Papuan Indigenous Model of Male Circumcision

January 13, 2024 updated by: Robert Bailey, University of Illinois at Chicago

The Papuan Indigenous Model of Voluntary Clinical Male Circumcision

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Chicago, School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Resident of either Nabiri or Jayapura Districts of Papua, Indonesia. Able to provide informed consent if over 17 and parental consent and personal assent if less than 18.

Focus group and interview participants had to be either a parent, boy or girl between 12-18, teacher or administrator, or community leader.

To be eligible for circumcision, a boy had to be uncircumcised, age 15 years or above, and not show signs or symptoms of an STI or any penile abnormality (e.g., hypospadias, phimosis) that made him clinically ineligible for circumcision.

Exclusion Criteria:

  • Unable to provide informed consent or assent. Any medical condition indicating should not undergo circumcision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of male exposed to intervention who get circumcised.
Time Frame: 6 months
The proportion of males who are recorded attending school-based PIM VMMC educational and informational sessions who are recorded as getting circumcised and at community health clinics.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels Satisfaction
Time Frame: 4 months
Levels of satisfaction by adolescent males and parents measured through face-to-face interview questionnaires using a five item likert scale.
4 months
Sexual Behavior
Time Frame: 4 months
Sexual activity within the first 6 weeks after circumcision measured by face-to-face interview, including whether or not they have had sex, number of sex partners and condom use.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Atma Jaya Catholic University of Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0661
  • R21AI155926 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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