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Sexually Transmitted Disease Surveillance 1995

Division of STD Prevention

September 1996

U.S. Department of Health and Human Services 
Public Health Service 
Centers for Disease Control and Prevention  
National Center for HIV, STD, and TB Prevention 
Division of STD Prevention 
Atlanta, Georgia 30333

Copyright Information 

All material contained in this report is in the public domain and may be
used and reprinted without special permission; citation to source, however,
is appreciated.

Suggested Citation

Division of STD Prevention. Sexually Transmitted Disease Surveillance,
1995. U.S. Department of Health and Human Services, Public Health Service.
Atlanta: Centers for Disease Control and Prevention, September 1996.

Copies can be obtained from Information Technology and Services Office,
National Center for HIV, STD, and TB Prevention, Centers for Disease
Control and Prevention, 1600 Clifton Road, Mailstop E-06, Atlanta, Georgia
30333 or by telephone at (404) 639-1819.

The reports for 1993 through 1995 are now available electronically on CDC
WONDER. For information about registering for CDC WONDER, please contact
CDC's Information Resource Management Office at (404) 332-4569. These
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http://www.cdc.gov.


                         Special Focus Profiles

The Special Focus Profiles section highlights trends and distribution of
sexually transmitted diseases (STDs) in populations of particular interest
for STD and HIV prevention programs in state and local health departments.
These populations are most vulnerable to STDs and their consequences: 
women and infants; adolescents and young adults; minorities; and
populations in the southern United States. The Special Focus Profiles refer
to figures located in disease-specific sections in the National Profile. In
addition, there are figures (Figures A-P) that highlight specific points
made in the following text.


                        STDs in Women and Infants

Public Health Impact

Women and infants disproportionately bear the long term consequences of
STDs. Women infected with Neisseria gonorrhoeae or Chlamydia trachomatis
can develop pelvic inflammatory disease (PID), which, in turn, may lead to
adverse reproductive consequences, e.g., ectopic pregnancy and tubal factor
infertility. If not adequately treated, 20 to 40 percent of women infected
with chlamydia (1) and 10 to 40 percent of women infected with gonorrhea
(2) develop PID. Among women with PID, scarring sequelae will cause
involuntary infertility in 20 percent, ectopic pregnancy in 9 percent, and
chronic pelvic pain in 18 percent (3). Approximately 70 percent of
chlamydial infections and 50 percent of gonococcal infections in women are
asymptomatic (4-6). These infections are detected primarily through
screening programs. The vague symptoms associated with chlamydial and
gonococcal PID cause 85% of women to delay seeking medical care, thereby
increasing the risk of infertility and ectopic pregnancy (7). Ectopic
pregnancy is the leading cause of first-trimester, pregnancy-related deaths
in American women (8). Both gonorrhea and chlamydia also result in adverse
outcomes of pregnancy, including neonatal ophthalmia and, in the case of
chlamydia, neonatal pneumonia. Although topical prophylaxis at delivery is
effective for prevention of ophthalmia neonatorum, prevention of neonatal
pneumonia requires antenatal detection and treatment.

Infections with human papillomavirus (HPV) are a major concern because
specific HPV subtypes (e.g., types 16, 18, 31, 33, and 35) have been
associated epidemiologically with cervical dysplasia and cervical cancer.
HPV types 6 and 11 in child bearing women can cause laryngeal
papillomatosis in infants.

When a woman has a syphilis infection during pregnancy, she may transmit
the infection to the fetus in utero. This may result in fetal death or an
infant born with physical and mental developmental disabilities. Most cases
of congenital syphilis (CS) are preventable if women are screened for
syphilis and treated early through prenatal care (9).

HIV-infected pregnant women can pass this fatal infection to their unborn
infants. Treatment with zidovudine during pregnancy can prevent as much as
two-thirds of these infections (10,11).

Observations

--  Since 1988, CDC has supported screening programs for Chlamydia
    trachomatis infections in women to quantify the prevalence of these
    infections and determine the impact of screening programs on prevention
    of long term consequences. Due to increasing interest in chlamydial
    infections, many states have implemented reporting procedures for
    chlamydia and have begun collecting chlamydia case data. In 1995, 48
    states had implemented legislation mandating reporting of chlamydia and
    reported cases to CDC; an additional state without reporting laws
    collected and reported cases on a voluntary basis (Figure_A,
    Table_3).

--  Between 1994 and 1995, the reported rate of chlamydial infections in
    women increased from 260.2 per 100,000 population to 290.3
    (Figure_5, Table_4). These rates reflect trends in screening
    rather than trends in disease incidence for the following reasons:
    chlamydia infections in women are largely asymptomatic and can only be
    identified through screening; reported cases include both persistent
    and acute cases; and many state/local health departments are in the
    process of developing chlamydia prevention programs, including
    surveillance infrastructure to collect information from laboratories
    and providers. Despite considerable under-reporting, it is important to
    note that chlamydia rates exceed gonorrhea rates in women in many
    states (Figure_B, Table_4 and Table_12).

--  The ability of large-scale screening programs to reduce chlamydia
    prevalence in women has been documented in areas where this
    intervention has been in place for several years. For example, the
    screening programs in federal Region X (Alaska, Idaho, Oregon,
    Washington) family planning clinics have demonstrated steady declines
    in chlamydia positivity since 1988 (Figure_C). Introduction of
    large-scale screening in other areas (Wisconsin, San Francisco, and
    Columbus, Ohio) has been followed by similar declines in chlamydia
    positivity. Data from a randomized controlled trial of chlamydia
    screening in a managed care setting suggest that such screening
    programs can also reduce the incidence of PID by as much as 60% (12).

--  Based on the successful model in Region X and as part of the
    development of a national infertility prevention program, infertility
    prevention services aimed at women in three additional PHS regions
    (III, VII, VIII) were initiated in 1993 and piloted in the remaining
    PHS regions (I, II, IV, V, VI, IX) in 1995. Each region has adopted a
    model for the prevention of STD-related infertility based on
    collaboration between family planning and STD programs. In some of the
    PHS regions, public sector chlamydia screening and treatment
    supplements ongoing local and state prevention activities; in others,
    chlamydia screening was newly introduced. In 1995, state-specific
    chlamydia test positivity among 15- to 24-year-old women screened
    varied from 2.8% to 9.4% among those attending family planning clinics
    (Figure_D). These chlamydia test positivity rates are from those
    states reporting data on 3,000 or more women screened during 1995.

--  Like chlamydia, gonorrhea is often asymptomatic in women and can only
    be identified through screening. Large-scale screening programs for
    gonorrhea in women began in the late 1970's. After an initial increase
    in cases detected through screening, gonorrhea rates for both women and
    men declined steadily throughout the 1980's and early 1990's
    (Figure_10; Table_12 and Table_13). Gonorrhea rates
    decreased slightly for women from 150.7 cases per 100,000 population in
    1994 to 140.3 in 1995; rates in men continued to decline during this
    period. Men with gonorrhea are usually symptomatic and seek care;
    therefore, trends in men are considered a relatively good indicator of
    trends in incidence of disease. However, trends in women are largely
    determined by screening patterns, similar to chlamydia.

--  The rate of congenital syphilis (CS) closely follows the trend of
    primary and secondary (P&S) syphilis in women (Figure_26). Peaks in
    CS usually occur one year after peaks in P&S syphilis in women. The CS
    rate peaked in 1991 at 107.3 cases per 100,000 live births and has
    declined 64% to 39.0 in 1995 (Figure_27 and Table_34). The rate
    of P&S syphilis in women peaked at 17.3 per 100,000 population in 1990
    and declined 66% to 5.8 in 1995 (Figure_23 and Figure_26;
    Table_24). 

--  Although the 1995 rate of CS was below the revised Healthy People 2000
    Objective of 40 cases per 100,000 live births, this objective is many
    times greater than the rate of CS of most industrialized countries
    where syphilis and CS have nearly been eliminated (13).

--  Accurate estimates of pelvic inflammatory disease (PID) and tubal
    factor infertility from gonococcal and chlamydial infections are
    difficult to obtain largely due to the requirement for complex and
    invasive procedures (e.g., laparoscopy or laparotomy, and tubal patency
    studies) to accurately document these conditions. Most cases of PID are
    treated on the basis of interpretations of clinical findings, which
    vary between individual practitioners. In addition, the settings in
    which care is provided can vary considerably over time. For example,
    women with PID who would have been hospitalized in the 1980's may be
    treated in out-patient facilities during 1990's. These factors make
    surveillance for PID difficult. Trends in hospitalized PID have
    declined steadily throughout the 1980's and early 1990's
    (Figure_28). However, these trends may be more reflective of
    changes in the etiologic spectrum (with increasing proportions of more
    indolent chlamydial infection) and clinical management of PID (from
    inpatient to outpatient) rather than true trends in disease (14).

--  Recent evidence suggests that health care practices associated with
    ectopic pregnancy also changed in the late 1980's and early 1990's.
    Before that time, treatment of ectopic pregnancy usually required
    admission to a hospital. Hospitalization statistics were therefore
    useful for monitoring trends in ectopic pregnancy (Figure_E).
    Beginning in 1990, hospitalizations for ectopic pregnancy began to
    decline. Data from out-patient care surveys suggest that nearly half of
    all ectopic pregnancies are currently treated on an outpatient basis
    (15). The total number of ectopic pregnancies in the U.S. in 1992 was
    estimated at 108,800 (or 19.7 cases per 1,000 pregnancies), the highest
    level in more than two decades (15).

Figure_A.  Chlamydia -- Number of states with reporting laws for
               Chlamydia trachomatis infections and reported rates: United
               States, 1987-1995 
Figure_B.  Chlamydia -- Rates for women by state: United States, 1995
Figure_C.  Chlamydia -- Percent positivity among women tested in family
               planning clinics by state: Region X, 1988-1995
Figure_D.  Chlamydia -- Percent positivity among 15-24 year-old women
               tested in selected family planning clinics by state, 1995
Figure_E.  Ectopic pregnancy -- Hospitalizations of women 15-44 years of
               age: United States, 1980-1993

---------------
(1)  Stamm WE, Guinan ME, Johnson C. Effect of treatment regimens for
     Neisseria gonorrhoeae on simultaneous infections with Chlamydia
     trachomatis. N Engl J Med 1984;310:545-9.
(2)  Platt R, Rice PA, McCormack WM. Risk of acquiring gonorrhea and
     prevalence of abnormal adnexal findings among women recently exposed
     to gonorrhea. JAMA 1983;250:3205-9.
(3)  Westrom L, Joesoef R, Reynolds G, et al. Pelvic inflammatory disease
     and fertility: a cohort study of 1,844 women with laparoscopically
     verified disease and 657 control women with normal laparoscopy. Sex
     Transm Dis 1992;19:185-92.
(4)  Hook EW III, Hansfield HH. Gonococcal infections in the adult. In:
     Holmes KK, Mardh PA, Sparling PF, et al, eds. Sexually Transmitted
     Diseases, 2nd edition. New York City: McGraw-Hill, Inc, 1990:149-65.
(5)  Stamm WE, Holmes KK. Chlamydia trachomatis infections in the adult.
     In: Holmes KK, Mardh PA, Sparling PF, et al, eds. Sexually Transmitted
     Diseases, 2nd edition. New York City: McGraw-Hill, Inc, 1990:181-93.
(6)  Zimmerman HL, Potterat JJ, Dukes RL, et al. Epidemiologic differences
     between chlamydia and gonorrhea. Am J Public Health 1990;80:1338-42.
(7)  Hillis SD, Joesoef R, Marchbanks PA, et al. Delayed care of pelvic
     inflammatory disease as a risk factor for impaired fertility. Am J
     Obstet Gynecol 1993;168:1503-9.
(8)  Goldner TE, Lawson HW, Xia Z, et al. Surveillance for ectopic
     pregnancy -- United States, 1970-1989. In: CDC Surveillance Summaries,
     December 17, 1993. MMWR 1993;42(No.SS-6):73-85.
(9)  CDC. Guidelines for prevention and control of congenital syphilis.
     MMWR 1988;37(No.S-1).
(10) CDC. Recommendations of the U.S. Public Health Service task force on
     the use of zidovudine to reduce perinatal transmission of human
     immunodeficiency virus. MMWR 1994;43(No.RR-11).
(11) Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant
     transmission of human immunodeficiency virus type I with zidovudine
     treatment. N Engl J Med 1994;331:1173-80.
(12) Scholes D, Stergachis A, Heidrich FE, Andrilla H, Holmes KK, Stamm WE.
     Prevention of pelvic inflammatory disease by screening for cervical
     chlamydial infection. N Engl J Med  1996;34(21):1362-66.
(13) Division of STD/HIV Prevention. Healthy People 2000: National Health
     Promotion and Disease Objectives. Progress Review: Sexually
     Transmitted Diseases, October 26, 1994.
(14) Rolfs RT, Galaid EI, Zaidi AA. Pelvic inflammatory disease: trends in
     hospitalization and office visits, 1979 through 1988. Am J Obstet
     Gynecol 1992;166:983-90.
(15) CDC. Ectopic pregnancy -- United States, 1990-1992. MMWR 1995;44:46-8.


                  STDs in Adolescents and Young Adults

Public Health Impact

Compared with older adults, adolescents (10- to 19-year-olds) and young
adults (20- to 24-year-olds) are at higher risk for acquiring STDs for a
number of reasons:  they may be more likely to have multiple (sequential or
concurrent) sexual partners rather than a single, long-term relationship;
they may be more likely to engage in unprotected intercourse; and they may
select partners at higher risk. In addition, for some STDs, e.g., Chlamydia
trachomatis, adolescent women may have a physiologically increased
susceptibility to infection due to increased cervical ectopy and lack of
immunity. During the past two decades, the age of initiation of sexual
activity has steadily decreased and age at first marriage has increased,
resulting in increases in premarital sexual experience among adolescent
women and in an enlarging pool of young women at risk (1,2,3). In addition,
the higher prevalence of STDs among adolescents reflects multiple barriers
to quality STD prevention services, including lack of insurance or other
ability to pay, lack of transportation, discomfort with facilities and
services designed for adults, and concerns about confidentiality.

Observations

--  Numerous prevalence studies in various clinic populations have shown
    that sexually active adolescents have high rates of chlamydial
    infection (4). Large-scale screening demonstration projects in federal
    Region X (Alaska, Idaho, Oregon, and Washington) (5) have demonstrated
    that younger women have consistently higher positivity rates of
    chlamydia than older women (Figure_F).

--  Rates of gonorrhea among male adolescents have steadily decreased
    during the four year period 1992-95 (Table_9B). In the 10- to
    14-year-old group, the rate for males decreased from 26.2 per 100,000
    in 1992 to 12.6 in 1995, a decrease of 52%. In the 15- to 19-year-old
    group, the rate declined from 770.3 in 1992 to 498.4 in 1995, a 35%
    decrease. Among young adult men in the 20- to 24-year-old group, the
    rate of gonorrhea fell from 896.1 in 1992 to 666.4 in 1995, a decrease
    of 26%.

--  Rates of gonorrhea among female adolescents also generally decreased
    over the four year period 1992-95 (Table_9B). However, both
    adolescent age groups exhibited an increase between 1993 and 1994,
    which was followed by a decrease in 1995. This pattern also occurred
    among young adult women. In the 10- to 14-year-old group, the rate for
    females decreased from 91.2 per 100,000 in 1992 to 72.8 in 1995, a
    decrease of 20%. In the 15- to 19-year-old group, the rate declined
    from 973.8 in 1992 to 839.7 in 1995, a 14% decrease. Among young adult
    women in the 20- to 24-year-old group, the rate of gonorrhea fell from
    766.5 in 1992 to 624.6 in 1995, a decrease of 19%.

--  In 1995, the highest age-specific gonorrhea rates among women and the
    second highest rates among men were in the 15- to 19-year-old group
    (Figure_12).

--  Increases in gonorrhea between 1994 and 1995 were noted among Hispanic
    adolescents and young adults (Table_9B).

--  Since 1990, approximately 20,000 female Job Corps entrants have been
    screened each year for chlamydia. The Job Corps, administered by the
    U.S. Department of Labor at 108 sites throughout the country, is a
    residential occupational training program for urban and rural
    disadvantaged youth aged 16-24 years. Among women entering the Job
    Corps in 1995, based on their place of residence just before program
    entry, state-specific chlamydia test positivity ranged from 4.2% to
    17.1% (Figure_I). Chlamydia infection is widespread geographically
    and highly prevalent among these economically disadvantaged young
    women.

Figure_F.  Chlamydia -- Percent positivity among women tested in family
               planning clinics by age group: Region X, 1988-1995
Figure_G.  Gonorrhea -- Age-specific rates among women 10-44 years of
               age: United States, 1981-1995
Figure_H.  Gonorrhea -- Age-specific rates among men 10-44 years of age:
               United States, 1981-1995
Figure_I.  Chlamydia -- Percent positivity among 16-24 year-old women
               entering the U.S. Job Corps by state of residence, 1995

---------------
(1) CDC. Premarital sexual experience among adolescent women -- United
    States, 1970-1988. MMWR 1991;39:929-32.
(2) CDC. Pregnancy, Sexually Transmitted Diseases and Related Risk
    Behaviors Among U.S. Adolescents. Atlanta: Centers for Disease Control
    and Prevention, 1994. Adolescent Health: State of the Nation monograph
    series, No. 2. CDC Publication No. 099-4630.
(3) Forrest JD. Timing of reproductive life stages. Obstet Gynecol 1993;
    82(1):105-11.
(4) CDC. Recommendations for the prevention and management of Chlamydia
    trachomatis infections, 1993. MMWR 1993;42(No. RR-12).
(5) Lossick J, Delisle S, Fine D, Mosure D, Lee V, Smith C. Regional
    program for widespread screening for Chlamydia trachomatis in family
    planning clinics. In: Bowie WR, Caldwell HD, Jones RP, et al., eds.
    Chlamydial Infections: Proceedings of the Seventh International
    Symposium of Human Chlamydial Infections, Cambridge, Cambridge,
    University Press, 1990, pp. 575-9.


                           STDs in Minorities

Public Health Impact

Surveillance data show high rates of STDs for some minority racial/ethnic
groups when compared with rates for whites. There are no known biologic
reasons to explain why racial or ethnic factors alone should alter risk for
STDs. Rather, race and ethnicity in the United States are risk markers that
correlate with other more fundamental determinants of health status such as
poverty, access to quality health care, health care seeking behavior,
illicit drug use, and living in communities with high prevalence of STDs.
Acknowledging the disparity in STD rates by race/ethnicity is one of the
first steps in empowering affected communities to organize and focus on
this problem.

Surveillance data are based on cases of STDs reported to state and local
health departments (see Appendix). In many areas, reporting from public
sources (e.g., STD clinics) is more complete than reporting from private
sources. Since minority populations may utilize public clinics more than
whites, differences in rates between minorities and whites may be increased
by this reporting bias.

Observations

--  Although chlamydia is a widely distributed STD among all racial and
    ethnic groups, trends in positivity in women screened in federal Region
    X (Alaska, Idaho, Oregon, and Washington) show consistently higher
    rates among minorities (Figure_J).

--  In 1995, African-Americans accounted for about 79% of total reported
    cases of gonorrhea (Table_9A). The overall gonorrhea rates in 1995
    were 1,086.9 cases per 100,000 for African-Americans and 90.6 for
    Hispanics compared with 29.1 for non-Hispanic whites (Figure_11,
    Table_9B). Compared with 1994, 1995 rates decreased for all
    race/ethnic groups except Hispanics.

--  Gonorrhea rates are very high for African-American adolescents and
    young adults. In 1995, black 15- to 19-year-old women had a gonorrhea
    rate of 4,432.6 cases per 100,000 population. Black men in this age
    group had a gonorrhea rate of 3,267.3. These rates were on average more
    than 27 times higher than those of white adolescents 15- to
    19-years-old (Table_9B). Among 20- to 24-year-olds in 1995, the
    gonorrhea rate among blacks was 35 times greater than that of whites
    (4,238.9 vs. 121.1, respectively) (Table_9B).

--  Despite declines in gonorrhea rates for most age and race/ethnic groups
    during the 1980's, African-American adolescents did not show declining
    trends in rates until 1991 (black women) and 1992 (black men). Between
    1994 and 1995 gonorrhea rates for black 15- to 19-year-old women
    declined by 7.1%, and for black men in this age group, by 16.1%
    (Table_9B and Figure_K and Figure_L). 

--  The most recent epidemic of syphilis was largely an epidemic in
    heterosexual, minority populations (1). Since 1990, rates of primary
    and secondary (P&S) syphilis have declined among all racial and ethnic
    groups except American Indian/Alaska Native. However, rates among
    African-Americans and Hispanics continued to be higher than for
    non-Hispanic whites. In 1995, African-Americans accounted for about 86%
    of all reported cases of P&S syphilis (Table_21A). Although the
    rate among African-Americans declined from 58.6 cases per 100,000
    population in 1994 to 46.2 in 1995, the latter rate was nearly 60-fold
    greater than the non-Hispanic white rate of 0.8 per 100,000. The 1995
    rate of P&S syphilis in Hispanics was 3.0 (Figure_24 and
    Table_21B).

--  In 1995, the rate of congenital syphilis in African-Americans was 162.2
    per 100,000 live births and 49.7 in Hispanics compared with 3.9 in
    whites (Figure_M). Compared with 1994, this represented a 30%
    decrease among blacks and a 35% decrease among Hispanics.

Figure_J.  Chlamydia -- Percent positivity among women tested in family
               planning clinics by race and ethnicity: Region X, 1988-1995
Figure_K.  Gonorrhea -- Reported rates for 15- to 19-year-old females by
               race and ethnicity: United States, 1981-1995
Figure_L.  Gonorrhea -- Reported rates for 15- to 19-year-old males by
               race and ethnicity: United States, 1981-1995
Figure_M.  Congenital syphilis -- Rates for infants <1 year of age by
               race and ethnicity: United States, 1991-1995 and the Healthy
               People year 2000 objective

---------------
(1) Rolfs RT, Nakashima AK. Epidemiology of primary and secondary syphilis
    in the United States, 1981 through 1989. JAMA 1990;264:1432-7.


                            STDs in the South

Public Health Impact

The southern region (Alabama, Arkansas, Delaware, Florida, Georgia,
Kentucky, Louisiana, Maryland, Mississippi, Oklahoma, North Carolina, South
Carolina, Tennessee, Texas, Virginia, West Virginia) has had higher rates
of primary and secondary (P&S) syphilis and gonorrhea than other regions of
the country. The reasons for regional differences in rates are not well
understood, but may include differences in racial and ethnic distribution
of the population, poverty, and availability and quality of health care
services. These racial and ethnic differentials in STD rates are
particularly disturbing in light of the fact that STDs facilitate HIV
transmission at least two to five fold. High HIV prevalence among
childbearing women living in the South may be due, in part, to the high
rates of these others STDs. Data from a randomized controlled trial of STD
treatment to prevent HIV infection suggest that as much as a 40% reduction
in HIV incidence might be achieved in areas with high STD rates (1).

Observations

--  The South has consistently had higher rates of both gonorrhea and P&S
    syphilis compared with other regions throughout the 1980's and 1990's
    (Figure_7, Figure_8, Figure_19, and Figure_21,
    Table_11 and Table_23).

--  In 1995, the 10 states with the highest rates of gonorrhea were all
    located in the South (Figure_7 and Table_10). Thirteen of the
    17 states with rates of P&S syphilis above the revised HP2000 objective
    of 4 per 100,000 population were located in the South (Figure_19
    and Figure_20; Table_22). All 8 states with rates of P&S
    syphilis that exceeded 12 cases per 100,000 population (or three times
    the revised HP2000 national objective) were located in the South
    (Figure_19 and Table_22).

--  In 1995, 492 (84%) of 588 counties with P&S syphilis rates above the
    revised HP2000 objective were located in the South (Figure_20 and
    Figure_N).

--  Between 1994 and 1995, P&S syphilis rates increased in 244 (54%) of 449
    counties in the South that had 1995 rates greater than 4 cases per
    100,000 population (Figure_O).

--  Rates of P&S syphilis in African-Americans by region show that rates in
    this group, while decreasing, are high regardless of region
    (Figure_P).

Figure_N.  South -- Primary and secondary syphilis case rates by county, 
               1995
Figure_O.  South -- Increases and decreases in cases of primary and
               secondary syphilis in 1995 compared with 1994 cases, by
               county
Figure_P.  Primary and secondary syphilis -- Rates in African-Americans
               by region: 1981-1995

---------------
(1) Grosskurth H, Mosha F, Todd J, Mwijarubi E, Klokke A, Senkoro K, Mayaud
    P, Changalucha J, Nicoll A, ka-Gina G, Newell J, Mugeye K, Mabey D,
    Hayes R. Impact of improved treatment of sexually transmitted diseases
    on HIV infection in rural Tanzania: randomised controlled trial. Lancet
    1995;346:530-6.





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