Health Knowledge, Attitudes, Practice, Health Risk Behaviors
Conditions
Keywords
Early Infant Male Circumcision, HIV infection
Brief summary
This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear & Shield program.
Interventions
BEHAVIORALSpear 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.
BEHAVIORALLike 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.
Sponsors
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Early Infant Male Circumcision | 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 | 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 | 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) | 30 months | Clinic Level (Cluster) Number of EIMC within the total number of clinic patients being seen at each of the participating clinics |
Countries
Zambia
Participant flow
Pre-assignment details
The pilot study randomized 8 clinics to Experimental and Observation conditions. Participants were recruited from the four Experimental clinics. All expecting parents received the S&S + LFLS intervention. However, the circumcision outcomes were ultimately only measured in male infant and male adult participants. Observation clinics were not intended to recruit participants and as such, only clinic level data was intended to be obtained. These clinics ultimately did not provide their data.
Participants by arm
| Arm | Count |
|---|---|
| S&S + LFLS Group 300 expecting couples totaling 600 participants will be completing the S&S program followed by the LFLS Program.
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.
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. | 600 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 300 couples did not have a male child, and 4 clinics were only observed | 300 |
Baseline characteristics
| Characteristic | S&S + LFLS Group |
|---|---|
| Age, Continuous | 28.53 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 600 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Zambia | 600 participants |
| Sex: Female, Male Female | 300 Participants |
| Sex: Female, Male Male | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 600 |
| other Total, other adverse events | 0 / 600 |
| serious Total, serious adverse events | 0 / 600 |
Outcome results
Primary
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
Time frame: 30 months
Population: Participating clinics did not provide data that included the number of EIMCs for analysis.
Primary
Number of Early Infant Male Circumcision
As measured by the number of male infants who received circumcision during the first 60 days of life
Time frame: Up to 60 days of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S&S + LFLS Group | Number of Early Infant Male Circumcision | 300 participants |
Primary
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.
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S&S + LFLS Group | Number of Parents' Who Indicate They Plan to Circumcise Their Infants | 324 participants |
Primary
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.
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S&S + LFLS Group | Number of Voluntary Medical Male Circumcision | 150 participants |