Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men
Phase: NA
Conditions: HIV
Sponsor: University of California, San Diego

Official Title of Study:   Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black 
Men  
NCT Number: NCT01694121 
Date of Document: Last modified May 29, 2018 [outcome definition details amended] 
 
 

APPENDIX 1 – MEN Count Study Protocol  
Background 
The Making Employment Needs (MEN) Count intervention was originally developed and pilot tested 
using a community-based participatory research approach via funding from the National Institute of 
Mental Health Grant R21MH085614 grant in Boston, MA.1 The MEN Count study aimed to determine 
the efficacy of the MEN Count intervention in terms of its impact on incident STI and heterosexual risk 
for HIV (i.e., unprotected sex with multiple female sex partners in the past 90 days) among Black 
heterosexual men (n=454). The two armed quasi-experimental evaluation study enrolled participants in 
either the MEN Count counseling intervention or an attention comparison group focused on stress 
reduction. Participants were assessed via survey and HIV/STI testing at baseline and 6- and 12-month 
follow-ups to test the hypotheses that MEN Count participants, relative to attention comparison 
participants, would: (a) report a reduction in sexual risk, as measured by unprotected sex episodes and 
transactional sex in the past 90 days at each follow-up; and (b) have lower incident STI across the follow-
up period. This study also aimed to examine the MEN Count intervention’s impact on social 
determinants of health outcomes including employment and homelessness, as well as the intervention’s 
impact on expected mediators (i.e. masculinity ideologies, social-structural factors, and social-cognitive 
factors) of behavior change, and to explore whether these factors mediated the relationship between 
the intervention and study outcomes. 
Methods/Design 
Setting 
This study primarily took place in a local STI clinic in Washington D.C. 
Curriculum Development 
After pilot testing, prompts were embedded into the curriculum to identify checkpoints when MEN 
Count case managers (CMs) should provide referrals for HIV/STI testing.  Prompts were also added to 
help CMs inquire about the participant’s employment situation, potential violence in relationships, 
HIV/STI testing history and managing HIV risk. 
MEN Count Peer Counselors 
MEN Count CMs received professional development and training opportunities related to: stress 
management, anger management, DC resource referrals, mental health status assessment, substance 
abuse or addiction detection, sensitivity training about gender and sexual identity and LGBT diversity, 
healthy masculinity, and case note writing.  
Pilot Testing 
To ensure high quality implementation in the clinic setting prior to the RCT,  the MEN Count intervention 
and evaluation measures were piloted with 10 eligible Black men recruited from a community-based 
organization and stakeholder referrals in order to provide qualitative and quantitative feedback on the 
                                                          
1 Raj A, Dasgupta A, Goldson I, Lafontant D, Freeman E, Silverman JG. Pilot evaluation of the Making Employment 
Needs [MEN] count intervention: addressing behavioral and structural HIV risks in heterosexual black men. AIDS 
Care. 2014;26(2):152-159. 

intervention and protocol procedures.  Pilot participants completed the baseline survey, MEN Count 
intervention sessions given over the course of two months, follow-up survey and a brief interview about 
their response to the program.  Feedback from the pilot was used to tailor the intervention to the clinic 
setting.  Participants received $35 cash at baseline and $25 for their feedback interview. 
Intervention  
For the MEN Count study, participants received $30 cash at baseline and an additional $40 at six-month 
follow up and $50 at 12-month follow up. Clinic and study staff provided standard of care HIV/STI 
counseling and testing, including support for follow-up and linkage to care or treatment if a participant 
received a positive HIV/STI test result.  To document intervention participants' understanding of how 
the intervention affected their HIV/STI risk and protective behaviors, in-depth interviews were 
conducted with a subsample of participants (10%) at follow-up, and with all study CMs to assess their 
perspectives on program implementation and impact. Participants received a $50 cash incentive for 
their participation in the 60-90 minute interview. 
Each session included: 1) Personalized employment, housing stability and sexual risk assessments; 2) 
Guided examination of why identified risks (e.g., multiple sex partners, non-condom use) occur, 
considering theory-supported risk factors including traditional masculinity ideologies, substance use, 
mental health, and low HIV/STI knowledge and risk perceptions; 3) Identification of social or health 
service (e.g., substance abuse treatment and mental health services) referrals or known job 
opportunities to reduce concurrent sexual partnerships affected by these concerns; 4) Support for 
maintenance in stable job or housing situations when frustrations about these occur; and 5) Problem 
solving via an action plan of concrete steps the client could take to reduce non-condom sex practices 
and to stabilize their housing and employment; and recognition/positive reinforcement of enactment of 
action plans (Sessions 2&3). 
Figure 1: Structure and Timing of MEN Count Intervention Delivery over 60-90 Days 
 
 
Attention-Comparison Condition. The stress education and reduction program offered to control 
condition participants followed the same 60-90 day 3-session structure of the MEN Count intervention. 
This program focused on how to reduce stress and tension via diet, exercise, and effective 

communication. Excluded from focus were issues of HIV/STIs, substance use, and masculinity ideologies. 
The program did retain linkage to job placement and housing resource provision, however. 
Eligibility 
At recruitment, staff screened potential study participants to assess eligibility. Eligible participants self-
identified as Black or African American men, aged 18 years or older and English fluent; reported sex with 
two or more women in the past 12 months AND unprotected vaginal sex in the past 12 months; 
reported homelessness in the past 6 months (at least one night in shelter or on the streets) OR current 
unemployment (currently having no legal employment for money); were willing to participate in the 
MEN Count program, complete surveys, and be tested for STIs; and could provide contact information 
for themselves and two other individuals through whom we could reach them. Exclusion criteria were 
outlined on the basis of their potential impact on study participation or intervention testing effects. 
Participants were excluded from the study if they: 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.  
Methods for Data Collection.  
Quantitative. Study staff used mobile tablet surveys to collect detailed data on participants’ 
demographics, risk behaviors, HIV/STI risk profile, and HIV/STI knowledge, attitudes and risk 
perceptions. Trained research staff conducted surveys in a private room at the study site. Study 
participants could opt to enter their survey responses directly into the tablet survey system in real-time 
on their own, or study staff could enter responses.  Study staff uploaded completed surveys securely 
and directly to a secure server system. For STI testing, researchers collaborated with a D.C. area STI clinic 
and established a confidentiality agreement to share participant HIV/STI test results for only those 
participants that enrolled in the study and consented to have their HIV/STI results shared for the 
purposes of this study.  The STI clinic shared participant HIV/STI test results with the program manager 
securely on a monthly basis.  In order to link baseline survey and follow-up data, surveyors uploaded 
research ID-assigned (i.e., de-identified) test result data to the database.  
Qualitative. Qualitative interviews lasted between 45 and 60 minutes were conducted by the D.C.-based 
project director, a Black woman, and a Black male graduate research assistant either in-person or by 
phone. The semi-structured interview guide included questions designed to elicit feedback about 
participants’ experiences with the program, including what they liked and did not like about the 
program, the perceived effectiveness of the program in terms of facilitating housing and employment, 
and ways to improve the program.   
Data Management. All data collected for this study were assigned a unique identifier at each time point 
to facilitate linkage of longitudinal data over time. The web-based tracking system to which data were 
uploaded included only data with research ID numbers as identifiers.  
Data Safety and Monitoring. A data safety and monitoring board was created to assure adherence to 
safety protocols intended to protect participants and monitor data protection efforts.  
 

IRB  
The MEN Count protocol and study materials were approved by the Institutional Review Boards at The 
George Washington University, The University of California San Diego, and the District of Columbia 
Department of Health. 
Power Calculation 
Power calculations were conducted based on am intended sample size of 504 and assumed two-sided 
tests with a 0.05 type I error rate. Power calculations were focused on reduction of STI incidence as it 
was the more conservative analysis. A 25% attrition rate, assumed to be high and to be expected for this 
population, resulted in an assumed n=378 participants at follow-up. Power calculations were based on a 
two-sided Poisson regression of a dependent variable of counts (i.e. number of incident STI cases) on a 
binary independent variable (treatment group) with proportion of 0.50 (i.e. 189 participants) in each 
group adjusting for age, marital status, employment and homelessness (assuming the estimated R-
squared of the independent variable regressed on these four covariates is 0.04).  The estimates used for 
these power calculations were based on a recent HIV intervention study with young Black heterosexual 
men recruited from STI clinics. The STI clinic study found that comparison group participants were 
almost 3 times as likely to be STI-infected at follow-up relative to intervention participants. MEN Count 
pilot data were too small to see intervention impact on STI but did document a baseline STI rate of 13% 
in this target population. Using these data, the proposed sample size of n=378 would have at least 80% 
power to detect a rate ratio (Group 1/Group 2) of at least 0.28 (intervention incidence rate=2%), 
0.31(intervention incidence rate=2.5%), 0.34 (intervention incidence rate=3%) or 0.36 (intervention 
incidence rate=3.6%), respectively, assuming the 1-year cumulative STI incidence rate in the Comparison 
Group is 7%, 8%, 9%, or 10%. 
Though difference-in-difference multivariate regression models were used to assess outcomes (see 
below), analyses were also performed as outlined by power calculation assumptions (e.g. utilizing 
Poisson models and specified covariates) and also found null results for the incident STI outcome. 
Analytic Plan 
Outcome analyses were designed to focus on four outcomes of interest (defined in greater detail 
below): incident non-viral STI, sexual risk, homelessness, and unemployment. The primary comparison 
of outcomes by treatment group was assessed using mixed-effects multivariate regression models 
(logistic and multinomial, dependent on outcome) with random effects on individual to account for 
repeated measurements over time.  The treatment effect was evaluated via a time-by-treatment arm 
interaction term.  A categorical time effect was used.  This treatment effect can be interpreted as the 
individual-level effect of the intervention, and this analytic strategy addresses problems of attrition, 
missing data, variable timing of subject visits and other possible unintended violations of design 
common to longitudinal studies.  Demographic covariates were included in all outcome models if they 
were significantly associated with treatment group at baseline in bivariate chi-squared tests at p<0.20.  
For each outcome, additional potential covariates were included if they were associated with the given 
outcome in bivariate chi-squared tests at p<0.05.  Dose effects of the MEN Count intervention were 
evaluated using a similar analytic strategy, examining a time-by-dose interaction instead of time-by-
study arm. 

Outcome Definitions 
Pursuant to previous HIV prevention research with Black heterosexual men that used ordinal index of 
sexual risk categorization, sexual risk was categorized as very low, low, medium, and high.2 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 (n=20) or who reported that they themselves or (one of) their partner(s) was HIV-positive (n=31) 
were excluded from the sexual risk outcome analysis given the known differential HIV risk profile for 
these subpopulations and small numbers of participants in each.    
Where data for the direct item on number of female sex partners was missing (n=1) or inconsistent with 
other partner-related responses (n=36 reported both main and non-main partners in this time frame, 
but only 1 partner on the direct item), responses to questions about having had sex with a main and 
other partner(s) were used. Consistency of condom use was determined based on the ratio of the 
number of condom protected vaginal or anal sex acts to the total number of vaginal or anal sex acts in 
the past 90 days. Consistent condom use was categorized as yes (number of acts with condom equal to 
total number of acts) or no (number of sex acts with condom use less than total number of acts). 
Transactional sex was defined as answering yes to any of the following items: having had sex for money, 
having given money in exchange for sex, having had sex for a place to stay, having had sex for drugs, or 
having given drugs in exchange for sex in the past 90 days. 
Homelessness was characterized as at least one night of homelessness in the past 90 days. Participants 
were categorized as having experienced homelessness if they answered ‘homeless on the streets’ or 
‘homeless in a shelter’ in response to the question ‘what best describes your living situation in the past 
90 days?’ or if they had a non-zero response to either of two questions asking how many of the previous 
90 days the participant was homeless on the streets or homeless in a shelter.  
 
Employment was assessed via a single item asking the participant’s current employment status. 
Participants could indicate that they were not employed, were not legally employed but had a job with 
income, or were legally employed full-time or part-time. Participants reporting that they were 
unemployed or illegally employed were categorized as unemployed. 
 
Process Evaluation 
Quality assurance and process evaluation efforts aimed to ensure a high quality program via collection 
of data through eligibility screeners, surveys, and brief qualitative interviews regarding program 
feedback. Process evaluation determined fidelity to the intervention as well as confirmed and reviewed 
intervention sessions delivery. A licensed clinical social worker (LCSW) on the research team provided 
clinical supervision to the peer case managers delivering the MEN Count intervention and control 
                                                          
2 Bowleg, L., Burkholder, G. J., Massie, J. S., Wahome, R., Teti, M., Malebranche, D. J., & Tschann, J. M. (2013). 
Racial discrimination, social support, and sexual HIV risk among Black heterosexual men. AIDS and Behavior, 17, 
407-418. doi:10.1007/s10461-012-0179-0 

condition. Group phone meetings were held monthly (more frequently, if needed) with the case 
managers, along with the case manager’s project manager. Initially, sessions took place every two weeks 
when case managers were new. As the study progressed and client sessions ended, clinical supervision 
session frequency diminished. Clinical supervision check-ins involved discussion of the following topics. 
First, any crisis "SHADE" (Suicide, Homicide, Abuse, Drugs, Eating/Health issues) situations shared with 
case managers since the last clinical supervision check-in were prioritized. Discussion was then held on 
intervention delivery (as scripted, in 1-hr period) as well as any challenges with regard to covering the 
session material. During this time, the LCSW shared insights gleaned from listening to the case 
managers' recorded sessions with clients. The LCSW provided feedback and recommendations about 
how to strengthen case manager sessions, ways to include intervention material, and suggested case 
management resources and treatment plans. Finally, the LCSW and program manager discussed any 
questions or challenges from case managers regarding recruitment or follow up and assisted with 
developing solutions (such as modifications to follow-up surveys, transportation vouchers for 
participants to attend sessions, and more frequent check-ins between sessions).