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Women in low-income communities are disproportionately affected by HIV yet have been largely left out of efforts to raise awareness about pre-exposure prophylaxis (PrEP). To inform future awareness campaigns, we assessed women’s current knowledge of and attitudes toward PrEP. We surveyed 184 women living in public housing communities in North Carolina regarding PrEP knowledge, attitudes, and perceived norms, as well as reported HIV-associated factors and perceived HIV acquisition chances. 38 women participated in eight focus group discussions (FGDs) addressing personal and community PrEP perceptions. Survey participants were 46 years old on average, and 86% identified as Black/African American. Only 35% had heard of PrEP, yet, after being told what it was, 61% said they probably or definitely would take PrEP in the next 6 months. Most women believed that if they decided to take PrEP, their partner (72%) or their family (66%) would approve. When asked about the importance of factors influencing their interest in PrEP, women most frequently rated possible side effects as important or very important (76%), followed by cost considerations (67% for cost of PrEP, 74% for cost of clinic visits and labs). In the FGDs, women had limited PrEP knowledge, but several had heard of PrEP from television commercials, which gave them the impression that PrEP was only for men. Women were concerned about potential side effects, interactions with other medications, safety during pregnancy, and the burden of daily dosing. Most FGD participants expressed generally positive attitudes toward PrEP, but some thought other women would be uninterested due to low perceived chances of HIV acquisition. Overall, these results suggest that while few women had previously heard of PrEP, most were interested in PrEP after receiving information about it and perceived positive community attitudes toward PrEP. Our findings indicate the importance of community-based PrEP communication that speaks to cisgender women, provides information on side effects, and offers destigmatized messaging regarding reasons for HIV prevention for women to consider.

BackgroundPatients’ motivations for undergoing direct-acting antiviral (DAA) therapy for chronic hepatitis C may include anticipation of treatment benefits not well described in the literature.AimsEvaluate patients’ anticipated and actualized improvements in several domains of functioning before and after viral cure.MethodsPre–post-study utilizing in-depth interviews with 28 patients prior to, and several months after, DAA therapy. Interviews were audio-recorded, transcribed, coded, and analyzed by two qualitative experts.ResultsPatients had a median age of 54 years, 43% were male, 57% white, 25% had cirrhosis, and 71% were treated with sofosbuvir/ledipasvir. Pre-treatment, patients hoped for improvements in several domains including psychological, emotional, physical, social, and occupational functioning. After viral cure, increased energy and less fear of transmission were pathways to better quality of life. Psychological and emotional improvements positively affected physical, social, and occupational functioning. Social improvements were due to better mood and motivation, fewer symptoms, and reduced fear of stigma and transmission. Occupational benefits were linked to increased stamina, self-confidence, and less pain, anxiety, and stigma. Reduced fear of stigma had a pervasive impact on all life improvements after cure. Patient characteristics such as the presence of cirrhosis or psychiatric issues influence treatment motivations. Qualitative data correspond with change in pre–post-survey scores.ConclusionsTremendous hope is placed on the ability of DAA therapy to bring about substantial improvements in life functioning after viral cure. Highly interconnected effects on quality of life worked synergistically through improved physical and psychological well-being. Stakeholders should appreciate the multi-dimensional benefits that viral eradication bestows upon individuals and society.

Symptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings are not known. We characterized these patient-reported outcomes (PROs) among HCV-infected patients and explored associations with sociodemographic, liver disease, and psychiatric/substance abuse variables. PROP UP is a large US multicenter observational study that enrolled 1,600 patients with chronic HCV in 2016-2017. Data collected prior to initiating DAA therapy assessed the following PROs: number of medical comorbidities; neuropsychiatric, somatic, gastrointestinal symptoms (PROMIS surveys); overall symptom burden (Memorial Symptom Assessment Scale); and functional well-being (HCV-PRO). Candidate predictors included liver disease markers and patient-reported sociodemographic, psychiatric, and alcohol/drug use features. Predictive models were explored using a random selection of 700 participants; models were then validated with data from the remaining 900 participants. The cohort was 55% male, 39% non-white, 48% had cirrhosis (12% with advanced cirrhosis); 52% were disabled or unemployed; 63% were on public health insurance or uninsured; and over 40% had markers of psychiatric illness. The median number of medical comorbidities was 4 (range: 0-15), with sleep disorders, chronic pain, diabetes, joint pain and muscle aches being present in 20-50%. Fatigue, sleep disturbance, pain and neuropsychiatric symptoms were present in over 60% and gastrointestinal symptoms in 40-50%. In multivariable validation models, the strongest and most frequent predictors of worse PROs were disability, unemployment, and use of psychiatric medications, while liver markers generally were not. This large multi-center cohort study provides a comprehensive and contemporary assessment of the symptom burden and comorbid medical conditions in patients with HCV treated in real world settings. Pain, fatigue, and sleep disturbance were common and often severe. Sociodemographic and psychiatric markers were the most robust predictors of PROs. Future research that includes a rapidly changing population of HCV-infected individuals needs to evaluate how DAA therapy affects PROs and elucidate which symptoms resolve with viral eradication. (Clinicaltrial.gov: NCT02601820).

Choice of initial antiretroviral therapy regimen may help children with HIV maintain optimal, continuous therapy. We assessed treatment-naïve children for differences in time to treatment disruption across randomly-assigned protease inhibitor versus non-nucleoside reverse transcriptase inhibitor-based initial antiretroviral therapy. We performed a secondary analysis of a multicenter phase 2/3, randomized, open-label trial in Europe, North and South America from 2002 to 2009. Children aged 31 days to <18 years, who were living with HIV-1 and treatment-naive, were randomized to antiretroviral therapy with two nucleoside reverse transcriptase inhibitors plus a protease inhibitor or non-nucleoside reverse transcriptase inhibitor. Time to first documented treatment disruption to any component of antiretroviral therapy, derived from treatment records and adherence questionnaires, was analyzed using Kaplan-Meier estimators and Cox proportional hazards models. The modified intention-to-treat analysis included 263 participants. Seventy-two percent (n = 190) of participants experienced at least one treatment disruption during study. At 4 years, treatment disruption probabilities were 70% (protease inhibitor) vs. 63% (non-nucleoside reverse transcriptase inhibitor). The unadjusted hazard ratio (HR) for treatment disruptions comparing protease inhibitor vs. non-nucleoside reverse transcriptase inhibitor-based regimens was 1.19, 95% confidence interval [CI] 0.88-1.61 (adjusted HR 1.24, 95% CI 0.91-1.68). By study end, treatment disruption probabilities converged (protease inhibitor 81%, non-nucleoside reverse transcriptase inhibitor 84%) with unadjusted HR 1.11, 95% CI 0.84-1.48 (adjusted HR 1.13, 95% CI 0.84-1.50). Reported reasons for treatment disruptions suggested that participants on protease inhibitors experienced greater tolerability problems. Children had similar time to treatment disruption for initial protease inhibitor and non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy, despite greater reported tolerability problems with protease inhibitor regimens. Initial pediatric antiretroviral therapy with either a protease inhibitor or non-nucleoside reverse transcriptase inhibitor may be acceptable for maintaining optimal, continuous therapy.

Background 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. Methods 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. Results 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. Conclusions 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. Trial registration Clinicaltrials.gov, NCT00995176

Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.

Background Fidelity measurement of implementation strategies is underdeveloped and underreported, and the level of reporting is decreasing over time. Failing to properly measure the factors that affect the delivery of an implementation strategy may obscure the link between a strategy and its outcomes. Barriers to assessing and reporting implementation strategy fidelity among researchers are not well understood. The aims of this qualitative study were to identify barriers to fidelity measurement and pragmatic pathways towards improvement. Methods We conducted in-depth interviews among researchers conducting implementation trials. We utilized a theory-informed interview approach to elicit the barriers and possible solutions to implementation strategy fidelity assessment and reporting. Reflexive-thematic analysis guided coding and memo-writing to determine key themes regarding barriers and solutions. Results Twenty-two implementation researchers were interviewed. Participants agreed that implementation strategy fidelity was an essential element of implementation trials and that its assessment and reporting should improve. Key thematic barriers focused on (1) a current lack of validated fidelity tools with the need to assess fidelity in the short term, (2) the complex nature of some implementation strategies, (3) conceptual complications when assessing fidelity within mechanisms-focused implementation research, and (4) structural issues related to funding and publishing. Researchers also suggested pragmatic solutions to overcome each barrier. Respondents reported using specification and tracking data in the short term until validated tools become available. Participants suggested that researchers with strategy-specific content expertise lead the way in identifying core components and setting fidelity requirements for them. Addressing the third barrier, participants provided examples of what pragmatic prospective and retrospective fidelity assessments might look like along a mechanistic pathway. Finally, researchers described approaches to minimize costs of data collection, as well as more structural accountability like adopting and enforcing reporting guidelines or changing the structure of funding opportunities. Discussion We propose short- and long-term priorities for improving the assessment and reporting of implementation strategy fidelity and the quality of implementation research. Conclusions A better understanding of the barriers to implementation strategy fidelity assessment may pave the way towards pragmatic solutions.

Background Early initiation of antiretroviral therapy improves human immunodeficiency virus (HIV) outcomes. However, achieving earlier treatment initiation is challenging for many reasons including provider awareness and clinic barriers; this study sought to understand perceptions of an early initiation program. Methods We interviewed 10 providers from 3 HIV clinics in North Carolina (October-November 2020). We asked providers about overall perceptions of early initiation and the pilot program. We developed narrative summaries to understand individual contexts and conducted thematic analysis using NVivo. Results Providers believed earlier initiation would signal an “extra sense of urgency” about the importance of antiretroviral therapy—a message not currently reflected in standard of care. Safety was a consistent concern. Cited implementation barriers included transportation assistance, medication sustainability, and guidance to address increased staff time and appointment availability. Conclusion Our qualitative findings highlight the need for training on the safety of early initiation and addressing staffing needs to accommodate quicker appointments. Plain Language Summary Doctor and clinic staff perspectives on a program to immediately start HIV treatment among patients newly diagnosed with HIV Treating human immunodeficiency virus (HIV) is easier than ever. Starting newly diagnosed persons on HIV medication as soon as possible is a now recommended goal. However, starting patients right away can be challenging. This study interviewed doctors and clinic staff to better understand their perspectives prior to implementing a program that would provide newly diagnosed patients with HIV treatment immediately. Results showed that some doctors are worried patients will not return after receiving their medications. Providers want support for linking patients to the clinic and ensuring they will be able to receive their next dose of medication when they come in. Other providers saw the benefits of reducing HIV stigma if the program can more quickly start patients on treatment. Some providers explained that when you go to the doctor and are sick you receive medications immediately, yet for newly diagnosed patients living with HIV, patients can be told to come back a month later to start treatment. Some providers believe shifting this messaging may also help patients take their medications better. Most providers saw the need for clinics to have more same-day appointment availability to meet the needs of the new program. Overall, providers were excited about the opportunity to improve the HIV care by offering HIV medications to newly diagnosed patients immediately.

Background Self-reported antiretroviral therapy (ART) adherence measures that are associated with plasma viral load (VL) are valuable to clinicians and researchers, but are rarely examined among groups vulnerable to dropping out of care. One-seventh of all those living with HIV pass through incarceration annually and criminal-justice (CJ) involved people living with HIV (PLH) are vulnerable to falling out of care. We examined the association of self-reported ART adherence with VL in a criminal-justice sample compared to a routine-care sample. Methods Samples: We examined data from a multisite collaboration of studies addressing the continuum of HIV care among CjJ involved persons in the Seek, Test, Treat, and Retain cohort. Data pooled from seven CJ- studies ( n  = 414) were examined and compared with the routine-care sample from the Centers for AIDS Research Network of Integrated Clinical Systems’ seven sites ( n  = 11,698). Measures: In both samples, data on self-reported percent ART doses taken were collected via the visual analogue scale adherence measure. Viral load data were obtained by blood-draw. Analysis: We examined the associations of adherence with VL in both cohorts using mixed effects linear regression of log-VL, and mixed effects logistic regression of binary VL (≥ 200 copies/mL) outcomes. Interactions by CD4 count and self-reported health status were also tested. Results Among the CJ sample, the coefficient for log-VL was − 0.31 (95% CI = − 0.43, − 0.18; P  < 0.01) and that in the routine-care sample was − 0.42 (95% CI = − 0.45, − 0.38; P  < 0.01). For the logistic regression of binary detectable VL on 10% increments of adherence we found the coefficient was − 0.26 (95% CI = − 0.37, − 0.14; P  < 0.01) and in the routine-care sample it was − 0.38 (95% CI = − 0.41, − 0.35; P  < 0.01). There was no significant interaction by CD4 count level in the CJ sample, but there was in the routine-care sample. Conversely, there was a significant interaction by self-reported health status level in the criminal-justice sample, but not in the routine-care sample. Conclusions The visual analogue scale is valid and useful to measure ART adherence, supporting treatment for CJ- involved PLH vulnerable to falling out of care. Research should examine adherence and VL in additional populations.

Objectives. To evaluate the efficacy of an interactive, Web-based sexual health program (Health Education and Relationship Training [HEART]) for developing sexual assertiveness skills and enhancing sexual decision-making in adolescent girls. Methods. Participants were 222 tenth-grade girls (mean age = 15.2; 38% White, 29% Hispanic, 25% Black) in the Southeastern United States who were randomized in fall 2015 to the HEART intervention or an attention-matched control. We assessed participants at pretest, immediate posttest, and 4-month follow-up. Results. Both groups had similar demographic and sexual behavior characteristics at pretest. At immediate posttest, girls who completed the HEART program demonstrated better sexual assertiveness skills measured with a behavioral task, higher self-reported assertiveness, intentions to communicate about sexual health, knowledge regarding HIV and other sexually transmitted diseases (STDs), safer sex norms and attitudes, and condom self-efficacy compared with the control condition. At 4-month follow-up, group differences remained in knowledge regarding HIV and other STDs, condom attitudes, and condom self-efficacy. Conclusions. This brief online sexual health program can improve short-term outcomes among adolescent girls and offers an exciting new option in the growing array of digital health interventions available to youths. Trial Registration Number. NCT02579135.