“Video-Directly Observed Therapy: A promising solution for monitoring TB and HIV

treatment adherence for binational patients in the U.S.-Mexico border region”

Muñoz F., Collins K., Moser K., Cerecer-Callú P., Sullivan M., Chockalingam G., Rios P., Zúñiga M.L., Burgos J.L., Rodwell T., Rangel

M., Patrick K., Garfein R.

Division of Global Public HealthSchool of Medicine

University of California, San Diego

Sixth Annual CFAR International HIV/AIDS Research DaySan Diego, CA

September 18th, 2012

TB

TB/HIV Syndemic

TB is the leading cause of death among persons with HIV (PWHIV)

TB disease in PWHIV can be prevented with effective treatment

MMWR, CDC, 2012; WHO, 2012; Kwan & Ernst, 2011; Garfein 2010

TB

Human immunodeficiency virus (HIV) and tuberculosis (TB) syndemic that cause high morbidity and mortality worldwide

— 1/3 of the world’s population is infected with Mtb

— Worldwide there are 9 million new cases and 1.4-2 millions deaths from TB annually

— Each infected person will spread TB to 10-15 other individuals before death or cure

TBTuberculosis Burden

A bacterial infection caused by M. tuberculosis (Mtb)

TB usually affects the lungs but can spread to other parts of the body

TB is the 2nd leading cause of death from infectious diseases worldwide

MMWR, CDC, 2012; WHO, 2012 &2010

Estimated number of persons infected with TB –worldwide, WHO 2010

TB

CA

AZNM

TX

SONCHI

COH

TAMNL

B.C.

NATIONAL

BORDER

Cases

13,142

4,180

Rate*

4.2

6.8

NATIONAL

BORDER

Cases

15,649

4,290

Rate*

14.1

25.7

* Rate = cases per 100,000 population

26.417.1

16.5

31.9

40.5

19.9

7.0

3.53.0

6.2

Adapted from: Schneider E, et al. Rev Panam Salud Publica. 2004;16(1):23–34.

Mexico and U.S. TB Incidence Rates*By State

San Diego: 8.4

Tijuana: 46.1

CDC, 2008; CDPH, 2008; DGEPI Mexico, 2008; INEGI, 2005; SINAVE, 2007.

TB treatment

• Curable with antibiotics, but takes >6 months to treat– Side effects common– Contraindicated with other medications and alcohol– Careful monitoring is necessary to assure medication

adherence

• Poor adherence drug resistance (MDR/XDR-TB)– Delayed resolution or worsening symptoms– Resistant strains can be transmitted– Drastically increases treatment costs– Increase probability of death

MMWR, CDC, 2012; WHO, 2012 &2010

Directly Observed Therapy (DOT)

• Preferred treatment strategy for all patients – Improves adherence– Reduce acquired drug resistance,

treatment failure, and relapse– DOT saved 6.8 million lives in 1995-2010

• Care provider observes patient taking every medication dose until treatment is completed

Provider visits the patient

Patient goes to the clinicCDC, 2007; WHO, 2012

TB treatment: DOTHowever, DOT is …

o Costlyo Labor intensive and time consuming o Limit patient mobilityo Logistically difficult to administer for binational patientso May not be feasible for patients in rural areaso Potentially jeopardizes patient privacy and

confidentialityo Patient stigmatization

Technology to Improve Medication Adherence

• New opportunities to reach and improve the level of care for underserved population worldwide

• Previous studies• Monitoring medication adherence, patient education,

motivation and health messaging, frequent communication with patient, reminder system and data gathering.

• Broader range of diseases (TB, HIV/AIDS, Diabetes)

• Technology previously used• MEMS caps• short message system (SMS)• text messages • phone reminders

Pellowski & Kalichman, 2012; Hoffman et al, 2010

1st Generation Technology

• Count the number of doses dispensed (MEMS Caps, GlowCap, etc.)

2nd Generation Technology • Drug metabolite testing (blood, urine, hair, toenails)• Patient-facilitated tracking (Adhere.IO, Pill Apps) • Embedded sensors (Proteus, SmartPill)

Video Phone Experiment• Landline-based system• First 33 patients in 9 months• Advantages:

– High patient acceptance– Saved $$$– 27,840 miles saved ($10,161)– 795 hours saved ($15,000)

• Disadvantages:– Limited to business hours– Must take meds while at home– Won’t work for San Diego’s binational patients

“Mobile Phone‐Based Video Directly Observed Therapy (VDOT) for Tuberculosis”

Objectives

• To develop and pilot test the mobile phone-based video direct observed therapy (VDOT) program among TB patients in a bi-national border region.

• To assess the feasibility and acceptability of VDOT among patients, providers, and health officials.

13

Methods

Two phased pilot study in San Diego, CA and Tijuana, BC, Mexico (4/1/2009-10/1/2012)

Phase I: Focus Groups Phase II: Pilot VDOT trial

Both phases conducted in San Diego and Tijuana to evaluate VDOT simultaneously in high and low economic resource areas.

Pilot study approved by the UCSD Human Research Protection Program and the Bioethics Committee of COLEF.

• Participants: TB patients who recently completed in-person DOT, TB care providers and health officials.

• Explored feasibility, acceptability and general perceptions of VDOT.

– Participants’ ages ranged from 24-88 years (mean 47) and did not differ by city.

– In both cities, approximately half (49% overall) of the patients and providers were male; over half (67% overall) were Hispanic.

Phase I: Focus Group Design

San Diego Tijuana

# of Groups

# of Participants

# of Groups

# of Participants

Providers 2 14 1 19

Patients 4 14 1 9

Promotores 0 1 14

Focus Groups ResultsProviders Patients

Feasibility

• Solve transportation problems, save patients money, 

• Protect patient privacy from neighbors and friends, 

• Alleviate risk of stigma.

• Save transportation cost as well as alleviate stigma.

“With the demonstration that’s been shown I think it’s really easy.” 

‐Both providers and patients felt they could easily do it.

Acceptability

• Better option than the current system of “in‐person” DOT and “landline” video‐DOT.

• Wait to eat until his “promotor“ showed up, which sometimes did not happen until 2pm.  

“You’re not locked to your house, and you’re not locked to the time ofthe day that you have to take your medication.”

‐Both providers and patients had a little concern about using cell phones.

16

Video DOT Flow Diagram

Copyright © 2012 The Regents of the University of California. All Rights Reserved.

Phase II: Pilot Study Design• Population:

– Newly diagnosed pulmonary TB patients selected by TB Control Program– San Diego (n=40) and Tijuana (n=10)

• Patients provide informed consent• Patients taught to use phone by DOT case worker• Videos observed and tracked by TB Program staff• Patient interviews conducted pre and post treatment• $25 given for each interview, but nothing for doing VDOT• Planned to follow patients for 4-9 months on VDOT

• Data Collection: – Interviews assessed demographics, attitudes about TB, study

satisfaction and experience/comfort using technology including smart phones, number of doses observed by VDOT

18

Results

*Participants reported spent time in both cities

San Diego Tijuana

Number enrolled 43 9

Number of bi-national participants* 6 0

Cell phones lost/stolen/broken 2 2

Socio‐demographics San Diegon=37 (%)

Bi‐national n=6 (%)

Tijuanan=9 (%)

Age: Mean (range) 39 (18‐86) 37.5 (22‐50) 28 (19‐65)

GenderMaleFemale

20  (54.1)17  (45.9)

3  (50.0)3  (50.0)

5  (55.6)4  (44.5)

Hispanic or Latino 12  (32.4) 6  (100) 9  (100)

RaceAsianAfrican American/BlackCaucasian/WhiteOther/Mixed Race

13 (35.1)3 (8.1)

10 (27.0)11 (29.7)

0 (0)0 (0)0 (0)

6 (100)

0 (0)0 (0)

3 (33.4)6 (66.6)

Educational Attainment  Illiterate< High School> High School

0 (0)6  (16.2)28  (75.7)

0  (0)2  (33.3)4  (66.7)

1  (11.1)3  (33.3)5  (55.6)

Had employment (last 3 months) 35  (94.6) 3  (50.0) 4 (44.4)19

Pilot study: Patient characteristics

20

Pilot Study:Medication Doses by VDOT

Medication doses by VCP‐DOTSan Diego

n=37Bi‐national 

n=6Tijuanan=9

Mean (range) Mean (range) Mean (range)

Total medication doses expected 88.4 (10‐202) 107 (40‐107) 92.5 (2‐168)

Total medication doses observed 84  ( 9‐200) 96.1(21‐153) 88.4 (2‐165)

Proportion of total medication observed/ total medication expected (%) 94% (50‐100) 84% (52‐96) 95%(88‐100)

21

Pilot Study:Post-test survey results Experience with VDOT San Diego

n=35 (%)*Bi‐national n=6 (%)

Tijuanan=9 (%)

Had problems recording a video>½ the Time

RarelyNever

3  (  8.6)17  (48.6)15  (42.9)

0  (0)5  (83.3)1 (16.7)

1  (11.1)5  (55.6)3 (33.3) 

Had problems sending a video>½ the Time

RarelyNever

6 (17.1)23 (65.7)6 (17.1)

0  (0)5  (83.3)1 (16.7)

1 (11.1)6 (66.7)2 (22.2)

Unable to send a video due to poor reception 10 (28.6) 4 (66.7) 5 (55.6)

Able to send videos while traveling outside of SD or TJ     

Yes, AlwaysYes, Sometimes

Never Tried

6 (17.1)2 (5.7)

27 (77.2)

4 (66.7)2 (33.3)

0 (0)

2 (22.2)1 (11.1)6 (66.7)

Days practicing with a DOT workerbefore  recorded a video alone

123>4

20 (57.1)6 (17.1)2 (5.7)6 (17.1)

5 (83.3)0 (0)0 (0)

1 (16.7)

1 (11.1)0 (0)

3 (33.4)5 (55.6)

22

Pilot Study:Post-test survey results Convenience of VDOT

San Diegon=35 (%)

Bi‐national n=6 (%)

Tijuanan=9 (%)

VDOT more confidential that In‐Person DOT

MoreNo Difference

Less

27 (77.1)6 (17.1)2 (5.8)

7 (77.8)2 (22.2)

0 (0)

6 (100)0 (0)0 (0)

To redo TB treatment, they chooseVDOT

In‐person DOTNo Preference

33 (94.4)1 (2.8)1 (2.8)

8 (88.9)1 (11.1)

0 (0)

5 (83.3)0 (0)

1 (16.7)

Convenience using VDOT compared with In‐person DOT

InconvenientNeutral 

Convenient

3 (8.6)0(0)

32 (91.4)

0 (0)0 (0)

6 (100)

0 (0)0 (0)

9 (100)

Concern of people watching take a video 11 (31.4) 2 (33.3) 6 (66.7)

Recommend VDOT to other TB patients 35 (100) 6 (100) 9 (100)

VDOT allowed more freedom to travel outside of  home than in‐person DOT     

31 (88.6) 6 (100) 8 (88.9)

Patients, nurses, DOT workers/promotor and health officials considered VDOT to be highly feasible and acceptable

High patient satisfaction and appreciation for mobility that VDOT allows

Considerable savings in staff time and travel reported in both cities

SMS reminders lapse when cell/WiFi was unavailable

Some video uploads delayed by cell/WiFi limitations

2 patients preferred in-person DOT

23

Opportunities, Challenges and Observations

- Results showed VDOT to be feasible and acceptable in both high and low resource settings

- VDOT allows all doses taken by bi-national patients to be counted, even when they were traveling

- VDOT is a promising mobile solution to monitoring TB and other conditions such as HIV that require strict treatment adherence

- Future research is needed to test VDOT among patients with TB/HIV co-infection

24

Conclusions

AcknowledgementsUCSD Division of Global Public Health

Richard Garfein (PI), Jazmine Cuevas-Mota , Kelly Collins, Fatima Munoz, Maria Luisa Zuniga, Jose Luis Burgos, Timothy Rodwell, Maureen Clark

UCSD Department of Family and Preventive Medicine

Kevin Patrick

UCSD Calit2

Kevin Patrick, Fredric Raab, Mark Sullivan, Phillip Rios, Alison Flick, Ganz Chockalingam

San Diego County Health and Human Services Agency

Kathleen Moser, Christine Kozik, Krystal Liang, Deborah McIntosh

ISESALUD, Tijuana, BC, MexicoParis Cerecer, Cristhian Ambriz

El Colegio de la Frontera Norte, BC, MexicoMaria Gudelia Rangel

* Funded by the National Institutes of Health (R21-AI088326) and Alliance Healthcare Foundation.* Premium QIK membership accounts provided at no cost by QIK.COM.

26

GRACIAS Fátima Muñoz, M.D., M.P.H.Email: famunoz@ucsd.edu

Phone: 619-534-9670Division of Global Public Health