Health Knowledge, Attitudes, PracticeNCT04119414
Like Father Like Son
A study testing Spear and Shield (S&S) Program and Like Father Like Son (LFLS) Program in people with Health Knowledge, Attitudes, Practice and Health Risk Behaviors, run by University of Miami at 1 site in Zambia.
Trial summary
This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear \& Shield program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Health Risk Behaviors
- What is being tested?
- Spear and Shield (S&S) Program and Like Father Like Son (LFLS) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteZambia
- Study dates
- 8 Oct 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants not meeting any of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Spear and Shield (S&S) Program, Like Father Like Son (LFLS) Program
- Keywords
- Early Infant Male Circumcision, HIV infection
- Medical subject headings
- Behavior, Health Risk Behaviors, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spear and Shield (S&S) ProgramBehavioural
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) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| S&S + LFLS Group | Experimental | 300 expecting couples totaling 600 participants will be completing the S\&S program followed by the LFLS Program. Receives: Behavioral: Spear and Shield (S&S) Program; Behavioral: Like Father Like Son (LFLS) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Early Infant Male Circumcision
As measured by the number of male infants who received circumcision during the first 60 days of life
Measured: 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.
Measured: 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.
Measured: 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
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start8 Oct 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephen Weiss, University of Miami
- Investigators
- Stephen Weiss, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119414
- Sponsor's protocol ID
- 20190354
- Other IDs
- R34MH121111
- Status last verified
- Jul 2023
- First submitted
- 6 Oct 2019
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Early Infant Male Circumcision Uptake in Zambia: Like Father Like Son
- ClinicalTrials.gov ID
- NCT04119414
- Acronym / sponsor ID
- 20190354
- Keywords
- Early Infant Male Circumcision, HIV infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear \& Shield program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S&S + LFLS Group | Experimental | Behavioral: Spear and Shield (S&S) Program, Behavioral: Like Father Like Son (LFLS) Program300 expecting couples totaling 600 participants will be completing the S\&S program followed by the LFLS Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participants not meeting any of the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spear and Shield (S&S) ProgramThe 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. | Behavioural | S&S + LFLS Group |
| Like Father Like Son (LFLS) ProgramThe 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. | Behavioural | S&S + LFLS Group |
Primary outcome
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
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.
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Weiss, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spear and Shield (S&S) Program and Like Father Like Son (LFLS) Program in people with Health Knowledge, Attitudes, Practice and Health Risk Behaviors, run by University of Miami at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Early Infant Male Circumcision (time frame: Up to 60 days of life). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.