Health Center of Pho Yen - HIV Prevention Trials Network

Overview of Vietnam Site
PRESENTATION OVERVIEW
 HIV and PWID in Vietnam
 Study organizational structure
 Description of Pho Yen Center Health District
 Study strategies
HIV PREVALENCE IN VIETNAM
70% of HIV in Vietnam attributed to injecting
drug use
HIV prevalence in Vietnam
 General population - 0.04%
 People who inject drugs (PWID) – 18%
 (27% in current research in Thai Nguyen)
 Men who have sex with men – 17%
 Sex workers – 3%
PWID IN VIETNAM
 Traditionally opium, now heroin due to
price/availability
 210,000 PWID in Vietnam (207% increase since
2000)
 Government response
• Social Evils Campaign
• 30% of PWID involuntarily placed in Detoxification
Treatment Centers (DTC)
• MoH recent emphasis on harm reduction
DRUG TREATMENT SERVICES IN VIETNAM
Detoxification Treatment Centers (DTCs)
• Static
 136 centers in 63 provinces
Methadone Maintenance Therapy
• Expanding
 2008: first clinics in Ho Chi Minh City and Hai
Phong
 Present: implemented 20 cities/provinces with 60
MMT clinics and 12,000 clients
HIV SERVICES IN VIETNAM
 Needle exchange program
• Government administered, internationally-funded
• Coverage: 65% districts
 Condoms
•
distributed through health centers (Global Fund)
 HCT (HIV counseling and testing)
• 317 sites in 58 of 63 provinces
 ART
• ART roll out initiated (2005)
• 44,871 individuals on treatment (through 2010)
• Universal access (Global Fund)
CHALLENGES IN ACCESSING SERVICES
AMONG PWID
Despite availability of ART, in Thai Nguyen:
 23% of PWID have received HCT
 11% have received both an HIV test and results
 Among ART-eligible (CD4< 250), only 27% on ART
 At MMT initiation
• 67% unaware of status
• approximately 35% HIV-infected
PRESENTATION OVERVIEW
 HIV and PWID in Vietnam
 Study organizational structure
 Description of Pho Yen Center Health District
 Study strategies
LOCAL PARTNERS
HSPH (Hanoi School of Public Health)
Local IRB
Local IRB approval
MoH
(Ministry of Health) MoFA
(Ministry of Foreign Affair)
HPTN 074
TN PAC
Thai Nguyen Provincial Centre for HIV/AIDS Control
Technical Monitoring
VAAC
(Vietnam Administration of HIV/AIDS Control)
Dr. Bui Duc Duong – IoR
Approval for the study implementation in Thai Nguyen
PACCOM
(People’s Aid Coordinating Committee)
Operational Licence
HPTN 074 STUDY SITE
Pho Yen Health Center
STAFFING STRUCTURE
Site PI
Study
Coordinator
Investigator
of Record
Data
Manager
Lab
Coordinator
Specimen storage
Viral load
CD4
HIV
Phlebotomist
Counselor &
System navigators
Interviewers
MMT clinic
ART clinic
Recruiters
Community Site
Coordinator
Treatment
Coordinator
PRESENTATION OVERVIEW
 HIV and PWID in Vietnam
 Study organizational structure
 Description of Pho Yen Center Health District
 Study strategies
VIETNAM/THAI NGUYEN/PHO YEN DISTRICT
THAI NGUYEN PROVINCE
Semi-Urban
Population: ≈1,100,000
PWID: ≈6400
HIV SERVICES IN THAI NGUYEN
 16 Needle exchange sites (Global Fund funding)
 8 HTC sites
• No charge
• ≈450 clients/month
 10 ART clinics
ACCESS TO ART IN THAI NGUYEN
 Referral to ART clinics from HTC
(9 outpatient;1 inpatient)
 PWID assessed for ART eligibility at ART clinics
 Eligibility to initiate ART:
• CD4 cell count ≤ 350 cells/mm3 OR
• Clinical stage 3 or 4, irrespective of CD4 cell count
Barriers to ART
 Structural
• Complicated administrative requirements
• Several tests and results required for initiation
 Social
• Lack of social support and stability
• Anticipated stigma
 Individual
• Mental health
• Self-efficacy
• Lack of information
DRUG TREATMENT IN THAI NGUYEN
 Detoxification Treatment in DTCs (3 clinics)
 Methadone Maintenance Therapy (6 clinics)
• Implemented in Thai Nguyen since 2011
• Clinic capacity 350-400
• Free
• An individual must provide
 A registration form
 A notarized copy of one of following: ID, passport, birth certificate or
household registration
 Support person
• Current demand exceeds supply
SITE: Pho Yen Health District Center
 In Pho Yen district in Thai
Nguyen province
 60 km north of Hanoi;
 Serves 1 million residents
 ≈ 900 PWID reported
 Accessible to participants
by motorbike
SERVICES IN PHO YEN DISTRICT HEALTH CENTER
 HCT- 35 – 40 visits
per month
 ART- 390 clients
(unlimited capacity)
 MMT- 349 clients
(can absorb additional
100)
BUILDING INFRASTRUCTURE
2
3
1
1.
2.
3.
4.
Reception room
Data room
Interview room
Counseling room
4
5
6
7
8
5. Blood draw room
6. Specimen process
7. Recruiter’s room
8. Meeting room
LABORATORY
District level
Provincial level
National level
Hematology
Laboratory
Thai Nguyen
General Hospital
Pho Yen
HPTN074 study
site
- Blood sample
- Urine sample
- HIV rapid test
- Separating plasma/sera
from whole blood
-CD4
Laboratory
PAC Thai Nguyen
- HIV confirmation
- specimen storage
Microscopy Department
Bach Mai Hospital
- HIV
viral load
PRESENTATION OVERVIEW
 HIV and PWID in Vietnam
 Study organizational structure
 Description of Pho Yen Center Health District
 Study strategies
RECRUITMENT STRATEGIES: INDEX
DUAL METHOD:
 Outreach
• Recruiters are former and current drug users
• Recruiters approach drug networks
• Distribute brochures and answer questions about study
• Accompany or refer interested subjects for screening
• Recruiter receives $3USD for referral
 Snow-ball sampling
• Participant (peer) refers PWID to study
• Accompany or refer interested subjects for screening
• Participant receives $3USD for referral
RECRUITMENT STRATEGY: NETWORK
 Index identifies injecting network members
 Index accompanies network member to site or gives
them a card containing index ID number
 Network members are verified at site
• through a database of names provided by index
• matching age, frequency of contact with index and
duration of relationship with index.
 Index receives $3USD for successful enrollment
RETENTION STRATEGIES
TRACKING SYSTEM
 Computerized system tracks appointments
 Locator information updated every study visit
 Participants who miss a scheduled appointment are contacted
within 24 hours by cell phone or home visit
FIELD TEAM
 Men of similar demographics to participants
 Knowledge of neighborhood geography
 Cultural awareness
QUALITY ASSURANCE/QUALITY CONTROL
CRFs:
• All questionnaires checked by supervisors at the end of
each day in Pho Yen before faxing
• 50% are re-checked by second supervisor
Internal checklists:
•
To ensure adherence to SOPs
Monitoring recruitment and response rates
Resolving Datafax queries
DATA BACKUPS
PROTECTION OF PARTICIPANTS
Continuation of care:
• HPTN 074 participants will remain in any initiated treatment
program after study completion
Confidentiality:
• Thai Nguyen DoH will work with Thai Nguyen Department of
Public Security to obtain written agreement – protecting
participant’s information.
RELATIONSHIP WITH THAI NGUYEN AUTHORITIES
Foundation:
 12 year collaboration with the Thai Nguyen DoH and
Center for Preventive Medicine (CPM)
 Established protocols with law enforcement agencies to
prevent interference with participants
Current collaboration:
• Vietnam Administration of AIDS Control, MoH
• Thai Nguyen Provincial AIDS Control
THANK YOU
FIRST LINE ART REGIMEN
Prioritized regimens:
AZT + 3TC + NVP Or d4T + 3TC + NVP
Alternative regimens:
AZT + 3TC + EFV or d4T + 3TC + EFV
TDF + 3TC+ NVP or TDF + 3TC+ EFV
AZT + 3TC + TDF

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