Ana-Maria SCHWEITZER Fundatia Baylor ( Baylor Foundation ), Romania aschweitzer @ baylor-romania . ro

Luiza Stefania VLAHOPOL Fundatia Baylor ( Baylor Foundation ), Romania lvlahopol @ baylor-romania . ro

Mieke Kleppe Research Centre for Public Affairs , HAN University of Applied Sciences , Netherlands Mieke . Kleppe @ han . nl

Alexandra Dima Health Services and Performance Research ( HESPER ), Claude Bernard Lyon 1 University , Lyon , France alexandra . dima @ univ-lyon1 . fr

Table 2 : Item homogeneity values for subscale 1

Table 1 : Demographic and medical data of the sample ( N = 104 )

Table 3 : Item homogeneity values for subscale 2

Figure 2 : Bubble chart crosstab for Taking and Timing ( sum binary scores ) and viral load

Table 4 : Reliability indices for both scales

Table 5 : PROMAS-Rom _ HIV- 8 items

Figure 1 Heatplot Spearman correlations between item scores

HESPER

HAN

Adherence to antiretroviral medication in Romanian HIV patients : is it about taking or timing ?

Objective

We describe the development and validation in Romanian of the first self-report tool that assesses adherence to medication by taking into consideration two complementary behaviors : taking the medication and timing of intake .

Background

Antiretroviral treatment ( ART ) requires high adherence to achieve therapeutic benefits ; ideally , patients need to administer daily all doses recommended ( taking adherence ) and do so at exact time intervals ( timing adherence ). These two elements have been previously measured through electronic monitoring ( EM ), which is less easily applicable to routine care . Developing a self-report questionnaire that targets taking and timing adherence would facilitate clinical assessment and the effective planning of adherence interventions in clinical settings .

Methods

We developed the ProMAS-Rom-HIV , a 12-item questionnaire on adherence to ART , based on ProMAS , an 18-item Dutch adherence questionnaire validated for chronic conditions with item response theory methodology . The binary response scale of ProMAS (“ yes / no ”) was replaced with a 7 point response scale , to investigate the feasibility of increasing the amount of information obtained . The ProMAS items were back-translated to Romanian , adapted to ART , and piloted with a sample of 10 patients via cognitive interviewing .

Patients responded to a form that contained both socio-demographics and the adherence questionnaire and results of most recent viral load tests (+/ - 12 months from questionnaire completion date ) were collected from medical files . As suggested by the World Health Organization , a cut-off point of 1000 copies per ml was set to distinguish between HIV detectable and undetectable levels .

We used Mokken Scaling Analysis , Factor Analysis , classical test theory analysis and cluster analysis to examine the structural validity of ProMAS-Rom-HIV . Reliability was tested with Cronbach ’ s alpha , Guttmann ’ s lambda 6 , beta , omega . Regarding criterion validity , we hypothesized that adherence will be negatively correlated with viral load values and tested this hypothesis via Wilcoxon rank sum tests .

Results

Authors

Ana-Maria SCHWEITZER Fundatia Baylor ( Baylor Foundation ), Romania aschweitzer @ baylor-romania . ro

Luiza Stefania VLAHOPOL Fundatia Baylor ( Baylor Foundation ), Romania lvlahopol @ baylor-romania . ro

Mieke Kleppe Research Centre for Public Affairs , HAN University of Applied Sciences , Netherlands Mieke . Kleppe @ han . nl

Alexandra Dima Health Services and Performance Research ( HESPER ), Claude Bernard Lyon 1 University , Lyon , France alexandra . dima @ univ-lyon1 . fr

Sample :

We included 104 Romanian HIV patients with the following characteristics : 63 % women , mean age 31 + -7 , 20 % with detectable viral load , mean age since HIV diagnosis 11.12 , 27 % employed , 55 % not parents , 40 % living in rural areas ( see table 1 ).

Other treatment taken for other conditions or comorbidities

Structural validity :

Table 2 : Item homogeneity values for subscale 1

Criterion validity :

None 89 ( 85.9 )

Table 1 : Demographic and medical data of the sample ( N = 104 )

Table 3 : Item homogeneity values for subscale 2

People with undetectable viral load were more likely to show high adherence for both timing ( W = 857 , p =. 01 ) and taking ( W = 777 , p =. 04 ), as illustrated in figure 2 ( bubble chart cross tab ).

Figure 2 : Bubble chart crosstab for Taking and Timing ( sum binary scores ) and viral load

Reliability :

The values for reliability were satisfactory , with omega =. 87 for the “ taking scale ” and . 75 for the “ timing scale ”, as shown in table 4

Table 4 : Reliability indices for both scales

The items were weakly associated with each other ( Spearman ’ s rho =. 23 ), as seen in figure 1 .

English During the last month it so happened that

I simply forgot to take ( one of ) the medication During the last month it so happened that I took ( one of ) my medication at a different moment than indicated by the doctor ( or

the moment I usually take it ) During the last month it so happened that I took less medication than prescribed by my

doctor During the last month I took a break from taking ( one of ) my medication During the last month I decided to stop taking ( one of ) my medicines During the last month I changed by myself

the timing of ( one of ) my medication During the last month it so happened that I took ( one of ) my medicines at a later moment than usual During the last month it has happened that I did not take ( one of ) my medicines for a day .

Conclusions :

Table 5 : PROMAS-Rom _ HIV- 8 items

Figure 1 Heatplot Spearman correlations between item scores

Romanian In ultima luna mi s-a intamplat pur si simplu

sa uit sa iau ( unul din ) medicamente …

In ultima luna s-a intamplat sa imi iau ( unul din ) medicamentele la alta ora decat cand mi-a spus doctorul ( sau decat le iau de obicei )… In ultima luna s-a intamplat sa iau mai putine medicamente decat mi-a spus doctorul … In ultima luna am facut pauza din a-mi lua ( unul din ) medicamente … In ultima luna am hotarat sa sar cel putin unul din medicamente … In ultima luna am schimbat singur ora la

care imi iau medicamentele … In ultima luna s-a intamplat sa imi iau ( unul din ) medicamente mai tarziu decat de obicei … In ultima luna s-a intamplat sa sar toate medicamentele o zi intreaga …

This is the first questionnaire that clearly measures timing and taking as two separate behaviors that compose adherence . It also has the advantage of being a very short questionnaire , with a good reliability , thus adequate for large scale use in clinical settings . Using the ProMAS-Rom-HIV in clinical practice opens up new intervention possibilities . Since both behaviors can now be measured via self-report , the specific barriers for timing and taking adherence can be identified for patient groups and also for each individual patient and targeted at a later time , with more precise interventions . The tool was validated against viral load , but it would further benefit from validation against EM data and in other clinical contexts .