Safer Sex Program for Young African-American Men



Status:Completed
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:15 - 29
Updated:2/23/2019
Start Date:September 2012
End Date:April 2, 2018

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A Brief, Clinic-Based, Safer Sex Program for Young African-American Men

To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620
eligible African American men who have sex with men (MSM) will be conducted. Men in the
treatment condition will be compared to men receiving the control condition comprised of
standard of care counseling from the clinic plus a free bag of condoms and water-based
lubricants. This two-arm trial will test four hypotheses:

Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed
to reduce STD incidence and risk of HIV acquisition/transmission among young African American
men (15-29 years old) having sex with men and presenting for STD testing.

H1. Men randomized to receive the intervention will have a lower incidence rate of
laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving
the control condition.

H2. Men randomized to receive the intervention will report significantly fewer acts of
unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments
compared to those receiving the control condition.

H3. Men randomized to receive the intervention will report having significantly fewer
unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between
follow-up assessments compared to those receiving the control condition.

H4. Men randomized to receive the intervention will report having significantly fewer
negative experiences with condom use between follow-up assessments compared to those
receiving the control condition.

H5. Men randomized to receive the intervention will demonstrate significantly greater
improvement in condom application skills, throughout the 12-month study, compared to those
receiving the control condition.

The Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for
African Americans and has called for a heightened national response. The crisis is especially
dramatic in the South and it is now apparent that young African American men who have sex
with men (MSM) are exceedingly likely to be infected. Unfortunately, the ever-expanding HIV
epidemic experienced by this population has not been matched by equal attention to the
development of efficacious prevention programs. The proposed project expands upon an
NIMH-funded study (R21 MH066682-01A1) conducted by Dr. Crosby. His study of young African
American males found that a brief, clinic-based intervention reduced incidence of subsequent
STDs by about 50%. This brief, one-on-one, intervention program, known as Focus on the Future
(FOF), is a practical alternative to group-based safer sex programs that can be difficult to
translate from science into practice. The program is now classified as a "Best Practice"
intervention by CDC. This project will begin with an extensive formative phase designed to
adapt FOF to MSM. The adapted program will seek to "sexualize" condoms to promote their
consistent and correct use to better prevent STD/HIV. The program is uniquely flexible in
that it can be applied to MSM regardless of their HIV serostatus. The adapted program will be
tested by a two-arm efficacy trail. We will recruit 620 MSM (15-29 years of age) from a
publicly-funded STD clinic in Jackson MS. Men in the treatment condition will be compared to
men receiving the control condition comprised of standard of care counseling from the clinic
plus a free ditty bag of supplies from the "condom and lube buffet" (condom/lube
distribution). The trial will test four hypotheses: 1) Men randomized to receive the
intervention will have a lower incidence rate of laboratory-confirmed STDs (by urine assay
and rectal swab) at a 6-month and a 12-month follow-up assessment) compared to controls. 2)
Men randomized to receive the intervention will report significantly fewer acts of
unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments
compared to controls. 3) Men randomized to receive the intervention will report having
significantly fewer unprotected penetrative (penile-vaginal or penile-anal) sex partners
between follow-up assessments compared to controls. 4) Men randomized to receive the
intervention will report having significantly fewer negative experiences with condom use
between follow-up assessments compared to controls. Given the dearth of evidence-based
options for intervening with this vulnerable population in clinical settings, demonstrated
efficacy of the adapted program has important implications for U.S. public health efforts
directed towards the prevention of STD/HIV.

Inclusion Criteria:

- 15-29 years of age

- Identifying as an African American Male

- Males must be presenting themselves for STD testing

- Males must report recently (past 3 months) engaging in penile-anal sex with other
males as a "top" (meaning the insertive partner)

Exclusion Criteria:

- Males not identifying as African American

- Males older than 29 years of age

- Males that are not patients of the STD clinic

- Males who have not engaged in penile-anal sex with other males as a "top" within the
past 3 months
We found this trial at
1
site
Jackson, Mississippi 39216
Phone: 601-984-5560
?
mi
from
Jackson, MS
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