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Papuan Indigenous Model of Male Circumcision - Trial NCT06212531

Access comprehensive clinical trial information for NCT06212531 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Illinois at Chicago and is currently Completed. The study focuses on HIV Infections. Target enrollment is 239 participants.

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NCT06212531
Completed
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Trial Details
ClinicalTrials.gov โ€ข NCT06212531
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Papuan Indigenous Model of Male Circumcision
The Papuan Indigenous Model of Voluntary Clinical Male Circumcision

Study Focus

HIV Infections

Medical male circumcision using standard surgical technique.

Interventional

procedure

Sponsor & Location

University of Illinois at Chicago

Chicago, United States of America

Timeline & Enrollment

N/A

Sep 07, 2020

Aug 31, 2023

239 participants

Primary Outcome

Proportion of male exposed to intervention who get circumcised.

Summary

The purpose of the study is: AIM 1: To engage Papuan community members to explore
 acceptability, barriers and facilitators for introducing a school-based age and culturally
 appropriate, comprehensive VMMC intervention to reduce HIV incidence in the Papuan
 population. AIM 2: To assess the capacity of the community health system to meet
 international criteria for safe comprehensive VMMC services and to ensure the availability of
 resources and training necessary to meet these criteria in selected clinics. AIM 3: To design
 the PIM of school-based adolescent VMMC based on information collected in Aims 1 and 2 and in
 consultation with a community advisory board, the Ministry of Health and the Ministry of
 Education. AIM 4: To pilot-test the school-based PIM Intervention of VMMC with 400 boys ages
 12-18 years at two HIV high-risk Papuan locations: the Nabire and Jayapura. Primary outcomes
 are the proportion of adolescent males exposed to school-based PIM VMMC educational and
 informational sessions who get circumcised and surgical event safety. Secondary outcomes are
 satisfaction by adolescent males and parents, any sexual activity within 6 weeks after
 circumcision, changes in sexual risk behaviors between base-line and 12 weeks after
 circumcision, and perceptions of providers regarding MC training and implementation, ease of
 device use, and challenges encountered.

ICD-10 Classifications

HIV disease resulting in other viral infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06212531

Non-Device Trial