HIV InfectionNJIRANCT06200545

Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi

A study testing PrEP eligibility assessment, Rapid HIV antibody testing prior to provision and/or refill of PrEP and PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines in people with HIV Infection and Sexually Transmitted Infections, run by HIV Prevention Trials Network at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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 men receiving care for sexually transmitted infections (STIs) in… Read more about this study

Who is it for?: Ages 15 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infection, Sexually Transmitted Infections, Pre-exposure Prophylaxis
What is being tested?: PrEP eligibility assessment, Rapid HIV antibody testing prior to provision and/or refill of PrEP and PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteMalawi
Study dates: 2 Apr 2024to 28 Jul 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
Men only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Show all 15Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malawi1 site

Malawi CRS
Lilongwe

Other trials in Malawi

About this study

Official title: 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

Conditions: HIV Infection, Sexually Transmitted Infections, Pre-exposure Prophylaxis, Systems Navigation
Being tested: PrEP eligibility assessment, Rapid HIV antibody testing prior to provision and/or refill of PrEP, PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines, Evaluation of barriers and facilitators to ongoing PrEP use, Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement
Keywords: HIV, STI, PrEP, Heterosexual, Lilongwe, Malawi, Systems Navigation
Medical subject headings: HIV Infections, Sexually Transmitted Diseases, Heterosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrEP eligibility assessmentOther
PrEP eligibility assessment
Rapid HIV antibody testing prior to provision and/or refill of PrEPDiagnostic test
Rapid HIV antibody testing prior to provision and/or refill of PrEP
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelinesOther
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
Evaluation of barriers and facilitators to ongoing PrEP useBehavioural
Evaluation of barriers and facilitators to ongoing PrEP use
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagementOther
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement
Tracing for any missed PrEP visitsOther
Tracing for any missed PrEP visits
Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up periodOther
Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period

Study groups in NCT06200545
Study group	Role	What they receive
Standard of care PrEP services	Active comparator	Standard of care (SOC) PrEP services include PrEP eligibility assessment, rapid HIV antibody testing prior to provision and/or refill of PrEP, and PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines. Specifically, SOC services do not generally include point of contact STI testing (with the exception of rapid syphilis and Hepatitis B antigen testing, if kits are available, at PrEP initiation) nor tracing for missed PrEP visits. Participants randomized to the SOC condition will receive these standard PrEP services. Receives: Other: PrEP eligibility assessment; Diagnostic Test: 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
Intervention package PrEP services	Experimental	The intervention package is integrated into PrEP visits and includes evaluation of barriers and facilitators to ongoing PrEP use, point of contact STI testing to inform counseling regarding ongoing PrEP care engagement, tracing for any missed PrEP visits, and offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period. Recognizing increasingly cyclical PrEP use patterns, navigators serve as a direct entry point to retain or re-engage participants in HIV prevention care. Receives: Other: PrEP eligibility assessment; Diagnostic Test: 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; Behavioral: Evaluation of barriers and facilitators to ongoing PrEP use; Other: Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement; Other: Tracing for any missed PrEP visits; Other: Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual 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)
Measured: 26 weeks
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual 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.
Measured: 26 weeks
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual 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.
Measured: 26 weeks
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual 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.
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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)
Measured: 7 days
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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.
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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.
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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.
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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)
Measured: 26 weeks
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual 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.
Measured: 26 weeks

Secondary outcomes (7)

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
Measured: 52 weeks
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
Measured: 52 weeks
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)
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202428 Jul 2025

First posted11 Jan 2024
Study start2 Apr 2024
Primary completion28 Jul 2025
Study completion28 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06200545
Sponsor's protocol ID: HPTN 112
Other IDs: UM1AI068619-17
Acronym: NJIRA
Status last verified: Dec 2025
First submitted: 7 Dec 2023
Last updated: 12 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Rutstein SE, Limarzi-Klyn L, Chen JS, Agyei YO, Ahmed S, Bell I, Cohen M, Fogel JM, Go V, Haines D, Hamilton EL, Hoffman IF, Hosseinipour MC, Marzinke MA, Miller WC, Mukatipa M, Pulerwitz J, Spiegel HML, Ye T, Matoga M. Improving HIV Prevention Among Heterosexual Men Seeking Sexually Transmitted Infection Services in Malawi: Protocol for a Type I Effectiveness-Implementation Hybrid Randomized Controlled Trial of Systems Navigator-Delivered Integrated Prevention Package (HPTN 112-NJIRA Study). JMIR Res Protoc. 2025 Jun 18;14:e72981. doi: 10.2196/72981.
PubMed 40531570

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06200545
Acronym / sponsor ID: NJIRA / HPTN 112
Conditions: HIV Infection, Sexually Transmitted Infections, Pre-exposure Prophylaxis, Systems Navigation
Keywords: HIV, STI, PrEP, Heterosexual, Lilongwe, Malawi, Systems Navigation
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: HIV Prevention Trials NetworkResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 2 Apr 2024 (actual)
Primary completion: 28 Jul 2025 (actual)
Study completion: 28 Jul 2025 (actual)
First posted: 11 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of care PrEP services	Active comparator	Other: PrEP eligibility assessment, Diagnostic Test: 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 guidelinesStandard of care (SOC) PrEP services include PrEP eligibility assessment, rapid HIV antibody testing prior to provision and/or refill of PrEP, and PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines. Specifically, SOC services do not generally include point of contact STI testing (with the exception of rapid syphilis and Hepatitis B antigen testing, if kits are available, at PrEP initiation) nor tracing for missed PrEP visits. Participants randomized to the SOC condition will receive these standard PrEP services.
Intervention package PrEP services	Experimental	Other: PrEP eligibility assessment, Diagnostic Test: 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, Behavioral: Evaluation of barriers and facilitators to ongoing PrEP use, Other: Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement, Other: Tracing for any missed PrEP visits, Other: Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up periodThe intervention package is integrated into PrEP visits and includes evaluation of barriers and facilitators to ongoing PrEP use, point of contact STI testing to inform counseling regarding ongoing PrEP care engagement, tracing for any missed PrEP visits, and offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period. Recognizing increasingly cyclical PrEP use patterns, navigators serve as a direct entry point to retain or re-engage participants in HIV prevention care.

Who may qualify

Ages: 15 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (15 listed)

Adult and adolescent men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating PrEP:
Individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders:

Key exclusion criteria (7 listed)

Adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating PrEP:
Individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrEP eligibility assessmentPrEP eligibility assessment	Other	Intervention package PrEP services, Standard of care PrEP services
Rapid HIV antibody testing prior to provision and/or refill of PrEPRapid HIV antibody testing prior to provision and/or refill of PrEP	Diagnostic test	Intervention package PrEP services, Standard of care PrEP services
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelinesPrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines	Other	Intervention package PrEP services, Standard of care PrEP services
Evaluation of barriers and facilitators to ongoing PrEP useEvaluation of barriers and facilitators to ongoing PrEP use	Behavioural	Intervention package PrEP services
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagementPoint of contact STI testing to inform counseling regarding ongoing PrEP care engagement	Other	Intervention package PrEP services
Tracing for any missed PrEP visitsTracing for any missed PrEP visits	Other	Intervention package PrEP services
Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up periodOffering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period	Other	Intervention package PrEP services

Primary outcome

To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
Time frame: 26 weeks
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)
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
Time frame: 26 weeks
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.
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
Time frame: 26 weeks
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.
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
Time frame: 26 weeks
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.
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 7 days
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)
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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.
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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.
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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.
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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)
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
Time frame: 26 weeks
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.

7 secondary outcomes

To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks
To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks
To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks
To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks
To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks
To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks
To assess the feasibility of a future randomized controlled trial
Time frame: 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Derived from this study: PubMed 40531570Rutstein SE, Limarzi-Klyn L, Chen JS, Agyei YO, Ahmed S, Bell I, Cohen M, Fogel JM, Go V, Haines D, Hamilton EL, Hoffman IF, Hosseinipour MC, Marzinke MA, Miller WC, Mukatipa M, Pulerwitz J, Spiegel HML, Ye T, Matoga M. Improving HIV Prevention Among Heterosexual Men Seeking Sexually Transmitted Infection Services in Malawi: Protocol for a Type I Effectiveness-Implementation Hybrid Randomized Controlled Trial of Systems Navigator-Delivered Integrated Prevention Package (HPTN 112-NJIRA Study). JMIR Res Protoc. 2025 Jun 18;14:e72981. doi: 10.2196/72981.
Individual participant dataSharing planned: No

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah Rutstein, MD, PhD study chair

University of North Carolina, Chapel Hill

Mitch Matoga, MBBS, MSc study chair

UNC Project Malawi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi (time frame: 26 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200545, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.