Ann B. Williams

Use of Electronic Monitoring Devices to Measure Antiretroviral Adherence: Practical Considerations

The purpose of this paper is to describe electronic monitoring device (EMD) (e.g., MEMS caps) use among HIV-infected adults enrolled in a randomized clinical trial and to make explicit some of the benefits and caveats of using electronic monitoring device technology. This is a descriptive, exploratory study of EMD use among 128 HIV-infected adults treated with at least three antiretroviral agents. Thirty-six percent of the sample admitted that they did not use the EMD consistently. Forty-one percent of the subjects reported taking out more than one dose at a time and 26% reported opening the EMD but not taking the medication. Special subject-related issues accounted for only a small percentage of all reported problems with EMD use (e.g., transient housing, incarceration, substance abuse relapse and drug treatment). Results of this study suggest that EMDs may underestimate antiretroviral adherence among HIV-infected adults. Recommendations for improving EMD data quality are presented.

Home visits to improve adherence to highly active antiretroviral therapy : A randomized controlled trial

Background: Few rigorously designed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral. Data are needed to justify the use of limited resources for these programs. Methods: A 2-arm, randomized, controlled trial evaluated the efficacy of a community-based, home-visit intervention to improve medication adherence. Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents. The majority had a past or current history of substance abuse. Subjects were randomly assigned to receive home visits for 1 year or usual care. Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from randomization through 3 months after the conclusion of the intervention. Results: A larger proportion of subjects in the intervention group demonstrated adherence greater than 90% compared with the control group at each time point after baseline. The difference over time was statistically significant (Extended Mantel-Haenszel test: 5.80, P = 0.02). A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen, but there was a statistically significant association between greater than 90% adherence and an undetectable HIV-RNA over time (P < 0.03). Conclusion: Home visits from a nurse and a community worker were associated with medication adherence greater than 90% among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States.

Adherence to antiretroviral medication among HIV-positive patients in Thailand.

Background:The use of antiretroviral (ARV) medications is expanding rapidly in Thailand. The determinants of optimal adherence for HIV-positive patients in Thailand are unknown. Methods:A sample of 149 Thai patients receiving ARV therapy at Bhumrasnaradura Infectious Disease Institute located near Bangkok completed a structured questionnaire and reported medication adherence on a 30 day visual analog scale. HIV RNA test results were abstracted from the medical record. Results:Adherence ranged from 25% to 100%. The median was 100% and the mean was 96%. The majority of subjects (114, 77%) had an HIV RNA ≤50 copies/mL. An undetectable viral load was associated with adherence ≥95% (odds ratio [OR] = 3.0; 95% confidence interval [CI] 1.3 to 7.1; P = 0.02) and with a lower mean number of months on ARV therapy (22 versus 32 months; P = 0.03). Gender, educational level, method of payment, use of GPO-VIR, and whether or not the patient was on his or her initial ARV regimen were not associated with an undetectable viral load. In the multivariate analysis, only length of time in months was associated with an undetectable viral load. For each additional month, the odds of being undetectable were 0.975. (OR = 0.975; 95% CI 0.954 to .996; P = 0.02). Conclusions:Adherence was high in this cohort and was associated with HIV-RNA levels. However, these data confirm that adherence is only 1 factor that determines the effectiveness of ARV treatment. Duration of treatment was associated with virologic failure, controlling for adherence.

Methadone maintenance treatment and HIV type 1 seroconversion among injecting drug users

This study examined whether methadone maintenance treatment decreases drug injection enough to significantly limit HIV-1 transmission among injection drug users (IDU). When HIV-1 seroconversion status among prospectively followed methadone maintenance clients was analyzed by treatment retention, 1/56 (2%) of those who remained continuously in treatment seroconverted while 8/42 (19%) of those whose methadone treatment was interrupted seroconverted. When controlled for length of follow up, the difference in seroconversion rate was not statistically significant. Subjects in continuous treatment had a seroconversion rate of 0.7 per 100 person years (95% Confidence Interval [CI] = 0.1, 5.3) and those with interrupted treatment a rate of 4.3 per 100 person years (95% CI = 2.2, 8.6). Subjects in continuous treatment reported less needle sharing (p less than 0.0002), fewer needle sharing partners (p less than 0.002), fewer sexual partners (p less than 0.03), and were more likely to be women (p less than 0.01). These data indicate the need for larger studies to evaluate both client and drug treatment program characteristics which might concomitantly increase treatment retention and decrease HIV-1 risk.

Home-based study of anti-HIV drug regimen adherence among HIV-infected women: Feasibility and preliminary results

Collection of antiretroviral medication adherence data in the homes of HIV-infected people may have methodological advantages that can improve data quality. However, the feasibility of this approach has not been established. In addition, data on adherence, and its predictors, among HIV-infected women have been limited. Sixty-three HIV-positive women who were prescribed at least one antiretroviral drug in the last month were interviewed in their homes. A standard instrument was used to collect data on all antiretroviral medications prescribed and taken in the three days prior to the interview. Data were also collected on factors thought potentially to affect the ability to be adherent. The results of this study suggest that it is feasible to conduct home-based adherence research. Sixty-seven per cent reported taking all prescribed antiretroviral medication doses. One-third took a sub-optimal dose putting themselves at increased risk of treatment failure and the selection of resistant HIV strains. Unintentional reasons for missing doses were most commonly reported. An ability to describe the intended effect of antiretroviral therapy on HIV viral load was the best predictor of adherence. This finding is consistent with other research suggesting that adherence is associated with an understanding and belief in the effectiveness of antiretroviral therapy.

Stigma reported by people living with HIV in south central China.

&NA; This cross‐sectional study described the level of stigma reported by people living with HIV (PLWH) in south central China and identified factors associated with the individuals’ perceptions of stigma. The authors carried out face‐to‐face interviews among 322 PLWH. Over half (51%) reported experiencing stigma, 78% reported feelings of negative self‐worth, 75% reported interpersonal insecurity, 84% experienced financial problems, and 58% worried about disclosure of their disease. High levels of self‐perceived stigma were associated with subjects who were injection drug users (p = .001), who were less satisfied with responses from family members (p = .001), who had disclosed their HIV status widely (p = .001), and who reported poorer health status (p = .001). Nurses working with PLWH should carry out psychological assessments and care without judgmental attitudes and help PLWH disclose their HIV status to family members, which could reduce HIV‐related stigma in the context of Chinese culture.

New horizons: Antiretroviral therapy in 1997

Exciting advances in basic and clinical science brought a new strategy for antiretroviral therapy and new hope to people living with HIV in 1996. There are now three major categories of antiretroviral agents available for clinical use. All require replicating virus, and none are virucidal. The goal of antiretroviral therapy is a significant and prolonged reduction of the amount of actively replicating HIV (viral load). Carefully chosen combinations of antiretroviral drugs significantly reduce HIV load and are likely to extend life. However, not all patients respond to highly active antiretroviral therapy (HAART), and, for those who do, adjustment to demanding regimens and management of side effects may be difficult. The development of drug resistance is a serious concern, because resistance is associated with rising viral loads and with poorer prognosis in advanced disease.

Consistent ART Adherence Is Associated with Improved Quality of Life, CD4 Counts, and Reduced Hospital Costs in Central China

This study aimed to assess levels of ART adherence and to examine the relationship between adherence and treatment outcomes. A longitudinal study in Hunan and Hubei provinces used the CPCRA Antiretroviral Medication Self-Report and a 7-day Visual Analogue Scale to assess levels of adherence, while quality of life was evaluated using SF-36. CD4 cell count and the number, duration, and cost of hospitalizations were collected from participant medical records. Measurements were obtained at baseline, month 3, and month 6. A total of 113 participants enrolled and 98 completed the study. The mean level of adherence was 91%, 89%, and 88% at baseline and at 3 and 6 months, respectively. Of participants, 54/98 (58%) reported taking all doses at all three interviews and were classified as consistent adherers (CA). CAs had better physical function (p = 0.001), general health (p = 0.009), vitality (p = 0.016), social functioning (p = 0.001), and mental health (p = 0.023), and presented a higher CD4 cell count (p = 0.028). CAs also had fewer hospital admissions and readmissions (p = 0.005), shorter hospital stays (p = 0.005), and lower hospital expenses (p = 0.006). Consistent adherence is associated with better outcomes including improved quality of life, higher CD4 counts, and lower health care costs.

Evaluation of two self-care treatments for prevention of vaginal candidiasis in women with HIV.

Vaginal candidiasis (VC) is a common concern for women living with HIV infection. The authors evaluated the effectiveness of two self-care approaches to prophylaxis of VC among HIV-infected women, weekly intravaginal application of Lactobacillus acidophilus or weekly intravaginal application of clotrimazole tablets, in a randomized, double-blind, placebo-controlled trial. VC was defined as a vaginal swab positive for Candida species in the presence of signs/symptoms of vaginitis and the absence of a diagnosis of Trichomonas vaginalis or bacterial vaginosis. Thirty-four episodes of VC occurred among 164 women followed for a median of 21 months. The relative risk of experiencing an episode of VC was 0.4 (95% CI = 0.2, 0.9) in the clotrimazole arm and 0.5 (95% CI = 0.2, 1.1) in the Lactobacillus acidophilus arm. The estimated median time to first episode VC was longer for clotrimazole (p = .03, log rank test) and Lactobacillus acidophilus (p = .09, log rank test) compared with placebo. Vaginal yeast infections can be prevented with local therapy. Education about self-care for prophylaxis of VC should be offered to HIV-infected women.

Adjusting and censoring electronic monitoring device data. Implications for study outcomes.

Summary:Electronic monitoring device (EMD) data are widely used to measure adherence in HIV medication adherence research. EMD data represent an objective measure of adherence and arguably provide more valid data than other methods such as self-reported measures, pill counts, and drug level concentration. Moreover, EMD data are longitudinal, include many measurements, and yield a rich data set. This article illustrates potential pitfalls associated with this measurement technique, including lack of clarity associated with EMD data, and the extent to which adherence outcomes are affected by data management decisions. Recommendations are given regarding what information should be included in publications that report results based on EMD data so as to facilitate comparisons between studies.