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Description of Program
The Multicenter AIDS Cohort Study (MACS)
is a prospective, longitudinal, cohort study of HIV infection in
homosexual and bisexual men. The MACS continues to provide important
information on the natural history of HIV disease and changing nature
of disease outcomes; the impact of treatment on HIV-mediated disease
progression; the role of host and viral genetic factors; the impact
of opportunistic infections, co-infections, and malignancies; the
value of laboratory prognostic markers of disease progression and
responses to highly active antiretroviral therapy (HAART); post-HIV
host immune activation; identification of psychosocial and behavioral
risk factors; and novel methods for analyses of cohort data.
The MACS is primarily funded by the NIAID, with additional co-funding
provided by the NCI and NHLBI. The MACS is conducted at four clinical
centers (Baltimore, MD, Chicago, IL, Los Angeles, CA, and Pittsburgh,
PA) through collaborative agreements. Initial enrollment to the
MACS (in 1984) was 5,622, with additional enrollment of 1,369 predominantly
minority men accomplished between 2001-2003. As of November 2003,
the MACS has 3,056 active participants, comprised of 1,158 HIV seroprevalent,
252 seroconverter, and 1,646 HIV seronegative men. The cohort reflects
11% Hispanic/Latino and 27% Black/African-American participation.
The primary goals of the MACS are to:
Types of Data Collected and Specimens Stored
Specimens from the MACS are of particular value because they are
linked to a wealth of clinical, demographic, and biological data
collected since the study's inception. Clinical specimens are collected
every six months and include cells, serum, plasma, and tissue (including
lymph node biopsies and tissue obtained at autopsy). Semen, throat
washings, and fecal scrubs were collected intermittently and also
may be available. Extensive personal interviews, neuropsychological
testing, and physical examinations are conducted, with clinical
outcomes confirmed by medical record review.
Requests for specimens can be received from investigators who wish
to develop preliminary data, seek collaboration in preparation for
a formal grant submission, or establish collaboration once your
funding has been granted. Please note that specimens and data may
be used only to study HIV disease, its treatment, and opportunistic
infections of HIV-disease related progression. No funds are provided
to non-MACS investigators for collaborative projects.
Process for Requesting Specimens
A researcher interested in obtaining MACS specimens is encouraged
to seek initially the advice of the NIAID MACS
Program Officer or DAIDS contact person listed below. A proposal
should also be prepared by thoroughly completing the Multicenter
AIDS Cohort Study/Women's Interagency HIV Study Collaboration Concept
Sheet Submission Form. Submit this document to the DAIDS
contact person for distribution and review by the MACS Executive Committee (EC).
Based on the outcome of the MACS EC's review, the proposed collaboration
may be either: 1) approved, with or without provisions; 2) deferred,
pending revisions and/or further EC consideration; or 3) rejected.
Proposals may be rejected due to direct overlap with ongoing MACS-approved
project(s), inappropriate or poorly justified techniques, likely
value of the study deemed not greater than the potential depletion
of unique subsets of the existing MACS inventory (e.g., from long-term
non-progressors and seroconverters), or lack of appropriate samples
in the Repository. Additional review of provisionally approved or
deferred proposals will usually occur at the subsequent EC meeting/conference
call. In addition, referral to appropriate MACS investigators who
are charged with making specific recommendations to the EC may be
necessary if the proposed study requires novel techniques and/or
unique expertise, or there is a need to address potential overlap
with future MACS projects. If the proposed techniques are unproven,
the proposing investigator may be encouraged to attempt a pilot
study, in which case a limited number of MACS specimens may be made
available. If the proposed study is approved, a MACS investigator
with relevant expertise is assigned to be the point person for the
collaborating investigator to contact. Quite often, close collaborations
are formed between current MACS grantees and external researchers.
MACS investigators have extensive expertise in epidemiology, statistics,
immunology, virology, and medicine.
Finally, a representative from the Center
for the Coordination, Analysis and Management of MACS (CAMACS)
is assigned to work with the collaborating investigator of approved
projects in selecting the correct specimens. This also provides
the collaborating investigator with an opportunity to work with
biostatistical experts on the study design, should stronger hypotheses
and conclusions be deemed necessary by the MACS EC. Upon approval
of a proposed concept sheet, collaborators should thoroughly complete
and submit the Repository
Request Form, whereby the appropriate specimens and study visit
data can be identified for release.
Collaborating investigators are expected to report back to the
MACS EC at regular intervals to communicate progress with the study,
and may be expected to present ongoing and completed analyses at
MACS meetings. Finally, publication of study results should comply
with the manuscript review requirements and acknowledgement format
that are outlined on Pages 3 and 4 of the Multicenter
AIDS Cohort Study/Women's Interagency HIV Study Collaboration Concept
Sheet Submission Form.
Thank you for your interest in the MACS!
DAIDS MACS Contact
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