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Adapting and pilot testing an evidence-based ARV adherence intervention for China. Ann B. Williams, Honghong Wang, Xianhong Li, Kris Fennie, Jane Burgess UCLA School of Nursing & Xiangya School of Nursing Los Angeles, California, U.S.A. & Changsha, Hunan, China.

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Adapting and pilot testing an evidence based arv adherence intervention for china

Adapting and pilot testing an evidence-based ARV adherence intervention for China

Ann B. Williams, Honghong Wang, Xianhong Li, Kris Fennie, Jane Burgess

UCLA School of Nursing & Xiangya School of NursingLos Angeles, California, U.S.A. & Changsha, Hunan, China


Hiv aids medication adherence challenges
HIV/AIDS Medication Adherence Challenges intervention for China

  • Lifetime duration of treatment

  • Frequent (& serious) adverse drug effects

  • AIDS stigma


Adherence required

In order to achieve the optimal virologic, immunologic, and clinical outcomes possible with HAART, the level of adherence required is over 90%. (Bartlett, 2002; Paterson et al., 2000; Singh et al., 1999)

This is the equivalent of missing 1 dose per month on a once-a-day regimen.

Only 6% of patients report full adherence, with a mean level of 56% adherence. (Murphy et al., 2003)

Adherence may be the variable determining HAART failure or success. (Knobel et al., 1999)

While patients report a preference for once-a-day dosing, research suggests adherence rates are no better for QD dosing. (Stone et al., 2004)

Adherence required…

…and adherence achieved


Adapting and pilot testing an evidence based arv adherence intervention for china

Emerging Resistance clinical outcomes possible with HAART, the level of adherence required is over 90%.

PROBABILITY

OF SELECTING FOR

RESISTANT STRAINS

MOST DANGEROUS PLACE:

PARTIAL SUPPRESSION

0%

100%

SUPPRESSION OF VIRAL REPLICATION


Adapting and pilot testing an evidence based arv adherence intervention for china

Viral clinical outcomes possible with HAART, the level of adherence required is over 90%.

Virulence

Viral

Resistance

Effective

drug potency

PATIENTADHERENCE

PRESERVATION

OF IMMUNE

FUNCTION

AND

DELAY IN

DEISEASE

PROGRESSION

Rate

of viral

replication

Intracellular

drug

concentration

Host

Factors

Systemic drug

concentration

Pharmacokinetics


Background athena intervention
Background: ATHENA Intervention clinical outcomes possible with HAART, the level of adherence required is over 90%.

  • A home-based adherence intervention delivered by a nurse and peer educator team.

  • Demonstrated efficacy in the northeastern U.S. in a randomized controlled trial.


Adapting and pilot testing an evidence based arv adherence intervention for china

Clinician clinical outcomes possible with HAART, the level of adherence required is over 90%.

Characteristics

Patient

Characteristics

Regimen

Characteristics

Adherence

Illness

Characteristics


Adapting and pilot testing an evidence based arv adherence intervention for china

A focus limited to personal behavior change leads to a programmatic emphasis on individual responsibility for health, at the cost of an examination of individual response-ability, or the capacity of the individual for responding to his or her personal needs or the challenges posed by the environment.

Meredith Minkler

Health education, health promotion and the open society: An historical perspective.

HEQ, 16: 17-30, 1989


Adapting and pilot testing an evidence based arv adherence intervention for china

Social programmatic emphasis on individual

Context

Clinician

Characteristics

Patient

Characteristics

Regimen

Characteristics

Adherence

Illness

Characteristics


Adapting and pilot testing an evidence based arv adherence intervention for china

Intervention programmatic emphasis on individual

  • Home visit by a peer counsellor and a nurse

    • Once a week, first 3 months

    • Bi-weekly, months 4-6

    • Once a month, months 7-12

    • Visits last 15 minutes to one hour


Results
Results programmatic emphasis on individual

Selected characteristics of ATHENA participants at baseline*

*These characteristics did not differ significantly between the

intervention and control groups.


Results subjects with 90 adherence
Results programmatic emphasis on individual Subjects with ≥ 90% adherence

33

82

40%

24

64

38%

24

66

36%

19

60

32%

19

61

31%

16

44

36%

33

79

42%

18

68

27%

14

64

22%

14

60

23%

12

54

22%

9

37

24%

A greater proportion of subjects in the intervention group had adherence greater than 90% at each time point compared to the control group. The difference over time is significant (Extended Mantel-Haenszel Test: 5.80, p=.02)


Adapting and pilot testing an evidence based arv adherence intervention for china

Summary Results programmatic emphasis on individual

  • The intervention group maintained a higher proportion of subjects with adherence greater than 90% over time compared to the control group (p=.02).

  • A statistically significant intervention effect on viral load or CD4+ count was not seen.

  • There was an statistically signifcant association between >90% adherence and an undetectable viral load over time (p<.03).


Conclusions
Conclusions programmatic emphasis on individual

  • Home visits from a nurse and peer counselor significantly improved medication adherence compared to usual care.

  • The proportion of individuals with medication adherence >90% was unacceptably low in both control and experimental groups.


Adapting and pilot testing an evidence based arv adherence intervention for china
ATHENA to Ai Sheng Nuo programmatic emphasis on individual Reaching around the GlobeNurses working together to help patients take lifesaving medication


Purpose
Purpose programmatic emphasis on individual

  • To adapt the ATHENA intervention to the social and cultural context of Hunan Province

  • To conduct a pilot test of the adapted intervention


Adapting and pilot testing an evidence based arv adherence intervention for china

HIV/AIDS in Hunan Province programmatic emphasis on individual

  • HIV/AIDS cases reported through 2010: 10,794

  • Patients are:

    • Rural

    • Poor

    • High prevalence of IDU (40% of PLWHA)


Hiv aids in hunan province
HIV/AIDS in Hunan Province programmatic emphasis on individual

  • Free treatment (ARVs) is available

  • Medication adherence is a challenge

  • Evidence-based interventions to support adherence are limited and were developed for use in different social, cultural, and economic environments.


Adaptation framework
Adaptation Framework programmatic emphasis on individual

  • The ADAPT-ITT Model

    • 8 sequential steps

    • Qualitative and quantitative data


Step 1 assessment
Step 1: Assessment programmatic emphasis on individual

  • Cross sectional survey

    • 7 China CARES sites

    • 308 respondents

      • 20% reported <90% adherence

      • Associated with current heroin use


Step 1 assessment1
Step 1: Assessment programmatic emphasis on individual

  • Qualitative data

    • Stigma

    • Family relationships and responsibility

    • Guilt


Step 2 choosing athena
Step 2: Choosing ATHENA programmatic emphasis on individual

  • Freirian philosophy

    • Well suited to Chinese culture

    • Emphasizes community context

    • Known in China

      Process

      Action

      Reflection

      Action


Step 3 and 4

Administration programmatic emphasis on individual

Demonstrating the intervention

Reviewing original manuals

Consider applicability to Hunan context

Production

Identify core elements

Peer educators

Dialogue

Reflection

Produce plan for adaptation

Emphasis on family

Group activities

Step 3 and 4


Step 5 expert review
Step 5: Expert review programmatic emphasis on individual

  • PLWHA, families, and HCWs reviewed proposed intervention

  • Concerns: Risk for disclosure & stigma


Step 6 integration athena to ai sheng nuo
Step 6: Integration programmatic emphasis on individual ATHENA to Ai Sheng Nuo


Love life promise
Love, Life, Promise programmatic emphasis on individual

  • Ai Sheng Nuo

    • Family emphasis

    • Decreased frequency of home visits

    • More structured patient education

    • Option for group activities


Step 7 training developing manual
Step 7: Training & developing manual programmatic emphasis on individual


Step 8 pilot testing methods
Step 8: Pilot testing programmatic emphasis on individual Methods

  • Randomized controlled pilot

    • July 2010 – August 2012

  • Randomized to intervention or control

    • Intervention: Monthly visits and interim phone contact plus standard clinic support

    • Control: Standard clinic support


Study sites hunan province
Study Sites: Hunan Province programmatic emphasis on individual

  • 11th largest province of China, situated in the southeast.

  • Commercial sex work and injection drug use are highly prevalent.

  • Two clinical sites, in Hengyang City and Changsha.

  • Comprehensive evaluation and ARV when indicated.

  • However, mental health screening and treatment are not routinely available.


Pilot study subjects eligibility
Pilot study: Subjects programmatic emphasis on individual Eligibility

  • Living with HIV/AIDS

  • Attending one of the two clinical sites

  • Self-reporting adherence <90% to prescribed ARVs or to pre-ARV medications (TMP-SMX, multi vitamins)


Pilot study measures
Pilot study: Measures programmatic emphasis on individual

  • A 7-day visual analogue scale

  • Social Support Rating Scale

  • Center for Epidemiological Studies Depression Scale (Chinese)

  • HIV/AIDS Related Stigma Scale.


Pilot study data collection
Pilot study: Data collection programmatic emphasis on individual

  • Data were collected in structured face-to-face interviews conducted at the time of a regularly scheduled clinical visit.

  • Information regarding ARV regimen, treatment duration, time of diagnosis, CD4 count and HIV-RNA from medical record review.

  • Baseline, 6 months, 12 months


Results subjects n 114
Results: Subjects programmatic emphasis on individual N = 114

ARV status at baseline

  • 57 reporting <90% adherence to pre-ARV meds

  • 57 reporting <90% adherence to ARV

    Presumed HIV transmission routes

    • 36% IDU

    • 40% Heterosexual contact

    • 11% MTM sexual contact

    • 2% Transfusion

    • 11% Unclear


Results subjects
Results: Subjects programmatic emphasis on individual

Male: 82 (72%)

Female: 32 (28%)

Age

< 30 32 (28%)

30 – 45 57 (50%)

> 45 25 (22%)

Married 59 (52%)

High school or college 46 (40%)

Stably Employed 32 (28%)


Results subjects1
Results: Subjects programmatic emphasis on individual

  • Past or current drug abuse 35 (31%)

  • Has disclosed HIV status 84 (75%)

  • 2 years or less since diagnosis 90 (82%)

  • CD4 <350 cells/mm3 87 (98%)


Results subjects2
Results: Subjects programmatic emphasis on individual

  • ARV regimens

    • AZT + 3TC + NVP or EFV

    • D4T + 3TC + NVP or EFV

    • AZT + LPV/r + 3TC

    • LPV/r + TDF + 3TC


Depressive symptoms at baseline
Depressive symptoms at baseline programmatic emphasis on individual

  • 66% scored 16 or greater on the CESD-C

  • Those in the ARV prep treatment stage were more likely to report significant depressive symptomatology than those for whom ARV had already been prescribed.

    (OR = 2.84, 95% CI 1.26, 6.38; p = 0.01)


Factors independently associated with depressive symptoms
Factors independently associated with depressive symptoms programmatic emphasis on individual

  • History of drug use

    OR 4.10 (1.11, 15.15) p=.03

  • High perception of stigma

    1.06 (1.02, 1.09) p=.001

  • Lack of stable employment

    3.23 (1.01, 10.00) p=.05

  • Lack of social support

    1.10 (1.03, 1.19) p=.02


Results subjects with 90 adherence1
Results programmatic emphasis on individual Subjects with > 90% adherence

A greater proportion of subjects in the intervention group had adherence greater than 90% at both time points compared to the control group. The difference over time is significant (Extended Mantel-Haenszel Test: 8.8,p=.003)


Pilot test
Pilot Test programmatic emphasis on individual

  • Biological measures:

    • No difference between groups:

      • Quantitative HIV-RNA

      • CD4 counts

    • Results of ARV resistance studies

      • No resistance at baseline by standard genotype

      • Ultra Deep Sequencing ongoing


Other findings
Other findings programmatic emphasis on individual

  • Adherence barriers identified:

    • Medication side effects

    • Fear of disclosure

    • Knowledge deficits

    • Poor family relationships


Conclusions1
Conclusions programmatic emphasis on individual

  • Structured approach facilitates adaptation of evidence based interventions.

  • In spite of significant cultural differences, adaptation is possible.

  • Key barriers to ARV adherence appear to be universal.

  • Strategies to improve adherence may differ somewhat, but home based interventions are effective.


Future directions
Future Directions programmatic emphasis on individual

  • Logistics: Mobile communication technology.

  • Content: address mental health issues, especially depression.

  • Cost of intervention.