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Nurses could be key to expanding HIV prevention in rural america

NCT ID NCT07346508

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether nurses, instead of doctors, can safely and effectively give long-acting HIV prevention shots in rural public health clinics. About 250 adults at risk for HIV will take part across several clinics in Missouri. The goal is to see if this nurse-driven approach helps more people access and stay on this prevention method, especially in areas with few healthcare providers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Long-acting injectable cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)
What this could lead to
If successful, this nurse-driven model could make long-acting HIV prevention widely available in rural and underserved communities, reducing new HIV infections.
What could go wrong
This is an early implementation study, not a large-scale trial, so results may not apply everywhere. The approach depends on nurse training and local resources, which could limit success in other settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant seeking medical care at participating LPHDs for family planning, women's wellness exam, STI evaluation, screening, and treatment, and/or any other medical care services. 2. ≥ 18 years of age. The study's focus is on adults. Adolescents may have unique healthcare access challenges, behavioral factors, and parental consent requirements that could complicate study participation. 3. Has an indication for PrEP per guidelines. 4. Understand the commitment to the study and be willing to participate. Exclusion Criteria: 1. Recent high-risk HIV exposure in the last month and/or has signs/symptoms consistent with acute HIV infection (such as fever, weight loss, skin rash). 2. Unknown, positive, or indeterminate HIV-1 test result by a test approved by the FDA for the diagnosis of acute HIV-1 infection. 3. Any other contraindications based on the most current US Prescribing information. 4. Currently on LAI-CAB, prior use of oral PrEP is not an exclusion criterion. 5. Patients with mental health conditions that are severe enough to interfere with understanding of PrEP requirements (adherence, follow-up visits). The exclusion does not prevent these patients from receiving standard care at the LPHDs; it only excludes them from research-related activities. 6. Inability to provide informed consent, such as due to cognitive or language barriers that prevent understanding of the study requirements. 7. Institutionalized in prison, jail, or healthcare facility. Participants who are institutionalized are excluded because their autonomy may be restricted. Institutional settings also pose logistical challenges for ensuring follow-up and consistent participation in study-related activities. 8. Patients who do not have a confirmed means of contact. Participants must have a reliable means of contact (e.g., phone) to receive laboratory test results, follow-up reminders, and study-related communications. 9. Planning to move out of the area for the follow-up duration of the study. Justification: participants planning to move out of the area cannot reliably complete the study's follow-up visits, which could result in incomplete data. 10. Concurrent participation in another clinical trial. Participants enrolled in other clinical trials may face conflicting protocols, treatment regimens, or follow-up schedules, which could confound study results, introducing biases or safety concerns.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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