HIV
Conditions
Keywords
HIV prevention, African American men, evaluation study
Brief summary
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.
Interventions
BEHAVIORALMEN 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.
BEHAVIORALComparison
general health intervention for men, not inclusive of HIV or relationship health
Sponsors
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | 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. |
| Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-viral STI - 12 Month Follow-up | 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 |
| Non-viral STI - 6 Month Follow-up | 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 |
Countries
United States
Participant flow
Recruitment details
one individual was enrolled and surveyed twice. He remained in the study, but the initial survey was not included.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 227 |
| 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 | 227 |
| Total | 454 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant used false ID, was withdrawn | 1 | 0 |
Baseline characteristics
| Characteristic | MEN Count | Total | Comparison |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 227 Participants | 454 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 227 Participants | 454 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| full time employment status | 19 Participants | 53 Participants | 34 Participants |
| homeless in a shelter or on the streets in past 90 days | 116 Participants | 220 Participants | 104 Participants |
| non-Viral STI | 55 Participants | 106 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 227 Participants | 454 Participants | 227 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 227 Participants | 454 Participants | 227 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 227 Participants | 454 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 227 | 1 / 227 |
| other Total, other adverse events | 0 / 227 | 0 / 227 |
| serious Total, serious adverse events | 0 / 227 | 0 / 227 |
Outcome results
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.
Time frame: 12 month follow-up
Population: Those retained at 12 mo follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Low risk | 26 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | High risk | 7 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Medium risk | 30 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Excluded or missing risk | 29 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Very low risk | 28 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Excluded or missing risk | 22 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Very low risk | 18 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Low risk | 40 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | Medium risk | 34 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up | High risk | 9 Participants |
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.
Time frame: 6 month follow-up
Population: Those retained at 6 mo follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Low risk | 32 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | High risk | 6 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Medium risk | 25 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Excluded or missing risk | 17 Participants |
| MEN Count | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Very low risk | 15 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Excluded or missing risk | 22 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Very low risk | 18 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Low risk | 29 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | Medium risk | 28 Participants |
| Comparison | Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up | High risk | 8 Participants |
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
Time frame: 12 month follow-up
Population: Participants retained at 12mo follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEN Count | Non-viral STI - 12 Month Follow-up | Did not complete STI testing at 12mo follow-up | 16 Participants |
| MEN Count | Non-viral STI - 12 Month Follow-up | Positive for non-viral STI at 12mo follow-up | 17 Participants |
| MEN Count | Non-viral STI - 12 Month Follow-up | Negative for all non-viral STI at 12mo follow-up | 87 Participants |
| Comparison | Non-viral STI - 12 Month Follow-up | Did not complete STI testing at 12mo follow-up | 10 Participants |
| Comparison | Non-viral STI - 12 Month Follow-up | Positive for non-viral STI at 12mo follow-up | 15 Participants |
| Comparison | Non-viral STI - 12 Month Follow-up | Negative for all non-viral STI at 12mo follow-up | 98 Participants |
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
Time frame: 6 month follow-up
Population: Participants retained at 6mo follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MEN Count | Non-viral STI - 6 Month Follow-up | Positive for non-viral STI at 6mo follow-up | 7 Participants |
| MEN Count | Non-viral STI - 6 Month Follow-up | Negative for all non-viral STI at 6mo follow-up | 83 Participants |
| MEN Count | Non-viral STI - 6 Month Follow-up | Did not complete STI testing at 6mo follow-up | 5 Participants |
| Comparison | Non-viral STI - 6 Month Follow-up | Positive for non-viral STI at 6mo follow-up | 13 Participants |
| Comparison | Non-viral STI - 6 Month Follow-up | Negative for all non-viral STI at 6mo follow-up | 85 Participants |
| Comparison | Non-viral STI - 6 Month Follow-up | Did not complete STI testing at 6mo follow-up | 7 Participants |