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Incidence and Correlates of STIs among
Black Men who have Sex with Men
Participating in a US PrEP Study
HPTN 073
Lisa Hightow-Weidman, Manya Magnus,
Geetha Beauchamp, Christopher Hurt, Steve Shoptaw,
Lynda Emel, Estelle Piwowar-Manning, Kenneth Mayer,
LaRon E. Nelson, Leo Wilton, Phaedrea Watkins,
Sheldon Fields, Darrell Wheeler
HIV Among Black MSM
• Blacks/African Americans have the most
severe burden of HIV of all racial/ethnic
groups in the United States.
• Among all African Americans diagnosed with
HIV in 2014, an estimated 57% (11,201) were
gay or bisexual men.
• From 2005 to 2014, the number of new HIV
diagnoses among young Black gay and
bisexual men (aged 13 to 24) increased 87%.
CDC, 2014
PrEP and STI acquisition among MSM
• STI acquisition has ranged from
28%-57% in several recent PrEP
studies1-4
• Meta-analysis found MSM on PrEP5
– 25.3x more likely to acquire Gonorrhea,
– 11.2x more likely to acquire Chlamydia and
– 44.6x more likely to acquire syphilis
1McCormack
et al. Lancet 2015; 387: 53-60 2Molina et al. NEJM 2015; 373: 2237-46 3 Volk et al. CID 2015;
61: 1601-3 4Liu et al. JAMA Int Med 2015; 176: 75-84 5Kojima AIDS 2016 June 14 [Epub]
• 226 HIV-uninfected BMSM
enrolled from August 2013
- September 2014
Los Angeles, CA
Washington, DC
Chapel Hill, NC
Study Design
• All participants received client-centered care coordination and
offered daily oral PrEP with once daily Truvada®
(emtricitabine/tenofovir).
• Men followed for 12 months with scheduled clinical visits
• STI testing (rectal and urine NAAT for gonorrhea and chlamydia,
RPR for syphilis) at weeks 26 and 52.
Client-Centered Care Coordination
Comprehensive HIV risk assessment
Development of Prevention Plan
Intensive risk reduction counseling
Linkages to support services
Follow-up between study visits
Methods
• Logistic regression was used to examine the
unadjusted and adjusted associations between
STI prevalence and baseline characteristics.
• Associations between age, PrEP acceptance
and sexual risk taking behaviors and any STI
evaluated using generalized estimating
equations (GEE) to account for the repeated
observations at weeks 26 and 52.
• Incidence rates and confidence intervals
calculated based on Poisson distribution.
Demographics (n=226)
Age
<25 years, n(%)
Median (IQR)
91 (40.3)
26 years (23-32)
Education
Some college or more, n(%)
160 (70.8)
PrEP Acceptance
at Study
Initiation
21.2 %
Full-time employed, n(%)
85 (37.6)
Health Insurance, n(%)
155 (68.6)
Income <$20,000, n(%)
108 (47.8)
78.8 %
Yes
No
STIs at Screening and Follow-up
25
Overall STI prevalence did not increase over time; p=0.8463
Percent of Participants
20
18.2
16.2
15
14.2
11.8
11.5
9.6
10
4.3
5
2.4
2.2
0
1.3
2
2.5
2.4
2.4
0
Screening (n=226)
Any STI
Week 26
Rectal STI
Urethral STI
(n=198)
Pharyngeal STI
Week 52
(n=202)
Syphilis
Pharyngeal STIs were not specifically tested for per protocol but were reported as AEs after enrollment if detected.
STI Incidence by PrEP Uptake
Study Visit
Screening
Week 26
Week 52
Cases per 100 PY
(95% CI)
PrEP accepted
PrEP declined
32.8
26.8
(24.3, 43.2)
(12.9, 49.3)
36.2
22.5
(25.0, 52.4)
(8.4, 59.6)
37.6
23.5
(26.3, 53.8)
(8.8, 62.5)
P-value
0.56
0.37
0.37
Acquisition of STIs
• Men <25 years of age more likely to have an
STI at screening than men ≥25 years
– 25.3% vs. 6.7%; OR 4.39, (95% CI: 1.91, 10.11)
• Sixty participants acquired ≥1 STI during
follow-up
• Nine participants had an STI at both follow-up
visits.
Correlates of Incident STIs
• In a multivariable model:
– Having an STI diagnosis at screening was
associated with ≥1 incident STI at week 26 or
week 52
• OR 4.02 (95% CI 1.79,9.01)
– Study site, age, self-report of condomless sex,
alcohol or drug use before or during sex,
self-reported PrEP adherence and total and
mean C4 sessions were not associated with
having an incident STI.
Self-reported Condomless Anal Sex
No statistically significant change over time
Receptive
Insertive
Reported condomless anal sex, % of Participants
50
45
40
Any sex
35
30
with HIV–
25
with unknown
HIV status
20
15
with HIV+
10
5
0
Screening
Week 26
Week 52
Screening
Week 26
Week 52
STIs at HIV Seroconversion
• Among the 8 participants who
seroconverted
– 1 had syphilis at week 26
– 1 had urethral gonorrhea at week 26
• No data yet available regarding PrEP
adherence and STIs
– See Wheeler et al. Abstract WEAC0104
"Correlates for levels of self-reported PrEP
adherence among Black men who have sex with
men in 3 U.S. cities"
Limitations
• Only tested for STIs at baseline and weeks
26 and 52
– Recent data suggest more frequent testing
(q3 months) likely warranted1
– 5 additional cases diagnosed outside of the
protocol-specified testing windows and 3 cases
of presumptive treatment at other clinics
Ref: 1Liu et al. JAMA Int Med 2015; 176: 75-84
Conclusions
• The prevalence of STIs in this trial was lower
than in prior PrEP trials with no increase in
incidence over time.
• There was no significant difference in STI
incidence among BMSM who accepted or
declined PrEP.
• BMSM with STIs at PrEP initiation may require
additional counseling and more frequent STI
testing during follow-up.
ACKNOWLEDGEMENTS
The HIV Prevention Trials Network is sponsored by the
National Institute of Allergy and Infectious Diseases,
the National Institute of Mental Health, and the National
Institute on Drug Abuse, all components of the
U.S. National Institutes of Health.
HPTN 073 was sponsored by the US NIAID, the US NIMH
and the US NIDA. Study drug was provided by Gilead
Sciences, Inc.
We would like to thank the HPTN 073 participants as well as
the investigators and staff at participating sites and the
protocol team for their dedication to this project
BACKUP SLIDES
STIs in prior PrEP studies
PROUD1
IPERGAY2
Kaiser
Study3
3 city
Demo4
• 57% in immediate group and 50% in deferred group diagnosed with >1 bacterial
STI during f/u
• 41% in TDF/FTC arm and 33% placebo arm diagnosed with a new STI (39%
rectal)
• 28.5% were diagnosed with at least 1 STI during follow-up
• After 6 months of PrEP use, 30% of PrEP users were diagnosed with any STI,
after 12 months was 50%
• 50.9% diagnosed with at least 1 STI during follow-up
• Incidence (95% CI) was 90 (81-99) per 100 person-years for any STI
1McCormack
et al. Lancet 2015; 387: 53-60 2Molina et al. NEJM 2015; 373: 2237-46 3 Volk et al. CID
2015; 61: 1601-3 4Liu et al. JAMA Int Med 2015; 176: 75-84