Navigator program boosts HIV prevention in malawian men
NCT ID NCT06200545
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV infection are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Four weeks vs twelve weeks: can a shorter TB prevention course work?
- Can a phone app keep young people with HIV engaged in care?
- Massive Real-World database aims to map how chronic diseases interact
- How do HIV drugs behave when kidneys fail? study measures blood levels
- Can HIV-Positive mothers breastfeed without passing the virus to their babies?