Showing papers by "Carol E. Golin published in 2014"

The Harms of Screening: A Proposed Taxonomy and Application to Lung Cancer Screening

Abstract: Importance Making rational decisions about screening requires information about its harms, but high-quality evidence is often either not available or not used. One reason may be that we lack a coherent framework, a taxonomy, for conceptualizing and studying these harms. Objective To create a taxonomy, we categorized harms from several sources: systematic reviews of screening, other published literature, and informal discussions with clinicians and patients. We used this information to develop an initial taxonomy and vetted it with local and national experts, making revisions as needed. Results We propose a taxonomy with 4 domains of harm from screening: physical effects, psychological effects, financial strain, and opportunity costs. Harms can occur at any step of the screening cascade. We provide definitions for each harm domain and illustrate the taxonomy using the example of screening for lung cancer. Conclusions and Relevance The taxonomy provides a systematic way to conceptualize harms as experienced by patients. As shown in the lung cancer screening example, the taxonomy also makes clear where (which domains of harms and which parts of the screening cascade) we have useful information and where there are gaps in our knowledge. The taxonomy needs further testing and validation across a broad range of screening programs. We hope that further development of this taxonomy can improve our thinking about the harms of screening, thus informing our research, policy making, and decision making with patients about the wisdom of screening.

Sexual Communication Between Early Adolescents and Their Dating Partners, Parents, and Best Friends

Abstract: This study assessed early adolescents' sexual communication with dating partners, parents, and best friends about six sexual health topics: condoms, birth control, sexually transmitted diseases (STDs), human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), pregnancy, and abstinence/waiting. Using a school-based sample of 603 youth (ages 12 to 15; 57% female; 46% Caucasian), we examined communication differences across demographic and developmental factors, tested whether communication with parents and best friends was associated with greater communication with partners, and examined associations between communication and condom use. More than half of participants had not discussed any sexual topics with their dating partners (54%), and many had not communicated with parents (29%) or best friends (25%). On average, communication was more frequent among adolescents who were female, African American, older, and sexually active, despite some variation in subgroups across partner, parent, and friend communication. Importantly, communication with parents and friends--and the interaction between parent and friend communication--was associated with increased communication with dating partners. Further, among sexually active youth, increased sexual communication with partners was associated with more frequent condom use. Results highlight the importance of understanding the broader family and peer context surrounding adolescent sexual decision making and suggest a possible need to tailor sexual communication interventions.

Multilevel challenges to engagement in HIV care after prison release: a theory-informed qualitative study comparing prisoners’ perspectives before and after community reentry

Abstract: Although prison provides the opportunity for HIV diagnosis and access to in-prison care, following release, many HIV-infected inmates experience clinical setbacks, including nonadherence to antiretrovirals, elevations in viral load, and HIV disease progression. HIV-infected former inmates face numerous barriers to successful community reentry and to accessing healthcare. However, little is known about the outcome expectations of HIV-infected inmates for release, how their post-release lives align with pre-release expectations, and how these processes influence engagement in HIV care following release from prison. We conducted semi-structured interviews (24 pre- and 13 post-release) with HIV-infected inmates enrolled in a randomized controlled trial of a case management intervention to enhance post-release linkage to care. Two researchers independently coded data using a common codebook. Intercoder reliability was strong (kappa = 0.86). We analyzed data using Grounded Theory methodology and Applied Thematic Analysis. We collected and compared baseline sociodemographic and behavioral characteristics of all cohort participants who did and did not participate in the qualitative interviews using Fisher’s Exact Tests for categorical measures and Wilcoxon rank-sum tests for continuous measures. Most participants were heterosexual, middle-aged, single, African American men and women with histories of substance use. Substudy participants were more likely to anticipate living with family/friends and needing income assistance post-release. Most were taking antiretrovirals prior to release and anticipated needing help securing health benefits and medications post-release. Before release, most participants felt confident they would be able to manage their HIV. However, upon release, many experienced intermittent or prolonged periods of antiretroviral nonadherence, largely due to substance use relapse or delays in care initiation. Substance use was precipitated by stressful life experiences, including stigma, and contact with drug-using social networks. As informed by the Social Cognitive Theory and HIV Stigma Framework, findings illustrate the reciprocal relationships among substance use, experiences of stigma, pre- and post-release environments, and skills needed to engage in HIV care. These findings underscore the need for comprehensive evidence-based interventions to prepare inmates to transition from incarceration to freedom, particularly those that strengthen linkage to HIV care and focus on realities of reentry, including stigma, meeting basic needs, preventing substance abuse, and identifying community resources.

A marginalized zero-inflated Poisson regression model with overall exposure effects.

Abstract: The zero-inflated Poisson (ZIP) regression model is often employed in public health research to examine the relationships between exposures of interest and a count outcome exhibiting many zeros, in excess of the amount expected under sampling from a Poisson distribution. The regression coefficients of the ZIP model have latent class interpretations, which correspond to a susceptible subpopulation at risk for the condition with counts generated from a Poisson distribution and a non-susceptible subpopulation that provides the extra or excess zeros. The ZIP model parameters, however, are not well suited for inference targeted at marginal means, specifically, in quantifying the effect of an explanatory variable in the overall mixture population. We develop a marginalized ZIP model approach for independent responses to model the population mean count directly, allowing straightforward inference for overall exposure effects and empirical robust variance estimation for overall log-incidence density ratios. Through simulation studies, the performance of maximum likelihood estimation of the marginalized ZIP model is assessed and compared with other methods of estimating overall exposure effects. The marginalized ZIP model is applied to a recent study of a motivational interviewing-based safer sex counseling intervention, designed to reduce unprotected sexual act counts.

The Validity of Self-Reported Medication Adherence as an Outcome in Clinical Trials of Adherence-Promotion Interventions: Findings from the MACH14 Study

Abstract: In medication adherence-promotion trials, participants in the intervention arm are often cognizant of the researcher's aim to improve adherence; this may lead to their inflating reports of their own adherence compared to control arm participants. Using data from 1,247 HIV-positive participants across eight U.S. Studies in the Multi-site Adherence Collaboration on HIV (MACH14) collaboration, we evaluated the validity of self-reported adherence by examining whether its association with two more objective outcomes [1], electronically monitored adherence and [2] viral load, varied by study arm. After adjusting for potential confounders, there was no evidence of greater overestimation of self-reported adherence among intervention arm participants, supporting its potential as a trial outcome indicator.

Retention strategies and factors associated with missed visits among low income women at increased risk of HIV acquisition in the US (HPTN 064).

Abstract: Women at high-risk for HIV acquisition often face challenges that hinder their retention in HIV prevention trials. These same challenges may contribute to missed clinical care visits among HIV-infected women. This article, informed by the Gelberg-Andersen Behavioral Model for Vulnerable Populations, identifies factors associated with missed study visits and describes the multifaceted retention strategies used by study sites. HPTN 064 was a multisite, longitudinal HIV seroincidence study in 10 US communities. Eligible women were aged 18-44 years, resided in a census tract/zipcode with high poverty and HIV prevalence, and self-reported ≥1 personal or sex partner behavior related to HIV acquisition. Multivariate analyses of predisposing (e.g., substance use) and enabling (e.g., unmet health care needs) characteristics, and study attributes (i.e., recruitment venue, time of enrollment) identified factors associated with missed study visits. Retention strategies included: community engagement; interpersonal relationship building; reduction of external barriers; staff capacity building; and external tracing. Visit completion was 93% and 94% at 6 and 12 months. Unstable housing and later date of enrollment were associated with increased likelihood of missed study visits. Black race, recruitment from an outdoor venue, and financial responsibility for children were associated with greater likelihood of attendance. Multifaceted retention strategies may reduce missed study visits. Knowledge of factors associated with missed visits may help to focus efforts.

Characteristics of multiple and concurrent partnerships among women at high risk for HIV infection.

Abstract: Objectives We examined parameters of sexual partnerships, including respondents’ participation in concurrency, belief that their partner had concurrent partnerships (partners’ concurrency), and partnership intervals, among the 2,099 women in HIV Prevention Trials Network 064, a study of women at high risk for HIV infection, in ten US communities.

HIV and Stigma in Liuzhou, China

Abstract: This paper describes emergent stigma-related themes from individual descriptions of living with HIV in Liuzhou, China. Qualitative interviews were conducted with 23 people living with HIV (PLHIV). To provide contextual information, 14 public health personnel and 4 community workers in Liuzhou were also interviewed. PLHIV experienced enacted, anticipated, and internalized HIV-related stigma, which resulted in negative affective, behavioral, and physical health outcomes, including barriers to health care, preemptive self-isolation, suicidal ideation, and poverty. To lessen stigma, future programs should aim to increase HIV knowledge and empathy for PLHIV among family members, community workers, and health professionals. HIV programs should also include suicide risk assessment for PLHIV, especially immediately after diagnosis and at the onset of HIV-related symptoms.

The Association Between Poor Antiretroviral Adherence and Unsafe Sex: Differences by Gender and Sexual Orientation and Implications for Scale-up of Treatment as Prevention

Abstract: Non-adherence to safer sex and non-adherence to ART can each have adverse health consequences for HIV-infected individuals and their sex partners, but little is known about the association of these behaviors with each other. This “dual risk” has potential negative public health consequences since non-adherence can lead to the development of resistant virus that can then be transmitted to sex partners. Among participants in the Multi-site Adherence Collaboration in HIV we examined, at study baseline, the association between the frequency of unprotected sex (assessed by self-report) and ART adherence (assessed by Medication Event Monitoring System, Aardex) among the sexually active participants in the five studies (N = 459) that collected sexual risk behavior. The bivariate association between sexual risk behaviors and ART adherence was assessed by Pearson correlations; subsequently regression analyses were used to evaluate the role of demographic characteristics, depression and substance use in explaining the “dual risk” outcome (sexual risk and non-adherence). Among participants who had been sexually active, more unprotected anal/vaginal sex was weakly associated with poorer ART adherence (r = −0.12, p = 0.01 for the overall sample). Further analysis showed this association was driven by the heterosexual men in the sample (r = −0.29, p < 0.001), and was significant only for this group, and not for gay/bisexual men or for women (heterosexual and homosexual). Neither substance use nor depression accounted for the association between sexual risk and ART adherence. HIV-infected heterosexual men who are having difficulty adhering to ART are also more likely to engage in risky sexual behaviors and therefore may benefit from counseling about these risk behaviors. We must identify procedures to screen for these risk behaviors and develop interventions, appropriately tailored to specific populations and identified risk factors, that can be integrated into routine clinical care for people living with HIV. This will become increasingly important in the context of wider access to treatment globally, including new recommendations for ART initiation earlier in a patients’ disease course (e.g., “Test and Treat” paradigms).

Incarceration and unstable housing interact to predict sexual risk behaviours among African American STD clinic patients.

Abstract: Given the dramatic racial disparities in the rates of HIV/sexually transmitted infections (STIs) among African Americans, understanding broader structural factors that increase the risk for HIV/STIs is crucial. This study investigated incarceration history and unstable housing as two structural predictors of HIV risk behaviour among 293 African Americans (159 men/134 women, mean age = 27). Participants were recruited from an urban sexually transmitted disease (STD) clinic in the southeastern U.S. Approximately half the sample had been incarcerated in their lifetime (54%), and 43% had been unstably housed in the past six months. Incarceration was independently associated with the number of sex partners and the frequency of unprotected sex. Unstable housing was independently associated with the frequency of unprotected sex. However, these main effects were qualified by significant interactions: individuals with a history of incarceration and more unstable housing had more sex partners and more unprotected s...

Coping strategies for HIV-related stigma in Liuzhou, China

Abstract: This study explores the feelings, experiences, and coping strategies of people living with HIV (PLHIV) in Liuzhou, China. In a southwestern Chinese city with high HIV prevalence, we conducted semi-structured in-depth interviews with 47 PLHIV selected to represent individuals who had acquired HIV via different acquisition routes. Many participants felt severely stigmatized; they commonly reported having very low self-esteem and feelings of despair. Based on style of coping and whether it occurred at the interpersonal or intrapersonal level, four types of coping that participants used to deal with HIV-associated stigma were identified: (1) Compassion (Passive/Avoidant—Interpersonal); (2) Hiding HIV status (Passive/Avoidant—Intrapersonal); (3) Social support (Active/Problem-focused—Interpersonal; and (4) Self-care (Active/Problem-focused—Intrapersonal). Educational and stigma-reduction interventions targeting potential social support networks for PLHIV (e.g., family, close friends, and peers) could strengthen active interpersonal PLHIV coping strategies. Interventions teaching self-care to PLHIV would encourage active intrapersonal coping, both of which may enhance PLHIV quality of life in Liuzhou, China.

Examining the Role of Serostatus Disclosure on Unprotected Sex Among People Living with HIV

Abstract: Given the increasing prevalence of HIV, it is important to identify factors associated with safer sex behaviors between people living with HIV and their partners. Utilizing a diverse sample of 242 HIV-infected adults [n=69 men who have sex with men (MSM); n=68 men who have sex with women (MSW); n=105 women who have sex with men (WSM)], we examined the association between serostatus disclosure and unprotected anal or vaginal intercourse (UAVI) and the moderating effect of sexual behavior group on this association. Overall, 88.7% disclosed to their current partner. Approximately 18.8% of MSM, 17.7% of MSW, and 29.5% of WSM reported UAVI. Controlling for age, time since diagnosis, and partner serostatus, we found main effects on UAVI for disclosure and sexual behavior group; specifically, disclosure was inversely related to unprotected sex [AOR=0.09, 95% CI (0.02, 0.43), p<0.001], and MSM were less likely to engage in UAVI relative to WSM [AOR=0.11, 95% CI (0.17, 0.82), p<0.05]. However, the relationship between disclosure and UAVI was not moderated by sexual behavior group. Future strategies that aim to increase disclosure to partners may consider focusing on its value as a means by which to reduce sexual risk behavior.

Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study.

Abstract: Background: The challenge of identifying and recruiting U.S. women at elevated risk for HIV acquisition impedes prevention studies and services. HIV Prevention Trials Network (HPTN) 064 was a U.S. multisite, longitudinal cohort study designed to estimate HIV incidence among women living in communities with prevalent HIV and poverty. Venue-based sampling (VBS) methodologies and participant and venue characteristics are described. Methods: Eligible women were recruited from 10 U.S. communities with prevalent HIV and poverty using VBS. Participant eligibility criteria included age 18–44 years, residing in a designated census tract/zip code, and self-report of at least one high-risk personal and/or male sexual partner characteristic associated with HIV acquisition (e.g., incarceration history). Ethnography was conducted to finalize recruitment areas and venues. Results: Eight thousand twenty-nine women were screened and 2,099 women were enrolled (88% black, median age 29 years) over 14 months. The majority of participants were recruited from outdoor venues (58%), retail spaces (18%), and social service organizations (13%). The proportion of women recruited per venue category varied by site. Most participants (73%) had both individual and partner characteristics that qualified them for the study; 14% were eligible based on partner risk only. Conclusion: VBS is a feasible and effective approach to rapidly recruit a population of women at enhanced risk for HIV in the United States. Such a recruitment approach is needed in order to engage women most at risk and requires strong community engagement.

HPTN 062: A Feasibility and Acceptability Pilot Intervention to Reduce HIV Transmission Risk Behaviors Among Individuals with Acute and Early HIV Infection in Lilongwe, Malawi

Abstract: Acute HIV infection (AHI) is a relatively brief period of time when individuals are highly infectious and the opportunity to intervene to prevent forward transmission is extremely limited. HPTN 062 partnered with CHAVI 001 to evaluate the feasibility and acceptability of a motivational interviewing (MI)-based counseling intervention to reduce HIV-transmission risk behaviors among individuals with acute and early HIV infection in Lilongwe, Malawi. Participants were randomized to receive either (1) brief education sessions about HIV and AHI; or (2) the same brief education sessions plus an MI-based counseling intervention called Uphungu Wanga. Although Uphungu Wanga was determined to be feasible and acceptable, few major differences existed between the two arms with regard to acceptability, feasibility, and self-reported sexual behaviors. We therefore conclude that an additional MI-based counseling intervention may not be needed during the short period of AHI. Instead, we recommend that individuals with AHI receive frequent, but brief, counseling immediately after diagnosis and then transition to receiving counseling at less frequent intervals until they can initiate antiretroviral therapy. Other recommendations are provided.

Medication Therapy Management Interventions in Outpatient Settings [Internet]

Abstract: Objectives To describe intervention components and implementation features (Key Question [KQ]1) for outpatient medication therapy management (MTM) interventions with comprehensive medication review, followup, education, and care coordination; assess the effectiveness of these MTM interventions on intermediate, patient-centered, or resource utilization outcomes (KQ 2); identify intervention features (KQ 3) and patient characteristics (KQ 4) that moderate the effect of an intervention on outcomes; and assess harms associated with interventions (KQ 5). Data sources MEDLINE®, Cochrane Library, International Pharmaceutical Abstracts, gray literature, additional studies from reference lists and technical experts Review methods Two trained reviewers selected, extracted data from, and rated the risk of bias of relevant trials and cohort studies. We used random-effects models to estimate pooled effects for outcomes with three or more similar studies with a low or medium risk of bias. For other outcomes, we synthesized the data qualitatively. Results We included 44 eligible studies (21 randomized controlled trials, 4 controlled clinical trials, and 19 cohort studies) reported in 61 articles, described in detail in the report (KQ 1). Evidence was insufficient on the effect of outpatient MTM interventions on most outcomes (KQ 2). In a few instances, described below, the evidence led us to conclude benefit or lack of benefit. Specifically, we found evidence that MTM results in improvement when compared with usual care for some measures of medication adherence and appropriateness; medication dosing; health plan expenditures on medication costs; and, for patients with diabetes, the proportion hospitalized and costs of hospitalization. Similarly, we conclude, based on a low strength of evidence, that MTM confers no benefit for patient satisfaction and most measures of health-related quality of life. We found evidence on five intervention components and intervention features (KQ 3). One study provided information on each feature and yielded insufficient evidence for most outcomes, with the following two exceptions. An MTM program with pharmacist access to brief clinical summaries from the medical record reduces the mean number of adverse drug events when compared with a basic MTM program without such access (low strength of evidence). Community pharmacists increase the generic dispensing ratio more than call-center–based pharmacists (low strength of evidence). We found no relevant studies on patient characteristics moderating the effect of MTM interventions (KQ 4). Similarly, the evidence on harms associated with MTM was limited to one study on inconvenience and was rated as insufficient (KQ 5). Conclusions The evidence base offers low evidence of benefit for a limited number of intermediate and health utilization outcomes. We graded the evidence as insufficient for most other outcomes because of inconsistency in direction, magnitude, and precision, rather than lack of evidence. Wide variations in populations and interventions, both within and across studies, likely explain these inconsistencies. Given the widespread implementation of MTM and urgent need for actionable information, optimal investments in new research require a process of research prioritization in which the value of information from each proposed study is carefully considered. Studies designed to identify causal relationships between MTM interventions and their outcomes require adequate controls for confounding but may offer limited information on the factors that explain program success or failure. Studies designed to explore the reasons for program success or failure using qualitative or single-arm designs may offer hypotheses-generating rather than hypotheses-confirming insights on MTM effectiveness. New research, regardless of specific focus, will likely continue to find inconsistent results until underlying sources of heterogeneity are accounted for.