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European Journal of Medical Research - Deutsche AIDS ...

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112 EUROPEAN JOURNAL OF MEDICAL RESEARCH<br />

June 27, 2007<br />

(23/45) at week 12, the rate <strong>of</strong> those being dissatisfied or very<br />

dissatisfied was 26% (11/42) and 20% (9/45), respectively.<br />

Conclusions: Experience within the program suggests that<br />

improvement in satisfaction <strong>of</strong> enfuvirtide patients with therapy<br />

may be achieved by a structured training and experience<br />

exchange program. Detailed repeated instruction and support<br />

may lead to increased treatment acceptance and improved adherence.<br />

1. Lalezari J-P et al. New England J <strong>of</strong> Med., Vol 348, 22 2003<br />

2 Foy K et al. J <strong>of</strong> the Assoc. <strong>of</strong> Nurses in Aids Care, Vol 16, 2<br />

2005<br />

D.83 (Vortrag)<br />

Gesundheitstrainings HIV/<strong>AIDS</strong> - a nationwide<br />

structured patient education program for people<br />

living with HIV/<strong>AIDS</strong> in Germany<br />

Klumb S. 1 , Dannecker M. 1 , Gronski H. 1 , Schafberger A. 1<br />

1 Verein Gesundheitstraining HIV/<strong>AIDS</strong> e.V., Berlin, Germany<br />

Background: In 1998 a working group <strong>of</strong> HIV+ patients and<br />

treatment advocates started to develop a structured patient education<br />

program for people living with HIV/<strong>AIDS</strong> in Germany.<br />

From our perspective adherence is a consequence <strong>of</strong><br />

psychosocial factors and processes.<br />

From July 2005 on eight patient trainings have been conducted,<br />

61 patients were included. Trainings have been conducted<br />

in groups. Group size varied (mean 10.1, range 5 - 12).<br />

Mean age was 41.2 years. 15.1 % <strong>of</strong> participants were female<br />

84.9 % male.<br />

Two types <strong>of</strong> research have been conducted resp. are ongoing:<br />

an evaluation <strong>of</strong> the curricula and the qualification <strong>of</strong><br />

trainers (completed), and an evaluation <strong>of</strong> health economic<br />

consequences and long lasting effectiveness (still ongoing).<br />

Methods: The research utilized questionnaires several times<br />

during the program and 6 month after the last training session.<br />

In addition two group discussions leaded by the researchers<br />

were conducted as qualitative part.<br />

The second part <strong>of</strong> the research used two questionnaires<br />

(MOS-HIV and HADS) and collected “hard data” via self report<br />

and patients’ health insurance companies. Questionnaires<br />

and data collection was carried out after inclusion but before<br />

the first training session and 12 month after the last training<br />

session.<br />

Results: 41 patients were included in this OT-style analysis<br />

(LOF = 2, 18 did not fill out the last or any other questionnaire).<br />

Six month after the last training session 53.7 % (n =<br />

22) stated, that the patient education program has been very<br />

helpful and 41.5 % (n = 17) that it has been helpful in terms<br />

<strong>of</strong> living with HIV. Only 2.4 % respectively stated the intervention<br />

has been somewhat (n = 1) or not helpful (n = 1).<br />

Table 1<br />

The 95.2 % (n = 39) patients gave the following key topics<br />

as most valuable:<br />

1. exchange <strong>of</strong> experience (n= 21)<br />

2. develop a new (different) view <strong>of</strong> living with HIV (more<br />

self confidence/ less anxiety / improved QoL) (n= 16)<br />

3. information / diet / sport / coping with stress (n = 12)<br />

4. HAART / management <strong>of</strong> side effects / therapeutic options<br />

and strategies (n = 11)<br />

5. due to knowledge and training a more specific / focussed<br />

decision-making (n = 7)<br />

More detailed data and the results <strong>of</strong> ongoing evaluation <strong>of</strong><br />

“hard data” will be provided.<br />

D.84 (Poster)<br />

Health related quality <strong>of</strong> life changes in<br />

antiretroviral naïve HIV-infected patients on<br />

Atazanavir based regimens: Week 48 results from<br />

AI424-089<br />

Iloeje U. 1 , Kastango K. 1 , Malan N. 2 , David N. 3 ,<br />

Krantz E. 4 , Reeb I. 5 , Nakonz T. 5 , Matthew M. 1 ,<br />

Frederick D. 6 , Hammond J. 6<br />

1 Bristol-Myers Squibb, Pharmaceutical <strong>Research</strong> Institute,<br />

Wallingford, United States <strong>of</strong> America, 2 Triple M <strong>Research</strong>,<br />

Port Elizabeth, South Africa, 3 Brooklyn <strong>Medical</strong> <strong>Research</strong><br />

Center, Cape Town, South Africa, 4 Quinta-<strong>Research</strong>,<br />

Bloemfontein, South Africa, 5 Bristol-Myers Squibb<br />

GmbH&Co.KGaA, Munich, Germany, 6 Bristol-Myers Squibb,<br />

Wallingford, United States <strong>of</strong> America<br />

Background: HRQoL declines in HIV-infected patients in<br />

the absence <strong>of</strong> effective therapy or with older more symptomatic<br />

ARV regimens. Atazanavir is potent and well tolerated<br />

as a once daily protease inhibitor within a HAART regimen.<br />

Data on HRQoL in treatment naïve patients on ATV/r or ATV<br />

regimens are limited.<br />

Methods: In AI424-089 (a randomized open label study comparing<br />

ATV/r 300mg/100mg with ATV 400mg, both in combination<br />

with 3TC and extended-release d4T) HRQoL was assessed<br />

using the EQ-5D questionnaire, and the MOS-HIV, a<br />

disease specific questionnaire. HRQoL was assessed at baseline,<br />

Week 24 and 48. Primary endpoints were the physical<br />

(PHS) and mental (MHS) summary scores (mean score<br />

50±10) for the MOS-HIV; and the health index score (HIS,<br />

range 0-1), and visual analogue scale (VAS, range 0-100) for<br />

the EQ-5D. Clinically important changes include a 2 point<br />

change (MOS-HIV summary scores) and 0.03 change (EQ-5D<br />

HIS). Primary outcomes were changes in scores from baseline.<br />

Results: Of 199 treated subjects, ~88% <strong>of</strong> the subjects completed<br />

the EQ-5D and ~75% <strong>of</strong> the subjects completed the<br />

MOS-HIV at Weeks 24 and 48 (Table 1).

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