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Correlates for levels of self-reported PrEP
adherence among Black men who have sex with
men in the 3 U.S. Cities
HPTN073
20, July 2016
AIDS2016 – Durban, South Africa
Darrell P. Wheeler, Geetha Beauchamp ,Sheldon Fields, LaRon Nelson, Lis Hightow-Weidman, Manya
Magnus, Steve Shoptaw, Lynda Emel, Estelle Piwowar-Manning, Ying Q. Chen, Phaedrea Watkins, Kenneth
Mayer, HPTN073 Study Team
Why HPTN073?
• High and disproportionate rates of HIV infections among US Black Men who
Have Sex with Men
• Assess the initiation, acceptability, safety, and feasibility of PrEP for Black men
who have sex with men (BMSM) in three US cities
• Study Questions
• Will BMSM initiate PrEP?
• Why or why not?
• Will BMSM use PrEP daily?
• If not how often?
• Is it safe for BMSM to use PrEP?
• Will BMSM sexual practices change with uptake of PrEP?
HPTN073…
• Enrolled 226 HIV-uninfected BMSM in three US cities: Los
Angeles, CA; Washington, DC; and Chapel Hill, NC.
• Implemented August 2013 and September 2014.
• 40.2% of participants <25 yrs of age
• levels of PrEP use were monitored using self-reported adherence
and biologic markers.
HPTN 073 Study Design
• Demonstration project
• Offered once daily oral Truvada® as PrEP
• Client-centered care coordination (C4): individualized prevention
counseling, support, and service coordination
• Participants followed for a total of 12 months
Client Center Coordinated Care (C4)
• Longitudinal management of client-identified health and
psychosocial needs by an interdisciplinary team
• Acknowledges the unique experiences of BMSM in the U.S. with
regard to biomedical interventions, psychosocial issues and
barriers to accessing health care
• Informed by research experiences of HPTN
• Extensive literature supporting the efficacy and cost-effectiveness of
interdisciplinary team-based clinical care models
• Years of clinical practice experience providing expert medical, nursing,
social work, psychological care and treatment for BMSM
HPTN 073
Client Centered Care Coordination (C4) –
a culturally specific intervention package
to Support PrEP Use in HIV Risk
Reduction Menu of Options
PrEP Uptake: 79%
12-Month Retention: 92%
C4 Core
Components
Transition to Community
Follow-Up
Demographics of participants enrolled in the study by PrEP Initiation
Demographics
Overall N
On PrEP
Not on PrEP
226
79%
21%
<25
91
84%
16%
≥25
135
76%
24%
Gay
166
81%
19%
Bi-sexual
45
71%
29%
74
78%
22%
Female
3
100%
-
Transgender
-
-
-
204
78%
22%
Afro-Latino
17
82%
18%
Other
5
80%
20%
Site
Age
Marital Status
Primary or main partner
Male
Ethnicity
African-American/Black/Caribbean
Demographics of participants enrolled in the study by PrEP Initiation
Demographics
Overall N
On PrEP
Not on PrEP
Site
226
79%
21%
Healthcare Coverage
155
77%
23%
Incarceration
69
74%
26%
High School or less
56
77%
23%
Some college/vocational school
93
77%
23%
2yr/4yr or greater
77
82%
18%
108
74%
26%
20k – 49k
64
81%
19%
≥50k
51
84%
16%
Unemployed/disability/other
61
66%
34%
Employed part-time/self-employed
80
84%
16%
Employed full-time
85
84%
16%
Highest education level attained
Annual income (decline to answer 1%)
<20k
Declined to answer
Employment Status
HPTN 073 – Reasons Not Enrolled
Screened
344
118
Enrolled
226 (66%)
Major reasons
25 (21 %) Abnormal liver or kidney function
9 (8 %) Abnormal lab test results
9 (8 %) Withdrew consent
9(8 %) Unwilling to adhere to study procedures
7 (6%) HIV+ rapid test
5 (4%) Unable to complete enrollment w/in 45
days
4 (3%) Current/prior study participation
4 (3%) Serious and active mental or medical
illness
54 (46 %) Other reasons
Cumulative Probability of PrEP Uptake
Self Reported PrEP Adherence
Week
Self –reported adherence ≥ 50%
Self –reported adherence ≥ 90%
4
85% (126/149)
67% (100/149)
8
82% (121/148)
67% (99/148)
13
87% (131/151)
70% (106/151)
26
81% (112/139)
62% (86/139)
39
85% (93/109)
70% (76/109)
52
86% (89/103)
67% (69/103)
Correlates of self-reported adherence
>= 90% Self-Reported Adherence
< 50% Self- Reported Adherence
AOR
AOR
AOR
P Value < 50% Self- Reported Adherence
>= 90% Self-Reported Adherence
1.46
0.178OR (95% CI) AOR (95% CI) AOR
1.49
OR (95% CI)
AOR (95% CI)
AOR
P
Age >=25
Age >=25
2 year degree or higher vs. HS or less
2 year degree or
higher vs. HS or less
2.08
(1.25,3.45)*
1.59 2.48
(1.28,4.80)*
college or
1.11
Some college or vocational vs. HS orSome
1.02
vocational vs. HS or
(0.59,2.08)
less
less
Employed FT vs.
unemployed
Employed FT vs. unemployed
Primary partner
P Value
0.1782
0.48
(0.26,0.86)
0.209
1.59
(0.77,3.28)
0.2090
1.02
(0.52,1.99)
0.9513
1.49
(0.76,2.95)
0.248
Value
0.2482
0.46
0.34
(0.15,0.74)
0.46
(0.18,1.18)
0.1057
1.10
0.951(0.55,2.20)
1.06
(0.46,2.45)
0.8922
0.106
1.06
0.892
1.77
(0.85,3.70)
0.1275
0.34
(0.16,0.76)*
0.76
(0.28,2.04)
0.5801
1.77 1.04
0.128
0.76
1.01
0.966
1.09
0.90
1.01
1.09
0.9663
0.8372
(0.45,1.81)
(0.56,1.95)
(0.52,1.99)
(0.47,2.52)
0.46
0.49
0.0460
3.22
3.30
0.0079
(0.22,0.94)*
(0.24,0.99)
(1.36,7.60)*
(1.37,7.96)
Primary partner
1.71
1.75
0.0179
0.44
0.42
0.0104
(1.09,2.69)*
(1.10,2.79)
(0.24,0.82)*
(0.22,0.82)
* The factors included in the adjusted models are the factors that are <0.05 significance level in the unadjusted
model. Analysis was done using generalized estimating equation with exchangeable covariance structure.
The behavioral questions were asked for the past three months at each visit.
Abbreviation: AOR, adjusted odds ratio.
PT or self-employed
vs. unemployed
Poly drug use
PT or self-employed vs. unemployed
Poly drug use
2.66
(1.39,5.11)*
1.46
(0.84,2.54)
AOR P Value
0.580
0.837
0.49
0.046
3.30
0.008
1.75
0.018
0.42
0.010
* The factors included in the adjusted models are the factors that are <0.05 significance level in the unadjusted model. Analysis was done using GEE with exchangeable covariance structure.
The behavioral questions were asked for the past three months at each visit. AOR = adjusted odds ratio.
HTPN 073: Biomarkers of PrEP use
>= 90% selfreported
adherence
TFV
Any drug
FTC
>= 4 days/week
Any drug
>= 4 days/week
(includes undetectable)
Week 8
69% (99/148)
Plasma ng/ml
PBMC
fmol/106
Week 26
Plasma ng/ml
PBMC
fmol/106
69%
77%
64%
63%
72%
63%
76%
63%
68%
62%
60%
56%
63%
57%
68%
56%
54%
56%
67%
80%
61%
68%
62% (86/139)
Plasma ng/ml
PBMC
fmol/106
Week 52
75%
73%
67% (69/103)
Note:
25 participants initiated PrEP after the enrollment.
38 participants permanently discontinued before the last visit (week 52 visit.)
PrEP Uptake
• The median number of male partners in the prior 3 months was 3
• 33% reported a primary partner and 73% casual male partners
• 23 of 24 (96%) men reporting an HIV+ primary partner and 104/120
(86%) of men reporting casual partners with unknown or HIV+ status
accepted PrEP
• Those agreeing to take PrEP utilized a median of 6 C4 sessions
compared to men not accepting PrEP (median 4)
HIV Seroconversions
• Among the 178 men who accepted PrEP as part of
this study, 5 HIV infections occurred resulting in
incidence=2.9 (95% CI (0.9-6.8)) compared to 3 in
men who never accepted PrEP incidence=7.7 (95%
CI (6-22.5))(NS)
• Of the 5 seroconverters who accepted PrEP, 2
reported discontinuing PrEP at 50 and 272 days
prior to seroconversion.
Conclusions
• Providing theory-based, culturally tailored programs can potentially increase
adherence, support program retention and prevent HIV in BMSM
• HPTN 073 demonstrated high uptake of PrEP in BMSM utilizing C4
and suggest
• Consistency between self-report and biological markers for both TFV and FTC
• Supports primary research focus will PrEP be acceptable; will BMSM uptake;
will they utilize – YES!
• Encouraging that in an environment of new modes of PrEP administration
(eg. infusion and injections) oral PrEP for BMSM is a viable strategy for those
not able or willing to use other methods
• These findings help address a vital US public health gap in HIV prevention
Acknowledgements – THANKS!
U.S. Sponsors:
•HPTN 073 was sponsored by the U.S. National
Institute of Allergy and Infectious Diseases, the
U.S. National Institute of Mental Health
(Cooperative Agreement #UMI A1068619; #UMI
A1068617), and the U.S. National Institute on Drug
Abuse, all components of the U.S. National
Institutes of Health.
HIV Prevention Trials Network (HPTN):
• Leadership and Operations Center,
FHI 360
Laboratory Center, Johns Hopkins University
• Statistical and Data Management Center
SCHARP/Fred Hutch
• Network Leadership
Pharmaceutical Partner:
• Gilead Sciences, Inc.
FHI 360
• Scott Rose, Jonathan Lucas, Nikkia Frazier
JHU
• Shauna Wolf
SCHARP/Fred Hutch
• Lynda Emel
Site Staff and Study
Participants