HIV-infected individuals with high coping self-efficacy are less likely to report depressive symptoms: a cross-sectional study from Denmark.

OBJECTIVES: Having effective ways to cope helps HIV-infected individuals maintain good psychological and physical well-being. This study investigated the relationship between coping self-efficacy levels, as determined by the Coping Self-Efficacy Scale (CSE), HIV status disclosure, and depression in a Danish cohort. METHODS: In 2008, the CSE was administered to 304 HIV-infected individuals to measure their confidence in their ability to cope with HIV infection. HIV status disclosure was assessed on a three-point scale: living openly with the disease, partly openly, or secretly. The Beck Depression Inventory (BDI) was used to assess depression prevalence and severity. RESULTS: The CSE score was significantly related to depression (Spearman's rho = -0.71; the test of H0: BDI and coping, probability >t=0.0001). There was a significant relationship between higher CSE scores and living openly with HIV. The risk of depression was four times higher in HIV-infected individuals who did not disclose their HIV status (i.e. who lived 'secretly'; odds ratio = 4.1) than in individuals who lived openly. CONCLUSION: Those with low CSE scores were more likely to report living secretly with HIV and to be depressed. Disclosing HIV may constitute a social stressor, and a lack of coping self-efficacy may increase the likelihood of non-disclosure and depression. Interventions that enhance self-efficacy may help in managing the demands of daily life with HIV, increase disclosure, and reduce depression.

Can the poor adhere? Incentives for adherence to TB prevention in homeless adults.

SETTING: Community-based population of homeless adults living in San Francisco, California. OBJECTIVE: To compare the effect of cash and non-cash incentives on 1) adherence to treatment for latent tuberculosis infection, and 2) length of time needed to look for participants who missed their dose of medications. DESIGN: Prospective, randomized clinical trial comparing a 5 dollar cash or a 5 dollar non-cash incentive. All participants received directly observed preventive therapy and standardized follow-up per a predetermined protocol. Completion rates and amount of time needed to follow up participants was measured. RESULTS: Of the 119 participants, 102 (86%) completed therapy. There was no difference between the cash and non-cash arms. Completion was significantly higher among males (OR 5.65, 95%CI 1.36-23.40, P = 0.02) and persons in stable housing at study entry (OR 4.86, 95%CI 1.32-17.94, P = 0.02). No substance use or mental health measures were associated with completion. Participants in the cash arm needed significantly less follow-up to complete therapy compared to the non-cash arm (P = 0.03). In multivariate analysis, non-cash incentive, use of crack cocaine, and no prior preventive therapy were associated with more follow-up time. CONCLUSION: Simple, low cost incentives can be used to improve adherence to TB preventive therapy in indigent adults.

Failure to maintain adherence to HAART in a cohort of French HIV-positive injecting drug users.

The study, carried out in the French MANIF 2000 cohort of HIV positive patients contaminated through injecting drug use, assessed the impact of patients' sociodemographic and psychological characteristics, behaviors toward drug abuse, and antiretroviral treatment characteristics on the maintenance of adherence to HAART (highly active antiretroviral therapies). A total of 96 patients (30 men and 66 women), who were initially adherent at their first visit after HAART prescription, were considered for analysis. Among these 96 patients, 22 (22.9%) experienced adherence failure defined as a self-reported, non-adherence behavior at any visit before the 18th month of treatment. Logistic regression showed that lack of a stable relationship, active drug injection, and depression were independently associated with adherence failure. Patients' counseling for facilitating maintenance of adherence to HAART over time should focus on prevention of drug use, provision of social support and consider the potential impact of difficulties with treatment on psychological well-being.

Limited patient adherence to highly active antiretroviral therapy for HIV-1 infection in an observational cohort study.

BACKGROUND: Adherence to highly active antiretroviral therapy (HAART) for human immunodeficiency syndrome type 1 (HIV-1) infection is essential to sustain viral suppression and prevent drug resistance. We investigated adherence to HAART among patients in a clinical cohort study. METHODS: Patients receiving HAART had their plasma concentrations of protease inhibitors or nevirapine measured and completed a questionnaire on adherence. We determined the percentage of patients who reported taking all antiretroviral medication on time and according to dietary instructions in the past week. Drug exposure was compared between patients reporting deviation from their regimen and fully adherent patients. Among patients who received HAART for at least 24 weeks, we assessed the association between adherence and virologic outcome. RESULTS: A total of 224 of 261 eligible patients completed a questionnaire. Forty-seven percent reported taking all antiretroviral medication on time and according to dietary instructions. Patients who reported deviation from their regimen showed lower drug exposure compared with fully adherent patients (median concentration ratio, 0.81 vs 1.07; P =.001). Among those receiving HAART for at least 24 weeks, patients reporting deviation from their regimen were less likely to have plasma HIV-1 RNA levels below 500 copies/mL (adjusted odds ratio, 4.0; 95% confidence interval, 1.4-11.6) compared with fully adherent patients. CONCLUSIONS: Only half of the patients took all antiretroviral medication in accordance with time and dietary instructions in the preceding week. Deviation from the antiretroviral regimen was associated with decreased drug exposure and a decreased likelihood of having suppressed plasma HIV-1 RNA loads. Patient adherence should remain a prime concern in the management of HIV-1 infection.

Anger inhibition potentiates the association of high end-tidal CO2 with blood pressure in women.

OBJECTIVE: High resting end-tidal CO2 (PetCO2) has been shown to be an independent predictor of systolic blood pressure (SBP) in women, particularly older women. The study reported in this article investigated whether the tendency to experience, express, and/or suppress anger contributes to the association of PetCO2 and SBP in women and in men. METHODS: The Spielberger Anger Expression Inventory was administered to 403 healthy male and female participants in the Baltimore Longitudinal Study on Aging. Resting PetCO2 was obtained by means of a respiratory gas monitor, and resting blood pressure was obtained with an oscillometric device. The associations of resting PetCO2 and the anger scales with SBP and diastolic blood pressure (DBP) were investigated using multivariate regression analyses. RESULTS: PetCO2, as well as age and body mass index, was an independent predictor of SBP in women with low, but not high, trait anger and in women with low, but not high, anger-out. PetCO2 was not an independent predictor of SBP in men with either high or low anger. In addition, PetCO2 was not an independent predictor of DBP in either men or women. CONCLUSIONS: The results of this study indicate that inhibition of anger potentiates the relationship of high PetCO2 with SBP in women but not men. Additional studies are needed to determine the origins of the observed gender differences and the psychophysiological pathways by which high resting PetCO2 contributes to elevated resting blood pressure in women.

Association of high resting end tidal CO2 with carotid artery thickness in women, but not men.

BACKGROUND: A previous study found high resting end tidal CO2 (PetCO2) to be an independent determinant of systolic blood pressure in women, but not men. The present study investigates the association of PetCO2 with the common carotid artery intima-media thickness (IMT) and wall-to-lumen (W/L) ratio in a sample of normotensive men and women. DESIGN AND METHODS: Resting PetCO2 of 188 healthy volunteers, including 88 men and 100 women, in the Baltimore Longitudinal Study on Aging was monitored continuously for 25 min via a respiratory gas monitor. At another session, carotid artery IMT was determined via high-resolution B-mode carotid ultrasonography. The ratio of IMT to carotid artery diameter was calculated as W/L ratio. Resting blood pressure was determined oscillometrically every 5 min for 20 min during each session. RESULTS: Univariate associations of PetCO2 with systolic blood pressure (SBP) (P< 001), IMT (P< 001) and W/L ratio (P< 001) were significant in women, but not men. Multiple regression analyses showed that high resting PetCO2 was a predictor of SBP (P < 01), IMT (P< 01) and W/L ratio (P< 01) in women, independent of age, body mass index and SBP. For men, age (P < 001) and SBP (P < 01) were independent predictors of carotid IMT, while age (P< 001) was the only independent predictor of W/L ratio in men. CONCLUSIONS: This study indicates that PetCO2 can play a role in cardiovascular structure, as well as function, in women, and that the relationship is independent of the association of PetCO2 with blood pressure.

Cardiovascular responses in anticipation of changes in posture and locomotion.

Measurements were made in 29 adult baboons that were housed in social groups, allowing the occurrence of the full range of species-specific behavioral interactions. The cardiovascular variables measured included blood pressure, heart rate, renal blood flow, lower limb blood flow, and occasionally mesenteric blood flow. The data were telemetered from backpacks worn by the animals and were recorded in analogue form on a polygraph, digitally on a computer and were also recorded on the audio channels of videotape being made of the behavior and social interactions of the baboons. The video and the computer recordings were synchronized by a timing system that made it possible to relate the cardiovascular responses to the behavioral responses. A numerically based behavioral code was developed that allowed the categorization of the totality of the behavior, including postural and locomotor changes. Comparisons between baseline cardiovascular values and those occurring 1 s before the initiation of a movement or posture change gave no evidence of anticipatory cardiovascular responses unless the movement was associated with behavior that included emotional content. Hypothalamic perifornical lesions reduced or eliminated these anticipatory changes.

Does HIV reporting by name deter testing? MESH Study Group.

OBJECTIVE: Name-based HIV reporting is controversial in the United States because of concerns that it may deter high-risk persons from being tested. We sought to determine whether persons at risk of HIV infection knew their state's HIV reporting policy and whether they had delayed or avoided testing because of it. DESIGN: A cross-sectional anonymous survey. METHODS: We interviewed 2404 participants in one of three high-risk groups: men who have sex with men (MSM), heterosexuals attending a sexually transmitted disease (STD) clinic, and street-recruited injection drug users (IDU). Participants were asked standardized questions about their knowledge of reporting policies and reasons for having delayed or avoided testing. We recruited in eight US states: four with name-based reporting and four without; all offered anonymous testing at certain sites. RESULTS: Fewer than 25% correctly identified their state's HIV reporting policy. Over 50% stated they did not know whether their state used name-based reporting. Of the total, 480 participants (20%) had never been tested. Of these, 17% from states with name-based reporting selected concern about reporting as a reason for not testing compared with 14% from states without name-based reporting (P = 0.5). Comparing previously tested participants from states with name-based reporting to those from states without, concern about HIV reporting was given as a reason for delaying testing by 26% compared with 13% of IDU (P < 0.001), and for 26% compared with 19% of MSM (P = 0.06). CONCLUSION: Most participants did not know their state's HIV reporting policy. Name-based reporting policies were not associated with avoiding HIV testing because of worry about reporting, although they may have contributed to delays in testing among some IDU.

Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG).

This paper describes the AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG). The questionnaires were administered to 75 patients at ten AACTG sites in the USA. All patients were taking combination antiretroviral therapy (ART), including at least one protease inhibitor. Eleven per cent of patients reported missing at least one dose the day before the interview, and 17% reported missing at least one dose during the two days prior. The most common reasons for missing medications included 'simply forgot' (66%) and a number of factors often associated with improved health, including being busy (53%), away from home (57%) and changes in routine (51%). Less adherent patients reported lower adherence self-efficacy (p = 0.006) and were less sure of the link between non-adherence and the development of drug resistance (p = 0.009). They were also more likely to consume alcohol, to be employed outside the home for pay and to have enrolled in clinical trials to gain access to drugs (all p < 0.05). Twenty-two per cent of patients taking drugs requiring special instructions were unaware of these instructions. Each questionnaire took approximately ten minutes to complete. Responses to the questionnaires were favourable. These questionnaires have been included in six AACTG clinical trials to date and have been widely disseminated to investigators both in the USA and abroad.

Acceptability of a novel vaginal microbicide during a safety trial among low-risk women.

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.

Factors affecting adherence to antiretroviral therapy.

In both clinical trials and clinical practice, nonadherence to medications is widespread among patients with chronic diseases. The shift to combination therapies for treating human immunodeficiency virus (HIV)-infected individuals has increased adherence challenges for both patients and health-care providers. Estimates of average rates of nonadherence to antiretroviral therapy range from 50% to 70%. Adherence rates of <80% are associated with detectable viremia in a majority of patients. The principal factors associated with nonadherence appear to be patient-related, including substance and alcohol abuse. However, other factors may also contribute, such as inconvenient dosing frequency, dietary restrictions, pill burden, and side effects; patient-health-care provider relationships; and the system of care. We discuss the major reasons reported by HIV-infected individuals for not taking their medications. Improving adherence probably requires clarifying the treatment regimen and tailoring it to patient lifestyles.

Adherence to HIV combination therapy.

The emergence of drug-resistant strains of HIV virus and treatment failure can result from non-adherence to antiretroviral therapy. While non-adherence to therapy is not a new issue or specific to HIV/AIDS, it has received renewed attention because of the complicated combination treatment regimens being prescribed. This paper reviews the relevant background literature on the contributions of social and behavioural science to non-adherence to HIV medications. Data indicating problems with adherence prior to combination therapy are reported. Despite limitations, even self-report assessments have already succeeded in showing that adherence to combination therapy is significantly related to HIV viral load. Recent research data are discussed. Implications of findings for counselling patients to increase their adherence are presented.

Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population.

OBJECTIVE: To examine the relationship between adherence, viral suppression and antiretroviral resistance in HIV-infected homeless and marginally housed people on protease inhibitor (PI) therapy. DESIGN AND SETTING: A cross-sectional analysis of subjects in an observational prospective cohort systematically sampled from free meal lines, homeless shelters and low-income, single-room occupancy (SRO) hotels. PARTICIPANTS: Thirty-four HIV-infected people with a median of 12 months of PI therapy. MAIN OUTCOMES: Adherence measured by periodic unannounced pill counts, electronic medication monitoring, and self-report; HIV RNA viral load; and HIV-1 genotypic changes associated with drug resistance. RESULTS: Median adherence was 89, 73, and 67% by self-report, pill count, and electronic medication monitor, respectively. Thirty-eight per cent of the population had over 90% adherence by pill count. Depending on the measure, adherence explained 36-65% of the variation in concurrent HIV RNA levels. The three adherence measures were closely related. Of 20 genotyped patients who received a new reverse transcriptase inhibitor (RTI) when starting a PI, three had primary protease gene substitutions. Of 12 genotyped patients who received a PI without a new RTI, six had primary protease gene substitutions (P < 0.03). CONCLUSION: A substantial proportion of homeless and marginally housed individuals had good adherence to PI therapy. A strong relationship was found between independent methods of measuring adherence and concurrent viral suppression. PI resistance was more closely related to the failure to change RTI when starting a PI than to the level of adherence.

Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide.

BACKGROUND AND OBJECTIVES: Potential rectal microbicides, as an adjunct to condoms for HIV/STD prevention, have not been studied previously. GOAL OF THIS STUDY: Advantage 24 (1.5 ml of a bioadhesive gel containing 52.5 mg nonoxynol-9 administered by single-use applicator)-under investigation as a vaginal microbicide-was evaluated for acceptability among male couples. STUDY DESIGN: Twenty-five HIV-negative and 10 HIV-positive male couples participated in a frequency use escalation trial. Diaries and self-administered questionnaires assessed product use, acceptability, sexual behavior, and gastrointestinal and urologic side effects. RESULTS: Excluding participants who felt no need for an HIV prevention method, 58% said they would use Advantage 24 if approved for rectal use; 69% of receptive users reported rectal fullness and related side effects after insertion of the gel, and 68% reported applicator-related discomfort; 59% of insertive participants found the gel too sticky. CONCLUSIONS: Acceptability remains inconclusive and warrants further study of redesigned applicators and ways to minimize rectal side effects.

Smokeless tobacco cessation intervention for college athletes: results after 1 year.

OBJECTIVES: The purpose of this study was to determine the efficacy of a college-based smokeless tobacco cessation intervention targeting college athletes. METHODS: Sixteen colleges were matched for prevalence of smokeless tobacco use in their combined baseball and football teams and randomly assigned within college pairs to the intervention or the control group. One-year prevalence of cessation among smokeless tobacco users was determined by self-report of abstinence for the previous 30 days. Differences between groups were analyzed in a weighted version of the Fisher 1-sided permutation test for paired samples after adjustment for significant predictors of quitting other than the intervention (i.e., smokeless tobacco uses per week and most frequently used brand). RESULTS: Cessation prevalences were 35% in the intervention colleges and 16% in the control colleges when subjects with unknown quit status were defined as nonquitters. After adjustment for other significant predictors of quitting, the difference of 19% increased to 21%. The intervention effect increased with level of smokeless tobacco use. CONCLUSIONS: This intervention was effective in promoting smokeless tobacco cessation, especially among those who were more frequent users.

Adherence: a necessity for successful HIV combination therapy.

Patient adherence to combination therapy is a critical component of successful treatment outcomes. While combination therapy is known to be effective in slowing disease progression, the long-term benefit of these therapies can only be sustained if resistant strains of HIV do not emerge. Among factors that can result in the emergence of resistance, non-adherence is perhaps the most amenable to intervention. To maximize intervention efforts, a program of research on adherence is needed. A prerequisite for progress in adherence research is a focused effort on developing reliable and valid methods for measuring adherence that are feasible for patients living with HIV/AIDS. If new adherence assessment procedures cannot be developed, it would be helpful if a consensus on measurement approaches could be achieved. This consensus might propose strategies for matching measurement approaches with research questions and recommendations for the use of multiple measures where appropriate. It is important that research continue to identify psychological, physiological, socio-cultural and environmental factors that are associated with non-adherence in various populations both in the developed and the developing world. Intervention programs that address these risk factors and promote adherence need to be developed and evaluated in controlled clinical trials. These programs will need to be tailored to different populations and cultural groups, and tested in both developed and developing countries where HIV therapies are being prescribed. The results of this research would significantly contribute to efforts to prevent virus breakthrough and, by doing so, assist persons living with HIV/AIDS in achieving the health benefits that the combination therapies offer.

HIV sexual risk behavior following bereavement in gay men.

The present study followed a group of 100 gay men up to 1 year before and 1 year after losing a partner to AIDS (University of California, San Francisco Coping Project). Following bereavement, participants were at increased risk for engaging in unprotected anal intercourse: at 4 to 6 months for HIV-negative men and at 8 to 12 months for HIV-positive men. Sociodemographic variables, HIV serostatus, substance use, depression, prebereavement relationship quality, and social support did not explain sexual risk-taking in this sample. However, men who engaged in unprotected anal intercourse were twice as likely to be involved in a new primary relationship as those who did not. The authors concluded that risk varies over time by HIV status and may involve engagement in new relationships.

New testing strategy to detect early HIV-1 infection for use in incidence estimates and for clinical and prevention purposes.

CONTEXT: Differentiating individuals with early human immunodeficiency virus 1 (HIV-1) infection from those infected for longer periods is difficult but important for estimating HIV incidence and for purposes of clinical care and prevention. OBJECTIVE: To develop and validate a serologic testing algorithm in which HIV-1-positive persons with reactive test results on a sensitive HIV-1 enzyme immunoassay (EIA) but nonreactive results on a less sensitive (LS) EIA are identified as having early infection. DESIGN: Diagnostic test and testing strategy development, validation, and application. Specimens were tested with both a sensitive HIV-1 EIA (3A11 assay) and a less sensitive modification of the same EIA (3A11-LS assay). SETTINGS AND PARTICIPANTS: For assay development: 104 persons seroconverting to HIV-1 comprising 38 plasma donors, 18 patients of a sexually transmitted disease clinic in Trinidad, and 48 participants in the San Francisco Men's Health Study (SFMHS); 268 men without the acquired immunodeficiency syndrome (AIDS) in the SFMHS who had been infected for at least 2.5 years; and 207 persons with clinical AIDS; for testing strategy validation: 488 men in the SFMHS from 1985 through 1990 and 1275449 repeat blood donors at 3 American Red Cross blood centers from 1993 through 1995; and for HIV-1 incidence estimates: 2717910 first-time blood donors. We retrospectively identified persons eligible for a study of early infection. MAIN OUTCOME MEASURE: Ability to identify early HIV infection. RESULTS: Estimated mean time from being 3A11 reactive/3A11-LS nonreactive to being 3A11 reactive/3A11-LS reactive was 129 days (95% confidence interval [CI], 109-149 days) [corrected]. Our testing strategy accurately diagnosed 95% of persons with early infection; however, 0.4% (1/268) of men with established infection and 2% (5/207) of persons with late-stage AIDS were misdiagnosed as having early HIV-1 infection. Average yearly incidence estimates in SFMHS subjects were 1.5% per year vs observed average incidence of 1.4 per 100 person-years. Incidence in repeat blood donors using the sensitive/less sensitive assay testing strategy was 2.95 per 100000 per year (95% CI, 1.14-6.53/100000) vs observed incidence of 2.60 per 100000 person-years (95% CI, 1.49-4.21/100000). Overall incidence in first-time blood donors was 7.18 per 100000 per year (95% CI, 4.51-11.20/100000) and did not change statistically significantly between 1993 and 1996. Use of the sensitive/less sensitive testing strategy alone would have identified all 17 persons with antibodies to HIV-1 eligible for a study of early HIV-1 infection and would have increased enrollment. CONCLUSIONS: The sensitive/less sensitive testing strategy provides accurate diagnosis of early HIV-1 infection, provides accurate estimates of HIV-1 incidence, can facilitate clinical studies of early HIV-1 infection, and provides information on HIV-1 infection duration for care planning.

Pilot randomized trial of education to improve self-management skills of men with symptomatic HIV/AIDS.

OBJECTIVE: To evaluate the acceptability, practicality, and short-term efficacy of a health education program to improve disease self-management in patients with symptomatic HIV/AIDS. DESIGN: Randomized controlled trial, baseline and 3-month follow-up questionnaire assessments. SETTING: San Francisco Bay communities. PARTICIPANTS: Seventy-one men with symptomatic HIV or AIDS were randomly assigned to a seven-session group educational intervention (N=34) or a usual-care control group (N=37). INTERVENTION: Interactive health education groups were used to teach wide-ranging disease self-management skills and information: symptom assessment and management, medication use, physical exercise, relaxation, doctor-patient communication, and nutrition. Each group was led by two trained peer-leaders (one of whom was HIV-positive) recruited from the community. MAIN OUTCOME MEASURES: The primary outcome of interest was symptom status. Secondary outcomes were self-efficacy and health behaviors. Analysis of covariance was used to compare experimental and control group mean outcomes, adjusting for baseline value differences. RESULTS: The symptom severity index (number of symptoms moderate or greater severity) decreased in the experimental, and increased in the control group (-0.9 versus +0.5; p < .03). Pain, fatigue, and psychological symptoms were not significantly different between groups. Self-efficacy for controlling symptoms improved in the experimental, and decreased in the control group (+4 versus -7; p < .02). Changes in stress/relaxation exercises and HIV/AIDS knowledge were not different between groups. A trend was shown toward more frequent physical exercise in the experimental group compared with less in the control group (+1.3 versus -0.5 times/week; p=.06). CONCLUSIONS: Health education emphasizing self-management skills for HIV/AIDS patients can be implemented and evaluated and was accepted by patients, peer-leaders, and health care providers. Whether this educational program can lead to prolonged improvement in HIV symptoms and behaviors can be adequately addressed only by a larger trial of longer duration.