Papuan Indigenous Model of Male Circumcision

NCT06212531 | Completed

• 2 other identifiers: 2020-0661R21AI155926
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

HIV Prevention; Male circumcision; Papua Indonesia

Outcome Measures

Primary Outcomes (1)

• Proportion of male exposed to intervention who get circumcised.

  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 Outcomes (2)

• Levels Satisfaction

  4 months

• Sexual Behavior

  4 months

Interventions

Medical male circumcision using standard surgical technique. PROCEDURE

Medical male circumcision using the WHO standard technique followed by examination of wound healing and behavioral risk assessment.

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Atma Jaya Catholic University of Indonesia: collaborator

Study Sites (1)

University of Illinois Chicago, School of Public Health

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor Emeritus

Model Details: Observational study of recruitment of young Papuan men who volunteer for medical male circumcision.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 19, 2024
• Study Start: September 7, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)