Like Father Like Son

July 18, 2023 updated by: Stephen Weiss, University of Miami

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Lusaka Province Community Health Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S&S + LFLS Group
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
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Early Infant Male Circumcision
Time Frame: Up to 60 days of life
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
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
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)
Time Frame: 30 months
Clinic Level (Cluster) Number of EIMC within the total number of clinic patients being seen at each of the participating clinics
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Stephen Weiss, Ph.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 6, 2019

First Submitted That Met QC Criteria

October 6, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20190354
  • R34MH121111 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Health Risk Behaviors

Clinical Trials on Spear and Shield (S&S) Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe