Status:
COMPLETED
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
Lead Sponsor:
HIV Prevention Trials Network
Collaborating Sponsors:
Division of AIDS, US National Institute of Allergy and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infection
Sexually Transmitted Infections
Eligibility:
MALE
15+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2025
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT06200545
Start Date
April 2 2024
End Date
July 28 2025
Last Update
December 12 2025
Active Locations (1)
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1
Malawi CRS
Lilongwe, Malawi