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Can a Choice-Based HIV prevention model with Long-Acting shots cut infections in east africa?

NCT ID NCT05549726

Prevention Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study tests whether offering a long-acting injectable HIV prevention drug called cabotegravir (CAB-LA) as one of several options in a person-centered 'dynamic choice' model can increase prevention coverage and reduce new HIV infections compared to standard care. The trial enrolls HIV-negative adults and adolescents in rural Uganda and Kenya who are already part of a larger HIV prevention study. Participants can choose and switch between prevention methods over time, and the study will measure how well this approach works in real-world settings.

What this could mean

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

Active substance
Cabotegravir injectable suspension (CAB-LA), a long-acting injectable for HIV pre-exposure prophylaxis (PrEP), offered as part of a dynamic choice prevention model.
What this could lead to
If successful, this approach could significantly reduce new HIV infections in high-burden regions by making prevention options more flexible and person-centered.
What could go wrong
The study is an extension and may face challenges in adherence, product switching, or implementation in rural settings. Results may not generalize beyond the specific populations and regions studied.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

984 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2025

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

15 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Inclusion criteria for the Extension include: 1. Enrollment in a SEARCH Sapphire Dynamic prevention study (NCT04810650) 2. HIV negative at start of extension 3. Residing in study region Additional inclusion criteria to access CAB-LA as a prevention option 1. Not pregnant or breastfeeding at time of initial CAB-LA injection 2. Participant weighs at least 35kg Exclusion Criteria: Exclusion criteria to access CAB-LA as a prevention option: 1. Participant has Hepatitis B or chronic Hepatitis C Diagnosis 2. Participant has ALT \>=5x ULN 3. Participant has clinical history of liver cirrhosis or current clinical evidence of cirrhosis 4. Previous hypersensitivity reaction to cabotegravir 5. Receiving the following co-administered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase: i. Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin ii. Antimycobacterials: Rifampin, rifapentine 6. Participants with a current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding, except for the use of anticoagulation for deep vein thrombosis (DVT) prophylaxis (e.g., postoperative DVT prophylaxis) or the use of low dose acetylsalicylic acid (≤325 mg).

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

  • GPRT / SEARCH Office

    Kisumu, Kenya

  • IDRC Southwest Uganda

    Mbarara, Uganda

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