HIV InfectionsNCT07649551
Optimizing Implementation of Long Acting Injectable PrEP
A study testing Plan-Do-Study-Act in people with HIV Infections, run by University of Minnesota.
Trial summary
Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Plan-Do-Study-Act
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Provider/staff inclusion criteria:
- 18 years of age or older,
- affiliated with a participating clinic, and
- be involved in prescribing or supporting PrEP care delivery.
Provider/staff exclusion criteria:
- 17 years of age or younger,
- not affiliated with a participating clinic, and
- not involved in prescribing or supporting PrEP care delivery.
De-identified electronic medical record review inclusion criteria:
- 16 years of age or older, and
- had a clinical visit for any form of PrEP care during the study period at a participating clinic site.
De-identified electronic medical record review exclusion criteria:
- 15 years of age or younger, and
- no clinical visit for any form of PrEP care during the study period at a participating clinic site.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available
- Conditions
- HIV Infections
- Being tested
- Plan-Do-Study-Act
- Keywords
- PrEP, Pre-Exposure Prophylaxis
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plan-Do-Study-ActBehavioural
Implementation strategy of conducting cyclical small tests of change using Plan-Do-Study-Act
| Study group | Role | What they receive |
|---|---|---|
| Clinic Implementation | Active comparator | We will implement changes responsive to current obstacles to LAI-PrEP care delivery with serial systematic evaluation. Preliminary impact of LAI-PrEP implementation will be evaluated using RE-AIM, assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance via electronic medical records review, survey, and exit interviews. Exit interviews will also determine feasibility, acceptability, and appropriateness of Plan-Do-Study-Act as a clinic-based implementation strategy. Receives: Behavioral: Plan-Do-Study-Act |
| Control | No intervention | Observational control period |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAI-PrEP prescribing
Proportion of eligible patients prescribed LAI-PrEP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- We will pilot and evaluate an implementation strategy of conducting cyclical small tests of change using Plan-Do-Study-Act within two outpatient clinics
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven A John, PhD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649551
- Sponsor's protocol ID
- R34MH135746
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Implementation of Long Acting Injectable PrEP
- ClinicalTrials.gov ID
- NCT07649551
- Acronym / sponsor ID
- R34MH135746
- Conditions
- HIV Infections
- Keywords
- PrEP, Pre-Exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Jun 2026 (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.
Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will pilot and evaluate an implementation strategy of conducting cyclical small tests of change using Plan-Do-Study-Act within two outpatient clinics
| Arm | Type | Receives |
|---|---|---|
| Clinic Implementation | Active comparator | Behavioral: Plan-Do-Study-ActWe will implement changes responsive to current obstacles to LAI-PrEP care delivery with serial systematic evaluation. Preliminary impact of LAI-PrEP implementation will be evaluated using RE-AIM, assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance via electronic medical records review, survey, and exit interviews. Exit interviews will also determine feasibility, acceptability, and appropriateness of Plan-Do-Study-Act as a clinic-based implementation strategy. |
| Control | No intervention | –Observational control period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Plan-Do-Study-ActImplementation strategy of conducting cyclical small tests of change using Plan-Do-Study-Act | Behavioural | Clinic Implementation |
Primary outcome
LAI-PrEP prescribing
Time frame: 3 months
Proportion of eligible patients prescribed LAI-PrEP
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 16 Jun 2026.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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.
Steven A John, PhD, MPH principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Plan-Do-Study-Act in people with HIV Infections, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Steven A John, PhD, MPH (612-625-1500, sajohn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LAI-PrEP prescribing (time frame: 3 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 16 Jun 2026.