Showing papers by "Carol E. Golin published in 2016"

On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings.

Abstract: Scale-up of viral load (VL) monitoring for HIV-infected patients on antiretroviral therapy (ART) is a priority in many resource-limited settings, and ART providers are critical to effective program implementation. We explored provider-perceived barriers and facilitators of VL monitoring. We interviewed all providers (n = 17) engaged in a public health evaluation of dried blood spots for VL monitoring at five ART clinics in Malawi. All ART clinics were housed within district hospitals. We grouped themes at patient, provider, facility, system, and policy levels. Providers emphasized their desire for improved ART monitoring strategies, and frustration in response to restrictive policies for determining which patients were eligible to receive VL monitoring. Although many providers pled for expansion of monitoring to include all persons on ART, regardless of time on ART, the most salient provider-perceived barrier to VL monitoring implementation was the pressure of work associated with monitoring activities. The work burden was exacerbated by inefficient data management systems, highlighting a critical interaction between provider-, facility-, and system-level factors. Lack of integration between laboratory and clinical systems complicated the process for alerting providers when results were available, and these communication gaps were intensified by poor facility connectivity. Centralized second-line ART distribution was also noted as a barrier: providers reported that the time and expenses required for patients to collect second-line ART frequently obstructed referral. However, provider empowerment emerged as an unexpected facilitator of VL monitoring. For many providers, this was the first time they used an objective marker of ART response to guide clinical management. Providers' knowledge of a patient's virological status increased confidence in adherence counseling and clinical decision-making. Results from our study provide unique insight into provider perceptions of VL monitoring and indicate the importance of policies responsive to individual and environmental challenges of VL monitoring program implementation. Findings may inform scale-up by helping policy-makers identify strategies to improve feasibility and sustainability of VL monitoring.

Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064).

Abstract: We sought to understand the multilevel syndemic factors that are concurrently contributing to the HIV epidemic among women living in the US. We specifically examined community, network, dyadic, and individual factors to explain HIV vulnerability within a socioecological framework. We gathered qualitative data (120 interviews and 31 focus groups) from a subset of women ages 18–44 years (N = 2,099) enrolled in the HPTN 064 HIV seroincidence estimation study across 10 US communities. We analyzed data from 4 diverse locations: Atlanta, New York City (the Bronx), Raleigh, and Washington, DC. Data were thematically coded using grounded theory methodology. Intercoder reliability was assessed to evaluate consistency of team-based coding practices. The following themes were identified at 4 levels including 1) exosystem (community): poverty prevalence, discrimination, gender imbalances, community violence, and housing challenges; 2) mesosystem (network): organizational social support and sexual concurrency; 3) microsystem (dyadic): sex exchange, interpersonal social support, intimate partner violence; and 4) individual: HIV/STI awareness, risk taking, and substance use. A strong theme emerged with over 80 % of responses linked to the fundamental role of financial insecurity underlying risk-taking behavioral pathways. Multilevel syndemic factors contribute to women’s vulnerability to HIV in the US. Financial insecurity is a predominant theme, suggesting the need for tailored programming for women to reduce HIV risk. Clinicaltrials.gov, NCT00995176

Identifying configurations of behavior change techniques in effective medication adherence interventions: a qualitative comparative analysis

Abstract: Interventions to improve medication adherence are diverse and complex. Consequently, synthesizing this evidence is challenging. We aimed to extend the results from an existing systematic review of interventions to improve medication adherence by using qualitative comparative analysis (QCA) to identify necessary or sufficient configurations of behavior change techniques among effective interventions. We used data from 60 studies in a completed systematic review to examine the combinations of nine behavior change techniques (increasing knowledge, increasing awareness, changing attitude, increasing self-efficacy, increasing intention formation, increasing action control, facilitation, increasing maintenance support, and motivational interviewing) among studies demonstrating improvements in adherence. Among the 60 studies, 34 demonstrated improved medication adherence. Among effective studies, increasing patient knowledge was a necessary but not sufficient technique. We identified seven configurations of behavior change techniques sufficient for improving adherence, which together accounted for 26 (76 %) of the effective studies. The intervention configuration that included increasing knowledge and self-efficacy was the most empirically relevant, accounting for 17 studies (50 %) and uniquely accounting for 15 (44 %). This analysis extends the completed review findings by identifying multiple combinations of behavior change techniques that improve adherence. Our findings offer direction for policy makers, practitioners, and future comparative effectiveness research on improving adherence.

Post-traumatic Stress Disorder Symptoms and Mental Health over Time among Low-Income Women at Increased Risk of HIV in the U.S

Abstract: Women living in poverty suffer more post-traumatic stress disorder (PTSD) symptoms than do members of the general population; however we know little about factors associated with changes in their PTSD symptoms over time. Using data from HPTN 064, a cohort of women from low-income, high-HIV-prevalence communities across six eastern states (n=1,860), we assessed the prevalence of and changes in PTSD symptoms over 12 months and the effect of potential predictors on symptom acquisition and remission (via the Primary Care-PTSD symptoms scale). Forty-three percent screened positive for PTSD symptoms. Those reporting food insecurity, ongoing abuse, depressive symptoms, or binge drinking were more likely to acquire PTSD symptoms. Those with ongoing abuse or depressive symptoms were less likely to experience PTSD symptom remission. Findings suggest a need to integrate programs to reduce abuse, depression, and economic hardship with those that address sexual health risks among women living in low-income, high-HIV-prevalence neighborhoods.

Using qualitative comparative analysis in a systematic review of a complex intervention

Abstract: Systematic reviews evaluating complex interventions often encounter substantial clinical heterogeneity in intervention components and implementation features making synthesis challenging. Qualitative comparative analysis (QCA) is a non-probabilistic method that uses mathematical set theory to study complex phenomena; it has been proposed as a potential method to complement traditional evidence synthesis in reviews of complex interventions to identify key intervention components or implementation features that might explain effectiveness or ineffectiveness. The objective of this study was to describe our approach in detail and examine the suitability of using QCA within the context of a systematic review. We used data from a completed systematic review of behavioral interventions to improve medication adherence to conduct two substantive analyses using QCA. The first analysis sought to identify combinations of nine behavior change techniques/components (BCTs) found among effective interventions, and the second analysis sought to identify combinations of five implementation features (e.g., agent, target, mode, time span, exposure) found among effective interventions. For each substantive analysis, we reframed the review’s research questions to be designed for use with QCA, calibrated sets (i.e., transformed raw data into data used in analysis), and identified the necessary and/or sufficient combinations of BCTs and implementation features found in effective interventions. Our application of QCA for each substantive analysis is described in detail. We extended the original review findings by identifying seven combinations of BCTs and four combinations of implementation features that were sufficient for improving adherence. We found reasonable alignment between several systematic review steps and processes used in QCA except that typical approaches to study abstraction for some intervention components and features did not support a robust calibration for QCA. QCA was suitable for use within a systematic review of medication adherence interventions and offered insights beyond the single dimension stratifications used in the original completed review. Future prospective use of QCA during a review is needed to determine the optimal way to efficiently integrate QCA into existing approaches to evidence synthesis of complex interventions.

A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial

Abstract: Importance Healthcare overuse, the delivery of low-value services, is increasingly recognized as a critical problem. However, little is known about the comparative effectiveness of alternate formats for presenting benefits and harms information to patients as a strategy to reduce overuse. Objective To examine the effect of different benefits and harms presentations on patients’ intentions to accept low-value or potentially low-value screening services (prostate cancer screening in men ages 50-69 years; osteoporosis screening in low-risk women ages 50-64 years; or colorectal cancer screening in men and women ages 76-85 years). Design, Setting, and Participants Randomized clinical trial of 775 individuals eligible to receive information about any 1 of the 3 screening services and scheduled for a visit with their clinician. Participants were randomized to 1 of 4 intervention arms that differed in terms of presentation format: words, numbers, numbers plus narrative, and numbers plus framed presentation. The trial was conducted from September 2012 to June 2014 at 2 family medicine and 2 internal medicine practices affiliated with the Duke Primary Care Research Consortium. The data were analyzed between May and September of 2015. Interventions One-page evidence-based decision support sheets on each of the 3 screening services, with benefits and harms information presented in 1 of 4 formats: words, numbers, numbers plus narratives, or numbers plus a framed presentation. Main Outcomes and Measures The primary outcome was change in intention to accept screening (on a response scale from 1 to 5). Our secondary outcomes included general and disease-specific knowledge, perceived risk and consequences of disease, screening attitudes, perceived net benefit of screening, values clarity, and self-efficacy for screening. Results We enrolled and randomly allocated 775 individuals, aged 50 to 85 years, to 1 of 4 intervention arms: 195 to words, 192 to numbers, 196 to narrative, and 192 to framed formats. Intentions to accept screening were high before the intervention and change in intentions did not differ across intervention arms (words, −0.07; numbers, −0.05; numbers plus narrative, −0.12; numbers plus framed presentation, −0.02; P = .57 for all comparisons). Change in other outcomes also showed no difference across intervention arms. Results were similar when stratified by screening service. Conclusions and Relevance Single, brief, written decision support interventions, such as the ones in this study, are unlikely to be sufficient to change intentions for screening. Alternate and additional interventions are needed to reduce overused screening services. Trial Registration clinicaltrials.gov Identifier:NCT01694784

ProjectHeartforGirls.com: Development of a Web-Based HIV/STD Prevention Program for Adolescent Girls Emphasizing Sexual Communication Skills.

Abstract: This article describes the development of ProjectHeartforGirls.com, an interactive web-based program designed to improve sexual communication skills and reduce the risk of HIV/STDs among adolescent girls, a population at heightened risk for negative sexual health outcomes (Centers for Disease Control and Prevention, 2013). Although sexual communication is a critical predictor of safer sex among teens, there are few online interventions that target these skills as a central program component. We developed ProjectHeartforGirls.com to fill this gap. Program development involved (1) identifying the target population (ethnically diverse high school girls), (2) clarifying the theoretical foundation (Reasoned Action Model), (3) conducting formative qualitative research (n = 25 girls), (4) drafting initial program content, (5) receiving ongoing feedback from a teen advisory board (n = 5 girls), (6) programming online content, and (7) conducting usability testing (n = 6 girls). These steps are described along with...

Oncology providers' perspectives on endocrine therapy prescribing and management.

Abstract: PURPOSE Adjuvant endocrine therapy (ET) can reduce the risk of recurrence among females with hormone receptor-positive breast cancer. Overall, initiation and adherence to ET are suboptimal, though reasons are not well described. The study's objective was to better understand ET decision making, prescribing, and patient management from oncology providers' perspectives. METHODS Using purposive sampling, we recruited oncology providers who saw five or more breast cancer patients per week (n=20). We conducted 30-45-minute telephone interviews, using a semistructured guide to elicit perspectives on ET use. We used thematic content analysis to systematically identify categories of meaning and double-coded transcripts using Atlas.ti. RESULTS Providers recommend ET to all eligible patients except those with contraindications or other risk factors. Providers base their ET prescribing decisions on the patient's menopausal status, side effects, and comorbidities. ET is typically discussed multiple times: at the onset of breast cancer treatment and in more detail after other treatment completion. Providers felt that the associated recurrence risk reduction is the most compelling argument for patients during ET decision making. While providers rarely perceived noninitiation as a problem, nonadherence was prevalent, often due to unresolvable side effects. CONCLUSION From the clinicians' perspectives, side effects from ET are the dominant factor in nonadherence. Efforts to improve adherence should focus on strategies to minimize side effects and ensure clinicians and patients are well informed regarding optimal side effect management. This finding has important implications for novel endocrine regimens that offer improved outcomes through longer duration or more intensive therapy.

Health of Older Adults in Assisted Living and Implications for Preventive Care

Abstract: Purpose of the Study Older adults in residential care and assisted living (RC/AL) are less healthy than the general elderly population, and some have needs similar to those in nursing homes, making this an important group in which to assess potential overuse or underuse of preventive services. We determined the health status of RC/AL residents and distinguished characteristics between those who may and may not benefit from preventive services requiring a life expectancy ≥5 years. Design and Methods Cross-sectional survey of a nationally representative sample of RC/AL residents using 2010 data from the National Survey of Residential Care Facilities. The primary outcome was the weighted frequency distribution of health states using three predictive mortality indices: Charlson Comorbidity Index, 4-year mortality index, and 9-year mortality index. Results A total of 666,700 of 733,300 (weighted) residents met criteria for inclusion. Based on the three indices, 10%-15% were in good health, 11%-70% in intermediate health, and 20%-76% in poor health. Implications Using triangulation between 3 well-validated mortality indices, 10%-15% of RC/AL residents are in good health and highly likely to benefit from preventive services that require ≥5 year life expectancy. In addition, many residents have uncertain benefit and would benefit from shared decision making.

Comparing HIV Case Detection in Prison During Opt-In vs. Opt-Out Testing Policies.

Abstract: Routine HIV screening in health care settings, including prisons and jails, is recommended by the US Centers for Disease Control and Prevention to enhance the detection of HIV infection.1,2 A centerpiece of this strategy is opt-out HIV screening whereby patients are informed that testing will be conducted unless they decline the test. Although incarceration is considered an opportunity to detect HIV and initiate or restart HIV care,3–6 there are few data describing the performance of an opt-out testing policy in prisons, where HIV prevalence is several-fold that found in the general population.3 In November 2008, the North Carolina Department of Public Safety (NCDPS) Division of Adult Correction changed its HIV screening policy for incoming inmates from opt-in to opt-out testing. At the time of the policy change, we were conducting a HIV seroprevalence study among incoming prisoners.7 The co-occurrence of the change in policy and our seroprevalence study provided a natural experiment to assess the impact of the testing policy on HIV case detection of both newly diagnosed and previously diagnosed cases.

Borderline Personality Disorder Symptom Severity and Sexually Transmitted Infection and HIV Risk in African American Incarcerated Men.

Abstract: Background Sexually transmitted infections (STI)/HIV rates are disproportionately high among men involved in the criminal justice system. Mental health disorders, including personality disorders, are also elevated among inmates. Borderline personality disorder (BPD) may be an important risk factor for STI/HIV, yet remains relatively understudied, particularly among inmates. Methods We used baseline data from Project DISRUPT, a cohort study of African American men being released from prison in North Carolina who were in heterosexual relationships at prison entry (n=189), to assess their STI/HIV risk in the 6 months before incarceration and BPD symptoms focused on emotional lability and relationship dysfunction. We created a continuous BPD symptom severity score and a dichotomous BPD indicator split at the top quartile of the score (BPD-TQ) to examine associations between BPD and STI/HIV outcomes using logistic regression. We also examined associations between individual symptoms and outcomes. Results After adjustment for sociodemographics and antisocial personality disorder, BPD-TQ was associated with sexual risk behaviors including multiple partnerships (adjusted odds ratio, 2.58; 95% confidence interval, 1.24-5.36) and sex with nonmonogamous partners (adjusted odds ratio, 2.54; 95% confidence interval, 1.17-5.51). Prevalence of previous STI (47.5% vs. 29.6%) and prevalent chlamydial infection (6.9% vs. 3.1%) seemed higher in those in BPD-TQ, although the associations were not statistically significant. Associations were similar to those with the continuous score. Borderline personality disorder symptoms most associated with STI/HIV risk were abandonment worry, mood swings, and shifts in opinions. Conclusions Borderline personality disorder is strongly associated with STI/HIV risk in this sample. Researchers should further evaluate the relationship between STI/HIV and BPD, in addition to mood disorders.

Individuals motivated to participate in adherence, care and treatment (imPACT): development of a multi-component intervention to help HIV-infected recently incarcerated individuals link and adhere to HIV care

Abstract: Policy-makers promote a seek, test, treat and retain (STTR) strategy to expand HIV testing, support linkage and engagement in care, and enhance the continuous use of antiretroviral therapy for those HIV-infected. This HIV prevention strategy is particularly appropriate in correctional settings where HIV screening and treatment are routinely available yet many HIV-infected individuals have difficulty sustaining sufficient linkage and engagement in care, disease management, and viral suppression after prison release. Our research team developed Project imPACT (individuals motivated to Participate in Adherence, Care and Treatment), a multi-component approach for HIV-Infected recently incarcerated individuals that specifically targets their care linkage, retention, and medication adherence by addressing multiple barriers to care engagement after release. The ultimate goals of this intervention are to improve the health of HIV-infected individuals recently released from prison and reduce HIV transmission to their communities by maintaining viral suppression. This paper describes the intervention and technology development processes, based on best practices for intervention development and process evaluation. These processes included: 1) identifying the target population; 2) clarifying the theoretical basis for intervention design; 3) describing features of its foundational interventions; 4) conducting formative qualitative research; 5) integrating and adapting foundational interventions to create and refine intervention content based on target audience feedback. These stages along with the final intervention product are described in detail. The intervention is currently being evaluation and a two arm randomized, controlled trial in two US state prison systems. Based on a literature review, qualitative research, integration of proven interventions and behavioral theory, the final imPACT intervention focused on the transition period two to three months before and three months after prison release. It emphasized pre-release readiness, pre- and post-release supportive non-judgmental counseling, linking individuals to a HIV care clinic and technological supports through videos and text messages. This article provides a useful model for how researchers can develop, test, and refine multi-component interventions to address HIV care linkage, retention and adherence. NCT01629316 , first registered 6-4-2012; last updated 6-9-2015.

Opt-Out HIV Testing of Inmates in North Carolina Prisons: Factors Associated with not Wanting a Test and not Knowing They Were Tested

Abstract: Opt-out HIV testing is recommended for correctional settings but may occur without inmates' knowledge or against their wishes. Through surveying inmates receiving opt-out testing in a large prison system, we estimated the proportion unaware of being tested or not wanting a test, and associations [prevalence ratios (PRs)] with inmate characteristics. Of 871 tested, 11.8 % were unknowingly tested and 10.8 % had unwanted tests. Not attending an educational HIV course [PR = 2.34, 95 % confidence interval (CI) 1.47-3.74], lower HIV knowledge (PR = 0.95, 95 % CI 0.91-0.98), and thinking testing is not mandatory (PR = 9.84, 95 % CI 4.93-19.67) were associated with unawareness of testing. No prior incarcerations (PR = 1.59, 95 % CI 1.03-2.46) and not using crack/cocaine recently (PR = 2.37, 95 % CI 1.21-4.64) were associated with unwanted testing. Residence at specific facilities was associated with both outcomes. Increased assessment of inmate understanding and enhanced implementation are needed to ensure inmates receive full benefits of opt-out testing: being informed and tested according to their wishes.

Venues for Meeting Sex Partners and Partner HIV Risk Characteristics: HIV Prevention Trials Network (HPTN064) Women's HIV Seroincidence Study (ISIS).

Abstract: Identifying venues where women meet sexual partners, particular partners who increase women’s risk of acquiring HIV, could inform prevention efforts. We categorized venues where women enrolled in HPTN 064 reported meeting their last three sex partners as: (1) Formal, (2) Public, (3) Private, and (4) Virtual spaces. We used multinomial logistic regression to assess the association between these venues and women’s individual characteristics and reports of their partners’ HIV risk characteristics. The 2099 women reported meeting 3991 partners, 51 % at Public, 30 % Private, 17 % Formal and 3 % at Virtual venues. Women meeting partners at Formal venues reported more education and condom use than women meeting partners at other venues. Fewer partners met through Formal venues had “high” risk characteristics for HIV than through other venues and hence may pose less risk of HIV transmission. HIV prevention interventions can help women choose partners with fewer risk characteristics across all venue types.