Papuan Indigenous Model of Male Circumcision

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT06212531
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-07
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-13
• Last Update Submitted: 2024-01-13
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of male exposed to intervention who get circumcised.	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.

Secondary Outcome Measures

Name	Time	Method
Levels Satisfaction	4 months	Levels of satisfaction by adolescent males and parents measured through face-to-face interview questionnaires using a five item likert scale.
Sexual Behavior	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.

Trial Locations

Locations (1)

University of Illinois Chicago, School of Public Health; 🇺🇸 Chicago, Illinois, United States