NCT06200545Completed
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi: Examining the Benefits, Acceptability, and Associated Costs of a Systems-navigator-delivered Integrated Prevention Package
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 199 (actual)
- First submitted
- 7 Dec 2023
- Start date
- 2 Apr 2024
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- HIV Prevention Trials Network
- Diseases
- HIV
- NCT number
- NCT06200545
What you commit to
- Study type: Interventional
- Participants enrolled: 199
- From 2 Apr 2024 to the primary completion date, 28 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 15 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Malawi CRS Coordinator of this site? Confirm its status | Lilongwe | Malawi | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.