The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy.

The Center for Adherence Support Evaluation (CASE) Adherence Index, a simple composite measure of self-reported antiretroviral therapy (ART) adherence, was compared to a standard three-day self-reported adherence measure among participants in a longitudinal, prospective cross-site evaluation of 12 adherence programs throughout the United States. The CASE Adherence Index, consisting of three unique adherence questions developed for the cross-site study, along with a three-day adherence self-report were administered by interviews every three months over a one-year period. Data from the three cross-site adherence questions (individually and in combination) were compared to three -day self-report data and HIV RNA and CD4 outcomes in cross-sectional analyses. The CASE Adherence Index correlated strongly with the three-day self-reported adherence data (p < 0.001) and was more strongly associated with HIV outcomes, including a 1-log decline in HIV RNA level (maximum OR = 2.34; p < 0.05), HIV RNA < 400 copies/ml (maximum OR = 2.33; p < 0.05) and performed as well as the three-day self-report when predicting CD4 count status. Participants with a CASE Index score >10 achieved a 98 cell mean increase in CD4 count over 12 months, compared to a 41 cell increase for those with scores < or =10 (p < 0.05). The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings.

The cost of HIV medication adherence support interventions: results of a cross-site evaluation.

The objective of this study was to determine the direct cost of HIV adherence support programmes participating in a cross-site evaluation in the US. Data on the frequency, type, and setting of adherence encounters; providers' professions; and adherence tools provided were collected for 1,122 patients enrolled in 13 interventions at 9 sites. The site staff estimated the average duration of each type of encounter and national wage rates were used for labour costs. The median (range) adherence encounters/year among interventions was 16.5 (4.3-104.6) per patient; encounters lasted 24.6 (8.9-40.9) minutes. Intervention direct cost was correlated with the average frequency of encounters (r = 0.57), but not with encounter duration or providers' professions. The median direct cost/month was 35 dollars(5 dollars-58 dollars) per patient, and included direct provider costs (66%); incentives (17%); reminders and other tools (8%); and direct administrative time, provider transportation, training, and home delivery (9%). The median direct cost/month from a societal perspective, which includes patient time and travel costs, was 47 dollars(24 dollars-114 dollars) per patient. Adherence interventions with moderate efficacy costing < or =100 dollars/month have been estimated to meet a cost-effectiveness threshold that is generally accepted in the US. Payers should consider enhanced reimbursement for adherence support services.

Increasing voluntary HIV testing by offering oral tests in incarcerated populations.

OBJECTIVES: This study reports responses of incarcerated persons to voluntary blood and oral HIV testing. METHODS: Males and females in local detention and juvenile justice facilities in Maryland (n = 1314) chose oral or blood testing and reported reactions to the oral HIV test. The relationship of demographics and HIV risk factors to test choice was examined. RESULTS: Reactions to oral testing were very favorable; some participants reported that they would not otherwise have been tested. Participants who chose oral testing were more likely to be male and African American, but they did not differ from those who chose blood testing in most risk factors or in seroprevalence. CONCLUSIONS: Oral HIV testing in correctional settings may promote voluntary testing among persons who otherwise would refuse or avoid testing, especially among groups (males and African Americans) disproportionately affected by HIV.

Duration of human immunodeficiency virus infection and likelihood of giving birth in a Medicaid population in Maryland.

The objective of this study was to examine the effect of duration of human immunodeficiency virus (HIV) infection on a woman's likelihood of giving birth. Using longitudinal data from the Maryland state Human Immunodeficiency Virus Information System and a retrospective cohort design, the authors compared 1,642 women with acquired immunodeficiency syndrome (AIDS) to 8,443 uninfected women enrolled in the Medicaid program between 1985 and 1995. The decade before AIDS diagnosis was divided into four 2.5-year periods. Proximity to AIDS diagnosis served as a proxy for duration of infection. An extension of the Cox model was used to estimate the relative risk for giving birth, with adjustment for covariates and repeated outcomes. The average number of births per 100 person-years was 6.0 for HIV-infected women and 11.1 for uninfected women (adjusted relative risk = 0.63; 95% confidence interval (CI): 0.57, 0.68). Accounting for duration of infection, the adjusted relative risks for birth among HIV-infected women, as compared with uninfected women, were 0.85 (95% CI: 0.71, 1.03), 0.74 (95% CI: 0.63, 0.86), 0.55 (95% CI: 0.47, 0.64), and 0.45 (95% CI: 0.38, 0.55) for successive 2.5-year periods before AIDS diagnosis. Demographic characteristics, contraception, abortion, fetal loss, or drug use could not fully explain the reductions. These results suggest that HIV-infected women experience a progressive reduction in births years before the onset of AIDS. This may compromise estimation of HIV prevalence and interpretation of time trends from serosurveillance of pregnant women.

Sexual practices of older adults in a high HIV prevalence environment.

Based on recent epidemiologic evidence, AIDS in older persons (ages 55-79) in Maryland appears to be increasingly contracted heterosexually, particularly in women. Little is known about sexual practices or beliefs about HIV in older persons living in high HIV prevalence urban populations. The purpose of this study was to assess sexual practices, particularly high risk behavior, modifications of behavior including condom use, and perceptions of risk. A behavioral survey, containing 41 potential responses, was developed through modification of The National AIDS Behavioral Survey, focusing on heterosexual activity. The survey was administered to a convenience sample of 55 to 79 year olds attending the Union Memorial Hospital medical clinic. Sexual activity is common within the older population, especially among men. Multiple partners is not unusual in older men. Condoms are commonly used. Older individuals typically are aware of HIV heterosexual transmission risk and a proportion have modified sexual behavior because of perceived risks.

Evaluation of a statewide non-name-based HIV surveillance system.

Recent advances in AIDS-related therapies have delayed the onset of AIDS-defining illnesses and reduced the usefulness of AIDS surveillance in assessing the incidence of early HIV disease and estimating future needs of the HIV-infected population. These changes have prompted renewed interest in expanding surveillance to include HIV and have engendered national debate on whether an HIV surveillance system should be based on reports of the names of infected individuals or employ non-name-based data codes. In 1994, the state of Maryland implemented a program to require HIV surveillance by unique identifier (UI) patient code. This evaluation of Maryland's program found that when complete, the 12-digit UI number provided a virtually unduplicated count 99.8% unique, was 99.9% unique with only the last four digits of the U.S. government Social Security Number (SSN), date of birth (DOB), and race, and 77.7% unique if the last four digits of the SSN were missing. Health care providers were willing to create the UI, with DOB and gender present 98.3% and 98.8% of the time, race was complete 84.1% and last four digits of SSN were complete 72.4%. The overall completeness of reporting for HIV tests was 87.8%.and 84.8%, respectively, using different methodologies. Evidence from the Maryland UI evaluation demonstrates that a non-name-based system can provide accurate, timely and valid data concerning the scope of the HIV epidemic, without the creation of state-wide name-based registry.

Adherence to antiretroviral and pneumocystis prophylaxis in HIV disease.

BACKGROUND: Medication nonadherence in the treatment of chronic diseases compromises the effectiveness of therapy. Little information is available about the extent of medication adherence or determinants of medication adherence in HIV disease, an issue of increasing importance in this new therapeutic era of combination antiretroviral therapy. METHODS: We studied 244 HIV-infected Medicaid-insured patients attending an HIV hospital-based clinic regarding the extent of and predictors of adherence to antiretroviral therapy and Pneumocystis carinii pneumonia (PCP) prophylaxis. Patients were asked to report medications being taken, patterns of use, and knowledge and attitudes about HIV therapies. Medical record report of type, dose, and frequency of medication was compared with self-report using the kappa statistic. Urine sulfamethoxazole assay was obtained from patients prescribed sulfamethoxazole-trimethoprim. RESULTS: Among patients prescribed antiretroviral therapy, 60% reported > or = 80% adherence in the previous 7 days; 49% reported > or = 80% adherence with PCP prophylaxis in the previous seven days. Seventy-nine percent of patients who reported taking daily sulfamethoxazole-trimethoprim had detectable urinary sulfamethoxazole. In multivariate analysis, > or = 80% adherence to antiretroviral therapy was associated with taking medication < or = twice a day (odds ratio [OR]=1.44; 95% confidence interval [CI], 1.01, 1.96), being likely to take medication when not at home, (OR=1.41; 95% CI, 1.04, 2.00) and patients' belief in their ability to adhere to therapy (OR=1.57; 95% CI, 1.13, 2.17). For PCP prophylaxis, > or = 80% adherence was associated with presence of family (OR=2.39; 95% CI, 1.01, 5.63) and patients' belief in their ability to adhere to therapy (OR=2.87; 95% CI, 1.44-1.78). Sociodemographic characteristics and belief in the efficacy of medications were not associated with adherence. CONCLUSIONS: A relatively low level of adherence to antiretroviral therapy and PCP prophylactic regimens was found. Although our results are principally from patients receiving antiretroviral monotherapy, these findings may have important implications for patients receiving highly active antiretroviral therapy (HAART). Decreasing the complexity of antiretroviral regimens, and working with patients to modify identified barriers to adherence may improve effectiveness of medications and prolong survival.

Update on adherence to HIV therapy.

AIDS: The Clinical Practices for Treatment of HIV Infection convened a 35-member panel in 1997 to examine clinical practice issues regarding HIV/AIDS treatment, resulting in a document on treatment guidelines. The controversial issues and the most likely sources of change that may occur during revisions of the document are reviewed. The issues that are reviewed include what constitutes no detectable virus in determining regimen effectiveness, what changes should be made in drug regimens that are considered failures, what to do when patients who are taking two nucleoside reverse transcriptase inhibitors have achieved the goal of undetectable virus, how to address the problems surrounding salvage therapy and the concept of class resistance among protease inhibitors, and the point at which antiretroviral therapy should be discontinued.^ieng

Clinical manifestations and risk factors of Pseudomonas aeruginosa infection in patients with AIDS.

Fifty-eight patients with human immunodeficiency virus infection were analyzed for clinical manifestations and potential risk factors for Pseudomonas aeruginosa infection by use of case-control methodology. Most had AIDS. Of 73 episodes of P. aeruginosa infection, 45 (62%) were bacteremias primarily associated with central venous catheters (16), pneumonia (12), soft tissue (4), or urinary tract infections (4). Twenty-eight episodes (38%) were nonbacteremic, with pneumonia (13), soft tissue infections (6), and sinusitis (4) accounting for the majority of infections. Fifty episodes (68%) were community-acquired. The recurrence rate was 23%. The overall mortality attributable to P. aeruginosa infection was 22%. Central venous and urinary catheter use and steroid therapy were significantly more frequent in cases than controls (P < .05). Thus, P. aeruginosa infection in patients with advanced human immunodeficiency virus disease is often community-acquired and associated with substantial mortality and, in some cases, specific risk factors.

Seroconversion, sexual activity, and condom use among 2915 HIV seronegative men followed for up to 2 years.

A cohort of 2915 HIV-1-seronegative men from the four centers of the Multicenter AIDS Cohort Study (MACS) was followed at 6 month intervals for 24 months to identify men who developed antibodies to HIV-1. Two hundred thirty-two men (8%) seroconverted. The highest attack rate was among men who reported practicing both receptive and insertive anal-genital intercourse. The attack rate among men who reported practicing receptive but not insertive intercourse was 3.6 times higher than among men practicing insertive intercourse although those practicing insertive only reported 38% more different partners. Only two men seroconverted who reported not practicing analgenital intercourse in the 12 month prior to the first antibody-positive visit. Because men were followed every 6 months, one of these men could have been infected within 6 months of the actual development of HIV-1 antibodies. The seroconversion rate was significantly lower among men who reported using condoms with all their partners. The results of this study (a) reaffirm that receptive anal-genital intercourse is the major route of infection among homosexual men of HIV-1, (b) suggest that there is a low risk of HIV-1 infection to the insertive partner in anal-genital intercourse, (c) suggest that infection may rarely occur through sexual activities other than anal-genital intercourse, (d) provide evidence that condoms as currently used by men in the MACS provide significant but not complete protection against HIV-1 infection, and (e) suggest that the number of men in the homosexual community engaging in high-risk behavior is declining.

Comparative immunogenicity of plasma and recombinant hepatitis B virus vaccines in homosexual men.

A randomized, double-blind clinical trial of plasma-derived and DNA recombinant hepatitis B virus vaccines was conducted in 186 homosexual men. Nine months after the immunization series (three doses) began, the seroconversion rate in the plasma vaccine group was 88% (68/77); this was significantly higher than the 74% (60/81) response rate of the recombinant vaccine group. Men positive for antibody to the human immunodeficiency virus (HIV) had a considerably higher nonresponse rate to either vaccine than expected in non-HIV-infected homosexual men. The odds ratios of nonresponse to hepatitis B virus vaccine for HIV-seropositive vs HIV-seronegative subjects were 12.0 (95% confidence interval, 1.7 to 89.3) and 13.6 (95% confidence interval, 2.3 to 148.3) for the plasma and DNA recombinant vaccines, respectively.

Dermatologic findings associated with human immunodeficiency virus infection.

Both human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) are associated with an increased prevalence of several dermatologic diseases. We studied healthy homosexual men with negative reactivity to HIV antibody, homosexual men without AIDS but with positive reactivity to HIV antibody, and homosexual men with AIDS to compare the prevalence of dermatologic disease in these groups. We found that five cutaneous disorders were increased in persons with HIV infection. Oral hairy leukoplakia was increased both in seropositive subjects without AIDS and in subjects with AIDS. Condylomata acuminata and seborrheic dermatitis were slightly increased in seropositive non-AIDS subjects and significantly increased in the AIDS group. Molluscum contagiosum and oral candidiasis were increased only in the AIDS group.

Clinical manifestations of acute infection with human immunodeficiency virus in a cohort of gay men.

During a prospective study of the natural history of human immunodeficiency virus (HIV) infection in a cohort of gay/bisexual men, information on self-reported symptoms lasting for 3 or more days during the previous 6 months was collected without knowledge of the subject's HIV serological status. Twenty-two people were retrospectively found to have seroconverted to HIV during the interval. Each seroconverter was matched to two seronegative and two seropositive controls. Matched case-control analyses using the seronegative controls determined that the following symptoms lasting for 3 or more days were associated with new HIV infection: fever greater than 37.7 degrees C, swollen lymph nodes, night sweats and headaches. Matched case-control analyses using the seropositive controls determined that the following symptoms lasting for 3 or more days were associated with new HIV infection: fatigue, fever greater than 37.7 degrees C, swollen lymph nodes, night sweats and headaches. It was notable that the majority of seroconversions were not associated with any symptoms lasting for 3 or more days. Due to their non-specificity, symptoms associated with seroconversion are not likely to have a high positive predictive value. In high risk populations, however, appearance of these symptoms may facilitate identification of early infection that may be important for studies of natural history or for optimal timing for initiating antiviral therapy.