Steven A. Safren

Depression and Diabetes Treatment Nonadherence: A Meta-Analysis

OBJECTIVE—Depression is common in patients with diabetes and is associated with worse treatment outcomes. Its relationship to treatment adherence, however, has not been systematically reviewed. We used meta-analysis to examine the relationship between depression and treatment nonadherence in patients with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS—We searched MEDLINE and PsycINFO databases for all studies published by June 2007 and reviewed references of published articles. Meta-analytic procedures were used to estimate the effect size r in a random effects model. Significance values, weighted effect sizes, 95% CIs, and tests of homogeneity of variance were calculated. RESULTS—Results from 47 independent samples showed that depression was significantly associated with nonadherence to the diabetes treatment regimen (z = 9.97, P < 0.0001). The weighted effect size was near the medium range (r = 0.21, 95% CI 0.17–0.25). Moderator analyses showed that the effect was significantly larger in studies that measured self-care as a continuous versus categorical variable (P = 0.001). Effect sizes were largest for missed medical appointments and composite measures of self-care (r values = 0.31, 0.29). Moderation analyses suggest that effects for most other types of self-care are also near the medium range, especially in studies with stronger methodologies. CONCLUSIONS—These findings demonstrate a significant association between depression and treatment nonadherence in patients with diabetes. Studies that used stronger methodologies had larger effects. Treatment nonadherence may represent an important pathway between depression and worse diabetes clinical outcomes.

A Randomized Controlled Trial of Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-infected Individuals

OBJECTIVE To evaluate cognitive-behavioral therapy to enhance medication adherence and reduce depression (CBT-AD) in individuals with HIV. DESIGN A two arm, randomized, controlled, cross-over trial comparing CBT-AD to enhanced treatment as usual only (ETAU). ETAU, which both groups received, included a single-session intervention for adherence and a letter to the patients provider documenting her or his continued depression. The intervention group also received 10 to 12 sessions of CBT-AD. MAIN OUTCOME MEASURES Adherence to antiretroviral therapy as assessed by Medication Event Monitoring Systems (MEMs) and depression as assessed by blinded structured evaluation. RESULTS At the acute outcome assessment (3-months), those who received CBT-AD evidenced significantly greater improvements in medication adherence and depression relative to the comparison group. Those who were originally assigned to the comparison group who chose to cross over to CBT-AD showed similar improvements in both depression and adherence outcomes. Treatment gains for those in the intervention group were generally maintained at 6- and 12-month follow-up assessments. By the end of the follow-up period, those originally assigned CBT-AD demonstrated improvements in plasma HIV RNA concentrations, though these differences did not emerge before the cross-over, and hence there were not between-groups differences. CONCLUSIONS CBT-AD is a potentially efficacious approach for individuals with HIV struggling with depression and adherence. Replication and extension in larger efficacy trials are needed.

Two strategies to increase adherence to HIV antiretroviral medication: Life-Steps and medication monitoring

Advances in the medical treatment of HIV have made it clear that adherence to highly active antiretroviral treatment is a crucial feature for treatment success. The present paper had two goals: (1) to examine psychosocial predictors of adherence in persons receiving HIV antiretroviral therapy; (2) to compared two minimal-treatment interventions to increase HIV medication adherence in a subset of persons who self-reported less than perfect adherence. One of the interventions, Life-Steps, is a single-session intervention utilizing cognitive-behavioral, motivational interviewing, and problem-solving techniques. The other intervention, self-monitoring, utilizes a pill-diary and an adherence questionnaire alone. Significant correlates of adherence included depression, social support, adherence self-efficacy, and punishment beliefs about HIV. Depression was a significant unique predictor of adherence over and above the other variables. Both interventions yielded improvement in adherence from baseline, and the Life-Steps intervention showed faster improvements in adherence for persons with extant adherence problems.

Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: A randomized controlled trial

CONTEXT Attention-deficit/hyperactivity disorder (ADHD) in adulthood is a prevalent, distressing, and impairing condition that is not fully treated by pharmacotherapy alone and lacks evidence-based psychosocial treatments. OBJECTIVE To test cognitive behavioral therapy for ADHD in adults treated with medication but who still have clinically significant symptoms. DESIGN, SETTING, AND PATIENTS Randomized controlled trial assessing the efficacy of cognitive behavioral therapy for 86 symptomatic adults with ADHD who were already being treated with medication. The study was conducted at a US hospital between November 2004 and June 2008 (follow-up was conducted through July 2009). Of the 86 patients randomized, 79 completed treatment and 70 completed the follow-up assessments. INTERVENTIONS Patients were randomized to 12 individual sessions of either cognitive behavioral therapy or relaxation with educational support (which is an attention-matched comparison). MAIN OUTCOME MEASURES The primary measures were ADHD symptoms rated by an assessor (ADHD rating scale and Clinical Global Impression scale) at baseline, posttreatment, and at 6- and 12-month follow-up. The assessor was blinded to treatment condition assignment. The secondary outcome measure was self-report of ADHD symptoms. RESULTS Cognitive behavioral therapy achieved lower posttreatment scores on both the Clinical Global Impression scale (magnitude -0.0531; 95% confidence interval [CI], -1.01 to -0.05; P = .03) and the ADHD rating scale (magnitude -4.631; 95% CI, -8.30 to -0.963; P = .02) compared with relaxation with educational support. Throughout treatment, self-reported symptoms were also significantly more improved for cognitive behavioral therapy (beta = -0.41; 95% CI, -0.64 to -0.17; P <001), and there were more treatment responders in cognitive behavioral therapy for both the Clinical Global Impression scale (53% vs 23%; odds ratio [OR], 3.80; 95% CI, 1.50 to 9.59; P = .01) and the ADHD rating scale (67% vs 33%; OR, 4.29; 95% CI, 1.74 to 10.58; P = .002). Responders and partial responders in the cognitive behavioral therapy condition maintained their gains over 6 and 12 months. CONCLUSION Among adults with persistent ADHD symptoms treated with medication, the use of cognitive behavioral therapy compared with relaxation with educational support resulted in improved ADHD symptoms, which were maintained at 12 months. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00118911.

Optimal Recall Period and Response Task for Self-Reported HIV Medication Adherence

Self-reported measures of antiretroviral adherence vary greatly in recall time periods and response tasks. To determine which time frame is most accurate, we compared 3-, 7-day, and 1-month self-reports with data from medication event monitoring system (MEMS). To determine which response task is most accurate we compared three different 1-month self-report tasks (frequency, percent, and rating) to MEMS. We analyzed 643 study visits made by 156 participants. Over-reporting (self-report minus MEMS) was significantly less for the 1-month recall period (9%) than for the 3 (17%) or 7-day (14%) periods. Over-reporting was significantly less for the 1-month rating task (3%) than for the 1-month frequency and percent tasks (both 12%). We conclude that 1-month recall periods may be more accurate than 3- or 7-day periods, and that items that ask respondents to rate their adherence may be more accurate than those that ask about frequencies or percents.

Preexposure antiretroviral prophylaxis attitudes in high-risk boston area men who report having sex with men: Limited knowledge and experience but potential for increased utilization after education

Background:Preexposure prophylaxis (PrEP) could protect individuals engaging in repeated high-risk behaviors from HIV infection. Understanding the demographic and behavioral predictors of intent-to-use PrEP may prove useful to identify clinical trial participants. Methods:In 2007, 227 HIV-uninfected men who report having sex with men (MSM) recruited through modified respondent-driven sampling completed an interviewer-administered survey assessing prior PrEP use and awareness, future intent-to-use PrEP, demographics, sexual risk, psychosocial variables, and drug/alcohol use. Bivariate and multivariable logistic regression procedures examined predictors of intent-to-use PrEP. Results:Mean age of participants was 41 (SD = 9.1); 54% were nonwhite. One participant reported prior off-label PrEP use (medication obtained from his HIV-infected brother). Nineteen percent had previously heard of PrEP, whereas 74% reported intent-to-use PrEP if available after being educated about its potential. In multivariable analysis controlling for age and race/ethnicity, significant predictors of intent-to-use PrEP included the following: less education [odds ratio (OR) = 7.7; P = 0.04], moderate income (OR = 13.0; P = 0.04), no perceived side effects from taking PrEP (OR = 3.5; P = 0.001), and not having to pay for PrEP (OR = 4.2; P = 0.05). Discussion:Many New England MSM indicated an interest in using PrEP after learning about its potential, particularly if they could obtain PrEP at no expense and if PrEP had no side effects. Less educated MSM and those who knew less about PrEP and antiretroviral therapy before entering the study were more open to using antiretroviral therapy for prevention once they had received some information suggesting its potential value. Findings suggest that careful educational messages are necessary to ensure appropriate PrEP use if clinical trials reveal partial efficacy.

Childhood Sexual Abuse Is Highly Associated With HIV Risk-Taking Behavior and Infection Among MSM in the EXPLORE Study

Background:Previous studies have found high rates of childhood sexual abuse (CSA) among US men who have sex with men (MSM). CSA history has been associated with a variety of negative effects later in life including behaviors that place MSM at greater risk for HIV acquisition and transmission. The present analysis is the first to examine the longitudinal association between CSA and HIV infection, unprotected anal sex, and serodiscordant unprotected anal sex, as well as mediators of these relationships among a large sample of HIV-uninfected MSM. Methods:The EXPLORE Study was a behavioral intervention trial conducted in 6 US cities over 48 months with HIV infection as the primary efficacy outcome. Behavioral assessments were done every 6 months via confidential computerized assessments. Longitudinal regression models were constructed, adjusting for randomization arm, geographical location of study site, age at enrollment, education, and race/ethnicity. Results:Of the 4295 participants enrolled, 39.7% had a history of CSA. Participants with a history of CSA [adjusted hazards ratio = 1.30, 95% confidence interval (CI): 1.02 to 1.69] were at increased risk for HIV infection over study follow-up. A significant association was seen between history of CSA and unprotected anal sex (adjusted odds ratio = 1.24, 95% CI: 1.12 to 1.36) and serodiscordant unprotected anal sex (adjusted odds ratio = 1.30, 95% CI: 1.18 to 1.43). Among participants reporting CSA, the EXPLORE intervention had no effect in reducing HIV infection rates. Participants reporting CSA were significantly more likely to have symptoms of depression and use nonprescription drugs. Conclusions:A predictive relationship between a history of CSA and subsequent HIV infection was observed among this large sample of HIV-uninfected MSM. Findings indicate that HIV-uninfected MSM with CSA histories are at greater risk for HIV infection, report higher rates of HIV sexual risk behavior, and may derive less benefit from prevention programs. Future HIV prevention interventions should address the specific mental health concerns of MSM with a history of CSA.

What's love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for hiv-serodiscordant couples

Objective:Adherence may be the “Achilles heel” of pre-exposure prophylaxis (PrEP), a promising biomedical approach to HIV prevention. This article presents an explanation of PrEP adherence for African serodiscordant couples derived from qualitative data. Design:Explaining quantitative findings is one way qualitative investigation contributes to research in medicine and public health. This qualitative interview study was nested in the Partners PrEP Study, a phase III randomized trial evaluating oral tenofovir and emtricitabine/tenofovir PrEP to prevent HIV acquisition by HIV-uninfected partners in serodiscordant heterosexual couples. Methods:In-depth qualitative interviews were provided by 60 Partners PrEP Study participants in Uganda. Interviews used open-ended questions eliciting information on adherence experiences, barriers, and facilitators. An inductive approach informed by grounded theory methodology was used to analyze study data. Results:The proposed explanation may be summarized as follows. Serodiscordance destabilizes couples, as the HIV-negative partner reacts with anger, fear, and sadness to the implication of infidelity represented by HIV infection. A “discordance dilemma” ensues, as the desire to avoid acquiring HIV and the advantages of preserving the relationship become competing priorities. PrEP is seen as a solution—a means of safeguarding health without ending the relationship. PrEP users benefit from the support of partners, who reinforce adherence. Where discord in the relationship persists, adherence suffers. Conclusions:PrEP adherence in serodiscordant couples may be understood as a function of the desire to reduce risk although preserving a partnered relationship. PrEP use in stable couples may be associated with improved adherence and thus, greater effectiveness.

Factor structure of the Social Interaction Anxiety Scale and the Social Phobia Scale

In the study of social anxiety, it is common to differentiate between social interaction versus performance anxiety. The Social Interaction Anxiety Scale was designed to assess social interaction anxiety, and the Social Phobia Scale to assess fear of scrutiny by others (Mattick and Clarke, 1989). In common use, these scales are typically administered together and treated as subscales of a larger measure. However, the joint factor structure of these instruments has never been examined; therefore, it is unclear whether or not the items on these scales actually represent distinct aspects of social anxiety. In the present study, a confirmatory factor analysis of the pooled items from the SIAS and SPS failed to adequately fit the data. An exploratory factor analysis yielded three factors: (1) interaction anxiety, (2) anxiety about being observed by others, and (3) fear that others will notice anxiety symptoms. However, hierarchical factor analysis suggested that these factors all load on a single higher-order factor, social anxiety. Relationships of the first-order factors to other measures of social and performance fear and avoidance are examined, and implications of our findings for the assessment of social phobia are discussed.

Effect of Same-Sex Marriage Laws on Health Care Use and Expenditures in Sexual Minority Men: A Quasi-Natural Experiment

OBJECTIVES We sought to determine whether health care use and expenditures among gay and bisexual men were reduced following the enactment of same-sex marriage laws in Massachusetts in 2003. METHODS We used quasi-experimental, prospective data from 1211 sexual minority male patients in a community-based health center in Massachusetts. RESULTS In the 12 months after the legalization of same-sex marriage, sexual minority men had a statistically significant decrease in medical care visits (mean = 5.00 vs mean = 4.67; P = .05; Cohens d = 0.17), mental health care visits (mean = 24.72 vs mean = 22.20; P = .03; Cohens d = 0.35), and mental health care costs (mean =