Like Father Like Son

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

Increasing Early Infant Male Circumcision Uptake in Zambia: Like Father Like Son

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119414
• Other study ID #: 20190354
• Secondary ID: R34MH121111
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear & Shield program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women must be able to understand and sign the Informed Consent in English or local language.

• All participants must be adults able to provide consent

• Women participants may be pregnant

• Individuals not yet adults (infants, children, teenagers) are not eligible to participate

• Prisoners will not be eligible for recruitment

Exclusion Criteria:

• Participants not meeting any of the inclusion criteria.

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice
• Health Risk Behaviors

Intervention

Behavioral:
• Spear and Shield (S&S) Program
The S&S Program is a comprehensive sexual risk reduction intervention consisting of 4 weekly 90-minute manualized group sessions conducted by a trained Community Health Center (CHC) facilitator.
• Like Father Like Son (LFLS) Program
The LFLS Program is a private 2 90-minute session conducted by a trained CHC facilitator. The sessions will be focused on exploring issues relevant to parental decision making related to voluntary medical male circumcision (VMMC) and early infant male circumcision (EIMC). Session 1 will be conducted antenatal and Session 2 will be immediately post-partum.

Locations

Country	Name	City	State
Zambia	Lusaka Province Community Health Clinics	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Early Infant Male Circumcision	As measured by the number of male infants who received circumcision during the first 60 days of life	Up to 60 days of life
Primary	Number of Voluntary Medical Male Circumcision	Number of Voluntary Medical Male Circumcision (VMMC) of adult male participants within the total number of clinic patients being seen at each of the participating clinics.	Up to 12 months
Primary	Number of Parents' Who Indicate They Plan to Circumcise Their Infants	Number of parents who indicate they plan to circumcise their infants prior to infants being born.	Up to 12 months
Primary	Clinic Level (Cluster) Number of Early Infant Male Circumcision (EIMC)	Clinic Level (Cluster) Number of EIMC within the total number of clinic patients being seen at each of the participating clinics	30 months