Clinical trial NCT06212531: Papuan Indigenous Model of Male Circumcision
Official title: The Papuan Indigenous Model of Voluntary Clinical Male Circumcision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Prevention
Male circumcision
Papua Indonesia
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Atma Jaya Catholic University of Indonesia
First posted: 2024-01-19
Enrollment: 239
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational study of recruitment of young Papuan men who volunteer for medical male circumcision.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of male exposed to intervention who get circumcised.
timeFrame: 6 months
Secondary outcomes:
measure: Levels Satisfaction
timeFrame: 4 months
measure: Sexual Behavior
timeFrame: 4 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago, School of Public Health
state: Illinois
Study officials:
References: