hiv self-testing and linkage in africa

HIV self-testing and linkage in Africa

8th IAS Conference on HIV pathogenesis, treatment and prevention– Vancouver

22nd July 2015

Dr Peter MacPherson MBChB PhD

Outline of presentation

1. Need for HIV self-testing in Africa

2. Completed and planned studies in Africa

3. Ongoing and planned studies

4. Priority areas for future research

What is HIV self-testing?

WHO HTS Guidelines 2015

An individual:

• Collects a specimen• Performs a test

• Interprets the result by him/herself

• (Often in private)

Models of HIV self-testing


Open access Semi-restricted Clinically-restricted

Supervised HIVST

Unsupervised HIVST

Community health worker distribution, with supervision

Supervised by a health worker in fa-cility

Over the counterKiosk/vendingInternet

Community health

worker distribu-tion, without supervi-sion

Clinic distribution without supervi-sion

A positive HIV self-test always requires additional testing and linkage to care


Test for triage in community

A0

A0: positiveA0: negative

Report negativeRetest as needed

Link for confirma-tory

testing, care, treatment, preven-

tion

Link to prevention services

Why do we need HIVST in Africa?

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Proportion who report testing for HIV in last 12 months, and know their status

Women Men

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

CameroonCongo (Brazzaville)EthiopiaGhanaKenyaLesothoMadagascarMalawiMozambiqueNigeriaRwandaSenegalTanzaniaUgandaZimbabwe

Staveteig 2013

Why do we need HIVST in Africa?

R Baggaley WHOUNAIDS Gap Report 2014

PLWHIV PLWHIV who know their status

PLWHIV on ART PLWHIV virally suppressed

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100% 90%90%

90%

45% 39%

29%

100% HIV testing gapHIV treatment gap

ART outcome gap

PLWHIV PLWHIV who know their status

PLWHIV on ART PLWHIV virally suppressed

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

HIV self-testing complements a strategic mix of HIV testing services

Facility-based HIV testing

services

Clinical settings Other settings

VCT

Drop in for key pops

ANC

TB

Outpatients

Other (STI)

Community-based HIV

testing services

Door-to-door

Index

Events

Workplace

Schools

WHO 2013

Primary HIVST research in Africa

Qualitative/survey

Cross-sectional

RCT

Modelling

14

10

5

2HIVST.org

2005 2007 2010 2011 2012 2013 2014 2015

1 1 13

1 2

16

5

General popu-lation

Health workers

Key populations

Policy makers

Young people

20

6

2

2

1

Completed or on-going

HIV self-testing studies in Africa

Qualitative/surveyModellingCross-sectional

Kalibala, Pop Council 2011(n=842, health workers)

90% HIVST kit uptake

Pant Pai, PLOS One 2013(n=251, health workers)Innovative internet and

smartphone support

Cambiano, JID 2015HIV synthesis model

Up to $75 million saved7000 DALYs averted over

20y

hivst.org

RCTs

Malawi

Population 16.4 millionAdult HIV prevalence 10.8%

Life expectancy at birth 55 years

Below $1.25/day 62%Strong National HIV Programme

770,369 New ART initiations to Dec 201473% pregnant women on Option B+ (Q4

2014)

Blantyre

Population ~660,000Adult HIV prevalence 18.5%

Identifying the need for HIVST & improved linkage

HIV care cascade - Blantyre, Malawi

Attended clinic HIV tested HIV positive Completed eligibility assesment

Eligible Initiated ART0

500

1000

1500

2000

2500

3000

3500

Attended clinic

HIV tested

HIV Positive

Eligibility assessed

ART eligible

ART treated

20,00018,021

13%

19% 53% 75% 75%

Number of

adults

MacPherson PLOS One 2012MacPherson TMIH 2012MacPherson JIAS 2013

Initial feasibility and accuracy of community-based HIVST

Accurate result first time

Own result "definitely correct"

Needed help

Made error

0% 20% 40% 60% 80% 100%

99.2%

96.5%

10.0%

10.0%

Feasibility study (2010), Blantyre

- Sensitivity: 97.9% (88.7 - 99.9%) - Specificity: 100% (98.3 -100%)

• 92% uptake

• 100% would recommend to friends and family

• 94% would accept self-test kits from a neighbour

Oral self-testing immediately followed by confirmatory blood tests (n=298)

Choko PLOS Med 2011

Effectiveness of HIVST and linkage to care interventions

HitTB Study, Blantyre, Malawi

28 neighbourhoodsTB active case finding

(n=34,456)

14 neighbourhoodsHIVST & linkage

(n=16,660)

14 neighbourhoodsFacility HTC(n=17,796)

Randomised

Bacteriologically-confirmed TB case notification ratesPrevalence of undiagnosed and untreated HIV

(Adult non-traumatic mortality)(Population prevalence of viraemia >1500 copies/ml)

PI: Liz Corbett

Cluster allocation

Volunteer-delivered community HIVST

MacPherson, JAMA 2014MacPherson, Amer J Epidemiol 2013Choko, PLOS Med 2011Choko, PLOS Med In Press

Total adult population: 16,660

Uptake of HIV self-testing in months 1-12 by gender

1 6 12 1 6 12 1 6 12 1 6 12 1 6 120%

25%

50%

75%

100%WomenMen

16-19y 20-29y 30-39y 40-49y ≥50yAge group

Month

Overall 1-12m: 76% of adult population self-tested

35% first time testers Choko, PLOS Med In Press

Uptake of HIV self-testing in months 13-24 by gender

Choko, PLOS Med In Press

16-19y 20-29y 30-39y 40-49y ≥50yAge group

Month

Overall 13-24m: 74% of adult population self-tested

19% first time testers

13 18 24 13 18 24 13 18 24 13 18 24 13 18 240%

25%

50%

75%

100%WomenMen

Preference for next HIV test


(n=11,389)

VCT centre/hospital

Home VCT by counsellor

Self-testing from counsellor

Private self-testing

0% 10% 20% 30% 40% 50%

Women Men

Concordance 99.4% (98.9-99.7)

Sensitivity* 93.6% (88.2-97.0)

Specificity 99.9% (99.6-100.0)

Accuracy of HIV self-testing in Blantyre

n=1649 randomly sampled individuals

*4/9 false negatives taking ART


Adverse events


Self-completed questionnaires (n=10,017)

2.9%

97.1%

Coerced to test

Highly satisfied with HIVST

Would recommend to friends/family

0% 20% 40% 60% 80% 100%

94%

92%

Male sex and couples testing associated with

reported coercion

Adverse events


Community key informant system (4 per cluster)- all deaths investigated by verbal autopsy

Months 1-12

Event Number of eventsSuicides 1 Not self-tested

Murders 4No temporal relationship to HIVST

Intimate partner violence episodes 0

Couples and older people: qualitative studies

Kumwenda AIDS Behav 2014Meghij (submitted)

Couples HIVST dynamics• Convenient and confidential

• Women able to influence mens’ decision to self-test, but not to modify sexual

PRISM:Partnerships in Self-testing in Malawi

Nic Desmond, Moses Kumwenda

Older people• HIV a disease of young, irresponsible people

• Narrative of non-sexual HIV transmission emerged to explain HIV diagnoses (social standing and expectations)

• Oral fluid tests (cf. blood) less trusted by older individuals

• Need for age-appropriate campaigns and interventions

Jamilah Meghij

Overall estimates of linkage into care


Accessed HIVST (months 1-12)13,966

Reported positive result

12% (26% on ART)

Attended HIV clinic56% (of not on ART)

CD4 measured80% (66%<350)

Reported result to counsellor

76%

Bypassed study clinic???

Improving linkage into HIV care

Optional home initiation of HIV care

28 neighbourhoodsTB active case finding

(n=34,456)

14 neighbourhoodsVolunteer-provided HIVST

(n=16,660)

14 neighbourhoodsFacility HTC(n=17,796)

Randomised

Bacteriologically-confirmed TB case notification ratesPrevalence of undiagnosed and untreated HIV

(adult non-traumatic mortality)(Population prevalence of viraemia >1500 copies/ml)

PI: Peter MacPherson


14 neighbourhoodsVolunteer-provided HIVST

(n=16,660)

MacPherson JAMA 2014

7 neighbourhoodsOptional home initiation of HIV

care(n=8194)

7 neighbourhoodsFacility-based HIV care

(n=8466)

Randomised

ART initiations (6m)HIVST uptake (6m)

Reporting of positive HIVST results to counsellor (6m)Loss from ART (after 6m)


MacPherson JAMA 2014

Home HIV self-testReported positive HIVST

to counsellorRequest home visit

Visit 1 (~3 days):Confirmatory testingWHO clinical stage

Blood for CD4TB screening, CPT, IPT

1st education

Visit 2 (~7 days):CD4 result

2nd educationHome ART initiation if:

- CD4<350- WHO 3/4

- Pregnant/breastfeeding

Attendance at HIV care clinic

HIV clinic appointment

made

Optional home initiation of HIV care after HIVST significantly increased population ART initiations over 6-months

MacPherson, JAMA 2014

Optional home initia-tion

Facility initiation0.0%

0.6%

1.2%

1.8%

2.4%

3.0%3-times increase

Risk ratio 2.94 (2.10-4.12)

Percentage of adult population(n=16,660)

n=181

n=63

Effect on HIVST uptake, reporting and loss


181

63

Home group Facility group

n=8194% or rate per 100 person-months

n=8466

% or rate per 100 person-months

Risk or rate ratio k

ART initiations

Unadjusted 181 2.2% 63 0.7% 2.94 (2.10-4.12) 0.15

Adjusted 2.44 (1.61-3.68)

HIV self-tests 5287 64.9% 4433 52.7% 1.23 (0.96-1.58) 0.23Reports of positive HIV self-tests to counsellors 490 6.0% 278 3.3% 1.86 (1.16-2.97) 0.50

Loss from ART (if initiated)

Unadjusted 52/181 63.4 15/63 53.5 1.18 (0.67-2.10)

Unadjusted 1.18 (0.62-2.25)

Economic costs of HIV testing

HIVST Facility HTC 1 Facility HTC 2 Facility HTC 3$0.00

$2.00

$4.00

$6.00

$8.00

$10.00

$12.00

$14.00

$16.00

User cost

Health provider cost

2014

US

Dol

lars

Maheswaran et al (IAS Late Breaker Poster #MOLBPE28)

Societal cost per individual tested


Cost of OraQuick kit US$ 4.40Cost of finger-prick kit US$ 0.69

Priorities for HIVST research in Africa1. Development and evaluation of new technologies to

facilitate HIV self-testing and stimulate market

2. Development and evaluation of “context-appropriate” tools to improve accuracy in hands of intended users

3. Evaluation of HIVST implementation in wider ranges of populations, settings and models (esp. older men, key populations)

4. Evaluation of new models to improve linkage to care (e.g. cellphone technologies, comprehensive home care, incentives)

5. Improving policy and regulation

Ongoing and planned studiesInvestigator Location Population Design Primary outcomes Reference

Choko Blantyre, Malawi

Pregnant women

attending ANC and their partners

Adaptive trial design RCT

Partner-uptake of HIVST and linkage Planned (2016)

Thirumurthy Kisumu, Kenya

FSWs, pregnant and postpartum

women and their partners

Pilot-> RCT Partner uptake of HIVSTIAS 2015 late

breaker #MOAC03

Kahn Agincourt, South Africa

Young women and their partners

RCT Uptake of HIVST, linkage Planned (Sept 2015)

El Sadr LesothoIndex case and partners from ANC, TB and HIV clinics

Pilot -> RCT Acceptability of HIVST among partners CROI 2015

Napierala Mavedzenge

Harare, Zimbabwe

HTC clinic attenders

Cross-sectional

Accuracy, optimization of materials

IAS 2015 abstract

#MOPDC01

Mkwamba South Africa Clinic atttenders

Cross-sectional Uptake of HIVST IAS poster

STAR team/PSI

Malawi, Zambia,

Zimbabwe, South Africa

General pop.Key pops

Implementation & RCTs

Uptake, harms, costs, policy and guidelines

Planned (Aug 2015)

Uptake: first time & re-testing

Equitable HTC coverage

Social Harms

User demand & preferences

Value for Money

HIV prevention (esp. VMMC)

Equitable ART coverage

Impact

STAR Project (PSI/UNITAID) – Aug 2015)Malawi

600,000 HIVST episodesZimbabwe

1.4 million HIVST episodesZambia

600,000 HIVST episodes

Diagnostic Accuracy Optimised instructions-for-use. Accuracy studies

Qualitative and economic studies: General and Key Populations

Impact evaluation of multiple different delivery models• Malawi: 10 intervention and 10 matched control communities• Zimbabwe: randomised trial of 80 intervention-control areas• Zambia: before-after HIVST in 30 established outreach sites

All countries will evaluate• Safety, unintended consequences

• Demand for ART and VMMC as well as HTC coverage

Community reporting systems. Long-term follow-up with sex workers

Market size, Cost-effectiveness, Decision / SPECTRUM Modelling

Target Pops Rural & periurban communities. Urban sex workers

Acknowledgements

Liz CorbettAugustine ChokoNic DesmondEmily WebbBarbara WilleyJoep van OosterhoutHendy MaheswaranRichard HayesStavros PetrouSimon MakombeGift RadgeJofrisi JofrisiWezi MukakaJoseph PhiriJoseph MsimukoRodrick SambakunsiMoses KumwendaWisdom ShongaEddie MandaDaniel MwaleAaron MdoloGeoffery ChipunguDeus ThindwaDavid LallooBertie Squire

Study participantscommunity membersand health providers.Ministry of Health of Malawi

hiv self-testing and linkage in africa

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