Papuan Indigenous Model of Male Circumcision

HIV Infections Clinical Trial

Official title:

The Papuan Indigenous Model of Voluntary Clinical Male Circumcision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06212531
• Other study ID #: 2020-0661
• Secondary ID: R21AI155926
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois Chicago, School of Public Health	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Atma Jaya Catholic University of Indonesia, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Levels Satisfaction	Levels of satisfaction by adolescent males and parents measured through face-to-face interview questionnaires using a five item likert scale.	4 months
Secondary	Sexual Behavior	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