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OpenTrials
Completed

NCT Number: NCT04119414

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.

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Key information

Conditions

Health Knowledge, Attitudes, Practice Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Health Risk Behaviors Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lusaka Province Community Health Clinics

Lusaka, Zambia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spear and Shield (S&S) Program

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2019
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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