Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi (NJIRA)

HIV Prevention Trials Network

Status: Completed

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

Treatments: 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: PrEP eligibility assessment; Other: Tracing for any missed PrEP visits; Diagnostic Test: Rapid HIV antibody testing prior to provision and/or refill of PrEP; Other: Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement; Other: Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period

Study type: Interventional

Funder types: NETWORK; Other; NIH

Identifiers

NCT06200545

UM1AI068619-17 (U.S. NIH Grant/Contract)

HPTN 112

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: Male

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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
   • 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

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. 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.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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199 participants in 2 patient groups

Standard of care PrEP services

Active Comparator group

Description:

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.

Treatment:

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

Other: PrEP eligibility assessment

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

Intervention package PrEP services

Experimental group

Description:

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.

Treatment:

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

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

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

Other: Tracing for any missed PrEP visits

Other: PrEP eligibility assessment

Behavioral: Evaluation of barriers and facilitators to ongoing PrEP use

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