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Can bringing HIV prevention to communities beat clinic visits?

NCT ID NCT06176859

Prevention Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study compares two ways to provide HIV prevention pills (PrEP) to young people in South Africa: the usual clinic-based approach versus a community-based model where pills are delivered and monitored outside clinics. Researchers will enroll 2,500 participants aged 16-30 to see which method leads to more people starting and staying on PrEP over 12 months. The goal is to find a safer, more effective way to expand access to HIV prevention.

What this could mean

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

Active substance
Pre-exposure prophylaxis (PrEP) for HIV prevention
What this could lead to
If successful, this could make PrEP more accessible and convenient for young people in South Africa, reducing new HIV infections.
What could go wrong
This is a large but early-stage implementation study; results may not apply to other regions or populations. Community-based delivery may face logistical challenges.

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

2,500 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 2026

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

16 to 30 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: * Aged 16 years - 30 years old, * Self-report living without HIV or unknown status. * Persons who have been sexually active within the last 3 months * Interested in the use of PrEP for HIV prevention. * Able and willing to provide informed consent for study procedures. * Access to a cellphone for study related communication * Reside in the study community for the duration of follow-up. Exclusion Criteria: * HIV infection based on negative HIV rapid tests * Clinically ineligible for PrEP * The participant doesn't reside in the study community for the duration of follow-up

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Conditions

The condition(s) this trial relates to.

AIDS Arts syndrome HIV infectious disease prevention target

As listed by the trial registrant

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

ART HIV Human immunodeficiency virus

Contacts and locations

Locations

  • Human Sciences Research Council

    Durban, KwaZulu-Natal, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.