Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite
Not a traditional drug phase: Peer Activate-LAI for HIV Infections
This randomly assigned Type 1 hybrid effectiveness-implementation trial (N=186) will measure the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to: Aim 1: measure the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory) Aim 2: To measure the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Peer Activate-LAI, or Standard of Care HIV treatment or prevention with LAI-PrEP/ART. The registry lists allocation as randomized. This randomly assigned Type 1 hybrid effectiveness-implementation trial (N=186) will measure the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV.
They plan to enroll about 186 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
Interventions: Peer Activate-LAI, Standard of Care HIV treatment or prevention with LAI-PrEP/ART
HIV negative with a negative HIV antibody/antigen test and meeting CDC(center for disease control and prevention) criteria for PrEP HIV positive with a positive antibody/antigen test
Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information
Moderate substance use, defined as a (World Health Organization Alcohol, Smoking and Substance Involvement Screening Test) WHO-ASSIST score of ≥4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or ≥11 for alcohol
Who the registry excludes
Contraindications to Cabotegravir-LA (HIV-) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV+) use based on prescribing information or other medical/psychiatric conditions that may interfere with study participation
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART).
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06501781?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06501781?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.