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Navigator program boosts HIV prevention in malawian men

NCT ID NCT06200545

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether a personal helper (a systems navigator) could help heterosexual men in Malawi keep taking HIV prevention medication (PrEP). 199 men who were getting care for sexually transmitted infections took part. The navigator provided support and reminders to help men stay on PrEP for 26 weeks.

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

199 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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

Male participants only

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: 1. Adult and adolescent men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating PrEP: * Age ≥18 years, or age 15-17 (with assent and parent/guardian consent) * Able to provide informed consent * No plans to move outside study area for at least 26 weeks after study enrollment * Willing to provide contact/locator information, including phone number, to facilitate tracing * Willing to participate in study activities, including specimen collection * Willing to participate in study activities, including systems navigation, counseling, and point of contact STI testing * Sought STI clinic services within 7 days of enrollment * Initiated on PrEP at STI clinic within 7 days of enrollment * Reports at least one female sex partner in the 6 months prior to enrollment * Self-identifies as heterosexual 2. Individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders: * Age ≥18 years at the enrollment visit * Able to provide informed consent * Involved in provision of clinical service navigation, systems navigation, STI or HIV care or prevention (including clinic management or oversight), or development of HIV prevention policy or programs at local or national level Exclusion Criteria: 1. Adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating PrEP: * Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators * Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the conduct of the study * Current participation in any HIV prevention study or other study considered to interfere the interpretation of study outcomes. 2. Individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder: * Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators * Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the study activities

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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.

Contacts and locations

Locations

  • Malawi CRS

    Lilongwe, Malawi

More trials for these conditions

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