Strong Communities
Equity, Opportunity and Access
Track 1: Understanding the Dynamics of HIV Prevention &
Care in LGBT Communities of Color
Program Goals
The goal of Strong Communities is to increase the utilization of
current HIV prevention, treatment, and care services in
community health centers by Black and Latino gay and bisexual
men and transgender women.
To achieve this goal, the Strong Communities program will focus
on building the capacity of community-based organizations and
community health centers that serve Black and Latino gay and
bisexual men and transgender women to promote and provide
quality HIV-related services and to work collectively to meet the
HIV-related needs of the community.
Training Objectives
1. Increase participants’ knowledge related to HIV prevention,
treatment, and care;
2. Increase participants’ knowledge of healthcare disparities
and social determinants that impede community health;
3. Increase participants’ motivation to address social
determinants that impede community health and drive
healthcare disparities;
4. Increase participants’ awareness of the available primary
care and preventive services available through local
community health centers; and
5. Increase participants’ likelihood to refer their clients to
community health centers for primary care and preventive
services.
The Central Actions of the
Immune System
KEEP IT OUT
if it doesn't belong.
ELIMINATE IT
if it gets in.
REPAIR IT
if it’s broken.
CONTROL IT
if we have to live with it.
The Immune System’s HIV Army
CD4 T cells regulate the
immune system. (The General)
B cells make antibodies.
(The Soldiers)
Antibodies coat or neutralize
germs. (The Weapons)
The “T” in “T cells” stands for thymus, the place in the body where the cells are made.
A CD4 count of . . .
Means you are at . . .
Less than 200
Highest risk for infections
Between 200 and 350
High risk for infections
Between 350 and 500
Increased risk for infections
More than 500
Low risk for infections
THE GOAL
How Does HIV Make You Sick?
1st HIV turns an infected CD4 T cell into a HIV factory.
• HIV can make billions of new virus copies a day.
2nd HIV makes so many copies of itself that the cell eventually
breaks down and dies.
3rd As more CD4 T cells die, the immune system gets weak.
4th A weak immune system makes it hard for the body to fight
germs and avoid infection.
How To Measure
Immune System Health
Test 1: Viral Load- tells how much HIV is in the blood.
• Lower viral load = fewer viruses that are attacking cells and
causing damage
Test 2: CD4 count- tells how many CD4 T cells are in the blood.
• Higher the CD4 count, the better the immune system is able to
fight infections
Understanding HIV Meds
• HIV regimens (3 or more drugs)* are called HAART (Highly
Active Antiretroviral Therapy).
• Each individual medication is an antiretroviral (ARV)
• “Antiretroviral therapy is recommended for all HIV-infected
individuals.”
• Although there is no cure, HIV can be treated with medicines.
• ARVs stop the virus from making copies of itself.
DHHS HIV/AIDS Treatment
Guidelines for Adults/Adolescents
• Antiretroviral therapy (ART) is recommended for all HIVinfected individuals, regardless of CD4 cell count.
• ART is also recommended for HIV-infected individuals to
prevent HIV transmission.
• On a case-by-case basis, ART may be deferred because of
clinical and/or psychosocial factors, but therapy should be
initiated as soon as possible.
When to start?
Results for randomized controlled trials START and TEMPRANO
were recently published, both demonstrating that the clinical
benefits of ART are greater when started early, with pretreatment CD4 counts >500 cells than when initiated at a lower
CD4 cell count threshold.
START
• Risk of developing serious illness or death was reduced by
53% among those in the early treatment group, compared to
those in the deferred group.
TEMPRANO
• Starting HIV treatment at CD4 count above 500 reduces the
risk of serious illness and death by 44%.
The Goals of Therapy
• Reduction of HIV-related morbidity (illness) and mortality
(death)
• Viral suppression
• Immune preservation or reconstitution
• Improved quality of life
• Minimize side effects and toxicities
• Prevent transmission
How do we measure goals of
therapy?
Prolonged
suppression of
viral load
•HIV RNA or viral load
Restoration or
preservation of
immune function
•CD4 T cell count
Improved clinical
outcome
•Physical exam
How do we know if treatment has
failed?
Virologic
failure
• pVL not < 50 by 48 weeks
• pVL rebound > 200 more than once
Immunologic
failure
• CD4 T cell count fails to increase by 50
cells in first year
• CD4 T cell count falls below baseline
Clinical failure
• HIV-related events after 3 months on
treatment
Drug Adherence
• Drug adherence (or compliance) means taking
your HIV medications exactly as prescribed — in
the right number, at the right time, with or
without food, every time.
• To reduce the chance of resistance, it is better to
STOP taking ALL anti-HIV medications than to
take them incorrectly.
• What is resistance?
Life Expectancy
• Life expectancy at age 20 –on treatment– was now equal to US men in the
general population, among heterosexual people with HIV and in white
people. (CROI 2016)
• It was also a remarkable 69 years at age 20 in gay men and people starting
ART before 350 cells – meaning that, if nothing else changed, these
groups, as long as they stay on ART, have a 50/50 chance of seeing their
89th birthday – a full seven years longer than women in the general US
population.
• However, there were notable differences in life expectancy depending
on several factors, including transmission group, race, and baseline
CD4 T cell count.
Life Expectancy
• However, life expectancy for some other groups – most
notably women and non-white people – is still considerably
below comparable members of the general population and
that for people who inject drugs, life expectancy in the era of
antiretroviral therapy (ART) has not improved at all.
• Other factors that increased the chance of death for people on
ART were smoking (50% higher AIDS mortality and 120%
higher non-AIDS mortality in smokers); depression (65% more
non-AIDS mortality and 58% more AIDS mortality); and high
blood pressure (42% higher AIDS and 30% higher non-AIDS
mortality).
Co-Morbidities and
Considerations
The HIV Care Continuum
HIV Treatment in Context
• HIV infection occurs against a backdrop of
longstanding socio-cultural issues and
challenges in affected communities.
• A patient’s social situation can have a
tremendous impact on his or her ability to
access care and adhere to medication regimens.
20
Social Determinants of Health
Factors that limit access to or discourage individuals
from seeking health care, HIV testing, and
medications include:
• Stigma and systematic discrimination
• Language barriers/concerns about immigration
status
• Lack of insurance
• Poverty
22
Social Determinants of Health
Social Determinants
People Living in Poverty
in the U.S. (2010)
People Living with HIV
in the U.S. (2010)
• 10 minutes to discuss
how their structural
barriers impact the
health of people living
with or at risk of HIV.
1. Stigma
2. Employment
3. Housing
4. Education
5. Poverty
6. Incarceration
7. Geography
8. Transportation
9. Age
10. Drug Use
11. Racism
12. Homophobia
24
Activity 1: Social Determinants
Social factors - Treatment Outcomes and
Health Disparities
• HIV is often only one of many conditions that plague
communities at greater risk for HIV infection.
• In many cases, it is not possible to effectively address
HIV transmission or care without also addressing
sexually transmitted diseases, substance use,
poverty, homelessness, and other issues.
25
Blacks More Likely to Die as Result of AIDS
Deaths per 100,000, Ages 25-44
32.9
Blacks
Latinos
White
Black men are 8x more likely to die than
Whites, and 4x more likely than Latinos.
Black women are 19x more likely to die
19.9
than Whites, and 8x more likely than
Latinas.
7.6
4.3
Males
Centers for Disease Control and Prevention. HIV/AIDS Surveillance Supplemental Report. Accessed June 3, 2010:
http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2009supp_vol14no3/pdf/HIVAIDS_SSR_Vol14_No3.pdf.
2.5
Females
1.0
26
Stigma and Discrimination
What is stigma?
CDC defines stigma as a “negative social label that identifies people
as deviant.”
The stigma associated with HIV is such that individuals known to be
or suspected of being infected with HIV may be excluded from their
communities and suffer isolation or abandonment.
What is discrimination?
Discrimination refers to any form of distinction, exclusion or
restriction affecting a person possessing an inherent personal
characteristic, irrespective of whether or not there is any justification
for these measures.
27
Effects of HIV Stigma on Treatment
HIV-positive individuals can suffer significant health
consequences in an effort to avoid stigma:
• They may avoid seeking medical care and social support
services for fear of disclosing status.
• They may not take medication if they fear stigma from
family members or friends.
• They may avoid contact with HIV care providers if they
fear stigma and/or mistreatment by health care workers.
28
Reducing Social Barriers to Improve Treatment
Outcomes
①Increase and improve educational programs to
address stigma, conspiracy beliefs, and medical
distrust;
② Encourage use of support groups, peer educators or
treatment buddies;
③Improving community knowledge of HIV and their
contact with PLWH personalizes the infection and
helps to reduce stigma;
④Implement HIV health literacy initiatives;
29
Reducing Social Barriers to Improve Treatment
Outcomes
⑤ Implement programs and case management services to
address unmet social needs and remove barriers;
⑥ Programs that assist patients with appointment
attendance, housing assistance, and other social services
will help patients access and adhere to treatment;
⑦ Lead the change of opinions and beliefs through the
dissemination of carefully-constructed messages
avoiding stigmatizing words, phrases, and language;
⑧ Require education and training for health care providers
on culturally-competent practices and confidentiality.
30
Substance Abuse and Mental Illness
• Many patients living with HIV also have depression
and/or experience substance abuse.
• Patients with serious mental illness and substance abuse
problems are at particularly high risk of non-adherence
given the associated cognitive, emotional, and
behavioral complications.
• These challenges may affect a patient’s immune system
and susceptibility to disease and infection, leading to a
more rapid progression to AIDS.
• For example, a recent study found that active cocaine use was associated
with a 41% decline in adherence and failure to maintain viral suppression.
31
32
Depression
• As many as 1 in 3 persons with HIV may suffer from
depression.
• Symptoms of depression vary but most health care providers
suspect depression if a patient reports feeling “blue” or having
very little interest in daily activities. If these feelings go on for
two weeks or longer, and the patient also has some of the
following symptoms, he or she may be depressed:
• Fatigue or feeling slow and sluggish
• Problems concentrating
• Problems sleeping
• Feeling guilty, worthless, or hopeless
• Decreased appetite or weight loss
32
33
Hepatitis C Virus
• Approximately, 25% of HIV-infected persons in the US are coinfected with HCV.
• Co-infection with HIV and HCV is common (50%–90%) among
HIV-positive injection drug users.
• In HIV-positive individuals, HCV infection progresses more
rapidly to liver damage.
• There is no treatment for acute HCV infection, but chronic HCV
infection may be treated and cured with existing medications.
• In the US, liver disease is the #1 cause of death for people living
with HIV.
33
34
Tuberculosis (TB)
• The rate of TB for people with HIV in the US is 40 times
the rate for people who are not HIV-infected.
• In a weakened immune system, TB can cause active
disease. Most cases of TB in people with HIV are due to
reactivation of a previous TB infection.
• Globally, TB is the leading cause of death for people
living with HIV.
34
35
Cardiovascular Disease (CVD)
• Cardiovascular disease (CVD) refers to a group of
problems related to the heart (cardio) or to blood vessels
(vascular).
• Approximately 81 million Americans (37%) have one or
more types of CVD and its currently the single leading
cause of death in the US.
• People with HIV have higher rates of CVD than the
general population.
• HIV infection itself increases some CVD risk factors.
35
36
Smoking
• Smoking is more dangerous for people living with HIV because
it weakens the immune system, making it more difficult to fight
off serious infections.
• Smoking can interfere with the liver’s ability to metabolize HIV
medications. It can also worsen liver problems like hepatitis.
• Patients with HIV who smoke may be more likely to suffer
complications, such as nausea and vomiting, from their HIV
medication than those who don’t smoke.
• Smoking may increase the risk of some long-term side effects
of HIV disease and treatment, such as cancer, cardiovascular
disease and osteoporosis.
36
Smoking
Tobacco Is More Dangerous to HIV-Positive Individuals than the Virus
Itself
• A recent study examined the health records of nearly 3,000 Danish
individuals with HIV from 1995 (which was the year antiretroviral
triple therapy became standard) until 2010.
• The study, published in the journal Clinical Infectious Diseases, found
that “a 35-year-old HIV patient who did not smoke was likely to live to
age 78, while one who smoked was likely to die before age 63….”
Comprehensive HIV
Prevention
Risk Factors for Sexual Transmission
The risk of becoming infected with HIV as a result of sexual
intercourse depends on:
• The probability that the sexual partner is infected
• The number of sexual partners
• The type of sexual contact involved
• The amount of virus present in the blood or secretions of
the infected partner
• The presence in either partner of other STIs and/or
genital lesions
Est. Per-Act Risk for Acquisition of
HIV by Exposure Route
Exposure Route
Risk per 10,000 exposures
Blood transfusion
9,000
Needle-sharing (IDU)
67
Receptive anal intercourse
50
Percutaneous needle stick
30
Receptive penile-vaginal intercourse
10
Insertive anal intercourse
6.5
Insertive penile-vaginal intercourse
1
Receptive oral intercourse
1
Insertive oral intercourse
0.5
*Assuming no condom use
Behavioral Interventions
(A)bstinence- refraining from sexual intercourse is the best way to
prevent transmission of HIV and STIs.
(B)e Faithful- if 2 partners are tested for HIV and found to be
uninfected, they may enter into a strictly monogamous sexual
relationship.
(C)ondoms- correct and use of latex condoms with each sexual act
greatly reduce the chances of acquiring or transmitting HIV and other
STIs.
Condoms
The evidence for the effectiveness of condoms is clearest
in studies of serodiscordant couples.
• A recent review of 14 studies involving discordant
couples concluded that consistent use of condoms led to
an 80% reduction in HIV incidence.
• Though highly effective, many people do not use
condoms and due to a number of issues including power
dynamics in sexual relationships, stigma, and a serious
lack of availability.
• According to the Global HIV Prevention Working Group,
only 9% of individuals at risk for HIV infection had access
to condoms in 2008.
STI Treatment as Prevention
• People infected with STIs are 2-5 times more
likely to get HIV if the they are exposed.
• STIs increase the concentration on CD4 cells in the
genital area.
• If HIV-positive, not virally suppressed and also
infected with another STI, that person is more
likely to transmit HIV.
• The concentration of HIV in semen is 10 times higher
in men who are infected with both gonorrhea and HIV
than in men infected only with HIV
Biomedical Interventions
• Treatment as Prevention (TasP)
• PrEP
• PEP
• Microbicides
• Vaccines
“The Swiss Statement”
The statement’s headline statement says that “after review of
the medical literature and extensive discussion,” the Swiss
Federal Commission for HIV/AIDS resolves that, “An HIVinfected person on antiretroviral therapy with completely
suppressed viremia (“effective ART”) is not sexually infectious,
i.e. cannot transmit HIV through sexual contact.”
Treatment as Prevention (TasP)
The HPTN 052 study (RCT) with the primary
objective of evaluating whether HIV treatment can
prevent the sexual transmission of HIV among
couples in which one partner is HIV-infected and
the other is not (serodiscordant couples).
Treatment as Prevention (TasP)
A total of 39 individuals became infected during the study.
 4 in the immediate treatment arm
 35 in the deferred treatment arm
A careful genetic analysis of virus samples from the HIV-positive
partner and the subsequently infected partner was conducted to
determine how many of the infections could be attributed to the
index partners. 11 cases of transmission were unlinked.
In the immediate treatment arm the one (1) verified transmission
took place during the early months of treatment when the
partner had a viral load of 400 and not undetectable (< 200).
Treatment as Prevention (TasP)
With ONLY 1 linked infection, this represented a reduction
in the risk of transmission of 96%, and was highly
statistically significant.
In the News: Treatment is prevention: HPTN 052 study
shows 96% reduction in transmission when HIV-positive
partner starts treatment early
What’s unknown?
• Can we say undetectable = no transmissions?
• Is treatment better than condoms?
• Is this true for oral, vaginal, and anal sex?
• What about intravenous drug users?
• Do co-infections/co-morbidities matter?
Purpose: PARTNER
The PARTNER study was designed to answer some
of the remaining questions after HPTN 052, mainly
does TasP work for gay couples (or rather anal sex).
Results: PARTNER
The main news is that in PARTNER so far there have been
no transmissions within couples from a partner with an
undetectable viral load.
Although some of the HIV-negative partners became HIV
positive, genetic testing of the HIV revealed that in all
cases the virus came from someone other than the main
partner.
Conclusion: PARTNER
When asked what the study tells us about the chance of
someone with an undetectable viral load transmitting HIV,
presenter Alison Rodger said: "Our best estimate is it's
zero.”
In the News: Zero HIV Infections Seen Through Condomless
Sex When HIV-Positive Partner Is on Effective Treatment
PARTNER & STIs
No transmissions occurred despite high levels of STIs,
especially in the gay couples. The PARTNER study may be
telling us that STIs (in either the positive or negative
partner) don’t increase the likelihood of HIV transmission if
the positive partner is on treatment and undetectable
(though of course STIs can still be transmitted themselves).
What do you think: Is the Swiss Statement True?
Can we get to zero?
“TasP is a simple acronym that masks considerable complexity”
Gary Dowsett
For treatment as prevention to work, large numbers of people
who are at risk of HIV infection need to understand that they are
personally at risk; find the idea of testing for HIV acceptable;
and be able to go to trusted, convenient and affordable HIV
testing services. They also need to be willing to test repeatedly,
perhaps once every year (and continue to have access to the
necessary health facilities).
What does it take to get to zero?
 Those who are diagnosed with HIV need to come to terms with
the result and believe that there are benefits to engaging with
health services now, even though they may not feel ill.
 Trusted, convenient, and affordable health services need to be
available.
 Those diagnosed need to stay in touch with their doctors and
nurses, and attend appointments regularly.
 Again and again, they need to overcome the same barriers
which may have made it hard for them to attend a clinic in the
first place – the stigma of HIV, other urgent personal priorities,
difficulties getting to a health service, and so on.
Do we need PrEP?
Why use PrEP if treatment is so effective
(undetectable, 96% decrease)?
Challenges with TLC+: Of the 1.2 million ppl HIV +
 Only 80% diagnoses
 40% Retained in care
 30% Adherent/Undetectable
9 in 10 New HIV Infections Come from People Not
Receiving HIV Care
Who would use PrEP?
Recommended during periods of highest-risk
• MSM
• Sex workers
• Serodiscordant couples (HIV+ partner)
• Prefer that the HIV+ partner be on treatment too
• Concurrent relationship
• Conceptions (HIV+ male partner)
• IDU
• Anyone who wants it*
When to start PrEP
 Adherence is best when taken daily. PrEP (Truvada) CANNOT
be taken immediately before exposure.
 Take 14 days (rectal) and 21 days (vaginal) to reach its
therapeutic dose.
FYI: online survey of 1013 MSM re: last anal sexual experience
 49% unplanned; 51% planned
 17% >3 days; 22% 1-3 days; 45% Hours; 17% Minutes
 83% would of the “Planned” would not have started in
time
How to take PrEP (Truvada)
 Today, PrEP involves the regular administration of Truvada, a
pill which combines 2 HIV meds, tenofovir and emtricitabine.
 Adherence is best when taken daily.
 PrEP (Truvada) CANNOT be taken immediately before
exposure. Truvada takes 7 days to offer protection in the rectal
tissue; 20 days for cervico-vaginal tissue and blood (systemic).
PrEP 1.0: 1-daily oral Truvada
• Potent antiretroviral activity, rapidly active
• Safe & Well Tolerated- substantial treatment safety
experience
• Easy to Use- once daily dosing and few drug interactions
• Potential kidney and bone complications
• With good adherence, clinical data suggests it’s above
90% effective
• PrEP 1.5 Descovy (F/TAF)
• PrEP does not work when it’s not taken.
PrEP 2.0: Long-Acting Injectables
• GSK744 is an experimental injectable integrase
inhibitor (Cabotegravir) being developed as a longacting medication.
• Early data suggest promise for the drug as an HIV
treatment and prevention option with dosing every
8-12 weeks.
• Approval and release is expected in 2019.
PrEP Is NOT
• A treatment for HIV
• Not for people already infected with HIV
• A cure for HIV
• Not for people with adherence challenges*
• Not for people who are unwilling or unable to
receive regular diagnostic monitoring
PrEP Take-Aways
 We have proof that medications used to treat HIV
provide protection against acquiring HIV.
 Truvada is an approved 1st Generation PrEP agent.
 Adherence to PrEP is critical for its effectiveness.
 Successful PrEP implementation requires program
strategies designed to provide support for selfevaluation of HIV risk, adherence support, and
regular HIV testing.
What do you think?
 Surveys show people do not want to get PrEP from HIV
specialists.
 The reason people will use PrEP is so they can stop using
condoms.
 What does that mean for other STI prevention?
 Why would we ask people to take a daily pill for a disease that
requires you to a daily pill, esp. in populations that has
demonstrated low adherence to condoms and risk reduction?
 What are your concerns or what have you heard about PrEP?
Who should take PEP?
• Unprotected or with failed condom use:
• Receptive anal intercourse
• Receptive vaginal intercourse
• Receptive oral intercourse with intraoral ejaculation with known
HIV+ source
• PEP is strongly recommended for anyone who has
unprotected receptive (“bottom”) anal intercourse with an HIV
positive partner or whose HIV status is unknown.
• PEP is rarely recommended for the insertive (“top”) partner or
for oral sex.
Microbicides
• A microbicide is a cream or gel, applied or inserted
pericoitally, that could be used to reduce a person’s risk
of HIV infection vaginally or rectally.
• Microbicides could offer both primary protection in the
absence of condoms and back-up protection if a condom
breaks or slips off during intercourse.
• Women, men, and transgender individuals will all be able
to use microbicides.
• CAPRISA 004 showed 39-54% protection against HIV and
51% protection against genital herpes.
Biomedical Prevention
"Effective interventions require social transformation. Some of
the biomedics seem to fail to understand that people live in
cultural and social worlds." Susan Kippax
 “Efficacy” refers to the impact of a drug or an intervention
during a research study, when extra financial and human
resources are usually available.
 “Effectiveness” describes impact in real-world settings, in
entire populations, and under resource constraints. It tells us
about the results achieved when an intervention is
implemented in a 'normal' healthcare system.
What the Future Holds
• Maraviroc- HPTN 069/ACTG A5305
• Long-Acting Therapies
• Microbicides
• Rings
• Implantable Devices
• Dissolvable Gels/Fibers
• Long-Acting Orals
What’s still needed?
Vaccines are one of the world’s most effective public health tools.
There are no effective HIV vaccines available today.
• Preventive Vaccine: A preventive vaccine would protect
people who do not have HIV from getting it. A vaccine is
necessary, because according to UNAIDS, for every 2 people
we put on treatment 3 more become infected.
• Functional Vaccine: A functional cure is near-complete
immune system control of HIV in the absence f HIV treatment,
HIV could remain dormant in the body, but unable to cause
harm.
• Sterilizing Cure: Every bit of HIV is eradicated from the body.
THANK YOU FOR YOUR PARTICIPATION
Danielle Houston, MSPH
Senior Program Manager, NMAC
[email protected]
202-853-0021