Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2025-07-28

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infection Sexually Transmitted Infections Pre-exposure Prophylaxis Systems Navigation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of care PrEP services

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.

Group Type ACTIVE_COMPARATOR

PrEP eligibility assessment

Intervention Type OTHER

PrEP eligibility assessment

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

Intervention Type DIAGNOSTIC_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 guidelines

Intervention Type OTHER

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

Intervention package PrEP services

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.

Group Type EXPERIMENTAL

PrEP eligibility assessment

Intervention Type OTHER

PrEP eligibility assessment

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

Intervention Type DIAGNOSTIC_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 guidelines

Intervention Type OTHER

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

Evaluation of barriers and facilitators to ongoing PrEP use

Intervention Type BEHAVIORAL

Evaluation of barriers and facilitators to ongoing PrEP use

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

Intervention Type OTHER

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

Tracing for any missed PrEP visits

Intervention Type OTHER

Tracing for any missed PrEP visits

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

Intervention Type OTHER

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

Interventions

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PrEP eligibility assessment

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

Evaluation of barriers and facilitators to ongoing PrEP use

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Tracing for any missed PrEP visits

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes