Men Together Making a Difference: Health Promotion for Black Men



Status:Completed
Conditions:Colorectal Cancer, Cancer, High Blood Pressure (Hypertension), Peripheral Vascular Disease, HIV / AIDS
Therapuetic Areas:Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:40 - Any
Updated:2/8/2019
Start Date:January 8, 2015
End Date:December 2018

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Health Promotion for HIV Positives: A Randomized Trial With HIV Positive Black Men

African American men infected with HIV are living longer and are acquiring the same chronic
non-communicable diseases affecting the general population of African American men age 40
years and older. African American men have disproportionately high rates of cardiovascular
disease, hypertension, diabetes, kidney disease, and cancer, particularly prostate and colon
cancer, but HIV is associated with an increased risk for co-morbidity from these conditions,
a risk heightened by not only HIV infection itself, but also its treatment with
antiretroviral therapy (ART). The risk for many of these chronic diseases is tied to
behavior: risk is increased by physical inactivity and unhealthful diet. Although the high
risk for behavior-linked chronic diseases among HIV-positive individuals has been recognized,
there is a lack of evidence-based interventions specifically tailored to their needs.

Hence, the broad objective of this research is to identify strategies to empower HIV positive
African American men to engage in behaviors that reduce their risk of chronic diseases. This
research will test the efficacy of a theory-based, contextually appropriate health promotion
intervention in inducing positive changes in behaviors linked to risk of chronic diseases
among HIV positive African American men age 40 years or older and will identify the
theoretical variables that mediate its efficacy.

In a randomized controlled trial, African American HIV positive men age 40 or older who are
receiving ART for HIV will be randomized to the Men Together Making a Difference Health
Promotion Intervention, which consists of three, 3-hour weekly intervention sessions, or the
1 session Health Awareness Control Group. The Men Together Making a Difference Health
Promotion Intervention is based on social cognitive theory and the reasoned action approach
integrated with formative research. Data will be collected at baseline, immediately post, and
3, 6 and 12 months post intervention. The trial will test whether the Men Making a Difference
Health Promotion Intervention increases self-reported physical activity compared with the
Health Awareness Control Group.

African Americans are heavily burdened with preventable and treatable diseases, including
cardiovascular disease, stroke, hypertension, diabetes, HIV/AIDS, sexually transmitted
diseases (STDs), and cancers. African Americans have the highest age-adjusted death rates for
heart disease, cancer, diabetes, and HIV/AIDS compared with other Americans. The broad
objective of this research is to identify strategies to empower African American men to
engage in healthful behaviors in an effort to help eliminate health disparities.
Specifically, this research addresses the urgent need for health promotion interventions
targeting African American men who are living with HIV. Despite the high risk for
cardiovascular disease and other behavior-linked diseases, including diabetes and certain
cancers, no studies have developed and tested interventions to encourage behaviors to reduce
risk of chronic disease in African American HIV positive men, a sub-group comprising the
largest segment of people living with HIV in the US. Moreover, irrespective of race and sex,
few studies have tested interventions to increase behaviors to reduce risk of chronic
diseases in people living with HIV.

From 2005 through 2007, the estimated number of persons living with HIV rose steadily in the
37 states with confidential name-based HIV infection reporting. At the end of 2007, an
estimated 580,371 persons in these states were living with HIV infection, including 48% who
were African-American and 73% who were men. In 2008, African Americans accounted for 52% of
all new diagnoses of HIV infection in the 37 states with confidential name-based reporting.
The estimated rate of diagnoses of HIV was higher in African American men (132 per 100,000)
than in White men (17 per 100,000), Hispanic men (52 per 100,000), and African American women
(56 per 100,000). In Philadelphia, where this study will be conducted, two-thirds of the
people living with HIV/AIDS were African American in 2008, two-thirds were male, and one-half
were age 45 years or older.

Since antiretroviral therapy (ART) has been available, there has been durable suppression of
HIV replication, prevention of AIDS-defining opportunistic infections and malignancies, and
higher survival and life expectancy rates in people living with HIV. In the US, 67% of people
living with HIV in 2007 were age 40 or older. Because of the aging of the HIV positive
population, several chronic non-HIV-related conditions are becoming increasingly important in
the clinical treatment of HIV. Several reviews have drawn attention to the prevention and
control of chronic diseases, including diabetes mellitus and cardiovascular, liver, and
kidney diseases, affecting people living with HIV. Mounting evidence suggests that both HIV
disease and its treatment with ART can accelerate the risks for chronic diseases associated
with aging, particularly cardiovascular diseases and diabetes mellitus. Studies indicate that
as HIV-infected patients live longer, they increasing experience mortality from causes not
directly attributable to HIV. For instance, among people with HIV, the proportion of deaths
not directly attributable to HIV increases with age from 36% among 30-year olds to 53% among
40-year olds and 72% among 50-year olds.

Quite apart from HIV infection, African Americans have higher mortality rates for
cardiovascular disease, cerebrovascular diseases, and diabetes than do Whites. Some evidence
also suggests that rates of hypertension and kidney disease are higher among HIV-infected
African Americans than among HIV-infected Whites. Indeed, in a cohort study, the incidence of
end-stage renal disease in people without HIV or diabetes was 2.3 times higher among African
Americans than Whites, in those with diabetes but no HIV it was 2.3 times higher among
African Americans than Whites, whereas in those with HIV but no diabetes, it was 8.1 times
higher among African Americans compared with Whites. African Americans also have the highest
mortality rates and the shortest survival rates for most cancers of any racial/ethnic group
in the US. The death rate from colon cancer, the third most common cancer among African
Americans, has decreased over the past 15 years, but incidence and mortality rates are still
disproportionately high among African Americans, particularly men. The colon cancer incidence
in African American men was 1.21 times higher than in White men and 1.31 times higher than in
African American women, and the mortality rate in African American men was 1.44 times higher
than in White men and 1.42 times higher than in African American women. The poor survival
rates for colon cancers in African American men are linked to later stage at diagnosis and
less access to appropriate and timely treatment.

Studies have shown that regular physical activity or physical fitness is associated with
reduced risk of early mortality, cardiovascular disease, diabetes mellitus, and colon cancer.
Consuming fruits and vegetables is associated with a lower risk of cardiovascular disease and
certain cancers, but only 35% of African Americans report consuming fruit the recommended 2
or more times per day and only 24% report consuming vegetables the recommended 3 or more
times per day. These findings underscore the need for interventions to encourage physical
activity and fruit and vegetable consumption among African Americans. Screening is important
to detect diseases in the early stages, but African Americans are less likely than Whites to
report being screened for colon cancer. Reinhold et al. found that, despite significantly
more visits with their primary care provider, HIV-infected patients age 50 years or older
were less likely to have ever been screened for colon cancer than age- and gender-matched
HIV-negative controls, and Bini et al. reported that HIV-infected individuals have a higher
prevalence of colonic neoplasms and develop advanced neoplasms at a younger age than do
uninfected individuals.

Few studies have examined health behaviors among HIV positive individuals, and fewer still
have tested the efficacy of interventions that target behaviors linked to chronic diseases.
This research will address this gap in the literature. It will test whether a health
promotion intervention increases physical activity and other healthful behaviors compared
with a health-awareness control group. The participants will be HIV positive African American
men age 40 years and older who are ART patients. Participants will be recruited through the
Clinical Registry of the Penn Center for AIDS Research, AIDS clinics and service
organizations, HIV care providers, advertisements in a local newspaper, and word of mouth
from participants.

The study will utilize a randomized controlled trial design. Computer-generated random number
sequences will be used to randomly assign the men to the Men Together Making a Difference
Health Promotion Intervention or the Health Awareness Control Intervention. The theoretical
basis of the Men Together Making a Difference Health Promotion Intervention is social
cognitive theory and the reasoned action approach. The intervention will seek to increase
self-efficacy, outcome expectancy, behavioral skills, and risk-reduction knowledge for
behaviors linked to cardiovascular disease, hypertension, diabetes, and cancer, including
physical activity, fruit and vegetable consumption, fat consumption, and colon-cancer
screening. The intervention will help men assess their health behavior, identify personal
barriers to engaging in the behaviors, develop strategies for surmounting those barriers, and
gain support for behavior change.

Participants will complete assessments before the intervention, immediately post and 3, 6,
and 12 months post-intervention. Self-report measures will be collected using audio
computer-assisted self-interviewing. The primary outcome is a binary variable indicating
whether the participant met the 2008 Department of Health and Human Services physical
activity guideline of engaging in muscle-strengthening activity on 2 days and engaging in
either 20 min of vigorous-intensity activity on at least 4 days or 30 min of
moderate-intensity activity on at least 5 days in the previous 7 days. The study tests
whether the Men Together Making a Difference Health Promotion Intervention increases
adherence to physical activities guidelines during the post-intervention period compared with
the Health Awareness Intervention control group and whether social cognitive theory and
reasoned action approach variables mediate the effects of the intervention.

A power analysis was used to calculate the sample size needed to detect a clinically
significant difference in adherence to physical activity guidelines of 9.1 percent, a
relative increase of 58.0%. Based on the sample of HIV positive men age 40 or older in
Project Eban, estimated correlation among physical activity guideline adherence rates at 3-,
6-month, and 12-month follow-up is intraclass correlation (ICC) = 0.314. Assuming a 2-tailed
test, alpha = 0.05, ICC = 0.314, 20% attrition, and a 9.1% increase in physical activity
guideline adherence from 15.7% in the control group to 24.8% in the health promotion
intervention group, a total N of 384 men enrolled will yield statistical power of 0.82.

Inclusion Criteria:

- Age 40 years or older

- Self-identify as Black or African American

- Receiving ART for HIV

Exclusion Criteria:

- Blood pressure of 180/110 mm Hg or higher

- Plan to relocate beyond a reasonable distance from the study in the next 18 months or
do not have an address where they can receive mail

- Participated in any health promotion intervention trial targeting physical activity,
diet, or prostate or colon cancer screening in the past 12 months.
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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from
Philadelphia, PA
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