Improving HIV Prevention Among Heterosexual Cisgender Men Seeking STI Services in Malawi

HIV Infection Clinical Trial

— NJIRA  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06200545
• Other study ID #: HPTN 112
• Secondary ID: UM1AI068619-17
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 215
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infection
• Infections
• Pre-exposure Prophylaxis
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

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
• Tracing for any missed PrEP visits
Tracing for any missed PrEP visits
• Offering a PrEP "restart" kit for cisgender men who choose to discontinue PrEP during the follow-up period
Offering a PrEP "restart" kit for cisgender men who choose to discontinue PrEP during the follow-up period

Locations

Country	Name	City	State
Malawi	Malawi CRS	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	Division of AIDS, US National Institute of Allergy and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants.; LAI: Receive on-time injections (+/- 7-day window for the first injection and 14-day window thereafter)	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants.; Daily Oral: Have protective PrEP concentration detected at designated study follow-up visits, based on intraerythrocytic Tenofovir-diphosphate collected as dried blood spot; Tenofovir-diphosphate concentrations associated with =4 doses/week will be classified as adherent.	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants.; Event-driven: Self-reported PrEP adherence (2+1+1), in the past 30 days, assessed through self-report of PrEP use and sex acts at study follow-up visits.	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants.; Event-driven: Self-reported PrEP adherence (2+1+1), in the past 30 days, assessed through intraerythrocytic Tenofovir-diphosphate concentrations.	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Proportion of intervention arm participants engaged by systems navigator within 7-days of enrollment visit (defined as any contact, i.e. text exchange, in-person communication)	7 days
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Proportion of intervention arm participants engaged by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Proportion of intervention arm participants with attempted engagement by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Mean (standard error) number of contacts (text, telephone call, home visit, other) with intervention arm participants made with systems navigators (mean contacts per participant) during first 26 weeks following initiation of PrEP.	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Proportion who self-report use of HIV self-test	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Proportion who self-report use of PrEP pill pack	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Proportion who self-report use of HIV self-test in conjunction with/prior to initiation of PrEP pill pack	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only)	26 weeks
Primary	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	Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews.	26 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Calendar time to enroll 200 participants	52 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Proportion of participants retained at each [eligible] study visit	52 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Complete all study visits through 26 weeks, 39 weeks, and 52 weeks (among participants eligible for longer follow-up)	52 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Proportion of PrEP visits on the same day as study visits, by PrEP modality	52 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Proportion of participants completing 30-day Timeline Follow-back at quarterly study visits	52 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Time to complete each study visit	52 weeks
Secondary	To assess the feasibility of a future randomized controlled trial	Consistent with this secondary study objective, the following endpoint will be assessed, considering all enrolled HIV seronegative participants: Additional time (at PrEP visits) engaging with systems navigators	52 weeks