (cabotegravir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence on CAB-LA
For the primary analysis, investigators will calculate the proportion of study participants who achieve PrEP persistence at 7 months post-initiation. Investigators will then calculate 95% confidence intervals around the proportion.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start24 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an implementation study, using long-acting injectable cabotegravir for its approved indication as HIV pre-exposure prophylaxis for people with sexual risk factors for HIV.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Fenway Community Health
- Responsible party
- Principal investigator, Suzanne McCluskey, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199335
- Sponsor's protocol ID
- 2025P002398
- Acronym
- ASCEND
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will not be shared publicly. IPD can be made available upon request to the principal investigator with proof of IRB approval and a fully executed data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Assessment of an Intervention to Provide Long-Acting Cabotegravir Injectable Pre-Exposure Prophylaxis to People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT07199335
- Acronym / sponsor ID
- ASCEND / 2025P002398
- Conditions
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- Keywords
- HIV, Substance use, pre-exposure prophylaxis, cabotegravir, long-acting cabotegravir, PrEP, implementation science, PrEP navigator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Fenway Community Health
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (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 study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk.
Detailed description
This is a Phase IV open-label single arm implementation study of the on-label use of an FDA approved drug, cabotegravir, as long-acting, injectable HIV pre-exposure prophylaxis (CAB-LA) among people who inject drugs. All enrollees will be prescribed CAB-LA based on CAB-LA's FDA approved indication, which is sexual risk of HIV transmission. Investigators will recruit participants from two sites in Boston, Massachusetts. The target study sample size is 100 participants.
Recruitment will be primarily by clinician referrals and medical records review at each site.
The study team will screen potential participants at both sites and assess their initial eligibility. Participants will be eligible to participate if they meet the inclusion and exclusion criteria. If an individual consents to participation, a 4th generation antibody/antigen (Ab/Ag) screening test (rapid or lab-based) and a confirmatory HIV-1 RNA test will be sent. If the HIV Ab/Ag screening test is negative, individuals will be enrolled.
Once a participant is enrolled, the participant will return 0-7 days later to complete a medical evaluation by a medical provider who will prescribe CAB-LA, and the participant will complete an enrollment survey. After the enrollment survey, participants will receive the first CAB-LA injection according to label instructions. The second injection visit will occur 1 month after the first injection. Thereafter, CAB-LA will be administered every 2 months for three additional doses. Thus, participants will remain in the study for seven months. CAB-LA for the study is supplied by ViiV Healthcare Ltd.
At each CAB-LA injection visit after the first one, participants will be asked to complete a short survey. A longer survey will be administered at the final study visit for each participant regarding acceptability of the intervention.
At each follow-up study visit prior to CAB-LA injection, HIV testing will be performed using both a screening Ag/Ab test and a confirmatory HIV-1 RNA test (if a blood sample for RNA testing can be obtained). If the screening HIV Ag/Ab test is positive, the CAB-LA injection will not be administered, and the participant will be withdrawn from the study and referred for HIV treatment. If the confirmatory HIV-1 RNA test returns positive from any study visit, including from the pre-enrollment sample, the participant will be withdrawn from the study and referred for HIV treatment. For any participant who is diagnosed with HIV during the study period, additional testing for antiretroviral drug resistance, including integrase strand transfer inhibitor resistance, will be collected, and the patient will be referred to HIV care.
Participants will also be screened for STIs (gonorrhea, chlamydia, and syphilis), HBV, and HCV at enrollment and at the time of the 3rd and 5th injections.
In addition to receiving CAB-LA, each participant will also receive support services while participating in the study. Specifically, participants will be connected with a PrEP Navigator who will work with participants between visits to provide support, education, and coordinate visits. The PrEP navigator will be a trained non-provider who can provide counseling about the risks and benefits of PrEP, discuss participant concerns, assist in coordinating clinic visits, and facilitate connections to medical care if needed. In addition, incentives for phlebotomy ($20) and appointment attendance ($20) will be provided to all participants. Transportation assistance for study appointments will also be provided.
After the study, participants will transition from study-supplied CAB-LA to commercially-available CAB-LA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an implementation study, using long-acting injectable cabotegravir for its approved indication as HIV pre-exposure prophylaxis for people with sexual risk factors for HIV.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: APRETUDE (cabotegravir)All participants will receive long-acting injectable cabotegravir and a suite of support services, including PrEP navigation, transportation assistance, and financial incentives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV Ab/Ag test (lab-based or rapid) negative at time of enrollment
- ≥18 years old
- Able to provide informed consent
- Have injected non-prescribed drugs within the past 6 months
- No prior history of receiving cabotegravir (Note: prior or active use of non-CAB PrEP ([FTC/TDF or FTC/TAF]) at screening is allowed, but participant will need to indicate that they prefer to switch to injectable PrEP).
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding people. Should a participant become pregnant, the treating physician will discuss with the participant whether to continue study medication, taking into consideration the risks and benefits of continuing cabotegravir compared with the risk of switching to an alternative recommended PrEP regimen.
- Has not had vaginal or anal sex in the past 6 months
- HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
- Already diagnosed with HIV
- Taking any of the following medications: Carbamazepine, Rifampin, Oxcarbazepine, Rifapentine, Phenobarbital, Phenytoin
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 |
|---|---|---|
| APRETUDE (cabotegravir)All participants will be prescribed APRETUDE based on APRETUDE's FDA approved indication, which is sexual risk of HIV transmission. | Drug | All participants |
Primary outcome
Persistence on CAB-LA
Time frame: 7 months
For the primary analysis, investigators will calculate the proportion of study participants who achieve PrEP persistence at 7 months post-initiation. Investigators will then calculate 95% confidence intervals around the proportion.
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 19 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD will not be shared publicly. IPD can be made available upon request to the principal investigator with proof of IRB approval and a fully executed data use agreement.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing APRETUDE (cabotegravir) in people with HIV and Substance Use Disorder (SUD), run by Massachusetts General Hospital at 2 sites in United States.
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 6 inclusion and 5 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Suzanne McCluskey, MD, MSc (617-726-9488, SMCCLUSKEY@MGH.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence on CAB-LA (time frame: 7 months). 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 19 Mar 2026.