Epidemiological Analysis: HIV Antiretroviral Therapy Study

This assignment presents an epidemiological analysis of a study investigating the impact of early antiretroviral therapy (ART) on preventing HIV-1 transmission to uninfected partners. The analysis examines the study's purpose, design (multi-site), and participant groups (early vs. delayed therapy). It details study procedures, including participant requirements and adherence measurement, and identifies the primary outcome of interest (HIV-1 transmission). The analysis delves into the randomization of participants, incidence rates of HIV in both treatment groups, and the calculation and interpretation of the hazard ratio for linked HIV transmission. The author concludes that the study provides strong evidence supporting the benefits of early ART as a key strategy to reduce the spread of HIV, based on the observed reduction in transmission rates. The analysis references the original study published in the New England Journal of Medicine.

Running head: EPIDEMIOLOGICAL ANALYSIS
Epidemiological analysis
Name of the student:
Name of the university:
Author note:

1EPIDEMIOLOGICAL ANALYSIS
Table of Contents
Question 1: 2
Question 2: 2
Question 3: 2
Question 4: 2
Question 5: 2
Question 6: 2
Question 7: 3
Question 8: 3
Question 9: 3
Question 10: 3
Question 11: 3
Bibliography: 5

2EPIDEMIOLOGICAL ANALYSIS
Question 1: What was the purpose of this study?
The purpose of this study was to evaluate the effect of combination antiretroviral therapy on
preventing the HIV1 transmission to uninfected partners.
Question 2: Was it a single-site or multi-site study?
It was a multi-site study.
Question 3: What were the two study groups? How many couples were assigned to each group?
The two study groups were early therapy group and delayed therapy group.
886 couples were assigned to early therapy group and 877 couples were assigned to delayed
therapy group.
Question 4: What were study participants required to do?
The study participants were asked to attend three monthly visits after enrolment, and in case
they remained fit, the visits were made quarterly. The HIV1 infected participants were instructed
to attend another additional visit in case they needed extended antiretroviral therapy.
Question 5: How did the investigators measure adherence to the protocol?
The study protocol was approved by local institutional review board affiliated to NEJM.org,
and along with that the study was monitored extensively twice each year by NIAID as well.
Question 6: What was the primary outcome of interest in the study?
39 HIV1 transmissions were detected primarily after the completion of the study, and the
time frame of the primary outcome had been February 21 of 2011.

3EPIDEMIOLOGICAL ANALYSIS
Question 7: How many people in the delayed therapy group dropped-out by declining further
participation?
9 partners belonging to the delayed therapy group declined to participate any further.
Question 8: Look at Table 1 and comment on the randomization of the study participants. Were
there any major differences among groups?
The research study designed employed muted block randomization on the study participants.
The study included various parameters although there were no major differences apparent.
Question 9: For all types of transmission, what was the total incidence rate of HIV in the early
treatment group? What was the incidence rate in the late treatment group? How was the Hazard
Ratio calculated?
Total incident rate was 0.3 per 100 person-years in the early treatment group.
Delayed treatment group had incident rate of 2.2 per 100 person-years.
The hazard ratio was calculated with the help of Kaplan-Meier method followed by Cox
regression analysis.
Question 10: From Table 3 and the text of the paper, what was the Hazard Ratio for linked HIV
transmission in the early group? Interpret this result.
The hazard ratio for linked HIV transmission in the early group had been 0.01, which can be
interpreted as the fact that early antiretroviral treatment can effectively reduce the probability of
sexual transmission of HIV1 virus. The reference for this analysis was contrasted with the group
with any transmission; hence he reference group can be the any transmission group.

4EPIDEMIOLOGICAL ANALYSIS
Question 11: Do you feel convinced that there is a benefit to using early antiretroviral therapy in
HIV infected people? Why or why not?
Yes, I feel convinced as the study explained the clinical benefits for early antiretroviral
therapy for both HIV1 infected and uninfected partners. And based on the data of the study, I
strongly believe that antiretroviral therapy can be a part of a strong HIV prevention strategy to
reduce the spread of the disease affectively.

5EPIDEMIOLOGICAL ANALYSIS
Bibliography:
Cohen, M. S., Chen, Y. Q., McCauley, M., Gamble, T., Hosseinipour, M. C., Kumarasamy,
N., ... & Godbole, S. V. (2011). Prevention of HIV-1 infection with early antiretroviral therapy.
New England journal of medicine, 365(6), 493-505.