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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH121111 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S&S + LFLS Group | Experimental | 300 expecting couples totaling 600 participants will be completing the S&S program followed by the LFLS Program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Participants not meeting any of the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Weiss, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lusaka Province Community Health Clinics | Lusaka | Zambia |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | S&S + LFLS Group | 300 expecting couples totaling 600 participants will be completing S&S + LFLS, in 4 different clinics. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Up to 60 days of life |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Weiss | University of Miami | 7862108684 | sweiss2@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2023 | May 3, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2022 | May 3, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073599 | Health Risk Behaviors |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Number | participants | Up to 12 months |
|
|
|
| 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. | Posted | Number | participants | Up to 12 months |
|
|
|
| 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 | Participating clinics did not provide data that included the number of EIMCs for analysis. | Posted | 30 months |
|
|
| 0 |
| 600 |
| 0 |
| 600 |
| 0 |
| 600 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |