Search

BackgroundHIV or sexually transmitted infections remain a significant public health concern in the United States, with adolescents affected disproportionately. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increase the risk for HIV/STIs. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Although at-risk adolescents are disproportionately affected by HIV/STI risk behaviors and infections and although the Centers for Disease Control and Prevention recommends routine HIV/STI testing for adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act combined with technological advances, health clinics and mobile health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, there is a dearth of efficacious mHealth interventions in health clinics to prevent and reduce both condomless sex and drug use and increase HIV/STI testing for at-risk adolescents.ObjectiveTo address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E [Storytelling 4 Empowerment]) that has demonstrated feasibility and acceptability in a clinical setting. The next step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by 2 aims: the first aim is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both iOS and Android operating systems and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and the second aim is to evaluate the preliminary efficacy of S4E, relative to usual care control condition, in preventing or reducing drug use and condomless sex and increasing HIV/STI testing in a clinical sample of at-risk adolescents aged 14-21 years living in Southeast Michigan.MethodsIn this study, 100 adolescents recruited from a youth-centered community health clinic will be randomized via blocked randomization with random sequences of block sizes to one of the 2 conditions: S4E mHealth intervention or usual care. Theory-driven and culturally congruent, S4E is an mHealth adaptation of face-to-face storytelling for empowerment, which is registered with the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices.ResultsThis paper describes the protocol of our study. The recruitment began on May 1, 2018. This study was registered on December 11, 2017, in ClinicalTrials.gov. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024.ConclusionsThis study has the potential to improve public health by preventing HIV/STI and substance use disorders.Trial registrationClinicalTrials.gov NCT03368456; https://clinicaltrials.gov/study/NCT03368456.International registered report identifier (irrid)DERR1-10.2196/47216.

In the United States, HIV outbreaks are occurring in areas most affected by the opioid epidemic, including West Virginia (WV). Cultural Theory contends that multiple cultures co-exist within societies distinguished by their differing intensities of rules or norms of behavior ('grid') or degree of group allegiance/individual autonomy ('group'). Accordingly, we would expect that perceptions about HIV, including stigma, correspond with individuals' grid/group attributes. To explore this, we conducted qualitative interviews with people who inject drugs (PWID) recruited from a WV syringe service program. This paper focuses on our unexpected findings on stigma during a coinciding HIV outbreak. PWID living homeless identified as belonging to a 'street family'. Its members were mutually distrustful and constrained by poverty and drug dependence but despite their conflicts, reported openness between each other about HIV + status. Interviewees living with HIV perceived little enacted stigma from peers since the local outbreak. Contrasting stigmatizing attitudes were attributed to the town's mainstream society. The 'High Five' (Hi-V) Club, expressing defiance towards stigmatizing behavior outside the street family, epitomized the tensions between a desire for solidary and mutual support and a fatalistic tendency towards division and distrust. Fatalism may hinder cooperation, solidarity and HIV prevention but may explain perceived reductions in stigma.

BackgroundMany health conditions perceived to be contagious, dangerous or incurable, or resulting in clearly visible signs, share a common attribute - an association with stigma and discrimination. While the etiology of stigma may differ between conditions and, sometimes, cultural settings, the manifestations and psychosocial consequences of stigma and discrimination are remarkably similar. However, the vast majority of studies measuring stigma or addressing stigma through interventions employ a disease-specific approach.Main bodyThe current paper opposes this siloed approach and advocates a generic concept of 'health-related stigma' in both stigma measurement and stigma interventions. Employing a conceptual model adapted from Weiss, the current paper demonstrates the commonalities among several major stigmatized conditions by examining how several stigma measurement instruments, such as the Social Distance Scale, Explanatory Model Interview Catalogue, Internalized Stigma of Mental Illness, and Berger stigma scale, and stigma reduction interventions, such as information-based approaches, contact with affected persons, (peer) counselling, and skills building and empowerment, were used successfully across a variety of conditions to measure or address stigma. The results demonstrate that 'health-related stigma' is a viable concept with clearly identifiable characteristics that are similar across a variety of stigmatized health conditions in very diverse cultures.ConclusionA more generic approach to the study of health-related stigma opens up important practical opportunities - cross-cutting measurement and intervention tools are resource saving and easier to use for personnel working with multiple conditions, allow for comparison between conditions, and recognize the intersectionality of many types of stigma. Further research is needed to build additional evidence demonstrating the advantages and effectiveness of cross-condition approaches to stigma measurement and interventions.

BackgroundMany health conditions perceived to be contagious, dangerous or incurable, or resulting in clearly visible signs, share a common attribute - an association with stigma and discrimination. While the etiology of stigma may differ between conditions and, sometimes, cultural settings, the manifestations and psychosocial consequences of stigma and discrimination are remarkably similar. However, the vast majority of studies measuring stigma or addressing stigma through interventions employ a disease-specific approach.Main bodyThe current paper opposes this siloed approach and advocates a generic concept of 'health-related stigma' in both stigma measurement and stigma interventions. Employing a conceptual model adapted from Weiss, the current paper demonstrates the commonalities among several major stigmatized conditions by examining how several stigma measurement instruments, such as the Social Distance Scale, Explanatory Model Interview Catalogue, Internalized Stigma of Mental Illness, and Berger stigma scale, and stigma reduction interventions, such as information-based approaches, contact with affected persons, (peer) counselling, and skills building and empowerment, were used successfully across a variety of conditions to measure or address stigma. The results demonstrate that 'health-related stigma' is a viable concept with clearly identifiable characteristics that are similar across a variety of stigmatized health conditions in very diverse cultures.ConclusionA more generic approach to the study of health-related stigma opens up important practical opportunities - cross-cutting measurement and intervention tools are resource saving and easier to use for personnel working with multiple conditions, allow for comparison between conditions, and recognize the intersectionality of many types of stigma. Further research is needed to build additional evidence demonstrating the advantages and effectiveness of cross-condition approaches to stigma measurement and interventions.

BACKGROUND: HIV, other sexually transmitted infections (STIs) and unintended pregnancies are critical and interlinked health risks for millions of women of reproductive age worldwide. Multipurpose prevention technologies (MPTs) offer an innovative approach for expanding combined pregnancy and/or disease prevention. So far, MPT development efforts have focused mostly on HIV prevention, but about half of product candidates comprise compounds active against non-HIV STIs as well. This review aims to provide a framework that promotes the efficient advancement of the most promising preclinical products through the development pathway and into the hands of end-users, with a focus on women in low- and middle-income countries (L/MICs). METHODS: This mini review provides a summary of the current landscape of the MPT field. It comprises a landscape assessment of MPTs in development, complemented by a series of 28 in-depth, semi-structured key informant interviews (KIIs) with experts representing different L/MIC perspectives. MAIN RESULTS: We identified six primary action strategies to advance MPTs for L/MICs, including identification of key research gaps and priorities. For each action strategy, progress to date and key recommendations are included. CONCLUSIONS: To realize the life-saving potential of MPTs and maximize the momentum made to date, a strategic, collaborative and well-funded response to the gaps and next steps outlined in this paper is critical. A coordinated response can add rigor and efficiency to the development process, to successfully advance the most promising MPT products to the hands of end-users.

BackgroundIn 2020, the Health Resources and Services Administration's HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites.MethodThe ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients.DiscussionThis approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care.

Background and objectiveStandard Precautions (SP) are infection control procedures universally applicable to every patient. Though SP reduces disease transmission, their implementation is dependent on the knowledge and skills of healthcare workers (HCWs). Poor knowledge regarding the appropriate use of SP can cause fear among HCWs, leading to stigma and discrimination while treating people living with HIV (PLWH). Stigma and discrimination are known barriers for PLWH to access HIV care services. The aim of the study was to assess nursing student knowledge of SP, SP self-efficacy and SP perceived efficacy of nursing students, and (2) to assess the association between SP knowledge, perceived efficacy, and intention to utilize unwarranted precautions, like using double gloves while treating PLWH.MethodsThis paper analyzes baseline (non-randomized) data of a cluster randomized controlled trial amongst 1868 Indian nursing students. Data was collected using computer-administered structured questionnaire. The associations between the measures were done using multiple, logistic and poisson regression models.ResultsAlthough 97% nursing students could identify SP, only 35.5% understood that they need to be used with all patients. Awareness of the importance of using SP with all patients was positively associated with self-efficacy. Students performing high-risk tasks frequently were significantly more likely to be confident in their ability to correctly use SP, but also had higher intention to use unwarranted precautions.ConclusionsExisting teaching and training programs for HCWs need to provide clear guidelines and emphasize on the correct use of SP with all patients. This will increase both skills and confidence in their abilities (self-efficacy).

Introduction: The effect of stigma on health and health inequity is increasingly recognized. While many medical conditions trigger stigmatization, the negative effects of HIV stigma are particularly well documented. HIV stigma undermines access, uptake, and adherence to both HIV prevention and treatment. People living with HIV face stigma in all aspects of their daily lives; however, stigma in the health system is particularly detrimental. A key component for health facility stigma-reduction interventions is participatory training of staff, often through several days of in-person training. Though this approach shows promise, it is time intensive and poses challenges for busy health facilities. In response, the DriSti study has developed a brief blended-learning approach to stigma reduction in Karnataka State, India. This paper describes the process and final content of the intervention development. The intervention is currently being tested. Final evaluation results will be published upon study completion. Methods: Grounded in behavior change strategies based on social cognitive theory principles that stress the importance of combining interpersonal interactions with specific strategies that promote behavior change, we used a three-phase approach to intervention development: (1) content planning-review of existing participatory stigma-reduction training activities; (2) story boarding-script development and tablet content production; and (3) pilot testing of tablet and in-person session materials. Results: The final intervention curriculum consists of three sessions. Two initial self-administered tablet sessions focus on stigma awareness, attitudes, fears of HIV transmission, and use of standard precautions. The third small group session covers the same material but includes skill building through role-play and testimony by a person living with HIV. A study team member administers the tablet sessions, explains the process, and is present throughout to answer questions. Conclusion: This paper describes the theoretical underpinning and process of developing the blended-learning curriculum content, and practical lessons learned.The approach covers three key drivers of HIV stigma-stigma awareness, fear of HIV transmission, and attitudes. Developing video content for the self-directed learning is complex, requires a diverse set of people and skills, and presents unexpected opportunities for stigma reduction. Co-facilitation of the in-person session by someone living with HIV is a critical component.

IntroductionThe rapid scale-up of HIV care and treatment in resource-limited countries requires concurrent, rapid development of health information systems to support quality service delivery. Mozambique, a country with an 11.5% prevalence of HIV, has developed nation-wide patient monitoring systems (PMS) with standardized reporting tools, utilized by all HIV treatment providers in paper or electronic form. Evaluation of the initial implementation of PMS can inform and strengthen future development as the country moves towards a harmonized, sustainable health information system.ObjectiveThis assessment was conducted in order to 1) characterize data collection and reporting processes and PMS resources available and 2) provide evidence-based recommendations for harmonization and sustainability of PMS.MethodsThis baseline assessment of PMS was conducted with eight non-governmental organizations that supported the Ministry of Health to provide 90% of HIV care and treatment in Mozambique. The study team conducted structured and semi-structured surveys at 18 health facilities located in all 11 provinces. Seventy-nine staff were interviewed. Deductive a priori analytic categories guided analysis.ResultsHealth facilities have implemented paper and electronic monitoring systems with varying success. Where in use, robust electronic PMS facilitate facility-level reporting of required indicators; improve ability to identify patients lost to follow-up; and support facility and patient management. Challenges to implementation of monitoring systems include a lack of national guidelines and norms for patient level HIS, variable system implementation and functionality, and limited human and infrastructure resources to maximize system functionality and information use.ConclusionsThis initial assessment supports the need for national guidelines to harmonize, expand, and strengthen HIV-related health information systems. Recommendations may benefit other countries with similar epidemiologic and resource-constrained environments seeking to improve PMS implementation.

There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locally driven infrastructure for multicentre research and trials in Nigeria known as the Nigeria Implementation Science Alliance Model Innovation and Research Centres (NISA-MIRCs). We used a participatory approach to establish a research network of 21 high-volume health facilities selected from all 6 geopolitical zones in Nigeria capable of conducting clinical trials, implementation research using effectiveness-implementation hybrid designs and health system research. The NISA-MIRCs have a cumulative potential to recruit 60 000 women living with HIV and an age-matched cohort of HIV-uninfected women. We conducted a needs assessment, convened several stakeholder outreaches and engagement sessions, and established a governance structure. Additionally, we selected and trained a core research team, developed criteria for site selection, assessed site readiness for research and obtained ethical approval from a single national institutional review board. We used the Exploration, Preparation, Implementation, Sustainment framework to guide our reporting of the process in the development of this network. The NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support collaborative research, inform policy decisions and thereby fill a significant research infrastructure gap in Africa's most populous country.

BackgroundAn increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.MethodsWe used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.ResultsWe interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.ConclusionThe increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

The HIV epidemic continues to disproportionally affect marginalized populations. Digital tools, including global positioning system and ecologic momentary assessment, have been studied as methods for improving data collection and interventions among HIV-affected communities. Although people living with HIV and populations at high risk have found it acceptable to use digital technologies for HIV research, concerns over privacy and trust have also been expressed. This paper explores and describes the use of geolocation technology data (e.g., location-based social media) in HIV research as well as the ethical and implementation considerations that warrant examination prior to use. Transparent and clear language in consent forms might improve participant trust in the project and investigators' ability to keep participant data secure and private. With respect to institutional review boards, a committee member who is knowledgeable about digital technologies and consumer protections may offer guidance in assessing adequate protections in study protocols. As technology used in research continues to evolve, investigators and the research community must continue to examine the ethical challenges that emerge to address participant concerns.

Smoking rates are disproportionately high among people living with HIV. Smokers living with HIV (SLWH) are also largely unaware of the HIV-specific deleterious effects of smoking and often lack motivation and confidence in their ability to quit tobacco. To address these issues, we developed the Wellness Intervention for Smokers Living with HIV (WISH). WISH is grounded in the Information-Motivation-Behavioral Skills (IMB) Model and is designed for all SLWH, regardless of their initial motivation to quit. It follows evidence-based, best practice guidelines for nicotine dependence treatment, but is innovative in its use of a comprehensive wellness approach that addresses smoking within the context of HIV self-management including treatment adherence and engagement, stress management, substance use, and other personally relevant health behavior goals. The described randomized trial will enroll SLWH who are receiving care at Veterans Affairs (VA) medical centers and compare WISH's impact on smoking behavior to standard care services offered through the National VA Quitline and SmokefreeVET texting program. It will also assess intervention impact on markers of immune status and mortality risk. If effective, WISH could be disseminated to Veterans nationwide and could serve as a model for designing quitline interventions for other smokers who are ambivalent about quitting. The current paper outlines the rationale and methodology of the WISH trial, one of a series of studies recently funded by the National Cancer Institute to advance understanding of how to better promote smoking cessation among SLWH.

BackgroundAn increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.MethodsWe used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.ResultsWe interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.ConclusionThe increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

People living with HIV (PLWH) are at increased risk for both melanoma and nonmelanoma skin cancers, but there is currently no data on sun protection behaviors among PLWH. We created a 28-question paper survey to collect information on patient demographics and sun protection behaviors among PLWH. We found that although 71.6% of respondents reported spending at least 30 minutes to two hours in the sun daily, only 29.7% reported consistent use of sunscreen. In addition, 41.9% rarely or never received sunscreen counseling by their healthcare providers. There is therefore a need for increased training for healthcare providers in sun protection behavior counseling for PLWH.

BACKGROUND: The Primary HIV Prevention among Pregnant and Lactating Ugandan Women (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants and service providers perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from womens partners. METHODS: PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data. RESULTS: At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples. CONCLUSION: This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.

Cardiovascular disease (CVD) is an increasingly important cause of morbidity and mortality among people living with HIV (PLWH) now that HIV is a manageable chronic disease. Identification and treatment of comorbid medical conditions for PLWH, including CVD and its risk factors, typically lack a critical component of care: integrated care for histories of trauma. Experiences of trauma are associated with increased HIV infection, CVD risk, inconsistent treatment adherence, and poor CVD outcomes. To address this deficit among those at greatest risk and disproportionately affected by HIV and trauma-i.e., Black and Latinx individuals-a novel culturally-congruent, evidence-informed care model, "Healing our Hearts, Minds and Bodies" (HHMB), has been designed to address patients' trauma histories and barriers to care, and to prepare patients to engage in CVD risk reduction. Further, in recognition of the need to ensure that PLWH receive guideline-concordant cardiovascular care, implementation strategies have been identified that prepare providers and clinics to address CVD risk among their Black and Latinx PLWH. The focus of this paper is to describe the hybrid Type 2 effectiveness/implementation study design, the goal of which is to increase both patient and organizational readiness to address trauma and CVD risk among 260 Black and Latinx PLWH recruited from two HIV service organizations in Southern California. This study is expected to produce important information regarding the value of the HHMB intervention and implementation processes and strategies designed for use in implementing HHMB and other evidence-informed programs in diverse, resource-constrained treatment settings, including those that serve patients living in deep poverty. Clinical trials registry: NCT04025463.

Cardiovascular disease (CVD) is an increasingly important cause of morbidity and mortality among people living with HIV (PLWH) now that HIV is a manageable chronic disease. Identification and treatment of comorbid medical conditions for PLWH, including CVD and its risk factors, typically lack a critical component of care: integrated care for histories of trauma. Experiences of trauma are associated with increased HIV infection, CVD risk, inconsistent treatment adherence, and poor CVD outcomes. To address this deficit among those at greatest risk and disproportionately affected by HIV and trauma-i.e., Black and Latinx individuals-a novel culturally-congruent, evidence-informed care model, "Healing our Hearts, Minds and Bodies" (HHMB), has been designed to address patients' trauma histories and barriers to care, and to prepare patients to engage in CVD risk reduction. Further, in recognition of the need to ensure that PLWH receive guideline-concordant cardiovascular care, implementation strategies have been identified that prepare providers and clinics to address CVD risk among their Black and Latinx PLWH. The focus of this paper is to describe the hybrid Type 2 effectiveness/implementation study design, the goal of which is to increase both patient and organizational readiness to address trauma and CVD risk among 260 Black and Latinx PLWH recruited from two HIV service organizations in Southern California. This study is expected to produce important information regarding the value of the HHMB intervention and implementation processes and strategies designed for use in implementing HHMB and other evidence-informed programs in diverse, resource-constrained treatment settings, including those that serve patients living in deep poverty. Clinical trials registry: NCT04025463.

Cardiovascular disease (CVD) is an increasingly important cause of morbidity and mortality among people living with HIV (PLWH) now that HIV is a manageable chronic disease. Identification and treatment of comorbid medical conditions for PLWH, including CVD and its risk factors, typically lack a critical component of care: integrated care for histories of trauma. Experiences of trauma are associated with increased HIV infection, CVD risk, inconsistent treatment adherence, and poor CVD outcomes. To address this deficit among those at greatest risk and disproportionately affected by HIV and trauma-i.e., Black and Latinx individuals-a novel culturally-congruent, evidence-informed care model, Healing our Hearts, Minds and Bodies (HHMB), has been designed to address patients trauma histories and barriers to care, and to prepare patients to engage in CVD risk reduction. Further, in recognition of the need to ensure that PLWH receive guideline-concordant cardiovascular care, implementation strategies have been identified that prepare providers and clinics to address CVD risk among their Black and Latinx PLWH. The focus of this paper is to describe the hybrid Type 2 effectiveness/implementation study design, the goal of which is to increase both patient and organizational readiness to address trauma and CVD risk among 260 Black and Latinx PLWH recruited from two HIV service organizations in Southern California. This study is expected to produce important information regarding the value of the HHMB intervention and implementation processes and strategies designed for use in implementing HHMB and other evidence-informed programs in diverse, resource-constrained treatment settings, including those that serve patients living in deep poverty. Clinical trials registry: NCT04025463.

BackgroundAfrican Americans are disproportionally affected by HIV and have poorer rates of antiretroviral therapy (ART) adherence compared to other racial or ethnic groups in the United States. Factors associated with poor HIV disease outcomes are commonly associated with sociostructural barriers that prevent engagement with and retention in HIV care. SMS text messaging interventions to promote ART adherence among predominantly non-Hispanic White persons with HIV (PWH) have been shown to be efficacious; however, limited research has been devoted to culturally tailoring interventions for underrepresented racial/ethnic groups. Considering African Americans show poorer engagement along the HIV care continuum, we developed an individualized and culturally tailored two-way SMS text messaging intervention to improve ART adherence and associated virologic suppression among African American PWH.ObjectiveIn this paper we describe the protocol of a culturally tailored individualized Texting for Adherence Building (iTAB) intervention in a 24- to 48-week, single-arm study.MethodsWe developed a culturally tailored iTAB intervention, which we are implementing in a 24- to 48-week, single-arm study. Participants were recruited from the Family Health Centers of San Diego (FHCSD), a federally qualified health center. Patient inclusion criteria were (1) receiving care at the FHCSD, (2) living with HIV, (3) self-identification as Black, African American, or of African ancestry, (4) English speaking, (5) age 18 or older, (6) currently on ART, and (7) able to provide informed consent. Study enrollment began in November 2017 and closed in July 2019. A total of 90 participants from the FHCSD enrolled in the iTAB intervention, and we anticipate completing data collection in July 2020. Participants were assisted in individualizing and customizing their SMS text message preferences at the baseline study visit. Self-assessment measures are collected at baseline, interim, and final study visits. Problems related to sending/receiving SMS text messages and barriers to ART adherence are assessed at each interim study visit. The FHCSD staff monitors and tracks participants' daily SMS text message responses to ART adherence reminders using a clinical dashboard.ResultsWe hypothesize that the proportion of individuals achieving HIV virologic suppression (viral load

This paper examines the concordance of reported shared sexual behaviors, including condom use, among 535 heterosexual, African American, serodiscordant couples and identifies factors that might predict discordant reports. Percentages of agreement, Kappa and McNemar's statistics and conditional probability indices are used to measure concordance. Logistic regression models identify predictors of couples' discordant sexual reports. Analyses revealed Kappa statistics for reporting anal sex, fellatio and cunnilingus indicated moderate to substantial agreement. The effects of demographics and the couples' relationship contexts on concordance of reported sexual behaviors were found to vary somewhat by gender and type of sexual behavior. Findings showed that concordance of reporting between the couples was consistent for the past 90 and 30 days. Findings from this paper provide new scientific insights into the knowledge base of self-reported couples' data and suggest that these data can be used to evaluate their accuracy and serve as a proxy for validity.

This paper examines the concordance of reported shared sexual behaviors, including condom use, among 535 heterosexual, African American, serodiscordant couples and identifies factors that might predict discordant reports. Percentages of agreement, Kappa and McNemar's statistics and conditional probability indices are used to measure concordance. Logistic regression models identify predictors of couples' discordant sexual reports. Analyses revealed Kappa statistics for reporting anal sex, fellatio and cunnilingus indicated moderate to substantial agreement. The effects of demographics and the couples' relationship contexts on concordance of reported sexual behaviors were found to vary somewhat by gender and type of sexual behavior. Findings showed that concordance of reporting between the couples was consistent for the past 90 and 30 days. Findings from this paper provide new scientific insights into the knowledge base of self-reported couples' data and suggest that these data can be used to evaluate their accuracy and serve as a proxy for validity.

Proteolysis associated with recombinant protein expression in Chinese Hamster Ovary (CHO) cells has hindered the development of biologics including HIV vaccines. When expressed in CHO cells, the recombinant HIV envelope protein, gp120, undergoes proteolytic clipping by a serine protease at a key epitope recognized by neutralizing antibodies. The problem is particularly acute for envelope proteins from clade B viruses that represent the major genetic subtype circulating in much of the developed world, including the US and Europe. In this paper, we have identified complement Component 1's (C1s), a serine protease from the complement cascade, as the protease responsible for the proteolysis of gp120 in CHO cells. CRISPR/Cas9 knockout of the C1s protease in a CHO cell line was shown to eliminate the proteolytic activity against the recombinantly expressed gp120. In addition, the C1s-/- MGAT1- CHO cell line, with the C1s protease and the MGAT1 glycosyltransferase knocked out, enabled the production of unclipped gp120 from a clade B isolate (BaL-rgp120) and enriched for mannose-5 glycans on gp120 that are required for the binding of multiple broadly neutralizing monoclonal antibodies (bN-mAbs). The availability of this technology will allow for the scale-up and testing of multiple vaccine concepts in regions of the world where clade B viruses are in circulation. Furthermore, the proteolysis issues caused by the C1s protease suggests a broader need for a C1s-deficient CHO cell line to express other recombinant proteins that are susceptible to serine protease activity in CHO cells. Similarly, the workflow described here to identify and knockout C1s in a CHO cell line can be applied to remedy the proteolysis of biologics by other CHO proteases.

Proteolysis associated with recombinant protein expression in Chinese Hamster Ovary (CHO) cells has hindered the development of biologics including HIV vaccines. When expressed in CHO cells, the recombinant HIV envelope protein, gp120, undergoes proteolytic clipping by a serine protease at a key epitope recognized by neutralizing antibodies. The problem is particularly acute for envelope proteins from clade B viruses that represent the major genetic subtype circulating in much of the developed world, including the US and Europe. In this paper, we have identified complement Component 1s (C1s), a serine protease from the complement cascade, as the protease responsible for the proteolysis of gp120 in CHO cells. CRISPR/Cas9 knockout of the C1s protease in a CHO cell line was shown to eliminate the proteolytic activity against the recombinantly expressed gp120. In addition, the C1s-/- MGAT1- CHO cell line, with the C1s protease and the MGAT1 glycosyltransferase knocked out, enabled the production of unclipped gp120 from a clade B isolate (BaL-rgp120) and enriched for mannose-5 glycans on gp120 that are required for the binding of multiple broadly neutralizing monoclonal antibodies (bN-mAbs). The availability of this technology will allow for the scale-up and testing of multiple vaccine concepts in regions of the world where clade B viruses are in circulation. Furthermore, the proteolysis issues caused by the C1s protease suggests a broader need for a C1s-deficient CHO cell line to express other recombinant proteins that are susceptible to serine protease activity in CHO cells. Similarly, the workflow described here to identify and knockout C1s in a CHO cell line can be applied to remedy the proteolysis of biologics by other CHO proteases.

IntroductionThis paper examines the extent to which an intervention succeeded in locating people who had recently become infected with HIV in the context of the large-scale Ukrainian epidemic. Locating and intervening with people who recently became infected with HIV (people with recent infection, or PwRI) can reduce forward HIV transmission and help PwRI remain healthy.MethodsThe Transmission Reduction Intervention Project (TRIP) recruited recently-infected and longer-term infected seeds in Odessa, Ukraine, in 2013 to 2016, and asked them to help recruit their extended risk network members. The proportions of network members who were PwRI were compared between TRIP arms (i.e. networks of recently-infected seeds vs. networks of longer-term infected seeds) and to the proportion of participants who were PwRI in an RDS-based Integrated Biobehavioral Surveillance of people who inject drugs in 2013.ResultsThe networks of PwRI seeds and those of longer-term infected seeds had similar (2%) proportions who were themselves PwRI. This was higher than the 0.25% proportion in IBBS (OR = 7.80; p = 0.016). The odds ratio among the subset of participants who injected drugs was 11.17 (p = 0.003). Cost comparison analyses using simplified ingredients-based methods found that TRIP spent no more than US $4513 per PwRI located whereas IBBS spent $11,924.ConclusionsFurther research is needed to confirm these results and improve TRIP further, but our findings suggest that interventions that trace the networks of people who test HIV-positive are a cost-effective way to locate PwRI and reduce HIV transmission and should therefore be implemented.

Exchanging money, drugs, and other goods for sex has been associated with sexual risk behaviors and increased STIs/HIV. While female sex work is well described, data on men who exchange sex for money or goods are more limited. This paper examined the prevalence and correlates of transactional sex among young men who have sex with men, especially focusing on substance use and HIV status. We conducted a cohort study of 511 participants recruited between August 2014 and December 2017 in Los Angeles, CA. Eligible participants were: (1) between 18 and 45 years of age; (2) male; and (3) if HIV-negative, reported condomless anal intercourse with a male partner in the past 6 months. By design, half were HIV-positive and half HIV-negative. At baseline and semi-annual follow-up visits, computer-assisted self-interviews were used to collect information on demographics, sexual behaviors including transactional sex which was defined as exchange of money, drugs, or a place to stay for anal intercourse. Laboratory testing was conducted for current STI/HIV status. The average age of participants was 31.4 years with 43% identifying as African American, followed by 36% as Hispanic/Latino. The prevalence of recent transactional sex across 1486 study visits was 17% (n = 255), with 74% of those reporting exchanging sex for drugs. The prevalence of transactional sex was higher among those who reported unstable housing (32 vs. 11%; p value

Methamphetamine use is highly prevalent among gay, bisexual, and other men who have sex with men (MSM) in the United States and has been associated with condomless anal intercourse (CAI), a common route of HIV infection. Text messaging is a very low-cost method of delivery for intervention content. This paper presents a cost-effectiveness analysis of a randomized controlled trial testing three nested methods of text message delivery designed to reduce methamphetamine use and HIV sexual risk behaviors among MSM (Project Tech Support2). From March 2014 to January 2016, 286 non-treatment seeking methamphetamine-using MSM were randomized into one of three study arms: 1) Interactive text message conversations with Peer Health Educators, plus five daily automated, unidirectional theory-based messages, plus a weekly self-monitoring text message assessment (TXT-PHE; n = 94); or, 2) Five daily automated, unidirectional theory-based messages plus a weekly self-monitoring text message assessment (TXT-Auto; n = 99); or, 3) The weekly self-monitoring text message assessment only (AO; n = 93). Methamphetamine use at nine months post-enrollment was lower than at baseline in all three arms. The addition of Peer Health Educators and/or theory-based text messages did not produce cost-effective reductions in methamphetamine use over the weekly AO text messages. However, both intervention arms outperformed the AO arm in reducing HIV risk behaviors, but the TXT-Auto arm dominated the TXT-PHE arm in achieving greater reductions in days of methamphetamine use and CAI at lower cost. The TXT-Auto arm achieved greater reductions in CAI than the attentional control at a cost in the base case of ~$37.50 per episode of CAI reduced per month. Sensitivity analyses showed that results were robust to a number of changes in assumptions. Interventions seeking to reduce methamphetamine use among non-treatment-seeking MSM may seek to add minimal attentional control-style text messages to their routines querying about recent methamphetamine use and/or high-risk sex. Interventions seeking to additionally reduce HIV sexual risk behaviors among non-treatment-seeking MSM, specifically engagement in CAI, may seek to additionally apply theory-based text messages.

Federally Qualified Health Centers (FQHCs) have long been important sources of care for publicly insured people living with HIV. FQHC users have historically used emergency departments (EDs) at a higher-than-average rate. This paper examines whether this greater use relates to access difficulties in FQHCs or to characteristics of FQHC users. Zero-inflated Poisson models were used to estimate how FQHC use related to the odds of being an ED user and annual number of ED visits, using claims data on 6,284 HIV-infected California Medicaid beneficiaries in 2008-2009. FQHC users averaged significantly greater numbers of annual ED visits than non-FQHC users and those with no outpatient usage (1.89, 1.59, and 1.70, respectively; P = 0.043). FQHC users had higher odds of being ED users (OR = 1.14; 95%CI 1.02-1.27). In multivariable analyses, FQHC clients had higher odds of ED usage controlling for demographic and service characteristics (OR = 1.15; 95%CI 1.02-1.30) but not when medical characteristics were included (OR = 1.08; 95%CI 0.95-1.24). Among ED users, FQHC use was not significantly associated with the number of ED visits in our models (rate ratio (RR) = 1.00; 95%CI 0.87-1.15). The overall difference in mean annual ED visits observed between FQHC and non-FQHC groups was reduced to insignificance (1.75; 95% CI 1.59-1.92 vs 1.70; 95%CI 1.54-1.85) after adjusting for demographic, service, and medical characteristics. Overall, FQHC users had higher ED utilization than non-FQHC users, but the disparity was largely driven by differences in underlying medical characteristics.

Interventions aiming to improve access to and retention in HIV care are optimized when they are tailored to clients' needs. This paper describes an initiative of interventions implemented by ten demonstration sites using a transnational framework to tailor services for Mexicans and Puerto Ricans living with HIV. Transnationalism describes how immigrants (and their children) exist in their "receiving" place (e.g., continental U.S.) while simultaneously maintaining connections to their country or place of origin (e.g., Mexico). We describe interventions in terms of the strategies used, the theory informing design and the tailoring, and the integration of transnationalism. We argue how applying the transnational framework may improve the quality and effectiveness of services in response to the initiative's overall goal, which is to produce innovative, robust, evidence-informed strategies that go beyond traditional tailoring approaches for HIV interventions with Latino/as populations.

Federally Qualified Health Centers (FQHCs) have long been important sources of care for publicly insured people living with HIV. FQHC users have historically used emergency departments (EDs) at a higher-than-average rate. This paper examines whether this greater use relates to access difficulties in FQHCs or to characteristics of FQHC users. Zero-inflated Poisson models were used to estimate how FQHC use related to the odds of being an ED user and annual number of ED visits, using claims data on 6,284 HIV-infected California Medicaid beneficiaries in 2008-2009. FQHC users averaged significantly greater numbers of annual ED visits than non-FQHC users and those with no outpatient usage (1.89, 1.59, and 1.70, respectively; P = 0.043). FQHC users had higher odds of being ED users (OR = 1.14; 95%CI 1.02-1.27). In multivariable analyses, FQHC clients had higher odds of ED usage controlling for demographic and service characteristics (OR = 1.15; 95%CI 1.02-1.30) but not when medical characteristics were included (OR = 1.08; 95%CI 0.95-1.24). Among ED users, FQHC use was not significantly associated with the number of ED visits in our models (rate ratio (RR) = 1.00; 95%CI 0.87-1.15). The overall difference in mean annual ED visits observed between FQHC and non-FQHC groups was reduced to insignificance (1.75; 95% CI 1.59-1.92 vs 1.70; 95%CI 1.54-1.85) after adjusting for demographic, service, and medical characteristics. Overall, FQHC users had higher ED utilization than non-FQHC users, but the disparity was largely driven by differences in underlying medical characteristics.

BACKGROUND:In the United States, disparities in the rates of HIV care among youth and young adults result from the intersections of factors that include stigma, substance use, homelessness or marginal housing, institutional neglect, and mental health issues. Novel interventions are needed that are geared to youth and young adults. OBJECTIVE:In this paper, we aim to describe the interventions used by participating sites for Using Social Media initiative, the process for classifying the intervention components, and the methods for conducting a comprehensive evaluation of the interventions. METHODS:In 2015, the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau, Special Projects of National Significance (SPNS) funded the Evaluation and Technical Assistance Center (ETAC) at the University of California, Los Angeles and 10 demonstration projects at sites across the United States that incorporated innovative approaches using a variety of social media and mobile technology strategies designed specifically for youth and young adults living with HIV. The ETAC developed a typology, or a classification system, that systematically summarizes the principal components of the interventions into broader groups and developed a multisite, mixed-methods approach to evaluate them based on the Department of Health and Human Services HIV health outcomes along the HIV care continuum. The mixed-methods approach is key to remove potential biases in assessing the effectiveness of demonstration projects. RESULTS:This SPNS project was funded in September 2015, and enrollment was completed on May 31, 2018. A total of 984 participants have been enrolled in the multisite evaluation. Data collection will continue until August 2019. However, data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. CONCLUSIONS:This HRSA-funded initiative seeks to increase engagement in HIV medical care, improve health outcomes for people living with HIV, and reduce HIV-related health disparities and health inequities that affect HIV-positive youth and young adults. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/10681.

The design and analysis of active-control trials to evaluate experimental HIV pre-exposure prophylaxis (PrEP) agents pose serious statistical challenges. We recently proposed a new outcome measure, the averted infections ratio (AIR) - the proportion of infections that would be averted by using the experimental agent rather than the control agent (compared to no intervention). The main aim of the current paper is to examine the mathematical connection between AIR and the HIV incidence rate ratio, the standard outcome measure. We also consider the sample size implications of the choice of primary outcome measure and explore the connection between effectiveness and efficacy under a simplified model of adherence.

Community-based HIV testing and counseling (HTC) programs have become an important part of the healthcare system in South Africa and other low- and middle-income countries with a high HIV prevalence and strained primary healthcare system. Current HTC programs excel at identifying people living with HIV (PLH) but leave gaps in linkage to care and antiretroviral therapy (ART) as most HTC programs do not have the capacity to ensure that linkage has occurred. This article presents the protocol for an mHealth study, that is, pilot testing a mobile platform in KwaZulu-Natal (KZN), South Africa, to improve linkage to care and ART adherence after home-based HTC. Testing data are shared with designated clinics. PLH are identified using fingerprint scans, mobile numbers, or South African IDs. If PLH do not present at a designated clinic after testing HIV positive, study field staff are sent SMS alerts to prompt follow-up visits. Similarly, if PLH do not refill ART prescriptions after their initial 1-month dose runs out, SMS alerts that are sent to field staff. This paper presents the mHealth study protocol and baseline sample characteristics (N = 101 PLH). Analyses will summarize rates of linkage to care and ART prescription refills. Cost-effectiveness analyses will examine the costs and benefits of linkage and ART adherence using our mHealth system. Linkage to care rates will be compared between our study and a historical control, that is, provided by a prior HTC program that was conducted in KZN without our mHealth system (n = 615).

BackgroundIn the United States, disparities in the rates of HIV care among youth and young adults result from the intersections of factors that include stigma, substance use, homelessness or marginal housing, institutional neglect, and mental health issues. Novel interventions are needed that are geared to youth and young adults.ObjectiveIn this paper, we aim to describe the interventions used by participating sites for Using Social Media initiative, the process for classifying the intervention components, and the methods for conducting a comprehensive evaluation of the interventions.MethodsIn 2015, the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau, Special Projects of National Significance (SPNS) funded the Evaluation and Technical Assistance Center (ETAC) at the University of California, Los Angeles and 10 demonstration projects at sites across the United States that incorporated innovative approaches using a variety of social media and mobile technology strategies designed specifically for youth and young adults living with HIV. The ETAC developed a typology, or a classification system, that systematically summarizes the principal components of the interventions into broader groups and developed a multisite, mixed-methods approach to evaluate them based on the Department of Health and Human Services HIV health outcomes along the HIV care continuum. The mixed-methods approach is key to remove potential biases in assessing the effectiveness of demonstration projects.ResultsThis SPNS project was funded in September 2015, and enrollment was completed on May 31, 2018. A total of 984 participants have been enrolled in the multisite evaluation. Data collection will continue until August 2019. However, data analysis is currently underway, and the first results are expected to be submitted for publication in 2019.ConclusionsThis HRSA-funded initiative seeks to increase engagement in HIV medical care, improve health outcomes for people living with HIV, and reduce HIV-related health disparities and health inequities that affect HIV-positive youth and young adults.International registered report identifier (irrid)DERR1-10.2196/10681.

AimThis paper examines HIV-infected Asian Americans' experiences with religion throughout the course of their illness and their family relationships.BackgroundAs the number of Asians in the United States continues to grow, health professionals are beginning notice obvious gaps of knowledge in caring for this population, including HIV-infected individuals. Little is known about the impact of religion and faith on Asian Americans with HIV and their families. The study focuses on the participants' reported experiences to understand the variety of roles religion can play in the progression of a highly stigmatized chronic disease.MethodsAn in-depth interview was conducted in San Francisco and New York City with 30 HIV-infected Asians. Narrative samples and summarized responses was used to highlight themes that emerged from the participants' anecdotes. Interpretive content analysis was employed.ResultsThese groups were categorized as (a) those who did not adhere to any religion, (b) those of tenuous religious faith with conflicted feelings, and (c) those of strong religious faith with congruent beliefs. Within these three groups, various themes were synthesized from the members' perceptions and past experiences with religion. Within each group, participants displayed various stages of reconciliation with their current faith-related beliefs and escape the family stress from their religion practices. Each participant's story shown the vast range of human understanding and faith experiences including self-actualization, acculturation, and depression.ConclusionsThis research provides new insight on the challenge of managing HIV-infected patients in a culturally and religiously appropriate manner.

BackgroundIn the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM.MethodsThis study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits.DiscussionEffective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.Trial registrationClinicalTrials.gov number NCT03175159 , registered June 5, 2017.

BACKGROUND:A tenth of all people who inject drugs in Kenya are women, yet their social contexts and experiences remain poorly understood. This paper reports how multiple forms of stigma are experienced by women who inject drugs in coastal Kenya and the impact that they have on their ability to access essential health services. METHODS:In 2015, in-depth interviews and focus group discussions were held with 45 women who inject drugs in two coastal towns. These data were supplemented with in-depth interviews with five individual stakeholders involved in service provision to this population. Data were analyzed thematically using NVivo. RESULTS:Women who inject drugs experience multiple stigmas, often simultaneously. These included the external stigma and self-stigma of injection drug use, external gender-related stigma of being a female injecting drug user, and the external stigma of being HIV positive (i.e., among those living with HIV). Stigma led to rejection, social exclusion, low self-esteem, and delay or denial of services at health facilities. CONCLUSION:HIV and harm reduction programs should incorporate interventions that address different forms of stigma among women who inject drugs in coastal Kenya. Addressing stigma will require a combination of individual, social, and structural interventions, such as collective empowerment of injecting drug users, training of healthcare providers on issues and needs of women who inject drugs, peer accompaniment to health facilities, addressing wider social determinants of stigma and discrimination, and expansion of harm reduction interventions to change perceptions of communities towards women who inject drugs.

IntroductionVery few pragmatic and community-level effectiveness trials integrate the use of qualitative research over all stages of the trial, to inform trial design, implementation optimization, results interpretation and post-trial policy recommendations. This is despite the growing demand for mixed methods research from funding agencies and awareness of the vital importance of qualitative and mixed methods research for understanding trial successes and challenges.DiscussionWe offer examples from work we have been involved in to illustrate how qualitative research conducted within trials can reveal vital contextual factors that influence implementation and outcomes, can enable an informed adaptation of trials as they are being conducted and can lead to the formulation of theory regarding the social and behavioural pathways of intervention, while also enabling community engagement in trial design and implementation. These examples are based on published findings from qualitative studies embedded within two ongoing large-scale studies demonstrating the population-level impacts of universal HIV testing and treatment strategies in southern and eastern Africa, and a qualitative study conducted alongside a clinical trial testing the adaptation, acceptability and experience of short-cycle therapy in children and adolescents living with HIV.ConclusionsWe advocate for the integration of qualitative with clinical and survey research methods in pragmatic clinical and community-level trials and implementation studies, and for increasing visibility of qualitative and mixed methods research in medical journals. Qualitative research from trials ideally should be published along with clinical outcome data, either integrated into the "main" trial papers or published concurrently in the same journal issue. Integration of qualitative research within trials can help not only to understand the why behind success or failure of interventions in different contexts, but also inform the adaptation of interventions that can facilitate their success, and lead to new alternative strategies and to policy changes that may be vital for achieving public health goals, including the end of AIDS.

IntroductionVery few pragmatic and community-level effectiveness trials integrate the use of qualitative research over all stages of the trial, to inform trial design, implementation optimization, results interpretation and post-trial policy recommendations. This is despite the growing demand for mixed methods research from funding agencies and awareness of the vital importance of qualitative and mixed methods research for understanding trial successes and challenges.DiscussionWe offer examples from work we have been involved in to illustrate how qualitative research conducted within trials can reveal vital contextual factors that influence implementation and outcomes, can enable an informed adaptation of trials as they are being conducted and can lead to the formulation of theory regarding the social and behavioural pathways of intervention, while also enabling community engagement in trial design and implementation. These examples are based on published findings from qualitative studies embedded within two ongoing large-scale studies demonstrating the population-level impacts of universal HIV testing and treatment strategies in southern and eastern Africa, and a qualitative study conducted alongside a clinical trial testing the adaptation, acceptability and experience of short-cycle therapy in children and adolescents living with HIV.ConclusionsWe advocate for the integration of qualitative with clinical and survey research methods in pragmatic clinical and community-level trials and implementation studies, and for increasing visibility of qualitative and mixed methods research in medical journals. Qualitative research from trials ideally should be published along with clinical outcome data, either integrated into the "main" trial papers or published concurrently in the same journal issue. Integration of qualitative research within trials can help not only to understand the why behind success or failure of interventions in different contexts, but also inform the adaptation of interventions that can facilitate their success, and lead to new alternative strategies and to policy changes that may be vital for achieving public health goals, including the end of AIDS.

BackgroundIn the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM.MethodsThis study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits.DiscussionEffective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.Trial registrationClinicalTrials.gov number NCT03175159 , registered June 5, 2017.

PurposeThis paper presents an overview of different kinds of risk and social network methods and the kinds of research questions each can address.Recent findingsIt also reviews what network research has discovered about how network characteristics are associated with HIV and other infections, risk behaviors, preventive behaviors, and care, and discusses some ways in which network-based public health interventions have been conducted. Based on this, risk and social network research and interventions seem both feasible and valuable for addressing the many public health and social problems raised by the widespread use of opioids in the US South.

BACKGROUND:A tenth of all people who inject drugs in Kenya are women, yet their social contexts and experiences remain poorly understood. This paper reports how multiple forms of stigma are experienced by women who inject drugs in coastal Kenya and the impact that they have on their ability to access essential health services. METHODS:In 2015, in-depth interviews and focus group discussions were held with 45 women who inject drugs in two coastal towns. These data were supplemented with in-depth interviews with five individual stakeholders involved in service provision to this population. Data were analyzed thematically using NVivo. RESULTS:Women who inject drugs experience multiple stigmas, often simultaneously. These included the external stigma and self-stigma of injection drug use, external gender-related stigma of being a female injecting drug user, and the external stigma of being HIV positive (i.e., among those living with HIV). Stigma led to rejection, social exclusion, low self-esteem, and delay or denial of services at health facilities. CONCLUSION:HIV and harm reduction programs should incorporate interventions that address different forms of stigma among women who inject drugs in coastal Kenya. Addressing stigma will require a combination of individual, social, and structural interventions, such as collective empowerment of injecting drug users, training of healthcare providers on issues and needs of women who inject drugs, peer accompaniment to health facilities, addressing wider social determinants of stigma and discrimination, and expansion of harm reduction interventions to change perceptions of communities towards women who inject drugs.

Young men who have sex with men (YMSM) face a disproportionately high burden of HIV. Oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV acquisition, but adherence to PrEP among YMSM may be inadequate. Medication adherence may be assessed via biomarkers, which are expensive and invasive, or via self-report through Audio Computer Assisted Self-Interview (ACASI), which may result in over-reporting of adherence. In this paper we assess the potential of a new method of self-report, the Interactive Questionnaire System (iQS), in validly estimating true adherence rates. PrEP adherence among 167 YMSM aged 15-23 was measured via dried blood spot (DBS), ACASI, and iQS twice over a 24-week study period. Both ACASI- and iQS-reported data revealed that over 40% of individuals self-reporting adequate PrEP adherence had DBS-estimated drug levels indicating inadequate adherence. Adjusted logistic repeated measures random intercept regression analyses indicated that younger YMSM had higher odds of over-reporting adherence than older YMSM-each 1 year increase in age was associated with 0.79 times the odds of over-reporting adherence (95% CI 0.63, 0.98; p value = 0.031), and being African American was associated with 3.22 times greater odds of over-reporting than non-African Americans (95% CI 1.51, 6.90; p-value = 0.0003). These results suggest that ACASI and iQS methods of self-report significantly overestimate true PrEP adherence rates among YMSM, and that the odds of over-reporting adherence may be affected by both age and race.

Purpose The purpose of this paper is to use secondary data from qualitative interviews that examined the sexual behaviors, HIV attitudes, and condom use of 17 gay, bisexual, and transgender women housed in a protective custody unit in the Los Angeles County Jail (Harawa et al., 2010), to develop a better understanding of the consensual sexual behaviors of male prisoners. Design/methodology/approach Study eligibility included: report anal or oral sex with another male in the prior six months; speak and understand English; and incarcerated in the unit for at least two weeks. Data analysis consisted of an inductive, qualitative approach. Findings Findings illuminate participants' experiences concerning how the correctional facility shaped their sexual choices and behaviors, and the HIV-risk reduction strategies they employed. Originality/value This study contributes to the prison-sex literature, and is timely, given current federal and local HIV/AIDS priorities. Recommendations that address male prisoners' sexual and health needs and risks are posed.

Genitogluteal porokeratosis is a disorder of keratinization that may present in men in their fourth decade of life. We describe a 52-year-old human immunodeficiency virus (HIV)-positive man with history of anal squamous cell carcinoma who developed verrucous lesions on the buttocks and genitals. The buttock lesions presented shortly after radiotherapy for anal carcinoma a decade prior, whereas the genital lesions presented three months prior in areas treated with injectable medication for erectile dysfunction. Skin biopsy revealed a cornoid lamella, leading to the diagnosis of genitogluteal porokeratosis. The buttock lesions were treated with shave excision and the genital lesions were treated with topical agents. Using the PubMed database, a literature search was performed with combinations of the following key words: acuminata, condyloma, cornoid lamella, genital, genitogluteal, HIV, penile, porokeratosis, verrucous, vulvar. The generated papers and their references were reviewed. To the best of our knowledge, we present the first reported case of genitogluteal porokeratosis in an HIV-positive man. Notably, these lesions developed in sites of prior radiation or injection. This condition should be included in the differential diagnosis of chronic lesions of the genitals and buttocks in patients with HIV and/or history of radiation treatment and/or trauma to the genitogluteal region.

PurposeThe patient-provider relationship is a central factor that can promote or hinder long-term engagement in care among people living with chronic illnesses. In this paper, we explore characteristics of the patient-provider relationship that facilitated or hindered engagement in care among patients receiving care at HIV specialty clinics.Patients and methodsWe conducted 6 focus group discussions with a total of 43 well-retained and less well-retained HIV+ patients in San Francisco, Seattle, and Birmingham, to elicit a wide range of perspectives on engagement in HIV care. Borrowing from the field of psychotherapy, we examined patient-provider relationship characteristics through the lens of the therapeutic alliance, and with regard to their therapeutic efficacy and impact on patient engagement.ResultsThe majority of participants emphasized how a strong patient-provider relationship defined by trust, intimacy, and collaboration promoted engagement, while a weak patient-provider relationship impeded engagement.ConclusionWe discuss practical strategies and therapeutic techniques that may be helpful to providers in building strong patient-provider relationship and contend that a strong patient-provider relationship is crucial for patients to feel cared for during clinical encounters, which can promote long-term and sustained engagement in HIV care.