iPrEx :

PrEP for
Men who have Sex with Men

Linda-Gail Bekker
Desmond Tutu HIV Foundation
IAS Vienna 2010
 Today….
• Why Prevention?
• Why PrEP?
• Why MSM?
• Why MSM in Africa?
• Where to from here?
• What else?
 The War on HIV….

• 7400 new infections

daily.
• 5.5 Million in MLIC
need ART
• For every 2 on ART
another 5 infected.
Why prevention must work…
 Management of
genital infections Microbicides
(STIs)
Cervical Barriers

Male
HIV circumcision
PREVENTION
Condoms

Behavioural
Chemoprophylaxis
Counselling and
Testing MTCTp
Vaccines HSV-2 PEP
Test +Treat Suppressive
PrEP
therapy
 Reported Prevention Trials
Efficacy of intervention (Padian,et al:AIDS 2010)

Type Positive Adverse Nil Total

behavioural -* - 7 7
µfinance - - 1 1
diaphragm - - 1 1
Vag microb -* 1* 11 12
PrEP - - 1 1
Male Circ 3 - 1 4
STI treat 1* - 8 9
vaccine 1 -* 3 4
total 5 1 33 39
 Male
circumcision
Not known to
be helpful for
men who have
sex with men
HIV
PREVENTION
Condoms

Behavioral
Counseling and Chemoprophylaxis
Testing
MTCTp
Intensive not PEP
better than
PrEP
standard
have unknown
efficacy
 Partial efficacy

PMTCT (HIVNET 012)

Circumcision (Orange F)

Vaccine (RV 144)

Prep

0% 100%
 Low Utilization of Prevention
Methods
Methods Utilization
• AIDS Education
– Primary Schools 50%
– Secondary Schools 48%
• Maternal to Child Prevention 2-40%
• Sex Workers Outreach 16%
• IDU Harm Reduction 4.3%
• MSM Outreach 11%

USAID, UNAIDS, UNICEF, Policy Project, June 2004

Why Chemoprophylaxis?

• Antiretroviral Drugs
– Inhibit HIV directly
– Prevent mother to child transmission
– Are already formulated and mass produced
• Chemoprophylaxis is a proven concept
– EG: Malaria, TB pneumonia, meningitis
– Perioperative prophylaxis
– A mainstay of prevention if no vaccine
Some Chemoprophylactic Agents
Therapy Year Indication Status

Zidovudine 1987 MTCTp licensed

PEP used
Lamivudine 1995 MTCTp used
PEP used
Nevirapine 1996 MTCTp efficacy shown
Tenofovir 2001 PEP used
Oral PrEP phase II/III
Microbicide phase II/III
MTCTp safety
Emtricitabine 2003 PEP used
Oral PrEP phase II/III
Entry Inhibitors 1st in 2007 PrEP primates
Microbicide primates
Integrase Inhibitors 1st in 2007 TBD TBD
 Trends in reduction of study results over time
1994 1998 2000 2004: HAART
ACTG Bangkok
076 AP/IP ZDV PHPT PHPT-2
ZDV ZDV + NVP
1998
Abidjan
AP/IP ZDV
2002
1999
Transmission (%)

DITRAME +1
PETRA
ZDV + NVP
AZT/3TC

1999 2003:
HIVNET 012 DITRAME +1.1
sdNVP ZDV/3TC+ NVP
PACTG 076
USPHS AZT
Recommendations

80%
decline
PrEP: Back to the Basics

• HIV Infection is The Cause of AIDS

– Not Sex, Not Drugs
– Antiretroviral Agents Target HIV Directly

• People Like Sex

– Pleasure, Intimacy, Company, Livelihood,
Pregnancy
– Prevention is utilized less if it alters sex
AVAC: Turning the page 2010
Post Exposure Prophylaxis
 Why Pre-exposure?

• Pre-exposure dosing increases efficacy

– SHIV exposed nonhuman primates (Garcia Lerma 2008)
• People have difficulty recognizing exposure
– Denial (Schechter JAIDS 2004)
– Substance use
– Imperfect communication with partners
• For those at highest risk
– Pre- and post-exposure periods overlap
 Data from Monkey Studies at CDC:
Prevention of Rectal SHIV Transmission by Chemoprophylaxis with ARVs

100 FTC/Tenofovir (subcut, n = 6)

% Uninfected animals

75
FTC/TDF (oral, n = 6)
p = 0.0075, [HR = 7.8]
50
FTC (subcut, n = 6)
p = 0.021, [HR = 3.9]
25 TDF (oral, n = 4)*
p = 0.3
Control (n = 18)
0
0 2 4 6 8 10 12 14
Number of rectal exposures

Courtesy of Laboratory Branch, DHAP, CDC

See also, Tsai ‘95; Van Rompay ‘99 ‘00 ‘01 ‘04;
Why Tenofovir and/or Emtricitabine?

• Protective in Animals
• Licensed for Human Use
• Excellent Safety Record
• Long Half Life (>48 hours)
• Enriched in Genital Fluids
• No interactions with
tuberculosis treatment or
hormonal contraception
 HIV Reverse Transcriptase
Single stranded RNA

RNA-DNA double helix

DNA Single stranded

Polymerase

Ribonuclease H
 Nucleoside Reverse Transcriptase Inhibitor

Azido side chain

DNA
RNA

Chain termination
 FTC and TDF have Long Intracellular Half Life
Approved Approved Approved Approved Approved Approved Approved
as BID as QD or BID as QD or BID as QD or BID as QD or BID as QD as QD

50 **
>60
45
40
35
T1/2 (hours)

30
25 24 hours
20 ‡ *
15
12 hours
10
* §
5
0
ZDV d4T ABC 3TC ddI TDF FTC
Serum/Plasma half-life Intracellular half-life

†
Data from Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002;51(RR-7):1-64 unless otherwise noted
*Anderson et al. AIDS 2003; 17(15):2159-2168. ‡Piliero et al. 43rd ICAAC, Chicago, 2003.
** Hawkins et al. 5th IWCPHT, Rome, 2004 § Wang et al. IAC, 2002, poster #4546.
Drug Exposure in the Male Genital Tract
Percent of Blood Plasma Levels
Kashuba et al. CROI 13 Abstract 569 (Vourvahis), 13th CROI
Abstracts 396 (Stekler), Abstract 618 (Katzenstein)

0 50% 100% 150% 200% 500% 600%

APV (20%) NVP (70%) ABC (150%) ZDV (200%) TDF (500%) 3TC (600%)

ENF (ND) IDV (100%)

d4T (2%)

EFV (3%)

SQV (3%)

RTV (3%)

LPV (5%)

NFV (5%)

NRTI PI NNRTI FI
 Preclinical Evaluation of Tenofovir
(TDF) + Emtricitabine (FTC)
• Either FTC or TDF were protective
– 70% to 100% Effective
• Emtricitabine + Tenofovir
– The combination was 100% effective
• After repeated rectal exposures (14)
• Given once prior to exposure, and once after
• Protection probably reflects
– High concentrations in genital tissues and fluids
– Long intracellular half life
– Activity in Macrophages

Tsai ‘95; Van Rompay ‘99 ‘00 ‘01 ‘04; Subbarao ’05; Heneine’06 ‘07 ‘08
 Mitochondrion outer membrane

christae

matrix
ribosomes
DNA polymerase 
Mitochondrial dysfunction with NRTI’s

Figure 1: Mitochondrial Oxidative Phosphorylation

(OXPHOS)
Energy
substrate) NAD Ubiquinone 2 Cytochrome C
(Fe 3+) H2O
+ 2H

Reduced NADH Ubiquinone 2 Cytochrome C ½O2

energy En +H (Fe 2+)
se
Energy release
e
substrate rg
y lea as e
re re rele
le gy rgy
as er En e
e En

ATP synthase

But... ADP + Pi ATP

Abnormal mitochondrial protein inefficient oxphos system

anaerobic metabolism, lactate build-up
 Mitochondrial DNA Depletion

DDI>DDC>D4T>AZT>Abacavir = 3TC = TDF

Birkus, Hitchcock, Cihlar. Antimicrob Agents Chemother 2002
FTC/TDF Toxicity Concerns
• TDF
– Few Case Reports of Renal Failure
– Headache, Dizziness, Cramps, Flatulence,
– Small changes in bone density in HIV positive individuals

• FTC
– Skin or nail discoloration (0-8%; blacks>>Latinos>whites)

• Both
– HBV flare in those stopping
– Lactic Acidosis
• All case reports involve other drugs as well (especially D4T or DDI)
• Monitor anion gap and total CO2
 2007

• Conducted between June 2004 and March 2006

• West Africa
• Daily dose of 300 mg oral Tenofovir DF vs. placebo
• All participants received testing, condoms, and counseling
• Safety evaluated in N=936 including 428 person years
 Findings From the
West African PrEP Study
• Safety in seronegative individuals confirmed
– No increase in grade 1 renal abnormalities
– No grade 2 or greater renal toxicity
– No flares among 23 known to be HBsAg+
• A trend toward efficacy
– 8 seroconversions (2 TDF: 6 Placebo; P=0.34)
– 2 seroconversions after 1 and 2 months of TDF
• No specimens to Rule Out Pre-PREP infection
• No bona fide case of PrEP failure yet documented

Peterson, Plos Clinical Trials, 2007

No TDF Resistance Detected in
TDF PrEP Seroconverter
R Atchison, Resistance Workshop, Barbados 2007
The PrEP Study: Safety, Efficacy,
Behavior, and Biology
Gladstone Institute
of Virology and
Immunology
The Global PrEP Study: iPrEx
Why MSM?

• From 2002 to 2004

– The PrEP agenda did not include MSM
• MSM bear a major burden of the HIV epidemic
– Throughout the Americas
– In at least some parts of Asia
– Burden in Africa is increasingly appreciated
• Efficacy could be different after rectal exposure
– Higher efficiency of transmission
– Possibly different tissue penetration of virus and drug
• PrEP is still the only efficacy study in MSM
Risk of Transmission
Type of contact Transmission Risk (per 10,000)

Receptive anal intercourse 50

Receptive vaginal intercourse 10

Insertive anal intercourse 6.5

Insertive vaginal intercourse 5

Receptive oral intercourse 1

Insertive oral intercourse 0.5

MSM in Sub-Saharan Africa

A neglected but significant population for

prevention research.
Ungass reporting : 2008

35/52 African
countries were unable
to report any
information relating to
MSM indicators
 HIV Incidence by modes of
transmission
(76,315) (74,263) (91,546) (118,279) (11,381) (23,269) (N)
100

80

60

40

20

0
Kenya Zambia Uganda Mozambique Swaziland Lesotho
Percent
Casual heterosexual sex Partners (Casual heterosexual sex)
new Clients of female sex workers
Men having sex with men
infections Partners of clients of female sex workers Injecting drug users
Low risk heterosexual
Other

Sources: Kevin De Cock, PEPFAR Implementers MEETING 2009

Draft results from Know your Epidemic project
 The Challenge of Politics and
Discrimination
• Homosexuality is outlawed in 38 African
countries.
• In 13 nations homosexuality is either legal or
there are no laws pertaining to it.
• Providing MSM focused services, or enrolling
MSM into studies in these countries becomes a
major challenge
Criminalization
 Law Public Opinion

Death
11 yr to life long imprisonment
1 to 10 yr imprisonment
Imprisonment, unstated duration Sources: Ottoman, LGBT 2009
No specific law Pew Global Attitudes Survey 2002
Protective legislation
 Studies with HIV-testing & MSM, 2000-2006
Egypt, 2006:
1%
Senegal, 2005: 22%
Sudan, 2006:
9%

Kenya, 2006:
11%

OR 3.8 (95% CI 3-4)

Baral et al, PlOS 2007
Studies with HIV-testing & MSM, 2000-
2008
6%: Egypt
Mauritania: 19% 8 - 9%: Sudan (2)

Senegal (2) : 22% 11 - 25%: Kenya (2)

Mali: 37%
12%: Zanzibar
Cote D’Ivoire: 19%
Ghana: 25% 33%: Zambia

Nigeria (2): 13 – 14 %
21%: Malawi

Namibia: 12%

Botswana: 20% 10 - 38%: South Africa (5)

A Smith, et al.Lancet 2009 HIV prevalence : Country (number of studies)

 Data from 4 sites in SADC

• Namibia
– The Rainbow Project
(TRP)
• Botswana
– Botswana Network on
Ethics, Law and
HIV/AIDS (BONELA)
• South Africa
– DTHF
• Malawi
– Center for
Development of
People (CEDEP)
 4 sites : Results
Characteristic Malawi Namibia Botswana RSA

Age 25 24 26 26

HIV 21.4 12.4 19.7 26

prevalence
>30 yrs 35 31 46 36
(township)
Cape Town Township study
200 MSM in informal venues in Nyanga,
Khayelitsha and Athlone and Mitchells Plain

Oraquick HIV prevalence

Short questionnaire
HIV Prevalence : CT township
40
35 MSM
30
25
% 20 males
15 females

10
5
0
15-19 20-29 30-39 40-49 50+

AGE
Soweto men’s study: Results

• N=378 (including 15 seeds)

• Soweto MSM population estimates:

• 16.1% gay-identified
• 33.6% bisexual-identified
• 43.2% straight-identified

• Crude sample HIV prevalence: 23.9%

• Adjusted HIV prevalence estimates:

13.2% overall; 34.0% gay-identified
Context, IAVI-supported studies,
Mombasa
Population: 1 million

Multiple ethnic and religious

groups

Local economy reliant on sea port

and international tourism

MSM and MSM sex work reported

in anthropology literature in
1960-80s
Gill Shepherd, 1987

Adult HIV prevalence (coast):

7.9%
Kenya AIDS Indicator Survey, 2009

21% of new HIV infections

attributed to ‘MSM & men in
prison’

Kenya Mode of Transmission Model, 2008

 The iPrEx Study
• Enrolled ~2500 High Risk MSM
• Daily Oral PREP
• Randomized 1:1 to FTC/TDF vs Placebo
• Followed on Drug for:
– HIV seroconversion
– Adverse Events (especially renal & liver)
– Metabolic Effects (Bone, Fat, Lipids)
– HBV Flares among HBsAg+
– Risk Behavior & STIs
– Adherence
– If infected
• Drug Resistance
• Viral load
• Immune responses & CD4 Count
 Ethnicity
black
coloured
white

Location

60

50

40

30 township
metro

20

10

0
township metro
 MSM Sensitivity Training For
Health Workers
• 120 HIV Counselors,
trainers, and coordinators
trained between Jan –
April 2010

– Partners include: city

health services, metro
district health services, and
NGO’s providing HIV
Counseling, testing, and
support in the Western
Cape
Adherence

• Measured by
– Quarterly Computer Assisted Survey
Instrument (CASI)
– Monthly Self Report to Counselor
– Pill Count
• Improves After First On-Study Drug Visit
• Individualized Counseling Strategies Used
– People Go From Pharmacy to Counseling
• Periodic Blinded Drug Levels
Timelines for PrEP Trials
 PrEP Issues

• Risk Compensation
• Costs
• Drug Resistance
 Protect or Disinhibit?
Jon Cohen, The New York Times Magazine, January 22, 2006

“…behavioral disinhibition:
what if fear of HIV declined
in people who took the
drug, and they then
skipped using condoms or
increased their number of
sex partners?”
What Do we see?
 Reported
Risk Behavior
Declined
With
Open-Label
Post-Exposure
Prophylaxis
and
Counseling

Martin et al., AIDS 2004

 Sexual Behavior during PREP Trial
Screening Follow-up
Number of partners 21 14
(30 days)
Number of new 11 6
partners (30 days)
Number of sex acts 12 15
(7 days)
Condom use 52% 94%
(last act)

Peterson, Plos Clinical Trials, 2007

Why No Risk Compensation?
 Proposed Explanations For Declining Risk
Behavior During PREP
• “…intense and consistent HIV/STI prevention
services and messages were provided…”
• “…taking a pill every day for HIV prevention
may have served as a timely reminder of
imminent HIV risk…”
• Participants become members of a
prevention community

Peterson, Plos Clinical Trials, 2007

 Analyses of Cost Effectiveness
(Grant et al, Toronto 2006; Abbas et al, Plos One 2007,
Paltiel CID 2009)

• PrEP Would be Cost Effective ONLY If:

– Efficacy is High (>60%) AND
– Used By High Risk Groups (>2% incidence) AND
– Risk Compensation is Small AND
– Monitoring For Safety Is Manageable AND
– Drug Resistance is Not Common AND
– Price of Drug is Less Than Now (Paltiel CID 2009)
• Intermitant Dosing Lowers Drug Costs
– To 2/7ths or 3/7ths
 Rise of wild virus
Wild virus predominant, Effective ARV’s, Crippled but
again, but large
‘chance’ resistant virus ineffective, non- pathogenic
population of
pathogenic virus
resistant virus
crippled virus

Good adherence,
high drug
pressure

Decreased drug pressure

Wild type virus
as resistance develops
Resistant virus Stop all drugs

time
The evolution of HIV resistance
Resistance and Adherence
Concerns For PrEP
• Starting or Restarting PrEP
– during the RNA+/Ab- window
– Expected to select resistance
• Non-adherence to the daily regimen
– Unclear effect on resistance
– Depends on efficacy, drug levels, selection
• Fear of resistance drives a high bar
– People who miss doses may give up
– People who miss doses when highly exposed
may be told to give up (both sex and PrEP)
The Importance of adherence

• PrEP is a Behavioral Intervention

– Requires Adherence
– Could Alter Risk Behavior
• Behavior is Complicated
– Especially Sexual Behavior
– Numbers of partners, types of partners,
practices with each partner
 Questions Not Addressed In
Current PrEP Research Program

• Dose Optimization
– Intermittent PrEP Studies Planned
• Long Term Safety
• Efficacy in Adolescents
• Treatability of PREP Failures
• Synergies and Antagonisms
• When to Start? When to Stop?
• How to Recruit? How to Counsel?
 MTN 003/VOICE
Global iPrEx in MSM
CDC Thai IDU
CDC US MSM Safety
CDC Botswana Heterosexuals

FHI FEMPREP Africa

 PrEP Trial Portfolio
• All recommend daily dosing
• Limited Cell Specimens
– iPrEx and CDC Studies
– Every 6 months and SC at best
– Not Expected to Identify a
Surrogate Marker of Protection
• Dose Optimization Will Remain
a Key Unanswered Question
PrEP Counseling for
Intermittent Exposure
The Rationale For
Intermittent Dosing
 FTC and TDF have Long Intracellular Half Life
Approved Approved Approved Approved Approved Approved Approved
as BID as QD or BID as QD or BID as QD or BID as QD or BID as QD as QD

50 **
>60
45
40
35
T1/2 (hours)

30
25 24 hours
20 ‡ *
15
12 hours
10
* §
5
0
ZDV d4T ABC 3TC ddI TDF FTC
Serum/Plasma half-life Intracellular half-life

†
Data from Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002;51(RR-7):1-64 unless otherwise noted
*Anderson et al. AIDS 2003; 17(15):2159-2168. ‡Piliero et al. 43rd ICAAC, Chicago, 2003.
** Hawkins et al. 5th IWCPHT, Rome, 2004 § Wang et al. IAC, 2002, poster #4546.
 Design SHIV
exposure

GROUP 1
(n =6)
-22h +2h

GROUP 2
(n = 6)
-3 days +2h

GROUP 3
(n = 6)
-7 days time +2h

GROUP 4
(n = 6) -2h +22h
GROUP 5
(n = 6) *
+2h +26h

CONTROLS
(n = 9)

* Virus challenges every 2 weeks

Gerardo Garcia-Lerma et al
 Risk reduction with iPrEP with oral Truvada
% Uninfected macaques

100 -22h/+2h HR = 16.7, p = 0.006

-3 days/+2h HR = 15.4, p = 0.008
-7 days/+2h# HR = 9.3, p = 0.003
75
Daily* HR = 9.9, p = 0.0 02

50
+2h/+26h (PEP) HR = 4, p = 0.03
-2h/+22h HR = 4.1, p = 0.02

25

0 Untreated controls (n=32)

(9 real time and 23 historical)
0 2 4 6 8 10 12 14
Number of rectal exposures

Cox proportional hazard model

# Interim results for the -7d/+2h arm; animals on

follow-up after completing the 14 challenges

*
Garcia-Lerma at al., PLoS Med 2008
Absence of drug resistance in macaques failing
iPrEP with oral Truvada (2 weekly doses)
1800 DM91 DM92X
Log10 RNA copies/ml

8 8 8
6 6 6
wt
4 4 wt
4 wt
2 2 2
0 0 0
0 4 8 12 16 20 0 4 8 12 16 20 0 4 8 12 16 20
Weeks Weeks Weeks

DK40 DL6V 35032

8 8
Log10 RNA copies/ml

8
6 wt 6
6 wt
wt
4 4 4
2 2 2
0 0 0
0 4 8 12 16 20 0 4 8 12 16 20 0 4 8 12 16 20
Weeks Weeks Weeks

Wild type Not tested

 Hypotheses and Aims
• Non-daily versus daily dosing may:
– Increase acceptance
– Increase adherence (to recommended usage)
– Decrease adverse events
– Increase tolerance
– Decrease costs
– Decrease the risk of drug resistance
– Be sufficient for protection
• Event-driven vs time-driven dosing
– May increase “agency” or “self-competence”
– May increase anxiety
• Identify surrogate markers of protection
– Minimum protective concentration of drug
– Hair vs intracellular PBMCs
– FTC-TP vs TDF-DP
 PrEP Counseling for
Intermittent Exposure Overview

• Factorial Randomized Phase IIB

• Randomized 3:1 to TDF/FTC vs Placebo
• Randomized 1:1:1 to Open Usage Groups
– Daily
– Time-Driven (3 times weekly)
– Event-Driven (pre- and post-exposure)
 Measurements
• Adherence
• Usage Arm Switch at 12 weeks
• Sexual Behavior
• Drug Levels
• Adverse Events and Tolerance
• HIV Seroconversion Events
• Drug Resistance, VL, CD4
• Costs (research and service)
Sample Size and Followup

• 2400 people
– 1200 MSM
– 1200 Heterosexuals
• 800 women
• 400 men
• Recruited over 72 weeks
• Followed for at least 24 weeks
 So-what if something works?
• In well designed and well run studies
• With robust results
• That show sufficient reduction in
acquisition
• To be deemed effective as well as
efficacious
• That can be rolled out to trial participants?
What then?
Future for Prevention Research
• Before we have the “small pox equivalent”
vaccine against HIV

• Just as research money “flat lines”

• the job just got harder and more

costly…….
 Since it got harder- we gotta get
smarter….
• Principle 1: Trial participants must receive the best
available (evidence based) standard of prevention.
• Principle 2 : prevention in the future will be drawn from a
menu-combo prevention already exists
• Principle 3: this may be an opportunity to design more
creative, broader clinical trials with innovative methods.
• Principle 4: this behoves us to really know volunteer
populations:
– Accurate incidence estimations with modeling input
– Accurate risk measurements
– Accurate Adherence measurements
– Good idea of preference/acceptability/feasibility
Incidence Adherence

(Padian)
The challenge is an opportunity
• Prevention research will need to move beyond
the silos and cabales
• Vaccine, Microbicide, T+T, behavioural, PrEP,
Circumcision, etc should get into one room when
trials are designed.
• Social Scientists, epidemiologists, modelers,
basic scientists, clinical trialists and clinicians
need to be on the team.
• We should consider a variety of innovative trials
design methodologies that take into account the
need to test more than one modality or
combination.
 PREP in Non-Human Primates
Garcia-Lerma et al

• Decreased plasma RNA level after

seroconversion during PREP
• Appears to persist after PREP stops
• Immune correlates being sought
• SIVmac239 in macaque monkeys causes high viral
load and simian AIDS in 1 year.
• Tenofovir dosing from 1-28 days after exposure
– caused durable decreases in viral load.
– Partial protection during viral rechallenge.
– Some antiviral immune responses.
Exposed Seronegatives
Douglas Nixon and Ann Erickson with iPrEx team

• PrEP Participants start as

exposed seronegatives:
– Anti-HIV immune responses
were detected in 4/20
– An antiviral clone was
derived in one
– No viral RNA (<2 copies)
• iPrEx will test whether:
– PrEP increases the
occurrence of immune
responses without systemic
infection
– Whether such immune
responses alter the course of
infection
 Other possibilities…
• PrEP in a vaccine trial may attract
participants who make up a subpopulation
with higher HIV incidence
• On the other hand, PrEP may reduce viral
load sufficiently for the immune response
in a vaccinated individual to abort
infection.
 Thanks to
• Bob Grant, Pedro and the iPrEx Team
• Ben, Andrew and Mens Division, DTHF
• Glenda Gray and Eduard Saunders
• Others whose slides and work we have
described.
• The thousands of volunteers who are
currently involved in evaluating PrEP.
MSM in SSA represent a concentrated
epidemic within a generalized epidemic.
HIV rates are higher than HS background.
They too, urgently need ways to protect
themselves from HIV.
Men CAN be reached and WILL volunteer.
Authentic community engagement key.
Final word:
“I would never worship a
homophobic God.”

Archbishop Emeritus Desmond Tutu