Non-Communicable
Diseases, Mental Health, Drug Abuse
Case
Study #2: Section 1 2
3 4 5
1.
Background about the economic, social and political context
in the country(ies) in which the study is being planned or
conducted.
Blocovia,
the hypothetical country, has only recently reorganized its
economic and political system to embrace, in some fashion,
democracy and capitalism. Previously, the country was under
centralized, one-party rule that dictated economic programs.
Under this regime, Blocovia’s economy was artificially
inflated, allowing its citizens to purchase goods and services
at unrealistically low prices. Since the political metamorphosis,
majority of the populace has remained relatively poor, and
the much of the country’s wealth is held by a small
minority. There is significant dissension due to unrealistic
expectations of a capitalist economy. The most intelligent
of the educated young adults are leaving the country to seek
more lucrative employment opportunities abroad, as the award
of any professional position is often dependent upon political
connections, rather than merit. Many individuals, including
highly educated professionals, must work two or three jobs
to earn sufficient money to support their families.
The
government does not have sufficient resources to support medical
care for many. As a result, many individuals are receiving
suboptimal care. Although hospital stays appear to be cost-free,
patients must pay for their medications and procedures.
The church is extremely strong in Blocovia and has condemned
abortion and alternative lifestyles, such as cohabitation
without the benefit of marriage and homosexuality. Although
women appear to enjoy the same political and economic privileges
as men, they remain relatively disadvantaged due to lower
wages for similar work. There is a high rate of alcoholism
in Blocovia, particularly among the men, but it has not been
recognized as a public health problem. There is an increasing
incidence of substance abuse, particularly of heroin, as Blocovia
is en route between a major heroin supplier-nation and a major
distributor-nation. The incidence and prevalence of partner
violence and child abuse are extremely high, but have only
recently been acknowledged by health authorities. In general,
women and children have little recourse if they suffer from
family violence and there are few shelters throughout the
country. Individuals of minority groups, those suffering from
HIV, and those suffering from injection drug use are often
stigmatized due to their ethnicity and/or disease.
[Top]
2.
Information about the disease or specific problem being addressed
by the research.
HIV
is the virus that is known to cause acquired immune deficiency
syndrome (AIDS). HIV is transmitted via contact with bodily
fluids, such as semen, vaginal fluid, and blood. Although
the virus is contained in tears, perspiration, and saliva,
there are no indications that it can be transmitted via these
fluids. Accordingly, HIV cannot be transmitted through casual
contact, such as through hugging or sharing utensils, but
is transmitted through unprotected intercourse (anal, vaginal,
and oral); through the use of contaminated equipment or blood
(contaminated medical equipment, transfusions with contaminated
blood, organ transplants from infected individuals, the shared
use of injection equipment); and through maternal-child transmission
(during pregnancy, labor and delivery, and through breastfeeding).
Transmission from men to women during intercourse is more
efficient than from women to men.
Treatment
for HIV is quite expensive. It consists of a drug regimen
of two antiretroviral medications and a protease inhibitor.
It is critical that individual adhere to their prescribed
regimen because failure to do so can result in increased drug
resistance by the virus. Physicians have often resisted prescribing
these drugs to injecting drug users, believing that they are
not sufficiently responsible to adhere to the prescribed regimen.
HIV transmission can be prevented by using condoms during
sexual intercourse; by using only new or sterile medical equipment
and injection equipment; by administering a specified antiretroviral
during specific periods of time before, during, and after
labor and delivery; and by screening the blood supply. In
many countries, programs have been established to allow injecting
drug users to exchange their used syringes and works for new
ones in order to reduce the risk that they will contract HIV
from sharing contaminated equipment. Most research indicates
that such exchange programs do not increase the use of drugs,
do not increase the frequency of injecting, do not increase
the numbers of needles disposed of on the streets, and reduce
the rate of transmission of HIV and hepatitis.
[Top]
3.
Information about the design of the study.
The
investigators are proposing to conduct a randomized controlled
trial to assess the efficacy of a needle exchange program
to reduce the transmission rate of HIV. Participants are to
include HIV-negative individuals who are current injectors
of heroin. They will be randomized to 2 groups. The experimental
group will be able to exchange syringes and “works”
(cotton, cookers, etc.) for clean/new equipment, in addition
to receiving basic information about HIV, the transmission
of HIV, and how to clean their needles and works (bleach rinses)
to prevent HIV transmission. The comparison group will receive
the information only.
Participants will be followed for a period of two years to
see how many become HIV-positive. Because the rate of HIV
is still relatively low in this population, the investigators
are proposing to also monitor the study population for new
cases of hepatitis B, which is more easily transmissible than
HIV and is often prevalent among injection drug users. Immunization
against hepatitis B is available but is quite expensive, and
the investigators do not plan to offer this to their participants.
[Top]
4.
Description of the main ethical problem and what is at stake
for the affected parties.
Issues
to be addressed include the following:
