Human Immunodeficiency Virus Research Research Articles

Lessons learnt conducting minimally invasive autopsies in private mortuaries as part of HIV and tuberculosis research in South Africa

Current estimates of the burden of tuberculosis (TB) disease and cause-specific mortality in human immunodeficiency virus (HIV) positive people rely heavily on indirect methods that are less reliable for ascertaining individual-level causes of death and on mathematical models. Minimally invasive autopsy (MIA) is useful for diagnosing infectious diseases, provides a reasonable proxy for the gold standard in cause of death ascertainment (complete diagnostic autopsy) and, used routinely, could improve cause-specific mortality estimates. From our experience in performing MIAs in HIV-positive adults in private mortuaries in South Africa (during the Lesedi Kamoso Study), we describe the challenges we faced and make recommendations for the conduct of MIA in future studies or surveillance programmes, including strategies for effective communication, approaches to obtaining informed consent, risk management for staff and efficient preparation for the procedure.

Social Desirability Bias Impacts Self-Reported Alcohol Use Among Persons With HIV in Uganda.

Self-report is widely used to assess alcohol use in research and clinical practice, but may be subject to social desirability bias. We aimed to determine if social desirability impacts self-reported alcohol use. Among 751 human immunodeficiency virus (HIV)-infected patients from a clinic in southwestern Uganda, we measured social desirability using the Marlowe-Crowne Social Desirability Scale (SDS) Short Form C, self-reported alcohol use (prior 3months) Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), and phosphatidylethanol (PEth), a biomarker of prior 3weeks' drinking. We conducted multiple regression analyses to assess the relationship between SDS score (low, medium, and high levels) and (i) any self-reported recent alcohol use, among those who were PEth-positive (≥8ng/ml), and (ii) continuous AUDIT-C score, among those reporting any recent alcohol use. We controlled for PEth level, age, gender, education, economic assets, marital status, religion, spirituality/religiosity, social support, and study cohort. Of 751 participants, 59% were women; the median age was 31years (interquartile range [IQR]: 26 to 39). Median SDS score was 9 (IQR: 4 to 10). Two-thirds (62%) self-reported any recent alcohol use; median AUDIT-C was 1 (IQR: 0 to 4). Among those who were PEth-positive (57%), 13% reported no recent alcohol use. Those with the highest SDS tertile had decreased odds of reporting any recent alcohol use compared to the lowest tertile, but the association did not reach statistical significance in multivariable analyses (adjusted odds ratio 0.55 [95% confidence interval (CI): 0.25, 1.23]). Among participants self-reporting recent alcohol use, SDS level was negatively associated with AUDIT-C scores (adjusted β: -0.70 [95% CI: -1.19, -0.21] for medium vs. low SDS and -1.42 [95% CI: -2.05, -0.78] for high vs. low SDS). While use of objective measures (e.g., alcohol biomarkers) is desirable for measuring alcohol use, SDS scores may be used to adjust self-reported drinking levels by participants' level of social desirability in HIV research studies.

Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.

Women are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis. We conducted an analysis of screening and enrollment during 2003-2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling ("screen out") varied by various individual, trial, or site characteristics. Of 10 744 persons screened, 18.9% were women. The percentages of women and men who screened out were 27.9% and 26.5%, respectively (P = .19); this small difference did not significantly vary by race, ethnicity, or age group. Most common reasons for screening out were not meeting eligibility criteria (30-35%) and opting out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing. In the absence of evidence of significantly higher trial screen-out for women, approaching more women to screen may increase female representation in HIV trials.

The Quest for Cellular Markers of HIV Reservoirs: Any Color You Like.

Combination antiretroviral therapy (ART) suppresses human immunodeficiency virus (HIV) replication and improves immune function, but is unable to eradicate the virus. Therefore, development of an HIV cure has become one of the main priorities of the HIV research field. The main obstacle for an HIV cure is the formation of latent viral reservoirs, where the virus is able to “hide” despite decades of therapy, just to reignite active replication once therapy is stopped. Revealing HIV hiding places is thus central to HIV cure research, but the absence of markers of these reservoir cells greatly complicates the search for a cure. Identification of one or several marker(s) of latently infected cells would represent a significant step forward toward a better description of the cell types involved and improved understanding of HIV latency. Moreover, it could provide a “handle” for selective therapeutic targeting of the reservoirs. A number of cellular markers of HIV reservoir have recently been proposed, including immune checkpoint molecules, CD2, and CD30. CD32a is perhaps the most promising of HIV reservoir markers as it is reported to be associated with a very prominent enrichment in HIV DNA, although this finding has been challenged. In this review, we provide an update on the current knowledge about HIV reservoir markers. We specifically highlight studies that characterized markers of persistently infected cells in the lymphoid tissues.

Contribution of animal models to HIV research

Even today, despite triple therapy, the epidemic of the human immunodeficiency virus (HIV) is a major public health problem. In this perspective, continuous research is essential for the development of curative and vaccinal approaches. Animal models contribute to the implementation of new therapeutic and preventive strategies. We present here the characteristics of major animal models of HIV, which are non-human primates (SIV or SHIV-infected macaques and natural hosts of SIV), as well as different humanized mouse models and their advances. We will also list how they have already allowed, and still allow today, to broaden our knowledge on the physiopathology of HIV infection, tissue distribution of the virus, viral reservoirs, immunological responses against the virus in the very early infection stages and at the tissue level, but also in the development of vaccine candidates (RhCMV, broad-spectrum antibodies, etc…) and clinical trials for a cure. The advantages and limitations of the different animal models will be described. While continuing research on alternative methods, refinement or reduction of the animal model, a good knowledge of the specificities of each animal model allows an adequate use in relation to the scientific questions addressed.

P181 Nutrition is Still Recurrently Disregarded as a Constituent of HIV/AIDS Management

Background The impact of human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) in Africa is still a major concern to the global community of public health professionals. Previous focus has been primarily on Highly Active Antiretroviral Therapy (HAART) and adherence, neglecting other key components of survival needed by people living with HIV (PLWHA). Research evidence has shown that HAART without nutrition education interventions cannot solely reduce HIV related morbidity and mortality rates. Objective The objective of this review is to provide insights on the role of nutrition as parts of key component in HIV and AIDS disease management. Study Design, Settings, and Participants Critical appraisal approach was used to identify review of previous nutrition intervention research for PLWHA published between January 2008 and December 31, 2018. Measurable Outcome/Analysis The articles were identified through PubMed, EBSCOhost platform (CINAHL, Medline, and Nursing Academic Edition), Cochrane Library and Google scholar as well as by perusing the reference list of selected articles. Inclusion and exclusion criteria were set within the scope of this review. Results The results of this review showed that there is lack of information on the relationship between HIV, HIV risk factors and nutrition and the role of nutrition in HIV management. This review also established that, there is an urgent need to provide scientific information on the current state of HIV and nutrition research. Some of the realistic approaches to reduce the impact of HIV/AIDS such as optimization of nutritional status of the PLWHA and regular physical activities were revealed. The needs for PLWHA to consume a varied diet in order to prevent opportunistic infections and nutrition deficiencies were also identified. Conclusion The review confirmed needs for further research on the development, implementation and evaluation of programme activities related to nutrition, quality of life (QoL) and physical activities of PLWHA. Funding National Research Foundation.

Medical Assistance in Death as a Unique Opportunity to Advance Human Immunodeficiency Virus Cure Research.

The inability to sample deep-tissue reservoirs in individuals living with human immunodeficiency virus (HIV) has greatly hindered accurate estimates of viral reservoir size and distribution. Animal models and collection of tissues during autopsies of HIV-positive individuals are 2 proposed solutions to this problem. Each, however, has its limitations. In this Viewpoint, we argue that tissue donation following medical assistance in death (MAiD) will form an invaluable resource for the characterization of the viral reservoir in the context of current HIV cure research. In support, we discuss a recent instance in which an individual living with HIV chose to donate their body/tissues to HIV research prior to undergoing MAiD at our institution. Going forward, we hope this will help provide support to individuals in their decisions around tissue donation following MAiD, while highlighting how healthcare providers, by complying with such wishes, can affect patient satisfaction in the last days of life.

Evolution of an International Research Collaborative in HIV and Rehabilitation: Community Engaged Process, Lessons Learned, and Recommendations.

Human immunodeficiency virus (HIV) is increasingly considered a chronic illness. Rehabilitation can address some of the health challenges of people living with HIV (PLWHIV); however, the field is emerging. We describe our experience establishing an international collaborative in HIV and rehabilitation research using a community engaged approach. The Canada-UK (now Canada-International) HIV and Rehabilitation Research Collaborative (CIHRRC) is a network of more than 85 PLWHIV, researchers, clinicians, and representatives from community-based organizations collectively working to advance knowledge on HIV and rehabilitation. Activities and outcomes include facilitating knowledge transfer and exchange (KTE), establishing and strengthening multistakeholder partnerships, and identifying new and emerging priorities in the field. Collaboration and support from community organizations fostered mechanisms to raise the profile of, and evidence for, rehabilitation in the context of HIV. Considerations of scope, partnership, and sustainability are important. We offer recommendations for developing an international community-academic-clinical research collaborative using a community-engaged approach. Research networks involving community-academic-clinical partnerships can help to promote KTE and establish a coordinated response for addressing priorities in an emerging field.

Lasso regularization for left-censored Gaussian outcome and high-dimensional predictors

BackgroundBiological assays for the quantification of markers may suffer from a lack of sensitivity and thus from an analytical detection limit. This is the case of human immunodeficiency virus (HIV) viral load. Below this threshold the exact value is unknown and values are consequently left-censored. Statistical methods have been proposed to deal with left-censoring but few are adapted in the context of high-dimensional data.MethodsWe propose to reverse the Buckley-James least squares algorithm to handle left-censored data enhanced with a Lasso regularization to accommodate high-dimensional predictors. We present a Lasso-regularized Buckley-James least squares method with both non-parametric imputation using Kaplan-Meier and parametric imputation based on the Gaussian distribution, which is typically assumed for HIV viral load data after logarithmic transformation. Cross-validation for parameter-tuning is based on an appropriate loss function that takes into account the different contributions of censored and uncensored observations. We specify how these techniques can be easily implemented using available R packages. The Lasso-regularized Buckley-James least square method was compared to simple imputation strategies to predict the response to antiretroviral therapy measured by HIV viral load according to the HIV genotypic mutations. We used a dataset composed of several clinical trials and cohorts from the Forum for Collaborative HIV Research (HIV Med. 2008;7:27-40). The proposed methods were also assessed on simulated data mimicking the observed data.ResultsApproaches accounting for left-censoring outperformed simple imputation methods in a high-dimensional setting. The Gaussian Buckley-James method with cross-validation based on the appropriate loss function showed the lowest prediction error on simulated data and, using real data, the most valid results according to the current literature on HIV mutations.ConclusionsThe proposed approach deals with high-dimensional predictors and left-censored outcomes and has shown its interest for predicting HIV viral load according to HIV mutations.

Prevalence of HIV Infection among Hemodialysis Patients

Human immunodeficiency virus (HIV) belongs to human retrovirus family and transmitted by blood transfusion and blood products. 36.9 million People were living with HIV infection worldwide in 2014 approximately 1 , during which 2 million (1.9–2.2 million) new infections with HIV had occurred. End-stage renal disease (ESRD) patients treated by hemodialysis (HD) are more susceptible for infection by human immunodeficiency virus infection. Renal failure can be an associated condition or could be a direct consequence of HIV infection 2 , 3 . Advanced HIV disease which is indicates by a low CD4 cell count is development of renal diseases subsequently 4 , however many other causes now may cause renal failure in patients with HIV, including drug-induced toxicity, hypertensive nephroangiosclerosis, and diabetes 5 . HIV infection and hemodialysis have same consequences such as cardiovascular diseases, immunosuppression, anemia, weight loss, and osteodystrophy 6 , 7 . Compared with rate of infection with other viral infection such as hepatitis B virus (HBV) or hepatitis C virus (HCV), the risk of HIV infection among hemodialysis patients is lower as the contact with contaminated sources. Although intensive HIV research has been done for 20 years, we have a little knowledge about mortality risk factor in ESRD on HIV-infected patients. Hemodialysis patients who have HIV-infected are assumed to a high risk for death 4 . The finding the current study demonstrated the prevalence of HIV in hemodialysis patients which was conducted in 5 hemodialysis centers in Tehran province, Iran, in the 2016. All the enrolled participants were informed about study and written informed consent was obtained. Statistical analysis was performed by SPSS version 16 (SPSS Inc, Chicago, IL, USA). Among 360 patients, 213 (59.17%) of patients were men and 147 (40. 83%) were females; the mean age of patients was 53.43. HIV Ab was negative in all cases. This result has been confirmed in other studies as well 8 . The highest frequency for duration of dialysis is 1-5 years. Nowadays viral transmission via hemodialysis routes is controlled and limited since more effective screening of blood donor. Screening and early diagnosis of kidney disease will improve outcomes in patients with HIV infection. Considering all of these evidences, further studies are recommended strongly to evaluate the real prevalence of HIV in these patients.

Output from the CIHR Canadian HIV Trials Network international postdoctoral fellowship for capacity building in HIV clinical trials.

As a response to the human immunodeficiency virus (HIV) epidemic and part of Canadian Institutes for Health Research’s mandate to support international health research capacity building, the Canadian Institutes for Health Research Canadian HIV Trial Network (CTN) developed an international postdoctoral fellowship award under the CTN’s Postdoctoral Fellowship Awards Program to support and train young HIV researchers in resource-limited settings. Since 2010, the fellowship has been awarded to eight fellows in Cameroon, China, Lesotho, South Africa, Uganda and Zambia. These fellows have conducted research on a wide variety of topics and have built a strong network of collaboration and scientific productivity, with 40 peer-reviewed publications produced by six fellows during their fellowships. They delivered two workshops at international conferences and have continued to secure funding for their research, using the fellowship as a stepping stone. The CTN has been successful in building local HIV research capacity and forming a strong network of like-minded junior low- and middle-income country researchers with high levels of research productivity. They have developed into mentors, supervisors and faculty members, who, in turn, build local capacity. The sustainability of this international fellowship award relies on the recognition of its strengths and the involvement of other stakeholders for additional resources.

Investigating the interaction between human immunodeficiency virus, nutrition, and disability: A cross-sectional observational study.

BackgroundThe average lifespan of people with human immunodeficiency virus (HIV) has increased because of the enhanced access to anti-retroviral treatment. This increased longevity has led to a heightened focus on the comorbidities which may arise, allowing a clearer understanding of the contextual, personal, psychological and functional problems and their interrelations. Disability (functional limitations) and insufficient nutritional intake may interact cyclically with HIV and/or acquired immunodeficiency syndrome (AIDS); however, no research to date has investigated this interaction.AimsThe objective of this article was to report on the nutritional outcomes using albumin and body mass index outcomes as a subset of a larger study among adults living with HIV and/or AIDS.SettingThis study was conducted at a large HIV clinic based in an urban area in Johannesburg, South Africa, which provides HIV treatment and support to over 6000 persons with HIV and TB. This clinic is part of a large public health regional hospital where extensive HIV research is undertaken.MethodsThis study was a cross-sectional observational study. The sample composed of 278 participants between 18 and 65 years of age and had been on highly active antiretroviral therapy (HAART) for more than six months. Statistical analyses were performed using the Statistical Package for the Social Sciences.ResultsThe results indicated that albumin level had significant inverse associations with functional limitations and physical health symptoms. Women were significantly more likely to have lower nutritional levels. A logistic regression analysis suggested that gender and physical health symptoms were the primary predictors of albumin levels.ConclusionThe findings presented in this article can be applied to HIV and/or AIDS treatment programmes, such as HAART. It re-emphasises the importance of providing individuals on anti-retroviral therapy with affordable and adequate nutrition, education on the importance of nutritional intake and the benefits of potentially adopting supplement programmes. As females seem to be more adversely affected by low nutritional levels, with the findings showing an increased likelihood of developing physical health symptoms, focus also needs to be given to cultural or social factors that impact nutritional intake in women.

Epidemiology of HIV, Sexually Transmitted Infections, Viral Hepatitis, and Tuberculosis Among Incarcerated Transgender People: A Case of Limited Data.

Transgender people experience a disproportionate burden of human immunodeficiency virus (HIV) and incarceration. Discrimination, victimization, poverty, and poor mental health drive vulnerability to HIV and related infections, as well as risk of arrest, detention, and incarceration. In this paper, we systematically review published data on HIV, sexually transmitted infections, viral hepatitis, and tuberculosis among incarcerated transgender people; describe potential structural determinants of HIV risk and transmission; identify gaps in the literature; and make recommendations for research and interventions to address this neglected population. We found that HIV and related infections among incarcerated transgender people have received little attention in the epidemiologic literature. The limited data available, which date from 1992, demonstrate high prevalence of HIV and sexually transmitted infections in this population internationally. Transgender people who had not had genital surgery were typically placed in jails and prisons corresponding to birth-assigned sex rather than gender identity. Once incarcerated, they routinely faced harassment, physical abuse, and sexual violence from inmates and staff and denial of access to medically necessary gender-affirming therapies. More HIV research with incarcerated transgender populations is urgently needed to inform correctional policy change that centers human rights and structural interventions, such as stigma reduction, pre-arrest diversion, and access to HIV prevention methods and gender-affirming care during incarceration.

Use of \u2018eradication\u2019 in HIV cure-related research: a public health debate

BackgroundThe landscape of Human Immunodeficiency Virus (HIV) research has changed drastically over the past three decades. With the remarkable success of antiretroviral treatment (ART) in decreasing AIDS-related mortality, some researchers have shifted their HIV research focus from treatment to cure research. The HIV cure research community often uses the term eradication to describe the science, and talks about eradicating the virus from the body. In public discourse, the term eradication could be conflated with disease eradication at the population level. In this paper, we call for a reframing of HIV cure research as control, as it is a more accurate descriptor and achievable goal in the foreseeable future.DiscussionThe properties of HIV are discordant with eradicability standards at both the individual level (as a clinical concept), and at the population level (as a public health concept). At the individual level, true eradication would necessitate absolute elimination of all latent HIV reservoirs from the body. Current HIV cure-related research strategies have proven unsuccessful at accurately quantifying, let alone eliminating these reservoirs. At the population level, eradication implies the permanent global reduction of HIV to zero new cases and to zero risk for future cases. Given the absence of an efficacious HIV vaccine and the impracticality and unethicality of eliminating animal reservoirs, global eradication of HIV is highly implausible. From a public health perspective, HIV eradication remains an elusive goal.ConclusionThe term ‘eradication’ is a misleading description of current HIV cure-related research. Instead, we call for the use of more realistic expressions such as ‘sustained virologic HIV suppression (or control)’ or ‘management of HIV persistence’ to describe HIV cure-related research. Using these terms reorients what HIV cure science can potentially achieve in the near future and avoids creating unrealistic expectations, particularly among the millions of people globally who live with HIV.

All-Round Manipulation of the Actin Cytoskeleton by HIV.

While significant progress has been made in terms of human immunodeficiency virus (HIV) therapy, treatment does not represent a cure and remains inaccessible to many people living with HIV. Continued mechanistic research into the viral life cycle and its intersection with many aspects of cellular biology are not only fundamental in the continued fight against HIV, but also provide many key observations of the workings of our immune system. Decades of HIV research have testified to the integral role of the actin cytoskeleton in both establishing and spreading the infection. Here, we review how the virus uses different strategies to manipulate cellular actin networks and increase the efficiency of various stages of its life cycle. While some HIV proteins seem able to bind to actin filaments directly, subversion of the cytoskeleton occurs indirectly by exploiting the power of actin regulatory proteins, which are corrupted at multiple levels. Furthermore, this manipulation is not restricted to a discrete class of proteins, but rather extends throughout all layers of the cytoskeleton. We discuss prominent examples of actin regulators that are exploited, neutralized or hijacked by the virus, and address how their coordinated deregulation can lead to changes in cellular behavior that promote viral spreading.

Development of an Index of Engagement in HIV Care: An Adapted Internet-Based Delphi Process.

BackgroundImproving engagement in medical care among persons living with human immunodeficiency virus (HIV) is critical to optimizing clinical outcomes and reducing onward transmission of HIV. However, a clear conceptualization of what it means to be engaged in HIV care is lacking, and thus efforts to measure and enhance engagement in care are limited.ObjectiveThis paper describes the use of a modified online Delphi process of consensus building to solicit input from a range of HIV and non-HIV researchers and providers, and to integrate that input with focus group data conducted with HIV-infected patients. The overarching goal was to generate items for a patient-centered measure of engagement in HIV care for use in future research and clinical practice.MethodsWe recruited 66 expert panelists from around the United States. Starting with six open-ended questions, we used four rounds of online Delphi data collection in tandem with 12 in-person focus groups with patients and cognitive interviews with 25 patients.ResultsWe recruited 66 expert panelists from around the United States and 64 (97%) were retained for four rounds of data collection. Starting with six open-ended questions, we used four rounds of online Delphi data collection in tandem with 12 in-person focus groups with patients and cognitive interviews with 25 patients. The process resulted in an expansion to 120 topics that were subsequently reduced to 13 candidate items for the planned assessment measure.ConclusionsThe process was an efficient method of soliciting input from geographically separated and busy experts across a range of disciplines and professional roles with the aim of arriving at a coherent definition of engagement in HIV care and a manageable set of survey items to assess it. Next steps are to validate the utility of the new measure in predicting retention in care, adherence to treatment, and clinical outcomes among patients living with HIV.

The Importance of Human Immunodeficiency Virus Research for Transgender and Gender-Nonbinary Individuals.

Transgender and gender-nonbinary (trans/GNB) individuals are disproportionally affected by human immunodeficiency virus (HIV), yet they are not adequately represented in HIV research and often underserved in clinical care. By building on community strengths and addressing structural, psychological and biological challenges, we can improve the engagement of trans/GNB people in research and ultimately improve prevention, testing, and care for this population. Here, we review the current state of the science related to HIV for trans/GNB people and discuss next steps to expand research that aims to improve the lives and well-being of trans/GNB persons.

Imbalance in the game of T cells: What can the CD4/CD8 T-cell ratio tell us about HIV and health?

Antiretroviral treatment (ART) has transformed human immunodeficiency virus (HIV) from a deadly disease to a chronic illness that potentially has little effect on life expectancy. Modern ART can eliminate viremia and lower the risk of transmission. National data from the United States demonstrate that 81% of infected individuals receiving ART are virally suppressed [1]. With treatment available, HIV morbidity and mortality are not determined by opportunistic infections or AIDS-defining illnesses but rather by non-AIDS–defining conditions, including cardiovascular disease, liver disease, kidney disease, malignancies, neurocognitive disorders, and even autoimmune diseases [2]. To some, autoimmunity coexisting with HIV may be surprising; however, its presence illustrates how HIV’s immunopathology is more consistent with immune dysfunction than immune suppression alone. HIV viral load and the resulting decrease in absolute CD4 T cells have historically served as biomarkers for HIV’s immune suppression and response to treatment. However, with successful modern ART and viral suppression, absolute CD4 count and HIV viral load may not accurately reflect the risks facing patients because immune dysfunction persists despite normalization of CD4 counts [3]. One explanation is that these markers fail to truly describe HIV’s overall immune dysfunction contributing to today’s morbidity and mortality. The CD4/CD8 ratio more accurately describes this overall immune dysfunction and may be a better biomarker for disease progression, response to treatment, morbidity, and mortality for the virally suppressed. A greater understanding of the CD4/CD8 ratio and the impact of its manipulation should be a target for future HIV research.

Using Digital Technologies in Clinical HIV Research: Real-World Applications and Considerations for Future Work

BackgroundDigital technologies, especially if used in novel ways, provide a number of potential advantages to clinical research in trials related to human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and may greatly facilitate operations as well as data collection and analysis. These technologies may even allow answering questions that are not answerable with older technologies. However, they come with a variety of potential concerns for both the participants and the trial sponsors. The exact challenges and means for alleviation depend on the technology and on the population in which it is deployed, and the rapidly changing landscape of digital technologies presents a challenge for creating future-proof guidelines for technology application.ObjectiveThe aim of this study was to identify and summarize some common themes that are frequently encountered by researchers in this context and highlight those that should be carefully considered before making a decision to include these technologies in their research.MethodsIn April 2016, the Global HIV Vaccine Enterprise surveyed the field for research groups with recent experience in novel applications of digital technologies in HIV clinical research and convened these groups for a 1-day meeting. Real-world uses of various technologies were presented and discussed by 46 attendees, most of whom were researchers involved in the design and conduct of clinical trials of biomedical HIV prevention and treatment approaches. After the meeting, a small group of organizers reviewed the presentations and feedback obtained during the meeting and categorized various lessons-learned to identify common themes. A group of 9 experts developed a draft summary of the findings that was circulated via email to all 46 attendees for review. Taking into account the feedback received, the group finalized the considerations that are presented here.ResultsMeeting presenters and attendees discussed the many successful applications of digital technologies to improve research outcomes, such as those for recruitment and enrollment, participant identification, informed consent, data collection, data quality, and protocol or treatment adherence. These discussions also revealed unintended consequence of technology usage, including risks to study participants and risks to study integrity.ConclusionsKey lessons learned from these discussions included the need to thoroughly evaluate systems to be used, the idea that early success may not be sustained throughout the study, that some failures will occur, and considerations for study-provided devices. Additionally, taking these key lessons into account, the group generated recommendations on how to move forward with the use of technology in HIV vaccine and biomedical prevention trials.

Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.

BackgroundWeb-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants.ObjectiveThe aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM).MethodsFrom July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension.ResultsOf the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant.ConclusionsVideo-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts.Trail RegistrationClinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N).