Enhancing adherence to combination antiretroviral

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Enhancing adherence to combination antiretroviral therapy in non-adherent HIVpositive men a

S. McPherson-Baker , R.M. Malow a

a b

D.L. Jones , N. Schneiderman & N.G. Klimas a

a

, F. Penedo ,

a

a b

University of Miami School of Medicine

b

University of Miami , Florida, USA Published online: 27 May 2010.

To cite this article: S. McPherson-Baker , R.M. Malow , F. Penedo , D.L. Jones , N. Schneiderman & N.G. Klimas (2000) Enhancing adherence to combination antiretroviral therapy in non-adherent HIV-positive men, AIDS Care: Psychological and Socio-medical Aspects of AIDS/HIV, 12:4, 399-404, DOI: 10.1080/09540120050123792 To link to this article: http://dx.doi.org/10.1080/09540120050123792

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AIDS CARE (2000), VOL. 12, NO. 4, pp. 399– 404

Enhancing adherence to combination antiretroviral therapy in non-adherent HIV-positive men S. MCPHERSON-BAKER,1 R.M. MALOW,1,2 F. PENEDO,1 D.L. JONES,1 N. SCHNEIDERMAN1 & N.G. KLIMAS1,2 Downloaded by [University of Miami] at 14:14 10 August 2015

1

University of Miami School of Medicine & 2University of Miami, Florida, USA

Abstract This paper describes a preliminary study aimed at testing the ef cacy of a brief medication counselling and behavioural intervention in improving adherence to combination antiretroviral medication therapy and prophylactic treatment among non-adherent men living with HIV. Twenty-one non-adherent HIV-positive men obtaining primary care clinical services at a Veterans Affairs Medical Center were recruited by health care providers. Intervention participants were primarily African-Americans with histories of intravenous drug use. During a period of ve months, participants were provided with monthly medication counselling and a weekly medication pill organizer. Participants were compared with 21 non-adherent matched controls receiving standard pharmacy care including review of medications. Intervention and control subjects were compared on several variables: medication re ll timeliness, appointment attendance, hospitalizations and opportunistic infections. Medical information was obtained from hospital and pharmacy records at baseline and post-intervention. Pre- to post-intervention rates of adherence to medication re lls and clinic appointments increased signi cantly among intervention participants. Relative to matched controls, intervention participants also signi cantly increased drop-in visits and showed fewer hospitalizations. Intervention participants also showed signi cant decreases in the number of opportunistic infections. Results suggest that exposure to medication counselling and behavioural interventions increase adherence, with associated reductions in negative clinical outcomes. Recent studies have established the ef cacy of combination antiretroviral therapy (CART) in the treatment of HIV illness (Carpenter et al., 1996; Rabkin & Ferrando, 1997). CART has been shown to produce sustained suppression of viral replication and decreased viral load to a level at which viral particles are undetectable. This has dramatically altered the progression of disease and associated morbidity and mortality among persons living with HIV. However, the utility of highly effective antiretroviral therapy is entirely associated with strict adherence to complex regimens that may require at least 18 pills or capsules taken on structured time lines with speci c food intake requirements. Furthermore, less than adequate adherence to CART may pose a public health concern given the potential for the rapid development of medication-resistant strains of HIV (Bangsberg et al., 1997; Besche et al., 1992; Blumen eld Address for correspondence: Dr Deborah L. Jones, University of Miami, Behavioral Medicine Research Center, Department of Psychology, Miami, FL 33136, USA. Tel: 1 1 305 325 7143; Fax: 1 1 305 325 7126; E-mail: Djones @med.miami.edu

ISSN 0954-0121 print/ISSN 1360-0451 online/00/040399-06 Ó

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S. MCPHERSON-BAKER ET AL.

et al., 1990; Morse et al., 1991). Thus while the clinical status and prognosis for people living with AIDS in the United States has improved, the necessity of adherence to medication regimens has become increasingly important as the incidence of HIV has continued to rise (CDC (Centers for Disease Control and Prevention), 1998). HIV medication adherence literature initially focused on adherence to a single medication regimen of zidovudine (AZT). AZT adherence, less complex than CART, has ranged from 26– 94% (Cortese et al., 1993; LoCapuro et al., 1993; Muma et al., 1995). Several factors have been associated with the less than adequate adherence rates to AZT, e.g. its complex dosing schedule, the extended duration of its prescription and unpleasant side effects (Wall et al., 1995). In addition, individuals expressing skepticism regarding the ef cacy or value of AZT have been found to be less compliant (Muma et al., 1995). When under directly observed therapy (DOT), supervised medication and dispensation, non-adherent intravenous drug users receiving AZT demonstrated signi cantly improved levels of adherence. However, obtained adherence gains remained signi cantly improved only during periods of direct supervision (Wall et al., 1995). Adherence to CART has also been found to be problematic, ranging from 20– 80% among various populations (Chesney, 1997). Several factors have been associated with HIV medication non-adherence, including negative side effects, forgetting doses, distraction due to other commitments, confusion, running out of medication, fear of disclosure of HIV status and depression (Chesney, 1997). Health beliefs (beliefs in the severity of illness, personal susceptibility to illness and the bene ts and ef cacy of treatment (Kirscht & Rosenstock, 1977)) have been found to be indirectly related to adherence through their direct effect on intentions to adhere. The development of a strong patient– provider alliance by presenting medication with direction and encouragement has been demonstrated to increase adherence (Wall et al., 1995) in previous studies of chronic illness, and cognitive behavioural interventions have been found to be effective in changing behaviour in HIV-positive individuals (Schneiderman et al., 1997). Interventions to improve HIV medication adherence that combine HIV-relevant health beliefs, a supportive provider alliance and self-management are clearly needed. Past studies have assessed adherence primarily among highly educated and motivated HIV-positive men who have sex with men (Muma et al., 1995; Stall et al., 1996) and have failed to address adherence in more challenging populations. Notable exceptions are a recent study presenting an individually based intervention designed to improve CART adherence among substance abusers (Sorenson et al., 1998) and another highlighting the need for population-tailored interventions (Crespo-Fiero, 1997). Prior investigation had identi ed extremely poor adherence among 290 HIV-positive urban Miami VAMC patients, of whom only 17% were fully compliant with CART (de ned as lling each prescription over a six-month period) (Cohen et al., 1997). Given the need for additional research among heterosexual substance abusing men living with HIV, this study evaluated CART medication compliance among non-adherent HIV-positive male veterans following participation in a brief behavioural intervention.

Methods Twenty-one participants identi ed by Medical Center staff as currently poorly adherent to their prescribed combination antiretroviral therapy and/or in receipt of more than four different HIV-related medications were recruited from the Miami Veterans Affairs Medical Center (VAMC). All participants met criteria for non-adherence, de ned as: failure to re ll


ENHANCING ADHERENCE TO COMBINATION ANTIRETROVIRALS

401

prescriptions of antiretroviral and opportunistic infection prophylactic medications, indicating prescription non-adherence, or hospitalization for an opportunistic infection, suggesting less than optimal adherence to their prophylactic medication regimen. Thirteen participants had been prescribed CART (including a protease inhibitor), and eight had been prescribed dual antiretroviral therapy with or without opportunistic infection medications as treatment or prophylaxis. The primary risk factor for HIV infection was intravenous drug use (50%), followed by heterosexual intercourse (35.7%) and homosexual intercourse (14.3%). The majority of participants had a past or current history of substance use, as identi ed by patient chart data. The age of the sample (n 5 42) ranged from 32 to 67 years (mean 5 46). Ethnic representation within the sample included African-Americans, 73.8% Hispanics, 14.3% and non-Hispanic whites 11.9%. Disease status was de ned as CD4 cell count and viral load; mean CD4 cell count was 152 cells/mm3 and mean viral load was 180,807 copies (n 5 39 above detectable level of 500, n 5 21 below detectable level). All participants were evaluated as functioning at a level of self-care suf cient to enable them to independently manipulate and ll a weekly medication pill organizer and adhere to appointments. Disease status and overall functioning was assessed using the Karnofsky scale (Karnofsky et al., 1948) and all participants given a score of 60 or less (‘requires occasional assistance, but is able to care for most of his needs’) were excluded. In addition, participants meeting the following criteria were excluded: having a primary caregiver, living in a long-term nursing care facility, unable to care for self due to a mental disability, history of being lost to clinic follow-up (failure to appear for appointment). All patients recruited had been diagnosed as seropositive for more than one year. Male participants were matched with 21 patients based on CD4 cell counts, ethnicity, risk factor and age. To determine the ef cacy of the intervention relative to ‘treatment as usual’, participants were also matched based on meeting the de ned criteria of non-adherence. Matched control patients received usual care, which included only a pharmacy overview of medications provided to all patients and no medication organizer. Following initial data collection immediately prior to the intervention, participants met each month for ve months on an individual basis with a doctor of pharmacy at the Miami Veterans’ Administration Special Immunology Clinic, and were provided with a multicompartment weekly pill organizer and focused medication adherence counselling. In addition to medication adherence counselling, the behavioural intervention included teaching participants to ll the pill container and demonstrate a day’s use of the container, following their medication schedule. In keeping with the health beliefs model, initial medication counselling sessions of approximately 25 minutes included a basic introduction to HIV and its potential impact on the body, the purpose and function of the prescribed antiretroviral medication, and clari cation of the medication regimen and potential side effects. Each follow-up 20-minute counselling session included a review of the prescribed regimen, barriers to adherence, side effects and positive reinforcement for self-management of the medication regimen. Participants were not compensated for their involvement in the intervention. Immediately following the intervention, the level of medication adherence was quanti ed using indices de ned as representing adherence: (1) number of prescribed medications re lled, (2) number of missed clinic appointments, (3) number of hospitalizations, and (4) number of opportunistic infections. Information was retrieved from medical records through the decentralized hospital computer system. Descriptive statistics and frequency distributions were used to determine the level of adherence and improvement over time. Independent samples t-tests were performed to test differences between individual and control conditions. Pearson zero-order correlations were performed to test relationships among outcome variables.

402


Table 1. Outcome variabilities: baseline and post-intervention Baseline Intervention Mean


Clinic appointment compliance Medication re ll compliance Hospitalizations CD4 1 cell count Viral load

SD

Post-intervention Control

Mean

Intervention SD

Mean

SD

Control Mean

SD

59.80

26.35

78.77

16.72

76.11

16.54

73.33

20.71

46.85

23.65

54.42

34.50

75.76

21.76

39.32

27.34

0.76 143.10

1.48 160.25

0.76 193.50

0.89 224.60

0.33 136.50

0.48 136.40

1.04 166.10

1.16 193.50

99,213

107,827

142,848

281,999

81,600

145,567

119,275

176,475

Results Study participants were matched with non-adherent controls for statistical analysis and assessed on the four outcome variables: medication re ll compliance, clinic appointment compliance, frequency of hospitalization and opportunistic infections (see Table 1). Results of the paired samples t-tests showed a signi cant increase from baseline at ve months post-intervention in compliance with HIV-related medication re lls (t20 5 4.2 1, p , 0.01; pre-intervention visit compliance, 46.7%, post-intervention re ll compliance, 75.8%) and clinic appointments (t20 5 2.67, p , 0.05; pre-intervention visit compliance, 56.7%, post-intervention visit compliance, 76.1%) among participants in the brief behavioural intervention. Results also showed intervention participants had signi cantly lower rates of hospitalizations than controls (t20 5 2 2.45, p , 0.05; mean intervention participant hospitalizations 5 0.33, SD 5 0.48, mean control hospitalizations 5 1.05, SD 5 1.24). Finally, an increased use of medication post-intervention was signi cantly associated with a decrease in hospitalizations (r 5 0.50, p , 0.05) and a lower number of opportunistic infections (r 5 0.48, p , 0.05). A repeated measures analysis of variance, condition (intervention, control) by time (pre- and post-intervention) indicated a signi cant interaction for medication re lls (F 5 4.76, p 5 0.04), while visit compliance and rate of hospitalizations approached signi cance (F 5 2.13, p 5 0.15 and F 5 2.07, p 5 0.16, respectively). Although not initially identi ed as outcome variables, an increased number of drop-in visits was also signi cantly associated with a decrease in viral load (r 5 0.52, p , 0.05) among intervention participants. Discussion This study examined the effects of a brief behavioural intervention on HIV medication adherence among male VAMC patients identi ed as non-adherent and/or receiving greater than four HIV medications. Results from this preliminary study were consistent with our hypotheses. Non-adherent participants in a behavioural intervention consisting of providing individualized medication counselling and self-management skills to improve adherence (e.g. weekly medication pill organizers, clinic visit compliance) signi cantly increased medication adherence, as measured by medication re lls and appointment attendance, when compared to controls receiving usual care. Subjects in the usual care condition, in contrast, showed relatively consistent rates of poor adherence across the duration of the study. This preliminary data con rms that adherence to CART remains problematic. However,


ENHANCING ADHERENCE TO COMBINATION ANTIRETROVIRALS

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with exposure to a brief behavioural intervention, adherence can be enhanced. A strength of the intervention was the increased opportunity for supportive communication and interaction between the participant and a health care provider, in this case, a doctor of pharmacy. Literature suggests that adherence is impacted by the patient– provider relationship, which allows the provider to address patient beliefs and concerns and provide information on their progress and condition (Muma et al., 1995). In addition, the intervention may have provided social support and encouragement through a health care provider, also theorized to enhance adherence (Haynes, 1976). The ndings from this study may be limited by several factors. First, the small sample size and the matched sample may restrict the generalizability of the results. Similarly, the exclusion of patients lost to follow-up necessarily limited the inclusion of the most challenging non-compliant participants from the study. In addition, we did not directly assess whether pills were taken at the prescribed times and dosages. However, we did use indices associated with medication adherence (medication re lls, appointment attendance, number of hospitalizations and opportunistic infections). Future studies may bene t by using a medication event monitoring system (MEMS; pill bottle cap, Aprex Corporation, Fremont, California) to more accurately measure medication adherence. Finally, health beliefs and psychological distress are known to in uence adherence (Kirscht & Rosenstock, 1977; Muma et al., 1995; Wall et al., 1995). It remains the task of future research to further clarify how knowledge, beliefs and attitudes as well as negative affect (e.g. depression or anxiety) may in uence medication adherence. These ndings may have important implications for CART. They suggest that a brief medication counselling and behavioural intervention may be valuable for improving CART adherence among HIV-positive individuals who do not adhere to medication regimens under usual care methods. This intervention coupled with intensive pharmaceutical medication may increase patient involvement in self-management, enhance patient medication education and lead to improved medical outcomes. Successful treatment relies on adherence. Medication non-adherence increases the potential for viral mutation and medication-resistant strains of HIV. Thus, continued research in this area is urgently needed to re ne interventions for improving adherence and to address this growing public health risk.

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