An investigation of trachoma vaccine regimens by the chlamydia vaccine CTH522 administered with cationic liposomes in healthy adults (CHLM-02): a phase 1, double-blind trial.

BACKGROUND: There is no vaccine against the major global pathogen Chlamydia trachomatis; its different serovars cause trachoma in the eye or chlamydia in the genital tract. We did a clinical trial administering CTH522, a recombinant version of the C trachomatis major outer membrane molecule, in different dose concentrations with and without adjuvant, to establish its safety and immunogenicity when administered intramuscularly, intradermally, and topically into the eye, in prime-boost regimens. METHODS: CHLM-02 was a phase 1, double-blind, randomised, placebo-controlled trial at the National Institute for Health Research Imperial Clinical Research Facility, London, UK. Participants were healthy men and non-pregnant women aged 18-45 years, without pre-existing C trachomatis genital infection. Participants were assigned into six groups by the electronic database in a pre-prepared randomisation list (A-F). Participants were randomly assigned (1:1:1:1:1) to each of the groups A-E (12 participants each) and 6 were randomly assigned to group F. Investigators were masked to treatment allocation. Groups A-E received investigational medicinal product and group F received placebo only. Two liposomal adjuvants were compared, CAF01 and CAF09b. The groups were intramuscular 85 µg CTH522-CAF01, or placebo on day 0 and two boosters or placebo at day 28 and 112, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (A); intramuscular 85 µg CTH522-CAF01, two boosters at day 28 and 112 with additional topical ocular administration of CTH522, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (B); intramuscular 85 µg CTH522-CAF01, two boosters at day 28 and 112 with additional intradermal administration of CTH522, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (C); intramuscular 15 µg CTH522-CAF01, two boosters at day 28 and 112, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (D); intramuscular 85 µg CTH522-CAF09b, two boosters at day 28 and 112, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (E); intramuscular placebo (F). The primary outcome was safety; the secondary outcome (humoral immunogenicity) was the percentage of trial participants achieving anti-CTH522 IgG seroconversion, defined as four-fold and ten-fold increase over baseline concentrations. Analyses were done as intention to treat and as per protocol. The trial is registered with ClinicalTrials.gov, NCT03926728, and is complete. FINDINGS: Between Feb 17, 2020 and Feb 22, 2022, of 154 participants screened, 65 were randomly assigned, and 60 completed the trial (34 [52%] of 65 women, 46 [71%] of 65 White, mean age 26·8 years). No serious adverse events occurred but one participant in group A2 discontinued dosing after having self-limiting adverse events after both placebo and investigational medicinal product doses. Study procedures were otherwise well tolerated; the majority of adverse events were mild to moderate, with only seven (1%) of 865 reported as grade 3 (severe). There was 100% four-fold seroconversion rate by day 42 in the active groups (A-E) and no seroconversion in the placebo group. Serum IgG anti-CTH522 titres were higher after 85 µg CTH522-CAF01 than 15 µg, although not significantly (intention-to-treat median IgG titre ratio groups A-C:D=5·6; p=0·062), with no difference after three injections of 85 µg CTH522-CAF01 compared with CTH522-CAF09b (group E). Intradermal CTH522 (group C) induced high titres of serum IgG anti-CTH522 neutralising antibodies against serovars B (trachoma) and D (urogenital). Topical ocular CTH522 (group B) at day 28 and 112 induced higher total ocular IgA compared with baseline (p<0·001). Participants in all active vaccine groups, particularly groups B and E, developed cell mediated immune responses against CTH522. INTERPRETATION: CTH522, adjuvanted with CAF01 or CAF09b, is safe and immunogenic, with 85 µg CTH522-CAF01 inducing robust serum IgG binding titres. Intradermal vaccination conferred systemic IgG neutralisation breadth, and topical ocular administration increased ocular IgA formation. These findings indicate CTH522 vaccine regimens against ocular trachoma and urogenital chlamydia for testing in phase 2, clinical trials. FUNDING: The EU Horizon Program TRACVAC.

The HI V O pen Call on I nformed C onsent and E thics in Research (VOICE) for Adolescents and Young Adults: A Digital Crowdsourcing Open Call in Low- and Middle-Income Countries.

BACKGROUND: Many adolescents and young adults (AYAs; 10-24 years old) are excluded from HIV research because of social, ethical, and legal challenges with informed consent, resulting in limited AYA-focused data. We use a participatory approach to identify strategies for improving AYA consent processes in HIV research in low- and middle-income countries (LMICs). METHODS: We conducted a digital crowdsourcing open call for ideas to improve AYA consent to HIV research in LMICs. Crowdsourcing involves engaging a group of people in problem-solving, then sharing emergent solutions. Submissions were evaluated by 3 independent judges using predefined criteria, with exceptional strategies receiving prizes. Demographic data were collected, and textual data were qualitatively analyzed for emergent themes in barriers and facilitators for improving AYA consent in HIV research, guided by a socioecological model. RESULTS: We received 110 strategies total; 65 were eligible for evaluation, 25 of which were identified as finalists. Fifty-eight participants from 10 LMICs submitted the 65 eligible submissions, of which 30 (52%) were 18 to 24 years old. Thematic analysis identified 10 barriers to AYA consent, including HIV stigma, limited education, and legal/regulatory barriers. Strategies for improving AYA consent processes revealed 7 potential facilitators: enhancing AYA engagement in research, involving parents/guardians, improving education/awareness, improving institutional practices/policy, making research participation more AYA-friendly, enhancing engagement of other key communities of interest, and empowering AYA. CONCLUSIONS: Diverse communities of interest in LMICs developed compelling strategies to enhance informed consent that may improve AYA inclusion in HIV research. These data will be used to develop practical guidance on improving AYA consent processes.

Using crowdsourcing at an academic conference to develop STI testing messaging for public dissemination.

OBJECTIVES: We provide a guide to conducting a crowdsourcing activity at an international sexually transmitted infection (STI) conference to design public messaging about STI testing and disseminating that messaging via social media. METHODS: A speaker gave a presentation at a conference plenary session on the concepts of cocreation, crowdsourcing and designathons, and the application of these participatory approaches in public health research. To illustrate one of these approaches (crowdsourcing), attendees in the audience were asked to take part in a voluntary participatory activity, in which they would pair up with a fellow attendee sitting nearby and write down an idea on a blank notecard. Dyads were given 10 min to create an entry responding to the prompt, 'Write something that inspires gonorrhoea and/or chlamydia testing (eg, picture, jingle, rhyme)'. Each entry was judged by at least four independent judges on a scale of 0 (lowest quality) to 10 (highest quality) based on their innovation and potential to promote chlamydia/gonorrhoea testing. Scores were averaged to determine the finalist entries. RESULTS: We received 32 entries. The average score was 6.41 and scores ranged from 4.5 to 8 (median 6.63, IQR 5.75, 7.06). Half of entries (n=16) were slogans, 15.6% (n=5) were poems/rhymes, 12.5% (n=4) were memes/images, 9.4% (n=3) were programme implementation ideas, 3.1% (n=1) was a song verse, and 3.1% (n=1) was a video idea. One finalist entry was a meme and received 720 impressions, 120 engagements, 27 detail expands, 19 likes, 6 reposts and 1 response on Twitter. The second finalist entry was a slogan and received 242 impressions, 16 engagements, 6 detail expands, 4 likes and 2 reposts. CONCLUSIONS: Conducting crowdsourcing activities at future conferences may be an innovative, feasible way to develop and disseminate engaging and important STI and other health messaging to the public in a short period of time.

Crowdsourcing to support training for public health: A scoping review.

Crowdsourcing is an interactive process that has a group of individuals attempt to solve all or part of a problem and then share solutions with the public. Crowdsourcing is increasingly used to enhance training through developing learning materials and promoting mentorship. This scoping review aims to assess the literature on crowdsourcing for training in public health. We searched five medical and public health research databases using terms related to crowdsourcing and training. For this review, the concept of crowdsourcing included open calls, designathons, and other activities. We used a PRISMA checklist for scoping reviews. Each full-text was assessed by two independent reviewers. We identified 4,071 citations, and 74 studies were included in the scoping review. This included one study in a low-income country, 15 studies in middle-income countries, 35 studies in high-income countries, and 11 studies conducted in multiple countries of varying income levels (the country income level for 12 studies could not be ascertained). Nine studies used open calls, 35 used a hackathon, designathon or other "a-thon" event, and 30 used other crowdsourcing methods, such as citizen science programs and online creation platforms. In terms of crowdsourcing purpose, studies used crowdsourcing to educate participants (20 studies), develop learning materials (17 studies), enhance mentorship (13 studies) and identify trainees (9 studies). Fifteen studies used crowdsourcing for more than one training purpose. Thirty-four studies were done in-person, 31 were conducted virtually and nine used both meeting options for their crowdsourcing events. Seventeen studies generated open access materials. Our review found that crowdsourcing has been increasingly used to support public health training. This participatory approach can be a useful tool for training in a variety of settings and populations. Future research should investigate the impact of crowdsourcing on training outcomes.

"Just felt so convenient and warm by the non-profit help". Optimizing HIV self-test secondary distribution among men who have sex with men in China.

ABSTRACTSecondary distribution of HIV self-test is promising to increase testing uptake while the facilitators and barriers of secondary distribution remain unclear. In-depth interviews were conducted with 22 MSM who had participated in secondary distribution of HIVST in southern China. Data were thematically analyzed to capture participants' motivations, procedures, and challenges when accessing and distributing self-tests. MSM in China are willing to distribute HIVST to members in their social network, but their decision-making is impacted by their ability to broach sexual health conversations, evaluations of the recipients, and perceived trustworthiness of the self-test. Our study suggested that several strategies, including creating a friendly environment for sexual health conversations and establishing nationwide policies related to quality assured self-tests and standardized self-testing protocols, may be helpful to advance this approach in China.

Sexual behaviours and sexual health among middle-aged and older adults in Britain.

OBJECTIVES: Population-representative studies of the sexual health of middle-aged and older adults are lacking in ageing societies. This study aimed to identify latent patterns of sexual behaviours and health of people aged 45-74 years. METHODS: We conducted a latent class analysis of the National Attitudes and Sexual Lifestyles Survey (Natsal-3), a nationally representative survey conducted in Britain in 2011. RESULTS: Of the 5260 respondents aged 45-74 years, 48.86% of men and 44.91% of women belonged to the Content Caseys class who reported good sexual health. The Infrequent Indigos (30.94% of men, 44.38% of women) were characterised by a lack of sexual activity, reported some dissatisfaction, and were more likely to have a disability. The Low-Functioning Lees (11.65% of men, 8.41% of women) reported some more disability and had issues with sexual functioning and higher levels of distress. The Multiple-Partnered Morgans (8.62% of men, 2.30% of women) were characterised by a greater number of sexual partners and several risk behaviours. CONCLUSIONS: The use of these four classes can aid in improved targeting of tailored sexual health services to improve sexual function, sexual satisfaction, reduce distress and risky behaviours among middle-aged and older adults. These services should be inclusive of the disabled community.

Comparison of blood and lymph node cells after intramuscular injection with HIV envelope immunogens.

Background: Harnessing CD4+ T cell help in the lymph nodes through rational antigen design could enhance formation of broadly neutralizing antibodies (bNAbs) during experimental HIV immunization. This process has remained hidden due to difficulty with direct study, with clinical studies instead focusing on responses in the blood as a proxy for the secondary lymphoid tissue. Methods: To address this, lymph node cells (LNC) were collected using ultrasound guided fine needle aspiration of axillary lymph nodes from 11 HIV negative participants in an experimental HIV immunogen study (European AIDS Vaccine Initiative EAVI2020_01 study, NCT04046978). Cells from lymph node and blood (PBMC), were collected after intramuscular injection with HIV Env Mosaic immunogens based on HIV Envelope glycoprotein and combined with a liposomal toll-like receptor-4 adjuvant; monophosphoryl lipid A. Simultaneously sampled cells from both blood and lymph node in the same donors were compared for phenotype, function, and antigen-specificity. Results: Unsupervised cluster analysis revealed tissue-specific differences in abundance, distribution, and functional response of LNC compared with PBMC. Monocytes were virtually absent from LNC, which were significantly enriched for CD4+ T cells compared with CD8+ T cells. T follicular helper cells with germinal center features were enriched in LNC, which contained specific CD4+ and CD8+ T cell subsets including CD4+ T cells that responded after a single injection with HIV Env Mosaic immunogens combined with adjuvant. Tissue-specific differences in response to an MHC-II dependent superantigen, staphylococcal enterotoxin B, indicated divergence in antigen presentation function between blood and lymph node. Conclusions: LNC are phenotypically and functionally distinct from PBMC, suggesting that whole blood is only a limited proxy of the T cell lymphatic response to immunization. HIV-specific CD4+ T cells in the lymph node are rapidly inducible upon experimental injection with HIV immunogens. Monitoring evolution of CD4+ T cell memory in LNC with repeated experimental HIV immunization could indicate the strategies most likely to be successful in inducing HIV-specific bNAbs.

Enhanced immune responses following heterologous vaccination with self-amplifying RNA and mRNA COVID-19 vaccines.

The optimal vaccination strategy to boost responses in the context of pre-existing immune memory to the SARS-CoV-2 spike (S) glycoprotein is an important question for global public health. To address this, we explored the SARS-CoV-2-specific humoral and cellular immune responses to a novel self-amplifying RNA (saRNA) vaccine followed by a UK authorised mRNA vaccine (BNT162b2) in individuals with and without previous COVID-19, and compared these responses with those who received an authorised vaccine alone. 35 subjects receiving saRNA (saRNA group) as part of the COVAC1 clinical trial and an additional 40 participants receiving an authorised SARS-CoV-2 vaccine only (non-saRNA group) were recruited. Antibody responses were measured by ELISA and a pseudoneutralisation assay for wildtype, Delta and Omicron variants. Cellular responses were measured by IFN-Æ´ ELISpot and an activation induced marker (AIM) assay. Approximately 50% in each group had previous COVID-19 prior to vaccination, confirmed by PCR or antibody positivity on ELISA. All of those who received saRNA subsequently received a full course of an authorised vaccine. The majority (83%) of those receiving saRNA who were COVID-19 naïve at baseline seroconverted following the second dose, and those with previous COVID-19 had an increase in antibody titres two weeks following saRNA vaccination (median 27-fold), however titres were lower when compared to mRNA vaccination. Two weeks following the 2nd authorised mRNA vaccine dose, binding and neutralising antibody titres were significantly higher in the saRNA participants with previous COVID-19, compared to non-saRNA, or COVID-19 naive saRNA participants. Cellular responses were again highest in this group, with a higher proportion of spike specific CD8+ than CD4+ T cells when compared to those receiving the mRNA vaccine only. These findings suggest an immunological benefit of increased antigen exposure, both from natural infection and vaccination, particularly evident in those receiving heterologous vaccination with saRNA and mRNA.

Evaluating and volunteering for crowdsourced interventions: Cross-sectional data on COVID-19 safety from a University Survey.

Despite many innovative ideas generated in response to COVID-19, few studies have examined community preferences for these ideas. Our study aimed to determine university community members' preferences for three novel ideas identified through a crowdsourcing open call at the University of North Carolina (UNC) for making campus safer in the pandemic, as compared to existing (i.e. pre-COVID-19) resources. An online survey was conducted from March 30, 2021 -May 6, 2021. Survey participants included UNC students, staff, faculty, and others. The online survey was distributed using UNC's mass email listserv and research directory, departmental listservs, and student text groups. Collected data included participant demographics, COVID-19 prevention behaviors, preferences for finalist ideas vs. existing resources in three domains (graduate student supports, campus tours, and online learning), and interest in volunteering with finalist teams. In total 437 survey responses were received from 228 (52%) staff, 119 (27%) students, 78 (18%) faculty, and 12 (3%) others. Most participants were older than age 30 years (309; 71%), women (332, 78%), and white (363, 83.1%). Five participants (1%) were gender minorities, 66 (15%) identified as racial/ethnic minorities, and 46 (10%) had a disability. Most participants preferred the finalist idea for a virtual campus tour of UNC's lesser-known history compared to the existing campus tour (52.2% vs. 16.0%). For graduate student supports, 41.4% of participants indicated no preference between the finalist idea and existing supports; for online learning resources, the existing resource was preferred compared to the finalist idea (41.6% vs. 30.4%). Most participants agreed that finalists' ideas would have a positive impact on campus safety during COVID-19 (81.2%, 79.6%, and 79.2% for finalist ideas 1, 2 and 3 respectively). 61 (14.1%) participants indicated interest in volunteering with finalist teams. Together these findings contribute to the development and implementation of community-engaged crowdsourced campus safety interventions during COVID-19.

Digital approaches to enhancing community engagement in clinical trials.

Digital approaches are increasingly common in clinical trial recruitment, retention, analysis, and dissemination. Community engagement processes have contributed to the successful implementation of clinical trials and are crucial in enhancing equity in trials. However, few studies focus on how digital approaches can be implemented to enhance community engagement in clinical trials. This narrative review examines three key areas for digital approaches to deepen community engagement in clinical trials-the use of digital technology for trial processes to decentralize trials, digital crowdsourcing to develop trial components, and digital qualitative research methods. We highlight how digital approaches enhanced community engagement through a greater diversity of participants, and deepened community engagement through the decentralization of research processes. We discuss new possibilities that digital technologies offer for community engagement, and highlight potential strengths, weaknesses, and practical considerations. We argue that strengthening community engagement using a digital approach can enhance equity and improve health outcomes.

Enhancing HIV Self-Testing Among Nigerian Youth: Feasibility and Preliminary Efficacy of the 4 Youth by Youth Study Using Crowdsourced Youth-Led Strategies.

Although HIV self-testing (HIVST) has expanded in many regions, a few HIVST services have been tailored for and organized by youth. Innovative HIVST models are needed to differentiate testing services and generate local demand for HIVST among youth. The current pilot study aimed at examining the feasibility and efficacy of crowdsourced youth-led strategies to enhance HIVST as well as sexually transmitted infection (STI) testing. Teams of youth iteratively developed HIVST interventions using crowdsourcing approaches and apprenticeship training. Five interventions were selected and then evaluated among youth (ages 14-24) from September 2019 to March 2020. Given the similar outcomes and approaches, we present cumulative data from the completed interventions. We assessed HIVST uptake (self-report), STI uptake (facility reports for gonorrhea, syphilis, hepatitis B, and chlamydia testing), and quality of youth participation. Mixed-effect logistic regression models estimated intervention effects at baseline and 6 months. Of the 388 youths enrolled, 25.3% were aged 14-19, 58.0% were male, and 54.1% had completed secondary education. We observed a significant increase in HIVST from 3 months compared with 6 months (20% vs. 90%; p < 0.001). Among those who received an HIVST at 3 months, 324 out of 388 were re-tested at 6 months. We also observed significant increases in testing for all four STIs: syphilis (5-48%), gonorrhea (5-43%), chlamydia (1-45%), and hepatitis B testing (14-55%) from baseline to the 6-month follow-up. Youth participation in the intervention was robust. Youth-led HIVST intervention approaches were feasible and resulted in increased HIV/STI test uptake. Further research on the effectiveness of these HIVST services is needed.

Joint international consensus statement on crowdsourcing challenge contests in health and medicine: results of a modified Delphi process.

OBJECTIVES: To develop a consensus statement to provide advice on designing, implementing and evaluating crowdsourcing challenge contests in public health and medical contexts. DESIGN: Modified Delphi using three rounds of survey questionnaires and one consensus workshop. SETTING: Uganda for face-to-face consensus activities, global for online survey questionnaires. PARTICIPANTS: A multidisciplinary expert panel was convened at a consensus-development conference in Uganda and included 21 researchers with experience leading challenge contests, five public health sector workers, and nine Ugandan end users. An online survey was sent to 140 corresponding authors of previously published articles that had used crowdsourcing methods. RESULTS: A subgroup of expert panel members developed the initial statement and survey. We received responses from 120 (85.7%) survey participants, which were presented at an in-person workshop of all 21 panel members. Panelists discussed each of the sections, revised the statement, and participated in a second round of the survey questionnaire. Based on this second survey round, we held detailed discussions of each subsection with workshop participants and further revised the consensus statement. We then conducted the third round of the questionnaire among the 21 expert panelists and used the results to finalize the statement. This iterative process resulted in 23 final statement items, all with greater than 80% consensus. Statement items are organised into the seven stages of a challenge contest, including the following: considering the appropriateness, organising a community steering committee, promoting the contest, assessing contributions, recognising contributors, sharing ideas and evaluating the contest (COPARSE). CONCLUSIONS: There is high agreement among crowdsourcing experts and stakeholders on the design and implementation of crowdsourcing challenge contests. The COPARSE consensus statement can be used to organise crowdsourcing challenge contests, improve the rigour and reproducibility of crowdsourcing research and enable large-scale collaboration.

Assessment of a Crowdsourcing Open Call for Approaches to University Community Engagement and Strategic Planning During COVID-19.

Importance: Reimagining university life during COVID-19 requires substantial innovation and meaningful community input. One method for obtaining community input is crowdsourcing, which involves having a group of individuals work to solve a problem and then publicly share solutions. Objective: To evaluate a crowdsourcing open call as an approach to COVID-19 university community engagement and strategic planning. Design, Setting, and Participants: This qualitative study assessed a crowdsourcing open call offered from June 16 to July 16, 2020, that sought ideas to inform safety in the fall 2020 semester at the University of North Carolina at Chapel Hill (UNC). Digital methods (email and social media) were used for promotion, and submissions were collected online for 4 weeks. Participation was open to UNC students, staff, faculty, and others. Main Outcomes and Measures: Submissions were evaluated for innovation, feasibility, inclusivity, and potential to improve safety and well-being. Demographic data were collected from submitting individuals, and submissions were qualitatively analyzed for emergent themes on challenges with and solutions for addressing safety and well-being in the fall semester. Data were shared with UNC leadership to inform decision-making. Results: The open call received 82 submissions from 110 participants, including current UNC students (56 submissions [68%]), people younger than 30 years (67 [82%]), women (55 [67%]), and individuals identifying as a racial/ethnic minority or as multiracial/ethnic (49 [60%]). Seven submissions were identified as finalists and received cash prizes with the encouragement to use these funds toward idea development and implementation. Seventeen runner-up teams were linked to university resources for further development. Thematic analysis of submissions regarding challenges with the fall semester revealed not only physical health concerns and the limitations of remote learning but also challenges that have been exacerbated by the pandemic, such as a lack of mental health support, structural racism and inequality, and insufficient public transportation. Solutions included novel ideas to support mental health among specific populations (eg, graduate students and racial/ethnic minorities), improve health equity, and increase transit access. All 24 finalists and runners-up indicated interest in implementation after being notified of the open call results. Conclusions and Relevance: This study suggests that open calls are a feasible strategy for university community engagement on COVID-19, providing a stakeholder-driven approach to identifying promising ideas for enhancing safety and well-being. Open calls could be formally incorporated into university planning processes to develop COVID-19 safety strategies that are responsive to diverse community members' concerns.

Increasing Men's Engagement in HIV Testing and Treatment Programs Through Crowdsourcing: A Mixed-Methods Analysis in Eswatini.

BACKGROUND: Sub-Saharan African HIV programs have had limited success in engaging men. Crowdsourcing contests may be a useful method to spur men's engagement in HIV services. We evaluated contributions and social media response to a crowdsourcing contest focused on increasing men's engagement in Eswatini HIV services. METHODS: We conducted a crowdsourcing contest to gain insight from the public on how HIV campaigns can more effectively engage young (20-40 years old) men in HIV services. Eligible submissions included images, songs, videos, and Internet memes. We used standard qualitative methods to examine textual themes from submissions. We examined social media response using Facebook analytics, comparing the number of people reached through crowdsourced HIV messages and the number of people reached through conventional HIV messages. RESULTS: We received 144 submissions from 83 participants. They represented 55 towns and all 4 regions of Eswatini. The contest page gained 461 followers on Facebook. Emergent themes included appealing to men's roles as protectors by suggesting that they need to take care of their own health to continue safeguarding their families. Crowdsourced messages reached a mean of 88 individuals across 4 posts; conventional messages reached a mean of 75 individuals across 4 posts. CONCLUSIONS: Crowdsourcing contest submissions provided insight on how to encourage men to engage in Eswatini HIV services. Crowdsourcing contests can be effective in collecting messages from men to create more locally relevant communication materials for HIV programs.

Youth engagement in HIV prevention intervention research in sub-Saharan Africa: a scoping review.

INTRODUCTION: Youth engagement in HIV research is generally recognized as essential, but often neglected or minimally implemented in practice. Engagement is a process of working collaboratively with diverse groups of people to address common issues. We conducted a scoping review of youth HIV prevention interventions in sub-Saharan Africa to identify and categorize forms and levels of youth engagement across the lifespan of intervention research. METHODS: We followed Arksey and O'Malley's framework for organizing a scoping review. We searched seven databases for related articles on identified intervention studies through May 28th 2020. Included studies focused on youth (10 to 24 years old) HIV prevention interventions in sub-Saharan Africa. Two reviewers independently examined citations and full manuscripts for inclusion. Data were extracted on study characteristics, location, description of youth engagement and extent of engagement. Youth engagement approaches were categorized based on Hart's ladder as substantial engagement (strong youth decision-making power), moderate engagement (shared decision making with adults), minimal engagement (no youth decision-making power) or no engagement. RESULTS: We identified 3149 citations and included 112 studies reporting on 74 unique HIV interventions. Twenty-two interventions were in low-income countries, 49 in middle-income countries, and three were in both. Overall, only nine interventions (12%) had substantial or moderate youth engagement, two-thirds (48, 65%) had minimal youth engagement and 17 interventions (23%) had no youth engagement. We also identified specific engagement strategies (e.g. youth-led research, crowdsourcing) that were feasible in multiple settings and resulted in substantial engagement. CONCLUSIONS: We found limited youth engagement in youth HIV prevention intervention studies in sub-Saharan Africa. However, several activities resulted in substantial youth engagement and could be relevant in many low-and-middle-income-country (LMIC) settings.

Adolescent participation in HIV research: consortium experience in low and middle-income countries and scoping review.

Adolescents in low and middle-income countries (LMICs) have a high prevalence of HIV, therefore, it is important that they are included in HIV research. However, ethical challenges regarding consent can hinder adolescent research participation. We examined examples from the Prevention and Treatment Through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H) research consortium, which investigates adolescent HIV prevention and treatment in seven LMICs: Brazil, Kenya, Mozambique, Nigeria, South Africa, Uganda, and Zambia. PATC3H researchers were asked to identify ethical and practical challenges of adolescent consent to research participation in these countries. We also did a scoping review of strategies that could improve adolescent participation in LMIC HIV studies. Examples from PATC3H research highlighted many ethical challenges that affect adolescent participation, including inconsistent or absent consent guidance, guidelines that fail to account for the full array of adolescents' lives, and variation in how ethical review committees assess adolescent studies. Our scoping review identified three consent-related strategies to expand adolescent inclusion: waiving parental consent requirements, allowing adolescents to independently consent, and implementing surrogate decision making. Our analyses suggest that these strategies should be further explored and incorporated into ethical and legal research guidance to increase adolescent inclusion in LMIC HIV research.

Expanding community engagement in HIV clinical trials: a pilot study using crowdsourcing.

OBJECTIVE: To assess the potential for crowdsourcing to complement and extend community advisory board (CAB) feedback on HIV clinical trials. Crowdsourcing involves community members attempting to solve a problem and then sharing solutions. METHODS: CAB and crowdsourced approaches were implemented in the context of a phase 1 HIV antibody trial to collect feedback on informed consent, participation experiences, and fairness. CAB engagement was conducted through group discussions with members of an HIV CAB. Crowdsourcing involved open events intended to engage the local community, including interactive video modules, animated vignettes, and a creative idea contest. Open coding and analysis of emergent themes were conducted to compare CAB and crowdsourced feedback. RESULTS: The crowdsourcing activities engaged 61 people across three events; nine people engaged in CAB feedback. Compared with CAB participants, crowdsourcing participants had lower levels of education and income, and higher levels of disability and unemployment. Overlap in CAB and crowdsourced feedback included recommendations for enhancing communication and additional support for trial participants. Crowdsourcing provided more detailed feedback on the impact of positive experiences and socio-economic factors on trial participation. CAB feedback included greater emphasis on institutional regulations and tailoring trial procedures. Crowdsourced feedback emphasized alternative methods for learning about trials and concerns with potential risks of trial participation. CONCLUSION: Conducting crowdsourcing in addition to CAB engagement can yield a broader range of stakeholder feedback to inform the design and conduct of HIV clinical trials. VIDEO ABSTRACT:.

Open to the public: paywalls and the public rationale for open access medical research publishing.

Public voices have largely been absent from the discussions about open access publishing in medical research. Yet the public have a strong interest in ensuring open access of medical research findings because of their roles as funders, advocates, research participants, and patients. By limiting access to research outputs, the current publishing system makes it more difficult for research to be held accountable to the public. Paywalls undermine the work of public advocacy, which requires open access in order to lobby for policy changes and research funding. Research participants generously give their time and energy to research studies with the assumption that the results will be broadly disseminated. Finally, members of the public have a stake in open access publishing as a resource for health information and decision-making. This commentary explores these crucial roles of the public in order to develop a public rationale for open access medical research. We outline a critique of the current academic publishing ecosystem, re-focus the open access debate from a public perspective, and respond to some of the arguments against public open access. Although open access to medical research is not a panacea, removing paywalls and other barriers to public access is essential. The public are critical stakeholders of medical research data.

Homoprejudiced violence among Chinese men who have sex with men: a cross-sectional analysis in Guangzhou, China.

BACKGROUND: Homoprejudiced violence, defined as physical, verbal, psychological and cyber aggression against others because of their actual or perceived sexual orientation, is an important public health issue. Most homoprejudiced violence research has been conducted in high-income countries. This study examined homoprejudiced violence among men who have sex with men (MSM) in Guangzhou, China. METHODS: MSM in a large Chinese city, Guangzhou, completed an online survey. Data about experiencing and initiating homoprejudiced violence was collected. Multivariable logistic regression analyses, controlling for age, residence, occupation, heterosexual marriage, education and income, were carried out to explore associated factors. RESULTS: A total of 777 responses were analyzed and most (64.9%) men were under the age of 30. Three-hundred-ninety-nine (51.4%) men experienced homoprejudiced violence and 205 (25.9%) men perpetrated homoprejudiced violence against others. Men who identified as heterosexual were less (AOR = 0.6, 95% CI: 0.4-0.9) likely to experience homoprejudiced violence compared to men who identified as gay. Men who experienced homoprejudiced violence were more likely to initiate homoprejudiced violence (AOR = 2.44, 95% CI: 1.6-3.5). Men who disclosed their sexual orientation to other people were more likely to experience homoprejudiced violence (AOR = 1.8, 95% CI:1.3-2.5). CONCLUSIONS: These findings suggest the importance of further research and the implementation of interventions focused on preventing and mitigating the effects of homoprejudiced violence among MSM in China.

Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial.

BACKGROUND/AIMS: Community engagement is widely acknowledged as an important step in clinical trials. One underexplored method for engagement in clinical trials is crowdsourcing. Crowdsourcing involves having community members attempt to solve a problem and then publicly sharing innovative solutions. We designed and conducted a pilot using a crowdsourcing approach to obtain community feedback on an HIV clinical trial, called the Acceptability of Combined Community Engagement Strategies Study. In this work, we describe and assess the Acceptability of Combined Community Engagement Strategies Study's crowdsourcing activities in order to examine the opportunities of crowdsourcing as a clinical trial community engagement strategy. METHODS: The crowdsourcing engagement activities involved in the Acceptability of Combined Community Engagement Strategies Study were conducted in the context of a phase 1 HIV antibody trial (ClinicalTrials.gov identifier: NCT03803605). We designed a series of crowdsourcing activities to collect feedback on three aspects of this clinical trial: the informed consent process, the experience of participating in the trial, and fairness/reciprocity in HIV clinical trials. All crowdsourcing activities were open to members of the general public 18 years of age or older, and participation was solicited from the local community. A group discussion was held with representatives of the clinical trial team to obtain feedback on the utility of crowdsourcing as a community engagement strategy for informing future clinical trials. RESULTS: Crowdsourcing activities made use of innovative tools and a combination of in-person and online participation opportunities to engage community members in the clinical trial feedback process. Community feedback on informed consent was collected by transforming the clinical trial's informed consent form into a series of interactive video modules, which were screened at an open public discussion. Feedback on the experience of trial participation involved designing three fictional vignettes which were then transformed into animated videos and screened at an open public discussion. Finally, feedback on fairness/reciprocity in HIV clinical trials was collected using a crowdsourcing idea contest with online and in-person submission opportunities. Our public discussion events were attended by 38 participants in total; our idea contest received 43 submissions (27 in-person, 16 online). Facebook and Twitter metrics demonstrated substantial engagement in the project. The clinical team found crowdsourcing primarily useful for enhancing informed consent and trial recruitment. CONCLUSION: There is sufficient lay community interest in open calls for feedback on the design and conduct of clinical trials, making crowdsourcing both a novel and feasible engagement strategy. Clinical trial researchers are encouraged to consider the opportunities of implementing crowdsourcing to inform trial processes from a community perspective.