Understanding the potential implementation determinants of Our Plan: a couples-based digital human immunodeficiency virus prevention intervention for same-gender male couples.

Background: There has been a proliferation of digital health interventions (DHIs) focused on addressing human immunodeficiency virus (HIV) prevention and treatment outcomes, including couples-based interventions with same-gender male couples. However, the barriers and facilitators of implementing couples-based HIV and sexually transmitted infection (STI) prevention interventions using digital platforms in community-based organizations remains largely unknown. The goal of this study was to explore the implementation determinants of Our Plan, a couples-based DHI designed for new relationships of same-gender male couples and dyadic, sexual partnerships. Methods: Qualitative interviews were conducted with 40 organization leaders, healthcare providers, and staff at acquired immunodeficiency syndrome (AIDS)-service and community-based organizations in 13 states serving populations in Ending the HIV Epidemic jurisdictions. Interview items and follow-up questions were guided by the Consolidated Framework for Implementation Research (CFIR) to inquire about implementation determinants of Our Plan. Results: Most participants highlighted several relative advantages of Our Plan: increasing capacity to support couples, potential synergy with existing programs, and opportunities to increase patient engagement. Participants also discussed relative disadvantages: misalignment with organizational values in the provision of patient-centered models of care and low interest from some priority populations. Participants emphasized the need for adaptability of Our Plan to fit within their local contexts, which encompassed support for both implementers and end-users, cultural tailoring, and privacy and security features. The desired evidence needed to implement Our Plan focused on data on impact, acceptability, and usability and functionality from communities most heavily impacted by the HIV epidemic. The majority of participants described how Our Plan could be integrated within service delivery and aligned with their organization's aspirational values; however, some noted that their organizational culture valued in-person interactions, particularly among patients experiencing structural vulnerabilities. Finally, participants discussed how the implementation of Our Plan would require additional training and funding for staff to support end-users and a relationship with the developers so that they could demonstrate their investment in the communities that their organizations served. Conclusions: Our Plan was deemed a promising tool among potential implementers. To ensure optimal implementation and organizational fit, Our Plan refinement and evaluation must include implementers and end-users most impacted by the HIV epidemic throughout the entire process.

Assessing Preferences for Long-Acting Injectable Pre-Exposure Prophylaxis Among Young Adult Sexual Minority Men and Transgender Women.

OBJECTIVE: Oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, oral PrEP uptake is low, particularly among sexual and gender minority youth who are vulnerable to HIV infection. Alternative methods of PrEP delivery, such as long-acting injectable (LAI) PrEP may overcome barriers and be preferred. However, attitudes and preferences of younger sexual and gender minorities towards LAI PrEP have not been well studied. The purpose of this study is to describe preferences for initiating LAI PrEP among sexual and gender minority youth. METHODS: We analyzed data collected as part of an HIV prevention randomized trial from January 2022 to February 2023, using multiple regression to identify factors associated with a preference for LAI PrEP. RESULTS: The study sample (N = 265) was 50% youth of color, mean age 25 years (SD=3.4, range=18-31), and primarily identified as gay (71%) and male (91%). Forty two percent had heard of LAI PrEP and 31% preferred LAI PrEP over other prevention methods. In multiple regression analysis, LAI PrEP preference was associated with identifying as White, previous PrEP experience, and perceived LAI PrEP efficacy. CONCLUSIONS: We conclude that gaps in awareness exist for LAI PrEP, however it may be preferred over other prevention methods especially in White youth, those with PrEP experience and higher perceptions of its efficacy. More education and outreach are needed to prevent extension of existing race and ethnicity disparities in use of oral daily PrEP to LAI PrEP.

Human immunodeficiency virus prevention outcomes associated with arts-based sexual health workshop participation among Northern and Indigenous adolescents in the Northwest Territories, Canada.

BACKGROUND: Contextually tailored, arts-based HIV prevention strategies hold potential to advance adolescent sexual health and wellbeing. We examined HIV prevention outcomes associated with arts-based sexual health workshop participation with Northern and Indigenous adolescents in the Northwest Territories (NWT), Canada. METHODS: An Indigenous community-based youth agency delivered arts-based workshops in school settings to adolescents aged 13-18 in 24 NWT communities. Pre and post-test surveys included socio-demographic characteristics, sexually infections (STI) knowledge, HIV/STI risk perception, sexual relationship equity, condom use self-efficacy, and safer sex efficacy (SSE). Latent change score models were conducted to assess pre-post differences and factors associated with these differences. RESULTS: Among participants (n = 344; mean age 14.3 years, SD: 1.3; Indigenous: 79%) most (66%) had previously attended this workshop. Latent change score models revealed a significant and large effect size for increased STI knowledge (ß = 2.10, SE = 0.48, p < .001) and significant and small effect sizes for increased HIV/STI risk perception (ß = 0.24, SE = 0.06, p < .001) and SSE (ß = 0.16, SE = 0.07, p = .02). The largest increases across several outcomes occurred with first time workshop participants; yet previous workshop participants continued to report increases in HIV/STI risk perception and SSE. CONCLUSION: Arts-based HIV prevention approaches show promise in advancing STI knowledge, risk perception, and SSE with Northern and Indigenous youth.

Virtual avatars as a new tool for human immunodeficiency virus prevention among men who have sex with men: a narrative review.

Background and Objective: Human immunodeficiency virus (HIV) continues to affect sexual and gender minorities, predominantly men who have sex with men (MSM). Stigma, medical mistrust, and apprehension towards discussing sexual health with one's medical provider are significant barriers in seeking or accessing preventive services. Those obstacles could be surpassed through novel digital and electronic health interventions, specifically with virtual avatar technology. Avatars are digital self-representative agents that are controlled with an interactive electronic device. Avatars allow for virtual self-immersion within infinitely customizable environments to practice skill building, fostering relationships and more, through an optional incognito approach. The objective of this narrative review is to examine recent uses of and developments in avatar technology, highlight the personalization attribute of this technology, and evaluate its strengths and limitations as a tool for HIV prevention among MSM. Methods: We reviewed recent scientific literature generated by PubMed that use virtual avatar technology in HIV prevention and treatment among populations put at risk. Articles that met the inclusion criteria were then categorized on how the avatar technology was used. Key Content and Findings: We identified eleven studies that met inclusion criteria. Avatar technology was found to create a comfortable environment for participants to address and discuss their sexual behaviors with less hesitation. Avatars can build rapport with populations put at high risk, creating an opportunity for reevaluation of their sexual behavior while assisting them in being able seek information, preventive services, or treatment for HIV or other sexually transmitted infections (STIs). Conclusions: Given the increased use of digital technology in health and prevention, avatars might be useful in sexual health education and HIV prevention among populations put at risk. The benefits and potential in utilizing this technology for HIV prevention are highlighted.

US Black cisgender women and pre-exposure prophylaxis for human immunodeficiency virus prevention: A scoping review.

BACKGROUND: Black cisgender women in the United States experience a disproportionate burden of human immunodeficiency virus acquisition. Pre-exposure prophylaxis is an effective oral daily medication that reduces the risk of human immunodeficiency virus through sex by 99% when taken as prescribed. However, less than 2% of eligible Black cisgender women take pre-exposure prophylaxis. The purpose of this scoping review was to describe the types of research studies done in this area, gaps in knowledge, and potential areas of research needed to increase pre-exposure prophylaxis use among Black cisgender women in the United States. METHODS: We conducted our search in MEDLINE (PubMed), Embase (Elsevier), CINAHL (EBSCOhost), PsycINFO (EBSCOhost), and Scopus (Elsevier) using a combination of keywords and database-specific subject headings for the following concepts: pre-exposure prophylaxis, African American/Black or minority, and women. We used the Joanna Briggs Institute's Reviewers' Manual process for Scoping Reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews to ensure comprehensive and standardized reporting of each part of the review. RESULTS: Fifty-nine studies were included in the final review. Results of the study were classified according to the three phases of the Human Immunodeficiency Virus Prevention Cascade-demand side, supply side, and adherence and retention. The majority of studies (n = 24, 41%) were cross-sectional quantitative surveys and 43 (34%) focused on the demand-side phase of the Human Immunodeficiency Virus Prevention Cascade. Fifty-eight percent of studies either assessed women's pre-exposure prophylaxis knowledge, attitudes, and intentions to use, or assessed perceived barriers and facilitators. Seven studies (12%) tested pre-exposure prophylaxis uptake and adherence among Black cisgender women. CONCLUSION: This review found multiple missed opportunities to increase women's demand for pre-exposure prophylaxis and health care provider screening and referral for pre-exposure prophylaxis. Additional studies are needed to effectively assess pre-exposure prophylaxis uptake and adherence among Black cisgender women.

Perceived Social Influences on Women's Decisions to use Medications not Studied in Pregnancy. A Qualitative Ethical Analysis of Preexposure Prophylaxis Implementation Research in Kenya.

Implementation research ethics can be particularly challenging when pregnant women have been excluded from earlier clinical stages of research given greater uncertainty about safety and efficacy in pregnancy. The evaluation of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) during pregnancy offered an opportunity to understand important ethical considerations and social influences shaping women's decisions to participate in the evaluation of PrEP and investigational drugs during pregnancy. We conducted interviews with women (n = 51), focus groups with male partners (five focus group discussions [FGDs]), interviews with health providers (n = 45), four FGDs with pregnant/postpartum adolescents and four FGDs with young women. Data were analyzed using thematic content analysis, including ethical aspects of the data. Our study reveals that women navigate a complex network of social influences, expectations, support, and gender roles, not only with male partners, but also with clinicians, family, and friends when making decisions about PrEP or other drugs that lack complete safety data during pregnancy.

Transformation of Australian Community Pharmacies Into Good Clinical Practice Compliant Trial Pharmacies for HIV Pre-Exposure Prophylaxis.

Background: In Australia, clinical trial drugs are conventionally dispensed through clinical trial pharmacies only, while community pharmacies dispense drugs approved by Australia's regulatory body. A large HIV pre-exposure prophylaxis study aimed to deliver clinical trial drug through community pharmacies to improve convenience and mimic real world prescribing. This paper describes the process of making community trials compliant with good clinical practice and reports outcomes of delivering clinical trial drug through community pharmacies. Methods: Eight community and four clinical trial pharmacies across three Australian states were approached to participate. A good clinical practice checklist was generated and pharmacies underwent a number of changes to meet clinical trial pharmacy requirements prior to study opening. Changes were made to community pharmacies to make them compliant with good clinical trial practice including; staff training, structural changes, and implementing monitoring of study drug and prescribing practices. Study drug was ordered through standard clinical trial processes and dispensed from study pharmacies by accredited pharmacists. Throughout the trial, record logs for training, prescriber signature and delegation, temperature, participant, and drug accountability were maintained at each pharmacy. The study team monitored each log and delivered on-site training to correct protocol variations. Results: Each pharmacy that was approached agreed to participate. All community pharmacies achieved good clinical practice compliance prior to dispensing study drug. Over the course of the study, 20,152 dispensations of study drug occurred, 83% of these occurred at community pharmacies. Only 2.0% of dispensations had an error, and errors were predominantly minor. On five occasions a pharmacist who was not accredited dispensed study drug. Conclusions: Community based pharmacies can undergo training and modifications to achieve good clinical practice compliance and dispense clinical trial study drug. Community based pharmacies recorded few variations from study protocol. Community based pharmacies offer a useful alternative to clinical trial pharmacies to increase convenience for study participants and expanded use of these pharmacies should be considered for large clinical trials, including HIV prevention trials.

Systematic review of sex work interventions in sub-Saharan Africa: examining combination prevention approaches.

OBJECTIVE: The incidence of HIV and sexually transmitted infections is disproportionately high among sex workers (SW). We aimed to update the evidence on the effectiveness of SW interventions in sub-Saharan Africa and to provide more insights into combination prevention. METHODS: The Systematic review followed PRISMA guidelines in a search of PUBMED and POPLINE for peer-reviewed literature published between 1 January 2000 and 22 July 2016 (registration number on PROSPERO: CRD42016042529). We considered cohort interventions, randomised controlled trials and cross-sectional surveys of SW programmes. A framework was used in the description and mapping of intervention to desired outcomes. RESULTS: Twenty-six papers(reporting on 25 studies) were included. A strategy that empowered peer educator leaders to steer community activities showed a twofold increase in coverage of behaviour change communication and utilisation of health facility among SW. Brief alcohol harm reduction effort demonstrated a significant effect on sexual violence and engagement in sex trading. A risk reduction counselling intervention among drug-injecting SW showed an effect on alcohol, substance use and engagement in sex work. No study on a promising intervention like PrEP among SWs was found. We observed that interventions that combined some structural components, biomedical and behavioural strategies tend to accumulate more desired outcomes. CONCLUSION: The evidence base that can be considered in intervention designs to prevent HIV in SW in SSA is vast. The health sector should consider interventions to reduce binge alcohol intake and intravenous drug use among sex workers. Programmes should staunchly consider multicomponent approaches that explore community-based structural approaches.

An Integrated Service Delivery Model to Identify Persons Living with HIV and to Provide Linkage to HIV Treatment and Care in Prioritized Neighborhoods: A Geotargeted, Program Outcome Study.

BACKGROUND: Recent studies have demonstrated that high human immunodeficiency virus (HIV) prevalence (2.1%) rates exist in "high-risk areas" of US cities that are comparable to rates in developing nations. Community-based interventions (CBIs) have demonstrated potential for improving HIV testing in these areas, thereby facilitating early entry and engagement in the HIV continuum of care. By encouraging neighborhood-based community participation through an organized community coalition, Project LINK sought to demonstrate the potential of the CBI concept to improve widespread HIV testing and referral in an area characterized by high poverty and HIV prevalence with few existing HIV-related services. OBJECTIVE: This study examines the influence of Project LINK to improve linkage-to-care and HIV engagement among residents of its target neighborhoods. METHODS: Using a venue-based sampling strategy, survey participants were selected from among all adult participants aged 18 years or more at Project LINK community events (n=547). We explored multilevel factors influencing continuum-of-care outcomes (linkage to HIV testing and CBI network referral) through combined geospatial-survey analyses utilizing hierarchical linear model methodologies and random-intercept models that adjusted for baseline effect differences among zip codes. The study specifically examined participant CBI utilization and engagement in relation to individual and psychosocial factors, as well as neighborhood characteristics including the availability of HIV testing services, and the extent of local prevention, education, and clinical support services. RESULTS: Study participants indicated strong mean intention to test for HIV using CBI agencies (mean 8.66 on 10-point scale [SD 2.51]) and to facilitate referrals to the program (mean 8.81 on 10-point scale [SD 1.86]). Individual-level effects were consistent across simple multiple regression and random-effects models, as well as multilevel models. Participants with lower income expressed greater intentions to obtain HIV tests through LINK (P<.01 across models). HIV testing and CBI referral intention were associated with neighborhood-level factors, including reduced availability of support services (testing P<.001), greater proportion of black/African Americans (testing and referral P<.001), and reduced socioeconomic capital (testing P=.017 and referral P<.001). Across models, participants expressing positive attitudes toward the CBI exhibited greater likelihood of engaging in routine HIV testing (P<.01) and referring others to HIV care (P<.01). Transgender individuals indicated greater intent to refer others to the CBI (P<.05). These outcomes were broadly influenced by distal community-level factors including availability of neighborhood HIV support organizations, population composition socioeconomic status, and high HIV prevalence. CONCLUSIONS: Project LINK demonstrated its potential as a geotargeted CBI by evidencing greater individual intention to engage in HIV testing, care, and personal referrals to its coalition partner organizations. This study highlights important socioecological effects of US-based CBIs to improve HIV testing and initiate acceptable mechanisms for prompt referral to care among a vulnerable population.

Barrier methods for human immunodeficiency virus prevention.

Condoms remain the most effective barrier against the sexual transmission of the human immunodeficiency virus (HIV). Male condoms have proven to be 80% to 90% effective, and female condoms have similar results. Poor adherence and improper use limit their effectiveness. In addition to condoms, microbicides are a promising barrier against HIV transmission. More than 50 candidate topical microbicide compounds have undergone preclinical or clinical testing in the last 10 years, but there are currently no US Food and Drug Administration (FDA)-approved compounds. Rectal microbicides are also being developed, as anal receptive sex is an effective mode of HIV transmission.