NCT04119414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 2, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

October 6, 2019

Results QC Date

May 3, 2023

Last Update Submit

July 18, 2023

Conditions

Health Knowledge, Attitudes, PracticeHealth Risk Behaviors

Keywords

Early Infant Male CircumcisionHIV infection

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

S&S + LFLS Group

EXPERIMENTAL

300 expecting couples totaling 600 participants will be completing the S\&S program followed by the LFLS Program.

Behavioral: Spear and Shield (S&S) ProgramBehavioral: Like Father Like Son (LFLS) Program

Interventions

Spear and Shield (S&S) ProgramBEHAVIORAL

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.

S&S + LFLS Group
Like Father Like Son (LFLS) ProgramBEHAVIORAL

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.

S&S + LFLS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lusaka Province Community Health Clinics

Lusaka, Zambia

Location

MeSH Terms

Conditions

BehaviorHealth Risk BehaviorsHIV Infections

Condition Hierarchy (Ancestors)

Health BehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Stephen Weiss
Organization
University of Miami
sweiss2@med.miami.edu
7862108684

Study Officials

  • Stephen Weiss, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

October 6, 2019

First Posted

October 8, 2019

Study Start

October 8, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 2, 2023

Results First Posted

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)