This document summarizes a study enhancing HIV care and treatment for people who inject drugs in Kenya. The study uses respondent-driven sampling to identify people who inject drugs for rapid HIV testing and point-of-care CD4 testing. Those with CD4 counts under 350 are linked to antiretroviral therapy through peer case managers. The study aims to evaluate this intervention, model its impact on community viral load, and assess its cost-effectiveness. Preliminary results show the combination of rapid testing and point-of-care CD4 testing effectively identifies HIV-positive people who inject drugs and links them to treatment. Linkage to care through peer case managers has proven very effective for initiating antiretroviral therapy.

1. ENHANCING HIV CARE AND TREATMENT THROUGH
POINT OF
CARE CD4 TESTING AND PEER SUPPORT FOR PEOPLE
WHO INJECT DRUGS
Eva Muluve, John Lizcano, Helga Musyoki, Martin Sirengo,
Charles M. Cleland, Ann Kurth, Peter Cherutich
6th Conference on Peer Education, Sexuality, HIV/AIDS
June 18, 2014

2. Presentation outline
• Background of the Test and Link to Care for
Injecting Drug Users Study (TLC- IDU Study)
• Study Setting
• Study design, aims and anticipated
outcomes
• Point of Care CD4 testing
• Results
• Conclusion

3. Background
• HIV infections in sub-Saharan Africa
increasingly occur among people who inject
drugs (PWID)
• Needle & syringe programs (NSP) and PWID-
specific ART support have been nearly non-
existent
• Kenya is among the first to implement gov’t-
run NSP at a country-wide level starting in
2013
– We are using Responding-Driven Sampling (RDS)
to seek out PWID, deliver rapid HIV testing,
point-of-care CD4, and peer-supported linkage
to ART
– Will evaluate community viral load impact

4. Study Sites: Nairobi & Coastal
Region
• Seek
– Respondent-Driven Sampling (RDS) to
find PWID
• Test
• Offer rapid HIV test at NSP service sites
(N=10)
• Treat
– Offer point of care (POC) CD4 assay if
HIV+
• Retain
– If HIV+ and CD4+ cell count <350/mm3
provide peer case manager (PCM) for
linkage to care
• Conditional cash transfer to participant &
PCM

5. Study Sites
 Nairobi Region
– Nairobi 1: NOSET – Ngara
– Nairobi 2: NOSET – Racecource/Kawangware
– Nairobi 3: MDM – Kangemi
– Nairobi 4: SAPTA – Pangani
 Coastal Region
– Coast 1: Bomu – Likoni
– Coast 2: Omari Project – Malindi
– Coast 3: MEWA – Kilifi
– Coast 4: Reachout – Oldtown Mombasa
– Coast 5: Bomu Hospital – Changamwe
– Coast 6: Teens Watch – Ukunda

6. Study Aims
Aim 1: Launch and evaluate TLC-IDU using a stepped
wedge cluster randomized design
Aim 2: Conduct mathematical modeling to estimate
community viral load in PWID injecting and sexual
networks and potential population-level impact
Aim 3: Assess incremental cost-effectiveness ratio of
TLC-IDU, compared with standard care

7. Study Design
• Ten sites, respondent-driven sampling, stepped wedge,
repeated surveys, HIV testing, viral load
Data Collection Periods
(6 Months Each)
1 2 3 4 5 6
5
4
3
2
1
Five Pairs of Sites
Randomized
to Start at Different
Times
Intervention
Control
done nowdone

8. Study
Flow
10 Study Sites
PWID informed of study via staff,
RDS, or service site personnel
Informed Consent
Behavioral Survey on
Computer Tablets
Rapid HIV Testing
HIV- HIV+
Point of Care CD4 Test
CD4 <350CD4 ≥ 350
Peer Case Management
Viral Load testing
(n=1,800 total)
GoK standard of care, refer for
services including addiction
treatment as needed
Inclusion Criteria:
 ≥ 18 years
 Live in Nairobi or Coast
 Ever injected any non-
prescribed drugs
 Any non-prescribed drugs
last 12 months

9. Biometrics & Data Management
Eliminates double
enrollment in time wave
Tracks mobility, repeat
services over time, incidence

10. Key Outcomes
• Successful linkage to care
– # days between first test positive and first visit with HIV
provider
• Time to ART initiation
– # days between first test positive and ART initiation
• ‘Community Viral Load’
– Specimens at each site/waves over time from all PWID
who tests HIV+, to document changes in infectivity
(median viral load)
– Using Dried Blood Spot (DBS) for VLs
• Start collecting specimens for phylogenetic analysis

11. Point of Care CD4 Testing
• CD4 test is conducted
for all HIV positive
participants at
intervention sites
• CD4 results are ready in
maximum 20 minutes
• If CD4 <350mm/µl
participant linked to
peer case manager

12. Referral documents

13. Study Periods
• Study Period One
–May 25, 2012 – December 1, 2012
• Study Period Two
–April 22, 2013 – November 29, 2013
• Study Period Three
–January 31, 2014 - Ongoing

14. Recruitment and Demographics
Period One Period Two Period Three*
Screened 1947 1739 1048
Enrolled 1785 1489 984
% Male 86.8 87.9 91.0
% Married/Living as Married 14.2 14.8 14.9
% Nairobi 37.1 41.4 41.3
% Coast 62.9 58.6 58.7
% Mobile 20.1 25.3 22.4
% Participated Before -- 34.5 61.1
* Survey Period Three is in progress.

15. HIV Testing Results

16. Unadjusted HIV Prevalence

17. CD4

18. Viral Load among Participants
with HIV Infection

19. Undetectable Viral Load

20. Clinically Eligible Participants
Retained in Care
N = 2
N = 30
N = 6
N = 2
N = 2
Initiated ART, N = 40
Number of Participant Eligible for ART (N= 42)
Declined Services
Retained in care
Stopped ART
Died
In jail
All participants were linked to ART within 24 hours after testing. Initiation of ARVs took a maximum of 2 weeks.

21. Conclusion
• Combination of RDS and rapid testing effective
strategy for finding PWID with HIV infection,
including those not previously diagnosed
• Use of CD4 POC an effective strategy of determining
eligibility to initiate PWIDs to ART
• Linkage to care by PCMs very effective for ART
initiation
• Relationships built among the PCM, HIV-positive
PWID, and HIV clinic staff have made linking to care
significantly easier and have reduced discrimination
towards PWID

22. Team Members
• NASCOP/MOH KENYA
– Peter Cherutich (PI)
– Study team members
– Helgar Musyoki
– Martin Sirengo
• Expert Advisors, CAB
– Claris Obiero, Elizabeth Ngugi,
Fred Owiti
– Don Des Jarlais, Steffanie
Strathdee
NYU
Ann Kurth (PI)
Chuck Cleland
Scott Braithwaite
John Lizcano
Population Council
Jerry Okal, Scott Geibel
NSP Implementers (NGOs)
Thanks to NIH – NIDA
1R01 DA032080
Redonna Chandler
Shoshana Kahana
Dionne Jones

23. Implementers, Staff, PCMs & Participants
All photos have consent