Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
NCT06200545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199
Last updated 2025-12-12
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 pre-exposure prophylaxis (PrEP) among heterosexual men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.
Conditions
- HIV Infection
- Sexually Transmitted Infections
- Pre-exposure Prophylaxis
- Systems Navigation
Interventions
- OTHER
-
PrEP eligibility assessment
PrEP eligibility assessment
- DIAGNOSTIC_TEST
-
Rapid HIV antibody testing prior to provision and/or refill of PrEP
Rapid HIV antibody testing prior to provision and/or refill of PrEP
- OTHER
-
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
- BEHAVIORAL
-
Evaluation of barriers and facilitators to ongoing PrEP use
Evaluation of barriers and facilitators to ongoing PrEP use
- OTHER
-
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement
- OTHER
-
Tracing for any missed PrEP visits
Tracing for any missed PrEP visits
- OTHER
-
Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period
Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period
Sponsors & Collaborators
-
Division of AIDS, US National Institute of Allergy and Infectious Diseases
collaborator UNKNOWN -
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
HIV Prevention Trials Network
lead NETWORK
Principal Investigators
-
Sarah Rutstein, MD, PhD · University of North Carolina, Chapel Hill
-
Mitch Matoga, MBBS, MSc · UNC Project Malawi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-02
- Primary Completion
- 2025-07-28
- Completion
- 2025-07-28
Countries
- Malawi
Study Locations
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