Clinical trial NCT06200545: Improving HIV Prevention Among Heterosexual Cisgender Men Seeking STI Services in Malawi
Official title: Improving HIV Prevention Among Heterosexual Cisgender Men Seeking STI Services in Malawi: Examining the Benefits, Acceptability, and Associated Costs of a Systems-navigator-delivered Integrated Prevention Package
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infection
Sexually Transmitted Infections
Pre-exposure Prophylaxis
Systems Navigation
Keywords: HIV
STI
PrEP
Cisgender
Heterosexual
Lilongwe
Malawi
Systems Navigation
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: Division of AIDS, US National Institute of Allergy and Infectious Diseases
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-01-11
Enrollment: 203
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 pre-exposure prophylaxis (PrEP) among heterosexual cisgender men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.


Eligibility criteria: Inclusion Criteria:

1. Cisgender adult and adolescent cisgender 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 cisgender 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. Cisgender 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 (see Section 4.4).
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

Primary outcomes:
measure: To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual cisgender men seeking STI clinical services in Lilongwe, Malawi
timeFrame: 26 weeks
measure: To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual cisgender men seeking STI clinical services in Lilongwe, Malawi
timeFrame: 26 weeks
measure: To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual cisgender men seeking STI clinical services in Lilongwe, Malawi
timeFrame: 26 weeks
measure: To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual cisgender men seeking STI clinical services in Lilongwe, Malawi
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 7 days
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
measure: To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual cisgender men initiating PrEP at STI clinics
timeFrame: 26 weeks
Secondary outcomes:
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
measure: To assess the feasibility of a future randomized controlled trial
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Malawi CRS
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sarah Rutstein, MD, PhD
role: STUDY_CHAIR
affiliation: UNC Project Malawi
name: Mitch Matoga, MBBS, MSc
role: STUDY_CHAIR
References: