Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02561286 |
| Other study ID # |
806708 |
| Secondary ID |
R01MH079736 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 24, 2015 |
| Last updated |
September 28, 2015 |
| Start date |
April 2008 |
| Est. completion date |
May 2012 |
Study information
| Verified date |
September 2015 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The incidence of HIV/AIDS among African American men who have sex with men (MSM) is
alarming, and the public health response to this urgent situation has been hampered by a
lack of sexual risk reduction interventions with solid evidence of efficacy in this
population. Accordingly, the broad, long-term objective of the proposed research is to
identify interventions to reduce the risk of sexually transmitted infection (STI) among
African American MSM. This application seeks funds to develop and test the efficacy of a
theory-based, contextually appropriate behavioral intervention to reduce sexual risk
behavior among African American MSM. Intervention development will be guided by social
cognitive theory, the theory of planned behavior, qualitative information from focus groups,
and findings from a longitudinal survey of men from the study population. A one-on-one
intervention will be utilized to address the specific prevention needs of each man and to
allay participants' concerns about revealing their sexual involvement with men by virtue of
participating in a group or workshop intervention. The study will utilize a randomized
controlled trial design, with baseline, immediate post intervention, and 6 and 12 months
post intervention assessments. The participants will be African American MSM who will be
randomized to a one-on-one sexual risk reduction intervention or a one-on-one health
promotion intervention that will serve as the control condition. The primary outcome is
consistent condom use during anal and vaginal intercourse. The study will test whether the
intervention increases the consistent use of condoms during anal intercourse, the primary
outcome, whether it decreases other sexual risk behaviors, and whether social cognitive
theory variables mediate the effects of the intervention on consistent condom use. This
study will provide an urgently needed intervention to reduce the risk of HIV and other STIs
in one of the highest risk populations in the United States.
Description:
HIV/AIDS has had a devastating impact on African American MSM. Although African Americans
represent only 13% of the US population, 49% of AIDS diagnoses in 2004 were in African
Americans. That HIV/AIDS has taken an increasing toll on African American injection drug
users and heterosexuals during the last decade is well documented. Nevertheless, MSM
continue to account for the largest number of African Americans with HIV/AIDS. Through 2004,
the MSM exposure category accounted for 37% of the cumulative AIDS cases in African American
men, whereas injection drug use accounted for 31% and heterosexual transmission accounted
for 10%. Consonant with these figures on HIV/AIDS cases, the HIV infection rates in several
studies the Centers for Disease Control and Prevention (CDC) conducted on African American
MSM have rivaled those found in many sub-Saharan African nations. For instance, a CDC 5-city
study found that of the African American MSM who were tested for HIV, two-thirds were
unaware of their status and 46% were HIV positive. Similarly, the 7-city CDC Young Men's
Survey found an HIV prevalence rate of 32% in African American MSM. Interestingly, although
African American MSM have relatively high HIV infection rates, evidence does not suggest
that they engage in riskier sexual practices than do other MSM. This may mean that African
American MSM are drawing their sexual partners from pools of people where HIV prevalence is
relatively high, which underscores the urgency of targeting interventions to this
population.
Quite apart from risk of HIV, African American MSM are at high risk for other STIs. The CDC
MSM Prevalence Monitoring Project conducted in 9 US cities, in 1999 through 2004 found that
the rates of gonorrhea and chlamydia were high in MSM, but especially high in African
American MSM. In 2004, urethral gonorrhea positivity was 16% in African Americans, as
compared with 11% in Whites, and 9% in Hispanics. The median urethral chlamydia positivity
was 6% overall, but 9% in African Americans. To curb the HIV epidemic and the high rates of
other STIs in African American MSM now, prevention efforts must be urgently undertaken.
Although several researchers have stressed the need for culturally appropriate prevention
interventions targeting African American MSM, scant progress has been made toward the
identification of such interventions. Ample evidence indicates that theory-based
interventions can decrease sexual risk behavior among MSM. A meta-analysis 40 controlled
studies of HIV prevention behavioral interventions for MSM found that the interventions
reduced the amount of reported unprotected sex by as much as 27%, but revealed that the MSM
populations at the highest risk, including African American MSM, have been underserved by
intervention research. Consider, for example, Project EXPLORE, a large-scale multi-site
controlled trial (RCT) that enrolled over 4,200 MSM and followed them for up to 4 years.
Fewer than 7% of participants were African American, eligible African Americans were less
likely to enroll in the trial than were eligible Whites, and African Americans were more
likely to drop out. Another meta-analysis found that, of 33 HIV sexual risk reduction
intervention trials on MSM, only 6 employed a sample that was at least a 10% African
American. The insufficient number of rigorous intervention trials directed at African
American MSM has hindered the ability to make definitive conclusions about how to combat
men's attitudes and beliefs concerning sexual risk behavior and ultimately determine the
effectiveness of HIV prevention strategies targeting African American MSM.
Reaching African American MSM may be particularly challenging because many African American
MSM do not use traditional resources and organizations that serve gay men because they do
not identify with White gay culture. In addition, African American MSM may also be difficult
to reach within African American communities because they are often closeted and isolated
due to real and perceived homophobia. That isolation, in turn, contributes to internalized
repression of gay sexual identity, which may further isolate them from resources available
to gay men. The investigators' approach to addressing the problem of reaching African
American MSM is to develop an intervention that can be used by community-based organizations
(CBOs) that already serve African American MSM. The investigators will create a Community
Advisory Board that includes representatives of CBOs that serve African American MSM and
representatives of the study population to advise them on the intervention design and other
aspects of the trial. In addition, the investigators have held a focus group with
representatives of CBOs that serve African Americans and have frequently consulted with them
regarding their approach.
Reviews of the literature have suggested that there have been 3 basic approaches to the
design of HIV/STI risk reduction programs aimed at MSM. One approach is to seek to reduce
risk through the implementation of small group or workshop interventions. The second
approach is through the use of community-level interventions. A third approach is the
individual one-on-one intervention. All three approaches have merit and have reduced risk
behavior among men in controlled trials. An advantage of the one-on-one is that it avoids
the problem of men having to risk revealing that they have sex with other men in order to
participate in the prevention program. There are added benefits of the one-on-one approach.
It permits tailoring the intervention to the specific needs of the man. A recent
meta-analysis has identified characteristics of effective HIV behavioral interventions for
MSM. Efficacy was associated with interventions having more than one session, duration of 4
or more hours, and a time span of at least 3 weeks.
The Proposed Randomized Controlled Trial (RCT)
This study will test the efficacy of the Being Responsible for Ourselves (BRO) HIV Risk
Reduction Intervention in increasing condom use and reducing other sexual risk behaviors
among African American MSM in Philadelphia, where African Americans account for 70% of the
reported cases of AIDS through June 2005. The study will use a RCT design, which is the most
scientifically sound method for assessing the causal impact of interventions. An
attention-matched control group, the Health Promotion Intervention, will provide controls
for Hawthorne effects and special attention. Computer-generated random number sequences will
be used to randomly assign participants to the intervention arms using concealment of
allocation techniques designed to minimize bias in assignment. The biostatistician will
generate the random assignments; the project director will implement the assignments. The
study will also examine theoretical variables the intervention is designed to affect, which
will permit mediation analyses addressing why the intervention is efficacious or not
efficacious. This study, then, will provide an urgently needed intervention to help curb the
alarmingly high incidence of HIV in urban, African American communities.
The BRO HIV Risk Reduction Intervention and the Health Promotion Intervention were developed
based on social cognitive theory and the reasoned action approach, integrated with extensive
formative research, including focus groups and pilot testing. Most relevant here are the
social-cognitive-theory constructs of "outcome expectancy," beliefs about the consequences
of a specific behavior, and "self-efficacy," people's confidence that they can execute a
specific behavior; its emphasis on behavioral skills; and its methods for increasing skills,
particularly practice with performance feedback (e.g., role-playing). The reasoned action
approach is an extension of the theory of planned behavior, which itself is an extension of
the theory of reasoned action. Most relevant here are the reasoned action approach's
emphasis on the importance of salient beliefs, its notion that such beliefs may vary from
population to population and from behavior to behavior, and its methods to identify such
population-specific beliefs: namely, the use of qualitative research, including focus
groups. By identifying and targeting a population's salient beliefs, an intervention can
change those beliefs resulting in changes in the targeted behavior. The investigators
utilized one-on-one interventions to allay concerns some African American MSM might have
about revealing their sexual behavior with other men by virtue of participating in a
group-based intervention, a concern expressed in the focus groups with African American MSM
and with representatives of CBOs serving African American MSM.
Consistent with the reasoned action approach, the investigators conducted qualitative
research, including 7 focus groups with African American MSM and 1 with representatives of
CBOs that serve African American MSM, to ensure the intervention was tailored to the
population. In addition, the investigators conducted 3 pilot tests of the interventions. The
BRO HIV/STI risk-reduction intervention was designed to strengthen outcome expectancies
expressed in focus groups with African American MSM, outcome expectancies that have been
observed in other populations, including the hedonistic outcome expectancy that using
condoms would not interfere with sexual enjoyment, the prevention outcome expectancy that
using condoms prevents STIs, including HIV, and the self-evaluative outcome expectancy that
using condoms would make the man feel good about himself. The intervention was designed to
address aspects of self-efficacy identified in the focus groups, including technical-skill
self-efficacy to use condoms correctly without interfering with sexual enjoyment,
impulse-control self-efficacy to exercise the necessary control to use condoms even when
sexually excited, under the influence of alcohol or drugs, or in the presence of other
triggers for unsafe sex, and skills and self-efficacy to negotiate condom use with sexual
partners. In addition, it was designed to increase knowledge regarding the risk of acquiring
or transmitting HIV and other STIs, and perceived vulnerability to HIV infection or
re-infection with a different strain of HIV.
Summary
In summary, African Americans have been disproportionately affected by the HIV epidemic. The
prevalence of HIV infection among African American MSM is alarmingly high, paralleling rates
observed in some countries in sub-Saharan Africa. For condoms to prevent the transmission of
HIV/AIDS, they must be used correctly and consistently. Behavioral interventions have been
found to be effective in reducing rates of sexual risk behaviors, but few have been
conducted with African American MSM. This research seeks to answer the call for culturally
appropriate interventions for high-risk subgroups of MSM. The primary hypothesis is that the
BRO HIV Risk Reduction Intervention will increase the consistent use of condoms and decrease
other sexual risk behaviors compared with the control group and that the intervention's
effects on condom use with be mediated by variables from the social cognitive theory and the
reasoned action approach.
