JAIDS Journal of Acquired Immune Deficiency Syndromes

25:182–187 © 2000 Lippincott Williams & Wilkins, Inc., Philadelphia

Design, Implementation, and Evaluation at Entry of a

Prospective Cohort Study of Homosexual and Bisexual
HIV-1–Negative Men in Belo Horizonte, Brazil:
Project Horizonte

*Mariângela Carneiro, *†Carlos Maurı́cio de Figueiredo Antunes, ‡Marı́lia Greco,

‡Edson Oliveira, ‡Júlio Andrade, ‡Luiz Lignani Jr, and ‡Dirceu Bartolomeu Greco for the
Project Horizonte

*Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais; †Santa Casa de
Misericórdia de Belo Horizonte; and ‡Departamento de Clı́nica Médica, Serviço de Doenças Infecciosas e Parasitárias e
Programa de Pós-Graduação em Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais,
Belo Horizonte, Brazil

Background and Objectives: Project Horizonte, an open cohort of homosexual and

bisexual HIV-1–negative men, is a component of the Minas Gerais AIDS Vaccine
Program of the Federal University of Minas Gerais, Belo Horizonte, Brazil. Its objec-
tives included the evaluation of seroincidence of HIV, to ascertain the role of coun-
seling on behavior modification and to assess their willingness to participate in future
HIV vaccine trials.
Methods: Various means of recruitment were used, including pamphlets, notices in
community newspapers, radio, and television, at anonymous testing centers, and by
word of mouth.
Results: From October 1994 to May 1999, 470 volunteers were enrolled. Their
mean age was 26 years and over 70% of them had high school or college education.
During the follow-up, they were seen every 6 months, when they received counseling
and condoms, and when HIV testing was done. Eighteen seroconversions were ob-
served, and the incidence rates estimates were 1.75 per 100 and 1.99 per 100 person-
years, for 36 and 48 months of follow-up, respectively. During the entire period, 139
volunteers were lost to follow-up. Among them, 59 (42.4%) never returned after the
initial visit and 51 (36.7) came only once after their initial visit. No losses were
observed for those observed during follow-up for more than 3 years. At enrollment,
50% of participants said they would participate in a vaccine trial, and 30% said they
might participate.
Conclusions: The results obtained up to this moment confirm the feasibility of
following this type of cohort for an extended period, estimating HIV incidence rate,
and evaluating counseling for safe sexual practices in preparation for clinical trials
with candidate HIV vaccines in Brazil.
Key Words: HIV—HIV incidence—Homosexual and bisexual—Open cohort—
Vaccines.

Address correspondence and reprint requests to Dirceu B. Greco, In Brazil, 179,541 cases of AIDS have been reported
Faculdade de Medicina—DIP, Universidade Federal de Minas Gerais, to the Ministry of Health between 1980 and November
Avenida Alfredo Balena 190, 30130-100 Belo Horizonte, Brazil; e-
mail: [email protected] 1999, a cumulative incidence of 124.2 cases per 100,000
Manuscript received February 2, 2000; accepted July 18, 2000. inhabitants, ranging from 0.1 to 20.0 per 100,000 per
182
 HOMOSEXUAL AND BISEXUAL HIV-1–NEGATIVE MEN IN BELO HORIZONTE, BRAZIL 183

year. Homosexual and bisexual transmission represented METHODS

23.6% of all new adult cases reported in the last two
years (1). The AIDS epidemic is still expanding in Brazil Study Protocol
and no prospective studies to estimate HIV infection in-
The Project Horizonte proposal was submitted to and approved by
cidence rate and to identify risk factors were carried out the Committee on Human Research of the Universidade Federal de
prior to 1994. Minas Gerais.
To prepare for possible trials of preventive HIV The Project Horizonte site coordinated by the Universidade Federal
vaccines in a population at high risk of infection, de Minas Gerais (UFMG) is established at the Infectious and Parasitic
Diseases Service (CTR DIP) and graduate program in tropical medicine
the Brazilian Ministry of Health established in October in Belo Horizonte, Brazil.
1992 centers to participate in an HIV vaccine program. The study protocol was divided in two phases: the selection process
Among the center’s objectives were the establishment (recruitment and enrollment) and the follow-up. The objective of the
and follow-up of an open cohort for the following pur- recruitment phase was to identify HIV-1–negative homosexual or bi-
sexual male, which would consent to participate in a cohort study.
poses:
Eligibility criteria for enrollment included sexually active homosexual
or bisexual men, aged between 18 and 59 years, consenting to do an
To evaluate the feasibility of following such a cohort for HIV test and having a negative result for HIV-1 infection. Methods for
recruitment were tailored to the resources of each study site and, as it
extended period of time
was devised as an open cohort, recruitment was initially planned for 4
To determine the HIV infection incidence rate and to years. Various recruitment methods were used, including pamphlets,
investigate risk factors for infection notices in community newspapers, radio, and television, at anonymous
To evaluate the impact of preventive programs in the testing centers and by word of mouth.
HIV incidence The objective of the follow-up phase was to monitor the participants
semiannually, to detect HIV incidence, to investigate risk factors for
To ascertain the efficacy of counseling and of education- infection, and to counsel patients about how to reduce these risk fac-
al interventions in reducing HIV risk practices tors. All negative volunteers were scheduled for 6-month visits, which
To evaluate the possibility of conducting clinical trials of included interview using the same psychosocial and epidemiologic
preventive HIV candidate vaccines with volunteers re- form, blood collection for HIV and other laboratory tests, and clinical
consultation. Preventive interventions implemented during the follow-
cruited among cohort members
up period included free condom distribution, HIV infection and AIDS
To discuss ethical and technical aspects of clinical trials information, opportunity to participate in discussion forums addressing
conducted with preventive HIV candidate vaccines questions as sexuality, HIV vaccine trials, safe sexual practices, and
other subjects. Medical assistance was provided to all volunteers; those
who became infected with HIV during follow-up received medical and
In April 1994, three vaccine centers were established psychological care, by the same health team, at the CTR DIP outpatient
in the States of Minas Gerais, Rio de Janeiro, and São clinic.
Paulo, funded by the Ministry of Health and the United
Nation’s AIDS Control Program (UNAIDS). These cen-
Data Collection: Core Interview
ters initiated close collaboration in designing and imple-
menting the study and following cohorts of HIV- A standardized form, given to all volunteers, was composed of five
negative homosexual and bisexual men, to conduct a modules: 1) current demographic characteristics, 2) history of sexual
similar investigation, including data collection and behavior; 3) other risk factors for HIV infection; 4) knowledge about
analysis, characterizing a multicenter study (2). During HIV/AIDS, and 5) knowledge about HIV vaccines and willingness to
participate in future trials. The psychosocial team conducted a face-to-
the first semester of 1994, the project teams developed
face interview, lasting around 1 hour, at each visit. Whenever possible
the study protocol, data collection forms, and manuals. the follow-up interviews were conducted by the same professionals
After a pilot test and data collection instruments’ defini- who enrolled the volunteers. At each visit, participants were encour-
tion, each center began, in September of the same year, aged to schedule their next visit.
to recruit volunteers.
This paper describes the design and data collec- Blood Collection and Laboratory Tests
tion methods of the Project Horizonte, which is located
in Belo Horizonte, Minas Gerais State, including Two blood samples were obtained, the first for anti-HIV serologic
selected characteristics of participants at enrollment tests, complete blood count, Venereal Diseases Research Laboratories
visit; HIV infection incidence rate during the first tests and CD4/CD8 lymphocyte cells counts (flow cytometry) and the
second to be stored at −20°C. A standardized clinical interview form
four and a half years of follow-up; an evaluation of
was applied at each clinical visit. The volunteers were asked about their
losses to follow-up during the same period; and an ap- health status and current illnesses, including specific questions related
praisal of their willingness to participate in future vac- to sexually transmitted diseases. A complete physical examination was
cine trials. performed and laboratory tests were done as necessary.

JAIDS Journal of Acquired Immune Deficiency Syndromes, Vol. 25, No. 2, October 1, 2000
184 M. CARNEIRO ET AL.

Statistical Methods TABLE 1. Social demographics and behavioral characteristics of

Project Horizonte HIV-negative recruited participants 1994–1999,
The sample size (500 participants) needed to estimate HIV incidence Belo Horizonte, Minas Gerais, Brazil
within 25% (relative precision) was calculated based on a 8 per 100 per
year underlying seroconversion rate, obtained by backcalculation (3,4) Characteristics N ⳱ 470 (%)
based on 1987 to 1992 seroprevalence in UFMG’s immunodeficiency Mean age, y (SD) 26.9 (6.8)
clinic. Incidence rates were calculated using the person-time function Median age, y (IQR) 26.0 (21–31)
method. To investigate whether the group of participants who came Race
only once differed from those who remained in the project, they were Mulatto 242 (51.8)
compared (using demographic, social, and behavioral characteristics) White 191 (40.9)
using multivariate logistic regression (5). Black 34 (7.3)
Education
Elementary school 123 (26.4)
RESULTS High school 196 (42.1)
College 147 (31.5)
Currently employed 359 (76.9)
The results presented here refer to volunteers recruited Monthly income (in BMW)
during the initial 4.5 years of Project Horizonte. Interim <1 68 (14.7)
analysis of selected data has been presented elsewhere 1–3 153 (33.1)
3–6 122 (26.4)
(6–13). 6–10 46 (10.0)
From October 1994 through May 1999, 567 volunteers >10 73 (15.8)
were screened; 46 did not complete the initial protocol Sexual identity
Homosexual 276 (59.4)
and 51 were considered ineligible (those who were not Bisexual 189 (40.6)
included had produced positive results when tested by Used alcohol in the last 6 months 368 (79.5)
enzyme-linked immunosorbent assay and Western blot at Used drug in the last 6 months 81 (17.6)
Had oral sex 336 (72.1)
entry). The remaining 470 were included after signing Had anal-receptive intercourse 265 (57.0)
the informed consent: 140 (30%) were recruited in the Had anal intercourse without condom
first year, 178 (38%) in the second year, 86 (18%) in the with occasional partnersa 109 (41.3)
Reactive VDRL 17 (3.8)
third year, and 66 (14%) in the last year and a half.
Word of mouth was the most frequent response given Data for refusal, “not done,” and “don’t know” are not shown.
a
by the volunteers (52%) when asked “How did you find Only for those who reported anal intercourse.
SD, standard deviation; IQR, interquartile range; BMW, Brazilian
out about this study?” In this case, most reported that minimum wage; VDRL; Venereal Disease Research Laboratories test.
they received information from partners/friends or per-
sons frequenting the same bars, restaurants, and saunas.
Other responses included newspaper notes (advertise- up. The incidence rates estimated using the person-time
ment in the personal add section), television and radio function (95% confidence interval [CI]) were 1.34 (0.58–
news (interviews given by members from the study 3.64), 1.75 (0.98–2.89) and 1.99 (1.18–3.14) per 100
team), and pamphlets (13.1 and 13.5%, respectively). person-years for 18, 36, and 48 months of follow-up,
The demographic and behavioral characteristics at en- with 7167, 10,269, and 10,866 person-months denomi-
try for the 470 enrolled men are shown in Table 1. The nators, respectively.
mean age was 27 years; 52% were mulattoes, 41%
whites, and 7% blacks; 73.6% had either high school or Losses to Follow-Up
college education, 77% were currently employed, and
52% received monthly more than three times the Brazil- During the entire study period, 139 volunteers were
ian minimum wage (i.e., the average for the region, or lost to follow-up. Among them, 59 (42.4%) never re-
about $250.00 U.S.). Approximately 60% reported prac- turned after the initial visit and 51 (36.7%) had only one
ticing anal receptive intercourse and among those, 41% interview. No losses were observed for those followed
reported having anal intercourse with occasional partners for more than 3 years.
without using condoms. Among the volunteers, 60%
identified themselves as homosexuals and 40% as bi- Characteristics of Single-Visit Participants Versus
sexuals. Participants Who Continued With the Study

Project Horizonte HIV Infection Incidence Rates Table 2 shows the results obtained comparing partici-
pants who made only a single visit with those being
During the follow-up period, 18 seroconversions were observed on a long-term basis (at entry data). In univari-
observed, eight of them in the first 18 months of follow- ate analysis, significant differences were observed for

JAIDS Journal of Acquired Immune Deficiency Syndromes, Vol. 25, No. 2, October 1, 2000
 HOMOSEXUAL AND BISEXUAL HIV-1–NEGATIVE MEN IN BELO HORIZONTE, BRAZIL 185

TABLE 2. Baseline demographic and behavioral characteristics of Project Horizonte, 1994–1999

Those who came Analysis

Only first visit >One visit OR Univariate OR Multivariatea

Characteristics (n ⳱ 59) (n ⳱ 411) (95% CI) p Value (95% CI)

Ageb
Mean (SD) 24.9 (5.2) 27.2 (7.0) .008
Median (IQR) 24 (21–29) 26 (22–31) .028 1.1 (1.0–1.1)
Income (%)
ⱕ3 BMW 29 (50) 195 (48)
>3 BMW 29 (50) 215 (52) 1.1 (0.6–1.9) .728
Currently employed (%) 46 (79) 314 (77) 1.2 (0.6–2.3) .645
Have health insurance (%) 39 (67) 331 (81) 0.5 (0.3–0.9) .018 0.5 (0.3–0.9)
Sexual identity (%)
Bisexual 23 (40) 94 (23)
Homosexual 35 (60) 313 (77) 0.5 (0.3–0.8) .008 0.4 (0.2–0.7)
Have knowledge about AIDS vaccine (%) 40 (69) 314 (77) 0.8 (0.5–1.5) .053
Willingness to participate in vaccine trials (%)
Yes 23 (40) 201 (49) 1.0
Maybe 16 (27) 121 (30) 1.1 (0.6–2.0) .746
No 19 (33) 86 (21) 0.5 (0.3–1.0) .049 0.5 (0.3–0.9)
a
Final model.
b
Test for mean and median.
OR, odds ratio; CI, confidence interval; SD, standard deviation; IQR, interquartile range; BMW, Brazilian minimum wage.

age, having health insurance, sexual identity, knowledge smaller number of volunteers admitted in the last year
about AIDS vaccine, and willingness to participate in and half. However, the initial goal of enrolling 500 vol-
vaccine trials. These variables, except for knowledge unteers was achieved and the capability of maintaining
about AIDS vaccine, remained in the multivariate final this open cohort for extended periods of time has been
model. demonstrated.
Word of mouth was the most efficacious recruitment
DISCUSSION technique. Similar results were reported in other longi-
tudinal studies on the natural history on HIV infection
The decision to start an incidence cohort with men (14–16). Inasmuch as gay groups are not as well orga-
who have sex with men (MSM) and in a multicenter nized in Belo Horizonte as was previously expected, it
fashion was a sound one. The reasons for starting with was difficult to reach different segments of this popula-
MSM were multifold. Even with increasing prevalence tion. This is reflected in the small number of transvestites
of AIDS in other groups, the group still produces a con- and sex professionals who have been enrolled. In view of
siderable number of cases; MSM are usually more orga- these considerations, the Project Horizonte participants,
nized as a group and in certain ways more homogeneous. due to a possible selection bias, may not be representa-
To do it as multicenter project (Belo Horizonte, Rio de tive of the wider Belo Horizonte homosexual/bisexual
Janeiro, and São Paulo) was necessary to grant the find- population. In addition, it was observed that a higher
ings more power and reliability. In addition, the ex- proportion of volunteers who remained in the Project
change of ideas and expertise helped in setting up other were older, reported having health insurance, identified
cohorts (e.g., women, commercial sex workers) by the themselves as homosexuals, and were more willing to
same or other groups, using the acquired experience. participating in future vaccine trials. Nonetheless, this
The main objective of the Project Horizonte was to group probably represents the population that would vol-
evaluate the feasibility of implementing and maintaining unteer in future vaccine trials.
a cohort of homosexual/bisexual HIV-negative men for The results are encouraging in relation to the follow-
an extended time and to appraise their willingness to up retention rates when considering those volunteers that
participate in future HIV-vaccine trials. returned for two or more visits; >80% of losses occurred
The capability of the cohort team in recruiting partici- in the first 12 months after enrollment. It should be noted
pants can be analyzed by the proportion of volunteers that the characteristics of those who came only once to
yearly entering the study: 0.28, 0.36, 0.23, and 0.13, the Project revealed that a large proportion of them prob-
from the first to the fourth years, respectively. Budge- ably never had the intention of participating in the co-
tary constraints were undoubtedly responsible for the hort; it is possible that the initial enrollment had to do

JAIDS Journal of Acquired Immune Deficiency Syndromes, Vol. 25, No. 2, October 1, 2000
186 M. CARNEIRO ET AL.

with the possibility of getting a free HIV test, because cide to participate in future HIV vaccine trials, although
many of them did not have health insurance. If these it will be necessary to discuss this issue with them fur-
volunteers are excluded, the retention rate achieved dur- ther. Moreover, the research team is ready to engage in
ing this period was >90%. Similar results were reported the implementation of a vaccine trial when a suitable
from other studies; MACS retained 88.5% of participants candidate is available.
after 9.5 years of follow-up and Project Praça Onze (Bra-
zil) 97%, 91%, and 88% at 6, 12, and 18 months, re- APPENDIX
spectively (17,18).
Despite the high level of counseling, condom distri- Project Horizonte’s members are A. C. Toledo Jr, U. Tupinambás, L.
G. Machado, C. A. J. Pádua, F. A. Ribeiro, F. G. F. Ferreira, R. M.
bution, and the participation in the discussion groups, a Ferraz, G. Câmara, W. Oliveira, M. A. Ribeiro, M. R. Oliveira, J. J.
proportion of the volunteers continues to engage in high- Fonseca, R. C. Dominguez, M. Matta-Machado, J. D. P. Nahass, M. J.
risk practices; this is reflected by the 18 seroconversions D. Utsch, F. A. Cardoso, and L. Gouveia.
that occurred in the 4 years of follow-up. A higher pro-
portion of seroconversion happened among those ob- Acknowledgments: Financial support for this study was
served <2 years (56%) when compared with those ob- provided by UNESCO-Brazilian Ministry of Health, agreement
no. 296/99. We express our thanks to the Brazilian Ministry of
served for longer than 2 years. It may be affirmed that Health, UNAIDS, Fundação de Amparo à Pesquisa de Minas
even knowing the risks for infection, the observed Gerais (FAPEMIG), Fundação para o Desenvolvimento da Pes-
changes in behavior were still unsatisfactory; as an ex- quisa (FUNDEP), Conselho Nacional de Desenvolvimento
ample, they diminished the number of occasional part- Científico e Tecnológico (CNPq), Fundação Coordenação de
ners and increased the usage of condoms, but the level of Aperfeiçoamento de Pessoal do Ensino Superior (CAPES), and
the Belo Horzonte Health Secretary.
unsafe sexual practices continued at unacceptably high
levels (19).
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