Like Father Like Son

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

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

Conditions
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Health Knowledge, Attitudes, Practice, Health Risk Behaviors

Intervention / Treatment
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* Behavioral: Spear and Shield (S&S) Program
* Behavioral: Like Father Like Son (LFLS) Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S&S + LFLS Group<br>300 expecting couples totaling 600 participants will be completing the S&S program followed by the LFLS Program. | Behavioral: Spear and Shield (S&S) Program<br>* 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.<br>Behavioral: Like Father Like Son (LFLS) Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Infant Male Circumcision, HIV infection