Trial Outcomes & Findings for Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (NCT NCT01694121)
NCT ID: NCT01694121
Last Updated: 2018-12-28
Results Overview
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.
COMPLETED
NA
455 participants
12 month follow-up
2018-12-28
Participant Flow
one individual was enrolled and surveyed twice. He remained in the study, but the initial survey was not included.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
227
|
|
Overall Study
COMPLETED
|
227
|
227
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Participant used false ID, was withdrawn
|
1
|
0
|
Baseline Characteristics
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Baseline characteristics by cohort
| Measure |
MEN Count
n=227 Participants
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.
|
Comparison
n=227 Participants
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
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
227 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
227 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
227 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
227 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
227 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
full time employment status
|
19 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
non-Viral STI
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
homeless in a shelter or on the streets in past 90 days
|
116 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 month follow-upPopulation: Those retained at 12 mo 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.
Outcome measures
| Measure |
MEN Count
n=120 Participants
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.
|
Comparison
n=123 Participants
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
|
|---|---|---|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Very low risk
|
28 Participants
|
18 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Low risk
|
26 Participants
|
40 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Medium risk
|
30 Participants
|
34 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
High risk
|
7 Participants
|
9 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Excluded or missing risk
|
29 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upPopulation: Those retained at 6 mo 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.
Outcome measures
| Measure |
MEN Count
n=95 Participants
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.
|
Comparison
n=105 Participants
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
|
|---|---|---|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Very low risk
|
15 Participants
|
18 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Low risk
|
32 Participants
|
29 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Medium risk
|
25 Participants
|
28 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
High risk
|
6 Participants
|
8 Participants
|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Excluded or missing risk
|
17 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 12 month follow-upPopulation: Participants retained at 12mo 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
Outcome measures
| Measure |
MEN Count
n=120 Participants
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.
|
Comparison
n=123 Participants
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
|
|---|---|---|
|
Non-viral STI - 12 Month Follow-up
Positive for non-viral STI at 12mo follow-up
|
17 Participants
|
15 Participants
|
|
Non-viral STI - 12 Month Follow-up
Negative for all non-viral STI at 12mo follow-up
|
87 Participants
|
98 Participants
|
|
Non-viral STI - 12 Month Follow-up
Did not complete STI testing at 12mo follow-up
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Participants retained at 6mo 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
Outcome measures
| Measure |
MEN Count
n=95 Participants
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.
|
Comparison
n=105 Participants
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
|
|---|---|---|
|
Non-viral STI - 6 Month Follow-up
Positive for non-viral STI at 6mo follow-up
|
7 Participants
|
13 Participants
|
|
Non-viral STI - 6 Month Follow-up
Negative for all non-viral STI at 6mo follow-up
|
83 Participants
|
85 Participants
|
|
Non-viral STI - 6 Month Follow-up
Did not complete STI testing at 6mo follow-up
|
5 Participants
|
7 Participants
|
Adverse Events
MEN Count
Comparison
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place