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Biomedical subjects

Carol E Golin

Publications and source records attributed to Carol E Golin.

At least 19 recordsLinked to original sources

Repeated measures analyses of dose timing of antiretroviral medication and its relationship to HIV virologic outcomes.

Medication adherence is a critical predictor of the effectiveness of antiretroviral medications in the treatment of HIV/AIDS. Studies of adherence, however, have focused primarily on the per cent of prescribed doses taken (per cent adherence). In the Adherence and Efficacy of Protease Inhibitor Therapy study, we collected detailed adherence data including dose timing information as well as data regarding patients' virologic responses. For 48 weeks, adherence data and virologic outcomes were collected every 4 weeks, and demographics and other measures were collected at baseline and at weeks 8, 24, and 48. We constructed eight different dose timing error (DTE) measures and evaluated their associations with virologic outcomes using longitudinal analyses. Repeated measures mixed effect models were fitted to evaluate the predicting power of each of the DTE measures. Among 52 036 electronically measured doses obtained from 122 patients, DTE measures significantly predicted virologic outcomes. Of the eight different DTE measures, the six DTE measures were significantly predictive of virologic outcomes even after controlling for per cent adherence. In conclusion, we identified several measures of DTE that explain HIV virologic outcomes not captured by traditional adherence measures. Investigations of adherence to antiretrovirals would benefit from measuring not only per cent adherence but dose timing adherence.

Adult↗

A practical method to calibrate self-reported adherence to antiretroviral therapy.

OBJECTIVE: Self-report of antiretroviral medications adherence is inexpensive and simple to use in clinical settings but grossly overestimates adherence. We investigated methods to calibrate patients' self-reported adherence to match objectively measured adherence more closely for the purpose of developing a practical and more accurate self-reported adherence measure. DESIGN: Longitudinal cohort design. METHODS: Using data from 2 prospective longitudinal clinical investigations conducted at 5 HIV clinics, we examined the discrepancy between self-reported adherence and objectively measured adherence. We evaluated the relation between attitudinal measures and the degree of discrepancy and used a cross-validation approach to propose candidate items to improve adherence survey methodology. RESULTS: Among 330 patients, self-reported adherence was consistently higher than objectively measured adherence. The best calibration models included the patient's self-reported adherence, duration of the antiretroviral regimen, and attitudinal measures (ability to take medication as instructed, believing medication can help one to live longer, whether or not it is too troublesome to take antiretrovirals, and feeling things are going the right way). CONCLUSION: The method efficiently identified survey items to improve self-reported adherence measurement. The calibrated measure more closely approximates objectively measured adherence and is more sensitive for detecting nonadherence. These models merit evaluation in other settings.

Adult↗

Role of the HIV/AIDS case manager: analysis of a case management adherence training and coordination program in North Carolina.

Highly active antiretroviral therapy (HAART) adherence rates of 90%-95% or more are required to be effective at treating the virus and preventing drug resistance. From both a medical and public health perspective, it is essential that HIV-positive clients strictly adhere to antiretroviral treatment regimens. One promising approach to promoting optimal adherence rates among HIV-positive individuals is training and reimbursing case managers to provide adherence coordination services to HIV-positive clients. In this study, a sample of 16 HIV/ AIDS case managers from agencies across North Carolina participated in a Case Management Adherence Training and Coordination Program for a 3-month period. After case manager training, case managers enrolled 1-4 of their existing clients, who met eligibility criteria, to receive the adherence coordination program. Data were analyzed from focus group interviews and individual interviews conducted with case manager participants; their respective client care plans were also analyzed to identify primary barriers and strategies reported by case managers. Although case managers perceived themselves to be well positioned to provide adherence coordination services for their HIV-positive clients, they also identified barriers that they face in providing these services, including lack of reimbursement for their time, inadequate training, and insufficient knowledge of HIV/AIDS and medications. The findings of this study suggest that, with appropriate training and reimbursement, HIV/AIDS case managers can play a pivotal role in promoting and improving client adherence to antiretroviral medications.

Antiretroviral Therapy, Highly Active↗

A pilot study of health beliefs and attitudes concerning measures of antiretroviral adherence among prisoners receiving directly observed antiretroviral therapy.

High level adherence to antiretroviral therapy (ART) is required to achieve and maintain suppression of HIV replication. Although directly observed therapy (DOT) has been suggested as an intervention to improve adherence, there is a paucity of data describing the attitudes and beliefs regarding DOT for ART among HIV-infected individuals. This study was designed to evaluate the acceptability and psychometric properties of a survey instrument for use in assessing barriers and facilitators of adherence to ART DOT in prison. From July 1, 1999 to April 1, 2000, we piloted an interviewer-administered questionnaire to assess health beliefs and attitudes regarding HIV treatment among 65 HIV-infected prison inmates receiving one or more of their antiretrovirals via directly observed therapy (DOT). The first 24 participants were administered the questionnaire to determine the feasibility of surveying prisoners in a correctional setting. There were no adherence data collected on these participants. The remaining 41 participants had their adherence measured in addition to receiving the questionnaire. Thirty-one were included in the final analysis because 10 did not complete the study. Multiple antiretroviral adherence measures (electronic device medication monitoring [eDEM] caps, medication administration records [MARs], and pill counts) were assessed among a subset of the participants (n = 31) and correlated to the instrument response items. The median internal consistency reliability coefficient for the multi-item scales was 0.79. The strongest correlation between inmates' beliefs and their adherence was between "positive beliefs about protease inhibitors" and the MAR adherence measure (r = 0.72; p < 0.001). This study provides preliminary support for the psychometric properties of the survey in this correctional setting.

Anti-Retroviral Agents↗

A comprehensive evaluation of survey questions for adherence to antiretroviral medications and exploratory analyses for identifying optimal sets of survey questions.

Although many methods for assessing adherence have been developed, most are not feasible for busy clinical settings. Using patients from the Adherence and Efficacy of Protease inhibitor Therapy (ADEPT) study (1998-2000), we systematically evaluated the relationship between psychosocial, environmental, clinical, and other factors with adherence to create composite variables (CVs) that are efficient with high sensitivity for detecting nonadherence and great potential for busy clinics. Eligible patients were protease inhibitor naïve or started a regimen within 3 months from baseline. Of the 128 patients who responded to survey at baseline, weeks 8, 24, and/or 48, mean (standard deviation [SD]) age was 39.3 (8.2) years with 81% male. About half of the patients were Latino, followed by 28% African American and 14% Caucasian. Sixteen percent reported injection drug use, and 40% had male-male sex. Mean CD4 count was 184.8 cells/mm(3) with a range from 1 to 1130 cells/mm(3). Thirty-two variables had a significant association with adherence at one or two time points and 9 were significantly associated with adherence over time. Among these significant factors, 8 also had a relationship with a clearly monotonic trend, by which 219 CVs were formed. Among these CVs, 8 were significantly associated with adherence and had a relationship with monotonic trend. Compared to traditional self-reported adherence, CVs had much higher sensitivities (p < 0.001) for detecting nonadherence. We conclude that CVs consisting of a combination of psychological, behavior, and adherence questions may be reasonable substitutes for direct adherence questions, which are limited by problems with recall and social biases. Trust in physicians, having a child, history of substance use, CD4 count, and belief that antiretrovirals can help living longer or improve quality of life can efficiently predict nonadherence. Because these variables are readily obtainable in clinical settings, these selected questions may provide a clinically useful means of screening patients for antiretroviral medication nonadherence.

Adult↗

Repeated measures longitudinal analyses of HIV virologic response as a function of percent adherence, dose timing, genotypic sensitivity, and other factors.

BACKGROUND: Adherence to antiretroviral medications is critical to achieving HIV viral suppression. Studies have been limited to cross-sectional analyses using measures that reflect only the percentage of prescribed doses taken (percent adherence), however. The contribution of dose timing and other factors to achieving virologic suppression has received less scrutiny. METHODS: In a longitudinal study, we collected detailed adherence information using multiple tools along with demographic, clinical, social-behavioral, and virologic measures. Subjects were followed for 48 weeks. Percent adherence, dose-timing, genotypic sensitivity, and virologic outcomes were collected every 4 weeks. Repeated measures mixed effects models (RMMEMs) were used to model the relation between virologic outcomes and adherence as well as genotypic sensitivity and others. RESULTS: Of the 141 subjects, mean percent adherence was 73% with a downward trend. Viral load (VL) dropped significantly (P = 0.01) over time. RMMEMs revealed that higher genotypic sensitivity, higher percent adherence, lower baseline VL, longer inclusion in the study, earlier HIV stage, and smaller dose-timing error were significantly associated with lower VL. In multivariate modeling, a 0.50 increase in the genotypic sensitivity score, a 10% increase in adherence, and a decrease of 3 hours of dose-timing error were associated with a decrease in log10 HIV RNA at 48 weeks of 0.69, 0.54, and 0.48, respectively (P < 0.05 for each). CONCLUSIONS: Long-term viral suppression requires consistent and high percent adherence accompanied by optimal interdose intervals. Efforts to improve viral outcomes should address not only missed doses but excessive variation in dose timing and prevention of adherence decline over time. Preventing the development and transmission of resistant variants is also critically important.

Adult↗

A 2-arm, randomized, controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (ART) among patients failing or initiating ART.

RATIONALE AND PURPOSE: Motivational interviewing (MI) is a counseling technique that has been used effectively to change a number of health-related behaviors. We sought to assess the impact on patients' antiretroviral therapy (ART) adherence of a multicomponent, MI-based ART adherence intervention compared with that of an HIV informational control program. STUDY DESIGN: Two-arm, randomized, controlled trial. SAMPLE: One hundred forty adult HIV-infected patients attending a large, academic center infectious diseases clinic who were either failing or newly initiating an ART regimen. STUDY ENDPOINTS: (1) Mean adherence level (% of prescribed doses take in the prior month) at the week 12 visit, (2) change in mean adherence, (3) percentage of patients achieving >95% adherence in the third 4-week block, and (4) change in viral load. MAIN FINDINGS: The MI group's mean adherence improved by 4.5% compared with a decrease in the control group's adherence by 3.83% (P = 0.10). In the treatment group, 29% achieved >95% adherence compared with only 17% in the control group (P = 0.13). When we controlled for ethnicity, the intervention group had 2.75 times higher odds of achieving more than 95% adherence than did the controls (P = 0.045; 95% confidence interval: 1.023, 7.398). Although a number of mediating variables (beliefs about ART, coping style, social support, and goals set) had statistically significant changes in the expected direction in the MI group compared with controls, in the intent-to-treat analysis, the mean adherence at study exit for the intervention group was 76% (SD = 27%) and 71% (SD = 27%) for the control group (P = 0.62). CONCLUSION: Although not definitive, this study provides some evidence that MI offers an effective approach to improving adherence. Future studies able to build MI into the intervention for longer than 3 months may have a greater impact.

Academic Medical Centers↗

Sexual behaviours of HIV-seropositive men and women following release from prison.

Twenty-five percent of the US HIV-infected population is released from a prison or jail each year. As the extent of risky sexual behaviours after prison release is largely unknown, we interviewed a cohort (n = 64) of HIV-infected, recently released (mean 45 days, SD 28) prisoners about their current sexual risk behaviours. Almost half (47%, n = 64) of the released prisoners reported sexual activity after release, mostly with regular partners. Although 26% (n = 27) reported engaging in unprotected sexual activity with their regular partners, none (n = 4) reported unprotected sex with their non-regular partners. Furthermore, 33% percent (n = 15) of the releasees with regular partners reported engaging in unprotected sex with HIV-seronegative partners. These results suggest that regular partners of HIV-infected prison releasees are at risk of acquiring HIV infection, and secondary risk-reduction strategies are needed for HIV-infected prison releasees.

Adult↗

Motivational interviewing to support antiretroviral therapy adherence: the role of quality counseling.

OBJECTIVE: Although research linking motivational interviewing (MI) to behavior change exists, few studies report on MI's quality or explore how it may influence effectiveness. We studied MI quality and adherence to antiretroviral therapy (ART) in the context of a randomized, controlled trial. METHODS: We used a structured instrument to code MI sessions and then correlated ART adherence (measured by electronic bottle cap monitor and pill count data at study exit) with specific counseling behaviors and the proportion of interactions that achieved quality benchmarks. RESULTS: The sample (n = 47) was predominantly male (79%), minority (90%), had a mean age of 40, and averaged 79% adherence at exit. On three of five benchmarks, most MI sessions achieved the targeted quality level: 100% achieved them for MI-consistent statements; 85% for complex reflections; 63% for reflections to questions ratio; 44% for global therapist rating; 19% for using open-ended questions. ART adherence was positively associated with the ratio of reflections to questions (r = .39, p = .02), affirming statements (r = .38, p = .02), and negatively associated with closed-ended questions (r = -.33, p = .04). DISCUSSION: Good quality MI can be conducted within the structure of a controlled trial but was generally not associated with ART adherence. CONCLUSION: Documenting treatment fidelity is critical to judging the efficacy of MI-based interventions. PRACTICE IMPLICATIONS: Regular feedback and close monitoring are needed to maintain MI quality.

Adult↗

How new subscribers use cancer-related online mailing lists.

BACKGROUND: Online cancer-related support is an under-studied resource that may serve an important function in the information seeking, care, and support of cancer patients and their families. With over 9.8 million cancer survivors (defined as anyone living with cancer) in the United States alone and the number growing worldwide, it is important to understand how they seek and use online resources to obtain the information they need, when they need it, and in a form and manner appropriate to them. These are stated cancer communication goals of the US National Cancer Institute. OBJECTIVES: Our purposes are to (1) present background information about online mailing lists and electronic support groups, (2) describe the rationale and methodology for the Health eCommunities (HeC) study, and (3) present preliminary baseline data on new subscribers to cancer-related mailing lists. In particular, we describe subscribers' use of mailing lists, their reasons for using them, and their reactions to participating shortly after joining the lists. METHODS: From April to August 2004, we invited all new subscribers to 10 Association of Cancer Online Resources mailing lists to complete Web-based surveys. We analyzed baseline data from the respondents to examine their perceptions about cancer-related mailing lists and to describe how cancer patients and survivors used these lists in the period shortly after joining them. RESULTS: Cumulative email invitations were sent to 1368 new mailing list subscribers; 293 Web surveys were completed within the allotted time frame (21.4% response rate). Most respondents were over age 50 (n = 203, 72%), white (n = 286, 98%), college graduates (n = 161, 55%), and had health insurance (n = 283, 97%). About 41% (n = 116) of new subscribers reported spending 1 to 3 hours per day reading and responding to list messages. They used the mailing lists for several reasons. Among the most frequently reported, 62% (n = 179) strongly agreed they used mailing lists to obtain information on how to deal with cancer, 42% (n = 121) strongly agreed they used mailing lists for support, and 37% (n = 109) strongly agreed that they were on the mailing lists to help others. Smaller proportions of new subscribers strongly agreed that others on the mailing lists had similar cancer experiences (n = 23, 9%), that they could relate to the experiences of others on the lists (n = 66, 27%), and that others on the list gave them good ideas about how to cope with cancer (n = 66, 27%). CONCLUSIONS: Cancer-related online mailing lists appear to be an important resource, especially for information seeking but also for support of cancer survivors. These were the primary motivators most members reported for joining mailing lists. The modest proportion of subscribers who strongly agreed that they could relate to others' cancer experiences (as well as similar responses to other process questions) is undoubtedly due at least in part to the short duration that these subscribers were involved with the mailing lists. Emerging data, including our own, suggest that mailing lists are perhaps under-used by minority patients/survivors. These preliminary data add to a growing body of research on health-related online communities, of which online mailing lists are one variant.

Health Personnel↗

HIV and stigma: analysis and research program.

Despite advances in our understanding of HIV transmission and optimal treatment of people with HIV infection, stigmatizing attitudes are a significant barrier to HIV prevention and treatment. Several studies demonstrate that stigma directed towards people with HIV infection presents an obstacle to getting tested for HIV, obtaining optimal HIV care, and engaging in safe sex practices. We review the literature on individual and societal factors associated with HIV-associated stigma and propose a framework for intervention design.

Attitude to Health↗

Preferences for medical collaboration: patient-physician congruence and patient outcomes.

Patient participation in medical care and in decision-making is generally viewed as a precursor to positive health outcomes. Patient participation is not always possible or desirable, however, and not all patients want to take an active part in their own medical care. This study examines the degree to which physician-patient congruence in preference for patient involvement is related to self-reported satisfaction, adherence, and health. Results indicate that when patients and their doctors share similar beliefs about patient participation, patient outcomes tend to be more positive, with highest satisfaction found in cases in which both patient and physician desire more patient involvement.

Adolescent↗

Influence of time stress and other variables on counseling by pharmacists about antiretroviral medications.

PURPOSE: The medication counseling practices of pharmacists caring for patients with HIV infection and the factors influencing their counseling behaviors regarding antiretroviral medications were examined. METHODS: A questionnaire was mailed in February 2000 to pharmacist-managers of 573 ambulatory care pharmacies providing medications to beneficiaries of the North Carolina AIDS Drug Assistance Program. The frequency of and attitudes about adherence counseling for patients with HIV infection; the time allocated, spent, and needed to provide high-quality care to these patients; and pharmacists' time pressure and time stress were measured. RESULTS: Of the 573 questionnaires mailed, 440 (77%) were usable. Fifty-nine percent of pharmacists reported that they did not have enough time to provide adherence counseling to patients receiving antiretroviral medications, and 45% reported that most of their patients did not receive such counseling. Time-stressed pharmacists were significantly less likely to perform 12 of 22 counseling behaviors, including discussing adverse effects (13% versus 24%, p < 0.0089), drug interactions (13% versus 31%, p < 0.0001), and what to do if a dose is missed (8% versus 23%, p < 0.0001). Multivariate analysis revealed that time stress, perceived skill and interest in adherence counseling, and job satisfaction were significantly associated with the counseling index. CONCLUSION: Time pressure and other barriers appeared to limit the care that some pharmacists offered to patients with HIV infection. Pharmacist age, job satisfaction, and perceived skill and interest in adherence counseling influenced the comprehensiveness of the counseling pharmacists provided for patients receiving antiretroviral medications.

Adult↗

No evidence of an association between transient HIV viremia ("Blips") and lower adherence to the antiretroviral medication regimen.

BACKGROUND: Transient human immunodeficiency virus (HIV) viremia, a common phenomenon among patients taking antiretroviral therapy, is often attributed to lapses in adherence to the medication regimen. We investigated this relationship in a prospective observational cohort of 128 patients initiating a new regimen. METHODS: A case of transient viremia was defined as an HIV RNA level of 40-1000 copies/mL ("blip") sandwiched between 2 months of HIV RNA levels <40 copies/mL ("pre" and "post"). Adherence was most often measured with a composite adherence score (CAS), which is primarily based on electronically measured adherence. Case subjects' adherence and dose-timing was compared with (1) that of other patients (control subjects), who had undetectable virus loads for 3 consecutive months, and (2) that during periods of sustained undetectable virus loads among the case subjects themselves, if available. RESULTS: Among the 28 case subjects, mean CAS-measured adherence did not decrease before transient viremia; adherence during the pre, blip, and post periods were 86%, 84%, and 80%, respectively. Control subjects had lower adherence levels during the corresponding 3 months (77%, 79%, and 75%, respectively; P = .046). Among the 19 patients able to serve as their own controls, CAS-measured adherence was higher during the period of transient viremia than during control periods (P = .01). Similar relationships were found when comparing only electronically measured adherence on a week-wise basis. There were no significant differences in dose-timing error between case subjects and control subjects. CONCLUSIONS: We found no evidence that transient HIV viremia is associated with decreases in adherence or differences in dose-timing. Other etiologies for transient viremia should be evaluated.

Adult↗

Brief motivational interviewing to improve adherence to antiretroviral therapy: development and qualitative pilot assessment of an intervention.

Because successful HIV treatment requires exceptional adherence to antiretroviral therapy (ART), interventions to improve ART adherence are essential. We developed and pilot-tested an intervention to improve ART adherence, based on brief motivational interviewing (MI), which has successfully improved selected health behaviors but has not been tested for ART adherence. We administered the 15- to 30-minute MI session to 20 HIV-positive adults and assessed its usefulness and relevance. Then, we content-analyzed the session for HIV care issues and strategies most salient to patients in the MI session. During the session, all participants chose an HIV-care-related topic that they wanted to discuss, and talked about issues, barriers, and facilitators related to their topic. Most participants (70%) developed strategies to help improve their health. Questions asked after the MI session revealed that almost all (95%-100%) participants found the session useful and helpful. This theoretically based, empowering health counseling approach for HIV-positive persons warrants further research.

Adult↗

Adherence counseling practices of generalist and specialist physicians caring for people living with HIV/AIDS in North Carolina.

CONTEXT: National guidelines recommend that practitioners assess and reinforce patient adherence when prescribing antiretroviral (ART) medications, but the extent to which physicians do this routinely is unknown. OBJECTIVE: To assess the adherence counseling practices of physicians caring for patients with HIV/AIDS in North Carolina and to determine characteristics associated with providing routine adherence counseling. DESIGN: A statewide self-administered survey. SETTING AND PARTICIPANTS: All physicians in North Carolina who prescribed a protease inhibitor (PI) during 1999. Among the 589 surveys sent, 369 were returned for a response rate of 63%. The 190 respondents who reported prescribing a PI in the last year comprised the study sample. MAIN OUTCOME MEASURES: Physicians reported how often they carried out each of 16 adherence counseling behaviors as well as demographics, practice characteristics, and attitudes. RESULTS: On average, physicians reported spending 13 minutes counseling patients when starting a new 3-drug ART regimen. The vast majority performed basic but not more extensive adherence counseling; half reported carrying out 7 or fewer of 16 adherence counseling behaviors "most" or "all of the time." Physicians who reported conducting more adherence counseling were more likely to be infectious disease specialists, care for more HIV-positive patients, have more time allocated for an HIV visit, and to perceive that they had enough time, reimbursement, skill, and office space to counsel. After also controlling for the amount of reimbursement and availability of space for counseling, physicians who were significantly more likely to perform a greater number of adherence counseling practices were those who 1). cared for a greater number of HIV/AIDS patients; 2). had more time allocated for an HIV physical; 3). felt more adequately skilled; and 4). had more positive attitudes toward ART. CONCLUSIONS: This first investigation of adherence counseling practices in HIV/AIDS suggests that physicians caring for patients with HIV/AIDS need more training and time allocated to provide antiretroviral adherence counseling services.

Acquired Immunodeficiency Syndrome↗

Availability of and access to medical services among HIV-infected inmates incarcerated in North Carolina county jails.

This study assessed human immunodeficiency virus (HIV)-related services in county jails and staff perceptions of HIV-infected inmates and their care. A statewide telephone questionnaire was administered to detention officers and health care workers providing medical services in North Carolina jails. Eighty-five percent of participating facilities employed one or more on-site medical personnel, including physicians (51%), physician assistants (14%), and nurses (71%). Only 25% of jails tested more than one inmate for HIV per month. In 75% of jails, initial medical screening was performed in a common area. Officers administered medical screening forms at 93% of jails and distributed medications at 81%. Ninety-three percent of officers and 94% of medical staff agreed with this statement: "If an inmate is taking medications in jail, other inmates will know about it." Overall, our data indicate that few North Carolina jail inmates are tested for HIV. Greater protection of confidentiality may improve screening and treatment of HIV-infected inmates.

Anti-Retroviral Agents↗

Adherence to directly observed antiretroviral therapy among human immunodeficiency virus-infected prison inmates.

Directly observed therapy (DOT) for human immunodeficiency virus (HIV) infection is commonly used in correctional settings; however, the efficacy of DOT for treating HIV infection has not been determined. We prospectively assessed adherence to antiretroviral therapy regimens among 31 HIV-infected prison inmates who were receiving >or=1 antiretrovirals via DOT. Adherence was measured by self-report, pill count, electronic monitoring caps, and, for DOT only, medication administration records. Overall, median adherence was 90%, as measured by pill count; 86%, by electronic monitoring caps; and 100%, by self-report. Adherence, as measured by electronic monitoring caps, was >90% in 32% of the subjects. In 91% of cases, adherence, as measured by medication administration records, was greater than that recorded by electronic monitoring caps for the same medications administered by DOT. Objective methods of measurement revealed that adherence to antiretroviral regimens administered wholly or in part by DOT was <or=90% in more than one-half of the patients. Different methods used to measure adherence revealed significantly different levels of adherence. These findings suggest that use of DOT does not ensure adherence to antiretroviral therapy.

Adult↗