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The purpose of this study is to evaluate the effectiveness of the Making Employment Needs (MEN) Count intervention, an HIV intervention and prevention program for heterosexual Black men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. MEN Count was developed and pilot tested using a Community-based participatory research (CBPR) approach via funding from a National Institutes of Health (NIH) R21, in Boston, Massachusetts. A more larger scale, two-armed quasi-experimental controlled trial design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic and other community-recruitment methods in Washington, DC. Study participants (N=504) will be Black men reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design will be conducted in which participants will receive either MEN Count or an attention comparison program similar to MEN Count in structure. We will assess program impact on reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia, gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted to ensure high quality program adherence and delivery, as well as to support program replication should the model prove effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEN Count | Experimental | 3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing. |
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| Comparison | Active Comparator | An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEN Count | Behavioral | The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. |
| Measure | Description | Time Frame |
|---|---|---|
| Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each. | 12 month follow-up |
| Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each. | 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Non-viral STI - 12 Month Follow-up | HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time | 12 month follow-up |
| Non-viral STI - 6 Month Follow-up |
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Inclusion Criteria: Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.
Exclusion Criteria: planned to leave Washington D.C., Maryland, or Virginia in the next 6 months, were cognitively impaired (based on Folstein Mini-Mental Exam at recruitment or baseline testing), and/or had self-reported health status that prohibited them from participating in the program
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| Name | Affiliation | Role |
|---|---|---|
| Anita Raj, PhD | UCSD | Principal Investigator |
| Lisa Bowleg, PhD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
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one individual was enrolled and surveyed twice. He remained in the study, but the initial survey was not included.
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| ID | Title | Description |
|---|---|---|
| FG000 | MEN Count | 3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing. MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. |
| FG001 | Comparison | An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle. Comparison: general health intervention for men, not inclusive of HIV or relationship health |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MEN Count | 3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing. MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each. | Those retained at 12 mo follow up | Posted | Count of Participants | Participants | 12 month follow-up |
|
Duration of the study (up to 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 | MEN Count | 3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing. MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anita Raj | Center on Gender Equity and Health at UCSD | 8588220229 | anitaraj@ucsd.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 | May 29, 2018 | Dec 4, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2015 | Dec 4, 2018 | ICF_001.pdf |
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| Comparison | Behavioral | general health intervention for men, not inclusive of HIV or relationship health |
|
HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
| 6 month follow-up |
| BG001 | Comparison | An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle. Comparison: general health intervention for men, not inclusive of HIV or relationship health |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| full time employment status | Count of Participants | Participants |
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| non-Viral STI | Count of Participants | Participants |
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| homeless in a shelter or on the streets in past 90 days | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | MEN Count | 3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing. MEN Count: The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. |
| OG001 | Comparison | An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle. Comparison: general health intervention for men, not inclusive of HIV or relationship health |
|
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| Secondary | Non-viral STI - 12 Month Follow-up | HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time | Participants retained at 12mo follow-up | Posted | Count of Participants | Participants | 12 month follow-up |
|
|
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| Secondary | Non-viral STI - 6 Month Follow-up | HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time | Participants retained at 6mo follow-up | Posted | Count of Participants | Participants | 6 month follow-up |
|
|
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| Primary | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each. | Those retained at 6 mo follow up | Posted | Count of Participants | Participants | 6 month follow-up |
|
|
|
| 1 |
| 227 |
| 0 |
| 227 |
| 0 |
| 227 |
| EG001 | Comparison | An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle. Comparison: general health intervention for men, not inclusive of HIV or relationship health | 1 | 227 | 0 | 227 | 0 | 227 |
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| Did not complete STI testing at 12mo follow-up |
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| Did not complete STI testing at 6mo follow-up |
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| Medium risk |
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| High risk |
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| Excluded or missing risk |
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