Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT07199335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Multi-Center Assessment of an Intervention to Provide Long-Acting Cabotegravir Injectable Pre-Exposure Prophylaxis to People Who Inject Drugs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCEND
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: