Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi

NCT06200545 | Completed DMC

• 2 other identifiers: HPTN 112UM1AI068619-17
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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 men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.

Conditions

Sexually Transmitted Infections; Pre-exposure Prophylaxis; Systems Navigation; HIV Infection

Keywords

HIV; STI; PrEP; Heterosexual; Lilongwe; Malawi; Systems Navigation

Outcome Measures

Primary Outcomes (13)

• 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)

  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.

  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.

  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.

  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)

  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.

  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.

  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.

  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

  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

  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

  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)

  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.

  26 weeks

Secondary Outcomes (7)

• To assess the feasibility of a future randomized controlled trial

  52 weeks

• To assess the feasibility of a future randomized controlled trial

  52 weeks

• To assess the feasibility of a future randomized controlled trial

  52 weeks

• To assess the feasibility of a future randomized controlled trial

  52 weeks

• To assess the feasibility of a future randomized controlled trial

  52 weeks

Study Arms (2)

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.

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.

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

Interventions

PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines OTHER

PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines

Intervention package PrEP services; Standard of care PrEP services

PrEP eligibility assessment OTHER

PrEP eligibility assessment

Intervention package PrEP services; Standard of care PrEP services

Rapid HIV antibody testing prior to provision and/or refill of PrEP DIAGNOSTIC_TEST

Rapid HIV antibody testing prior to provision and/or refill of PrEP

Intervention package PrEP services; Standard of care PrEP services

Evaluation of barriers and facilitators to ongoing PrEP use BEHAVIORAL

Evaluation of barriers and facilitators to ongoing PrEP use

Intervention package PrEP services

Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement OTHER

Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement

Intervention package PrEP services

Tracing for any missed PrEP visits OTHER

Tracing for any missed PrEP visits

Intervention package PrEP services

Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period OTHER

Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period

Intervention package PrEP services

Eligibility Criteria

• Age: 15 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• HIV Prevention Trials Network: lead
• Division of AIDS, US National Institute of Allergy and Infectious Diseases: collaborator

Study Sites (1)

Malawi CRS

Lilongwe, Malawi

Location

Related Publications (1)

• 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.

  PMID: 40531570 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Heterosexuality

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Study Officials

• Sarah Rutstein, MD, PhD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Mitch Matoga, MBBS, MSc

  UNC Project Malawi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 11, 2024
• Study Start: April 2, 2024
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)