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Could a shot every 6 months end HIV? new study tests lenacapavir in south africa

NCT ID NCT07390409

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will offer young people aged 15-35 in Cape Town a choice of HIV prevention methods: a new twice-yearly injection (lenacapavir), a two-monthly injection (cabotegravir), or daily pills. Researchers want to see which option people stick with over 18 months and how best to deliver these choices in clinics and mobile trucks. The goal is to make HIV prevention easier and more effective.

What this could mean

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

Active substance
lenacapavir injection
What this could lead to
If successful, this could provide a convenient twice-yearly injection that helps prevent HIV in young people, potentially improving adherence and reducing new infections.
What could go wrong
This is an early real-world study, not a large phase 3 trial. Results may not apply to other regions, and participants may still face side effects or injection-site reactions.

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.

Participants

About 3,700 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

May 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.

Who is studied

People accessing the sites (mobile clinics in Cape Town, South Africa) for general sexual and reproductive health services including PrEP will be invited to consecutively enrol on the ALIGN project. If enrolled on ALIGN, they will be able to select their preferred PrEP modalities (oral PrEP, LEN or CAB LA) to use for the duration of the study (18 months).

Ages

15 to 35 years

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: * All participants must be HIV negative at baseline \- 15-35 years * All participants must have a body weight ¬\> 35kg at baseline * All participants must be currently resident in the study area * All participants must be able to provide written, informed voluntary consent to partake in the study and willing and able to receive an injectable PrEP product * All participants must be sexually active (has had ≥ 2 intercourse encounters within the last 3 months) Exclusion Criteria: * Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection * Unknown or indeterminate HIV-1 status at screening or enrolment. * Suspected or known serious infection(s), such as active tuberculosis * Severe hepatic impairment or renal disease * Allergy or hypersensitivity to any of the PrEP agents * Known chronic Hepatitis B infection and currently taking oral PrEP * Use of contraindicated medications for LEN: ergot derivatives (ergotamine, ergonovine, dihydroergotamine, methylergonovine, ergometrine), and certain anticonvulsants. * Concomitant Use of known enzyme-inducing or contraindicated medications including: rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine and oxcarbazepine. * Do not spend a reasonable amount of time in the study area as residents, for school, or work, or are otherwise unable to participate in study visits for geographical reasons, according to the site investigator * Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records) * Current enrolment in another interventional research study that in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (as verified by registration on the South African Medical Research Council (SAMRC) biometric co-enrolment prevention system (BCEPS)).

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • DTHF Mobile Clinics

    Cape Town, WC, 7925, South Africa

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