Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males

University of Washington430 enrolled

Overview

This study will assess the safety of the PrePex device as applied to HIV positive men by assessing the rate of clinical adverse events. The study will include adult, HIV + men who are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child Care (MOHCC) eligibility criteria.

According to mathematical modeling, Voluntary Medical Male Circumcision (VMMC) has the potential to have a major impact on reducing HIV incidence in areas with high HIV prevalence and low prevalence of male circumcision, as is the case in Zimbabwe. Male circumcision devices have the potential to accelerate VMMC scale-up as the procedure is faster and simpler and can be safely performed by nurses. However, fear of social stigma and desire to avoid HIV testing remain potential barriers to those HIV+ men who would otherwise seek out VMMC. Study subjects (n=400) are HIV+ males who elect to undergo VMMC with PrePex as a study subject, and healthcare workers involved in implementation of PrePex on HIV+ male subjects. The aim of the study is to determine if PrePex can be used safely among HIV+ men with similar rates of adverse events to HIV-uninfected men. If so, then the barrier of mandatory HIV testing as part of VMMC could be removed, encouraging more men to undergo the procedure. Determining PrePex safety in HIV+ men would also allow both those with unknown status and those with positive status to undergo MC with PrePex. Determining the barriers to performing VMMC among HIV+ men among healthcare workers, if any, would also inform future policy.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

430

Conditions

HIV Seropositivity

Interventions

PrePex male circumcision deviceDEVICE

PrePex non-surgical male circumcision device applied to eligible, consenting HIV-infected men in Zimbabwe to determine the rate of adverse events as compared to non HIV-infected men.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Agrees to take an HIV test * HIV sero-positive * WHO HIV clinical stage 1 or 2 * Age 18 years and above * Agrees to be circumcised by PrePex * Able to understand the study procedures and requirements * Completes VMMC counseling * Agrees to return to the health care facility for follow-up visits or as instructed after this circumcision until complete healing 7 weeks from device application, or until cleared by a physician * Able to comprehend and freely give informed consent for study participation Exclusion Criteria: * Known bleeding/coagulation abnormality (excessive bleeding from nosebleeds, pulled tooth, or gums) * Uncontrolled diabetes (frequent treatment in a clinic or recent hospitalization for diabetes, frequent infections, hypertension, or kidney disease) * Active genital infection, anatomic abnormality or any other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision using PrePex. * HIV sero-negative * HIV status unknown * WHO HIV stage 3 and above * Does not agree to PrePex

Locations (1)

Zengeza Clinic

Chitungwiza, Harare, Zimbabwe

Outcomes

Primary Outcomes

Rate of adverse events among HIV+ males using PrePex device

The primary safety endpoint is the incidence of clinical adverse events and device-related incidents. * Clinical related incidents such as the following: * Site bleeding (bleeding that cannot be stopped with pressure of 30 seconds and requires suturing) * Penis-wide diffuse hematoma * Penis-wide diffuse edema * Incision site infection and related symptoms * Device-related incidents * Necrotic Process not initiated * Device does not remain in situ for the full 7 days (displacement) Note: This list of AEs is not exhaustive. Severity of AE will be determined according to PEPFAR/OGAC guidelines

Time frame: Device application through complete wound healing (up to 90 days)

Secondary Outcomes

Pain assessment at key time points

* Subject's subjective pain, tingling, and discomfort related to PrePex when applying the system, wearing it and removing it. This will be assessed by numeric pain, tingling and discomfort VAS scale (Pain = VAS x Duration in Minutes). Measured in the post placement recovery at 15 minutes after placement, and then 1, 2, and 3 hours post placement. * As the necrotic process initiates, it is expected that some of subjects will have temporary discomfort during the first 2 hours after deployment (hence anaesthetic cream), which vanishes thereafter for the rest of the weeklong period when the device is in place. * Some pain is expected for a short duration (about 10 seconds) when extracting the Inner Ring during the removal procedure.

Time frame: Placement through complete healing (up to 90 days)

Abstinence until complete wound healing

Survival analysis of the timing of resumed sexual activity among subjects

Time frame: Post placement through complete healing (up to 90 days)

Factors associated with abstinence until complete wound healing

Patient factors (knowledge, attitudes) associated with abstinence from sex until wound healing is complete

Data from ClinicalTrials.gov

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