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BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as sex workers. This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of PrEPare for Work,- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the PrEPare for Work Stage 1 intervention (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the PrEPare for Work Stage 2 intervention (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs unique life circumstances are urgently needed. In this study, we are evaluating whether PrEPare for Work can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention (PrEPare-for-Work) to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized.

BackgroundHIV outbreaks among people who inject drugs (PWID) and experience homelessness are increasing across the USA. Despite high levels of need, multilevel barriers to accessing antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention persist for this population. The Boston Health Care for the Homeless Program (BHCHP) initiated a low-threshold, outreach-based program to support engagement in PrEP services among PWID experiencing homelessness.MethodsTo inform dissemination efforts, we explored patient and provider perspectives on key program components. From March to December 2020, we conducted semi-structured qualitative interviews with current and former BHCHP PrEP program participants and prescribers, patient navigators, and outreach workers (i.e., providers). Thematic analysis explored perspectives on key program components.ResultsParticipants (n = 21) and providers (n = 11) identified the following five key components of BHCHP's PrEP program that they perceived to be particularly helpful for supporting patient engagement in PrEP services: (1) community-driven PrEP education; (2) low-threshold, accessible programming including same-day PrEP prescribing; (3) tailored prescribing supports (e.g., on-site pharmacy, short-term prescriptions, medication storage); (4) intensive outreach and navigation; and (5) trusting, respectful patient-provider relationships.DiscussionFindings suggest that more patient-centered services formed the basis of BHCHP's innovative, successful PrEP program. While contextual challenges including competing public health emergencies and homeless encampment "sweeps" necessitate ongoing programmatic adaptations, lessons from BHCHP's PrEP program can inform PrEP delivery in a range of community-based settings serving this population, including syringe service programs and shelters.

BackgroundHIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low.MethodsWe describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of "PrEP for Health," a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the "PrEP for Health" intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex).DiscussionFindings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the "PrEP for Health" intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population.Trial registrationClinicalTrials.gov number NCT04430257, registered June 12, 2020.

BackgroundIn the context of increasing injection-related HIV outbreaks across the United States, particularly among people who inject drugs (PWID) experiencing homelessness, there is an urgent need to expand access to pre-exposure prophylaxis (PrEP) for HIV prevention. Peer-based interventions for PrEP could be helpful for promoting PrEP uptake, yet the social experiences of using PrEP among PWID experiencing homelessness have not been thoroughly explored.MethodsTo better understand social experiences surrounding PrEP use among PWID experiencing homelessness, we conducted qualitative interviews from March-December 2020 with current and former PrEP patients of an innovative, low-threshold program implemented by Boston Health Care for the Homeless Program (BHCHP) in Boston, MA. Thematic analysis of coded interview data explored participants' perspectives and experiences with PrEP disclosure and discussions within their social networks.ResultsAmong interviews with 21 participants, we identified the following four interrelated aspects of their social experiences using PrEP: (1) participants' were aware of increasing HIV transmission within their social networks, which motivated their PrEP use and disclosure; (2)  participants generally avoided disclosing their PrEP use within public spaces or casual conversations; (3)  participants expressed greater willingness to discuss PrEP with their close social contacts; and (4)  some participants self-identified as leaders or expressed interest in leading the dissemination of PrEP information within their social networks.ConclusionsFindings highlight the significance of PrEP disclosure and discussions within the social networks of PWID experiencing homelessness, suggesting a need for continued social network and intervention research-particularly to establish the feasibility and acceptability of peer-based interventions for promoting PrEP-with this marginalized population.

OBJECTIVE: MSM in India are at a high risk for HIV infection given psychosocial challenges, sexual orientation stress, and stigma. We examined the cost-effectiveness of a novel resilience-based psychosocial intervention for MSM in India. DESIGN: We parameterized a validated microsimulation model (CEPAC) with India-specific data and results from a randomized trial and examined two strategies for MSM: status quo HIV care ( SQ ), and a trial-based psychosocial intervention ( INT ) focused on building resilience to stress, improving mental health, and reducing condomless anal sex (CAS). METHODS: We projected lifetime clinical and economic outcomes for MSM without HIV initially. Intervention effectiveness, defined as reduction in self-reported CAS, was estimated at 38%; cost was $49.37/participant. We used a willingness-to-pay threshold of US$2100 (2019 Indian per capita GDP) per year of life saved (YLS) to define cost-effectiveness. We also assessed the 5-year budget impact of offering this intervention to 20% of Indian MSM. RESULTS: Model projections showed the intervention would avert 2940 HIV infections among MSM over 10 years. Over a lifetime horizon, the intervention was cost-effective (ICER = $900/YLS). Results were most sensitive to intervention effectiveness and cost; the intervention remained cost-effective under plausible ranges of these parameters. Offering this intervention in the public sector would require an additional US$28 M over 5 years compared with SQ . CONCLUSION: A resilience-based psychosocial intervention integrated with HIV risk reduction counseling among MSM in India would reduce HIV infections and be cost-effective. Programs using this approach should be expanded as a part of comprehensive HIV prevention in India.

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159).

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood. From September to November 2021, we conducted qualitative interviews with 28 HIV-negative, adult (≥18 years) PWID in San Diego County, CA, to explore their perspectives on daily oral PrEP pills and long-acting PrEP modalities (i.e., injections, implants, intravaginal rings, and broadly neutralizing antibodies), which we explained using standard scripts. Thematic analysis identified variations in PrEP modality interest and acceptability. We identified three key factors across the 28 interviews that appeared to influence PrEP modality preferences: perceived convenience of use, invasiveness, and familiarity (based on past experience). Overall, most participants preferred injectable PrEP over other modalities because they viewed injectable medications as convenient, noninvasive, and familiar. While injectable PrEP was recently approved for use in the United States and was most the acceptable PrEP modality in this sample, our findings suggest that intervention and implementation research is urgently needed to improve our understanding of strategies that could support access, uptake, and sustained adherence to longer-acting PrEP for PWID.

Background & objectivesTransgender women (TGW) in India are at high risk of HIV infection. Despite behavioural interventions aimed at reducing HIV risk, no literature synthesis exists so far to evaluate their potential for reducing HIV incidence in India This review was aimed to identify and evaluate HIV-focussed behaviour change interventions for TGW in India.MethodsLiterature from three databases were reviewed up to June 2, 2021, for studies describing behavioural interventions for HIV prevention among TGW in India. The inclusion criteria were studies that included TGW and reported intervention effects on HIV prevention-related behaviour. Data were analyzed descriptively.ResultsOf the 146 articles screened, only three met the inclusion criteria. All three interventions were at the open pilot trial stage and included other high-risk groups (e.g. men who have sex with men). The interventions used behavioural counselling, increased sexually transmitted infection screening and sexual healthcare visits and leveraged community-based organizations to improve the outcomes. All these interventions showed modest improvements in health-seeking behaviour and access to services. However, none specifically targeted TGW.Interpretation & conclusionsThe scoping review highlights the need for behavioural interventions for HIV prevention tailored to TGW in India. This study emphasizes the need for research to move to the next stage of intervention development and testing utilizing more rigorous evaluation methods, such as a randomized controlled trial.

Nigerian gay, bisexual, and other men who have sex with men (GBMSM) experience social marginalisation, discrimination and violence due to their sexual orientation and same-sex attraction, which may affect mental health, substance use, and HIV sexual risk behavior. The goal of the current study was to conduct formative qualitative research to gain better understanding of these issues among GBMSM in Lagos, Nigeria. Face-to-face, semi-structured, in-depth interviews were conducted with 30 GBMSM in Lagos, Nigeria. Data were analysed using a deductive content analysis approach. We found that Nigerian GBMSM experienced both general life stressors as well as proximal and distal sexual minority identity stressors, including rejection by family members, harassment, and physical violence perpetrated by the general public and police officers. Participants described dealing with mental health problems within the context of family rejection, experienced stigma due to sexual orientation, and feelings of social isolation. Substance use was described as occurring within the context of social settings. Lastly, some participants mentioned that they engaged in risky sexual behaviour while under the influence of alcohol and drugs. These findings call for comprehensive and innovative, GBMSM-affirming behavioural healthcare, substance cessation services, and innovative HIV prevention interventions specifically designed and tailored for Nigerian GBMSM.

Geosocial networking applications (GSN apps) are widely utilized by gay, bisexual, and other men who have sex with men (GBMSM) to meet potential sexual/romantic partners, foster friendships, and build community. However, GSN apps usage has been linked to elevated levels of HIV sexual risk behavior among GBMSM. Little is known about how GSN apps can facilitate HIV sexual risk behaviors, especially among GBMSM in Africa. To fill this gap in research, the present study aimed to characterize the frequency of GSN apps usage and its association with sociodemographic characteristics, sexual health, healthcare access, psychosocial problems, and substance use in a large multicity sample of community-recruited GBMSM in Nigeria (N = 406). Bivariate and multivariable ordinal logistic regression procedures were used to examine factors associated with GSN apps usage. We found that 52.6% of participants reported recent (≤ 3 months) GSN apps use to meet sexual partners. Factors associated with increased odds of GSN apps usage included: being single, having a university degree or higher, reporting higher recent receptive anal sexual acts, being aware of PrEP, having a primary care provider, and reporting higher levels of identity concealment. HIV-related intervention delivered through GSN apps may help curb the spread of HIV among Nigerian GBMSM.

BackgroundIn the United States, the criminalization and stigmatization of drug use and sex work contribute to infectious disease transmission and healthcare disengagement. People who inject drugs (PWID) and engage in sex work experience exacerbated HIV risk. In the context of the ongoing HIV and overdose epidemics little research describes why PWID engage in sex work and its relative HIV risk. To inform intervention needs, we aimed to create a typology of sex work among PWID with a focus on HIV risk and healthcare utilization behaviours.MethodsWe drew from in-depth interviews conducted across Massachusetts and Rhode Island from 2016-2019. Participants were ≥18 years old and self-reported past-month injection drug use and HIV-negative status. Using data from individuals reporting sex work experience (n=33/78), we utilized the framework method to develop a typology of perspectives on sex work engagement and attributes pertaining to HIV risk and healthcare utilization behaviours.ResultsWe uncovered varying perspectives on sex work and associated HIV risks and prevention needs. A typology included three groups who viewed their sex work engagement as a (1) consistent job, (2) income supplement, or (3) survival method to abate withdrawal symptoms. The first group described more consistent sexual and injection behaviours to mitigate HIV risk than the second group. The third group appeared particularly vulnerable to HIV, describing inconsistent condom use and frequent sharing of injection equipment, low healthcare utilization, and limited disclosure of sex work and injection drug use to healthcare providers.ConclusionFindings highlight distinct perspectives on sex work among PWID involved in it and corresponding perceptions of HIV risk and healthcare utilization behaviours. Understanding the nuances in sex work engagement among PWID can inform interventions to prevent infectious disease transmission, including efforts to further connect this marginalized population to harm reduction, health, and low barrier opioid treatment services.

Purpose of reviewRecent HIV outbreaks among people who use drugs (PWUD) necessitate additional HIV prevention tools. Pre-exposure prophylaxis (PrEP) is highly efficacious yet uptake among PWUD remains exceedingly low. To address multilevel, complex barriers to PrEP use among PWUD, a range of intervention strategies are needed.Recent findingsThe literature on interventions to optimize PrEP use among PWUD is nascent, comprising small pilots and demonstration projects in early phases of intervention development. Initial studies suggest that structural, healthcare, interpersonal, and individual-level interventions can improve PrEP use for PWUD, and a number of efficacy trials are underway. Future studies are needed to optimize the use of new PrEP modalities (e.g., injectable PrEP), simultaneously target multilevel challenges to PrEP use, and evaluate the integration of PrEP into other service settings and substance use treatment modalities.

Multilevel barriers to pre-exposure prophylaxis (PrEP) care among male sex workers (MSW) include aspects of interactions with health services and providers. We examined relationships between health service- and provider-level factors and PrEP care among MSW. Between 2017 and 2019, we enrolled 111 MSW in the Northeast United States who were not on PrEP, but expressed interest in potentially using PrEP, in a behavioral intervention to promote PrEP uptake and adherence. Using baseline data, we examined whether having a primary care provider, past year frequency of medical visits, comfort discussing sexual practices with providers, and transportation difficulties to accessing general health care were associated with PrEP use self-efficacy, anticipated barriers to PrEP uptake, adherence, and retention (linear regression), and intention to initiate PrEP (logistic regression). Models adjusted for age, race/ethnicity, sexual identity, education, and income. Participants' mean age was 34.2 [standard deviation (SD) = 8.5], and 47% were non-White. Three-quarters (76%) intended to initiate PrEP within the next month. Comfort discussing sexual practices with providers was associated with PrEP use self-efficacy (b = 0.41, p = 0.008). Comfort discussing sexual practices with providers was negatively associated with anticipated barriers to PrEP uptake (b = -0.29, p = 0.006). Transportation difficulties to accessing general health care were associated with barriers to PrEP uptake (b = 0.30, p = 0.007) and barriers to PrEP adherence and retention (b = 0.57, p

Gay and bisexual men (GBM) who report engagement in transactional sex are at increased risk for HIV acquisition. The current study aimed to assess the prevalence of transactional sex and its association with demographic characteristics, social marginalization, HIV sexual risk behaviors, psychosocial health problems, and access to healthcare services among a multi-site sample of GBM in Nigeria. Bivariate and multivariable logistic regression were used to examine factors associated with engagement in transactional sex in the previous 3 months. More than a third (39.6%) of the participants reported engagement in transactional sex in the previous 3 months. In the multivariable model, factors associated with engagement in transactional sex included: reporting a monthly income of 30,000 Naira [adjusted odds ratio (aOR) 1.98; 95% CI: 1.12 to 3.35], compared to 30,000 or more Naira monthly income, reporting 4 or more receptive anal sex acts in the previous 30 days (aOR 2.45; 95% CI: 1.31 to 4.57) compared to reporting none, and having depressive symptoms (aOR 1.82; 95% CI: 1.06 to 3.14). There is an urgent need for interventions that address the economic disenfranchisement and psychosocial problems experienced by GBM in Nigeria, which has implications for sexual health.

BackgroundSubstantial research gaps exist regarding the relationship between transgender-related discrimination and substance use outcomes for transgender adults, with few studies accounting for other experiences of victimization.MethodsTransgender adults (N = 600) from Massachusetts and Rhode Island completed a survey online or in-person. Multivariable linear and logistic regression models examined the association between lifetime experiences of transgender-related discrimination using the validated 11-item Everyday Discrimination Scale (theoretical range = 0-44) and substance use outcomes: past 12-month substance use frequency, lifetime substance use disorder (SUD) diagnosis, and substance use treatment (SUTx) history. All models were adjusted for age, gender identity, race, survey modality, childhood physical/sexual abuse, intimate partner violence, and discrimination attributable to other reasons than being transgender.ResultsThe mean transgender-related discrimination score was 20.8 (SD = 9.6, range = 0-44). Overall, 11.8 % of the sample had a SUD diagnosis and 11.0 % had received SUTx. In separate multivariable models adjusted for sociodemographic and victimization experiences, the highest quartile of transgender-related discrimination was significantly associated with higher past 12-month substance use (B = 1.44; aR2 = 0.13; p = .009), SUD diagnosis (aOR = 3.64; 95 % CI = 1.46-9.07; p = .006), and lifetime treatment history (aOR = 3.93; 95 % CI = 1.50-10.21; p = .005).ConclusionsThere was a significant positive association between experiencing high levels of transgender-related discrimination and substance use outcomes among the transgender adults sampled. Longitudinal research is needed to understand the specific mediators driving these relationships and to address the implications of transgender-related discrimination on SUD treatment utilization.

BackgroundLimited research has explored risk factors for opioid pain medication misuse, concomitant substance misuse, and the unmet behavioral health treatment (BHTx) needs of transgender and gender diverse (TGD) adults.MethodsIn 2019, TGD adults (N = 562) in Massachusetts and Rhode Island were purposively recruited and completed a psychosocial and behavioral health survey (95 % online; 5% in-person). Multivariable logistic regression was used to examine factors associated with past 12-month opioid pain medication misuse and unmet BHTx needs.ResultsOverall, 24.4 % of participants were trans women; 32.0 % trans men; and 43.6 % were non-binary. Past-year substance misuse included: marijuana (56.8 %), hazardous drinking (37.5 %), hallucinogens (9.8 %), benzodiazepines (8.2 %), and opioid pain medication (8.0 %). Among participants with past-year substance misuse and BHtx need (n = 326), 81.3 % received BHtx and 18.7 % had unmet BHtx needs. Being a trans woman, having HIV, stigma in healthcare, and number of substances misused were associated with increased odds of past-year opioid pain medication misuse; high social connectedness was associated with decreased odds of opioid pain medication misuse (p-values

BackgroundMen who have sex with men (MSM) in India are extremely marginalised and stigmatised, and therefore experience immense psychosocial stress. As current HIV prevention interventions in India do not address mental health or resilience to these stressors, we aimed to evaluate a resilience-based psychosocial intervention in the context of HIV and sexually transmitted infection (STI) prevention.MethodsWe did a multicity, randomised, clinical efficacy trial in Chennai (governmental tuberculosis research institute) and Mumbai (non-governmental organisation for MSM), India. Inclusion criteria were MSM, aged 18 years or older, who were at risk of HIV acquisition or transmission, defined as having any of the following in the 4 months before screening: anal sex with four or more male partners (protected or unprotected), diagnosis of an STI, history of transactional sex activity, or condomless anal sex with a man who was of unknown HIV status or serodiscordant. Participants were required to speak English, Tamil (in Chennai), or Hindi (in Mumbai) fluently. Eligible individuals were randomly assigned (1:1) to either a resilience-based psychosocial HIV prevention intervention, consisting of group (four sessions) and individual (six sessions) counselling alongside HIV and STI voluntary counselling and testing, or a standard-of-care control comprising voluntary counselling and testing alone. The primary outcomes were number of condomless anal sex acts with male partners during the past month (at baseline and 4 months, 8 months, and 12 months after randomisation), and incident bacterial STIs (at 12 months after randomisation). Resilience-related mediators included self-esteem, self-acceptance, and depression. Recruitment is now closed. This trial is registered with ClinicalTrials.gov, NCT02556294.FindingsBetween Sept 4, 2015, and June 28, 2018, we enrolled 608 participants; 305 (50%) were assigned to the psychosocial intervention condition and 303 (50%) were assigned to the control condition. 510 (84%) of 608 men completed an assessment at 4 months after randomisation, 483 (79%) at 8 months, and 515 (85%) at 12 months. 512 (99%) of 515 men had STI data from the 12-month assessment. The intervention condition had a 56% larger reduction in condomless anal sex acts (95% CI 35-71; p

BackgroundMale sex workers (MSW) are disproportionately affected by HIV/AIDS, with an estimated HIV prevalence in the United States of 19.3%. Existing research suggests that MSW are also at risk of adverse psychosocial problems. Cross-sectional studies of MSW have suggested that co-occurring epidemics or a "syndemic" of psychosocial problems may increase vulnerability to HIV acquisition/transmission by elevated sexual risk. To the best of our knowledge, there are no published studies examining this relationship longitudinally among MSW. This study examined how a syndemic of 6 psychosocial problems result in additive risk for condomless anal sex (CAS) with male clients among a multicity, longitudinal cohort of MSW.SettingCommunity-based organization and health center in 2 Northeastern US cities.MethodsBetween 2015 and 2017, 100 MSW from Boston, MA and Providence, RI completed behavioral/psychosocial surveys at baseline, 6 months, and 12months. Generalized estimating equation modeling was used to examine the prospective relationship of additive psychosocial problems and subsequent CAS with male clients, adjusting for age, site, race/ethnicity, MSW-type, and HIV serostatus.ResultsMean age = 34.7 (SD = 11.8); 62% racial/ethnic minority; and 20% HIV+. The prevalence of 6 psychosocial syndemic problems was substantial at baseline and remained high at each time point (all within the past 6 months): 74% problematic depressive symptoms, 27% polydrug use (3+ drugs, not including stimulants), 57% stimulant (methamphetamine/cocaine/crack) use, 44% hazardous drinking, 15% experienced client-specific physical/sexual violence, and 57% childhood sexual abuse. Looking at the number of psychosocial problems experienced, 7% had zero, 27% had 1, 24% had 2, 27% had 3, and 15% had 4 or more. We identified a statistically significant positive "dose-response" relationship between the number of psychosocial problems and CAS with male clients over time, with the greatest odds of engaging in CAS with a male client over follow-up among those with 4 or more psychosocial problems (adjusted odds ratio = 5.18, 95% CI: 1.61 to 16.62).ConclusionsInternet escorts and street-based MSW are likely to experience psychosocial problems and engaging in HIV sexual risk with male clients. The accumulation of psychosocial problems additively predicted CAS with male clients in a prospective cohort of MSW. The specification of psychosocial problems presents distinct treatment targets for HIV prevention among MSW in the United States.

India has one of the largest numbers of men who have sex with men (MSM) globally; however, geographic data on sexually transmitted infection (STI) prevalence and associations with sexual behavior are limited. Six-hundred and eight MSM in Chennai and Mumbai underwent screening for a behavioral trial and were assessed for bacterial STIs (syphilis, chlamydia, gonorrhea), HIV, and past-month self-reported condomless anal sex (CAS). Mumbai (37.8%) had a greater prevalence of any STI than Chennai (27.6%) (prevalence ratio [PR] = 1.37, 95% CI: 1.09, 1.73). This pattern also emerged for gonorrhea and chlamydia separately but not syphilis. Conversely, Mumbai MSM reported lower rates of CAS (mean = 2.2) compared to Chennai MSM (mean = 14.0) (mean difference = -11.8, 95% CI: -14.6, -9.1). The interaction of city by CAS on any STI prevalence (PR = 2.09, 95% CI: 1.45, 3.01, p

BackgroundMen who have sex with men are disproportionately burdened by HIV/AIDS, and the advent of pre-exposure prophylaxis (PrEP) has provided an effective strategy to reduce the risk of HIV transmission. Research has shown that improving one partner's health-promoting behaviors increases the likelihood that their partner adopts healthier behaviors. We examined the longitudinal relationship between favorable HIV treatment outcomes with current PrEP use among HIV serodiscordant male partners.SettingData are from Project Stronger Together, a randomized controlled trial that recruited serodiscordant male couples from Atlanta, GA; Boston, MA; and Chicago, IL.MethodsSerodiscordant couples completed assessments at baseline, 6, 12, 18, and 24 months. We analyzed longitudinal data from 120 HIV serodiscordant male partners to assess the relationship between the HIV-negative partner's current PrEP use and their HIV-positive partner's current ART use, ART adherence, and viral load using generalized estimating equation models.ResultsFewer than half of the HIV-negative partners were on PrEP at baseline and nearly two-thirds of their HIV-positive partners were virally suppressed. HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user than HIV-negative partners with partners with a detectable viral load.ConclusionOur study highlights the need to develop dyad-level interventions to improve HIV medication use/adherence by HIV serodiscordant male couples. Our findings also suggest that dyad-level interventions may be able to leverage our understanding of how partners can influence each other's health-promoting behaviors to develop programs that improve health outcomes for both partners.

BackgroundYoung men who have sex with men (YMSM) are disproportionately impacted by HIV and other sexually transmitted infections (STIs) in the United States (US) and have low rates of HIV/STI testing. Provision of HIV self-testing and STI self-collection can increase testing rates, and access to these kits through mobile applications (apps) could help facilitate YMSM using HIV self-testing and STI self-collection.MethodsData for this study comes from two pilot randomized controlled trials (RCTs) of mobile apps within the Adolescent Trials Network-LYNX and MyChoices-aimed to increase HIV/STI testing among YMSM (age 15-24) who had not recently tested for HIV and were at high risk for HIV acquisition across five US cities. Both apps include the ability to order a HIV self-test with rapid results and a kit for STI self-collection and mailing of samples for syphilis, gonorrhea and chlamydia to a lab for testing. Using assessments of app users (n=80) at pre-randomization and at 3- and 6-months post-randomization and online interview data from a purposive sample of app users (n=37), we report on experiences and lessons learned with HIV self-testing and STI self-collection kits ordered via the apps.ResultsParticipants were on average 20.7 years of age (SD =2.4), and 49% were non-White or multiple race/ethnicity. Sixty-three percent had a prior HIV test. Over half (58%) had a prior STI test, but only 3% had tested within the past 3 months. Nearly two-thirds ordered an HIV self-testing kit; of whom, 75% reported using at least one self-test kit over the study period. STI self-collection kit ordering rates were also high (54%); however, STI self-collection kit return rates were lower (13%), but with a high positivity rate (5.3%). Both HIV self-testing and STI self-collection kits were highly acceptable, and 87% reported that it was extremely/very helpful to be able to order these kits through the apps. The most common reason for not ordering the HIV/STI kits was preferring to test at a clinic. In interviews, participants expressed feeling empowered by being able to test at home; however, they also raised concerns around STI sample collection.ConclusionsHIV self-testing and STI self-collection kit ordering via mobile apps is feasible, acceptable and may show promise in increasing testing rates among YMSM. The LYNX and MyChoices apps are currently being tested in a full-scale efficacy trial, and if successful, these innovative mobile apps could be scaled up to efficiently increase HIV/STI testing among youth across the US.

BackgroundThe estimated 2.2 million people who inject drugs (PWID) in the USA experience significant gaps in preventive healthcare and a high burden of infectious, psychiatric, and other chronic diseases. Many PWID rely on emergency medical services, which are costly and not designed to deliver preventive services, manage chronic conditions, or address social needs.ObjectiveThe objective of this study was to explore barriers and facilitators to primary care utilization from the perspectives of PWID in New England, a region highly affected by the overdose crisis.DesignParticipants completed semi-structured qualitative interviews exploring substance use and healthcare utilization patterns.ParticipantsWe recruited 78 PWID through community-based organizations (e.g., syringe service programs) in 16 urban and non-urban communities throughout Massachusetts and Rhode Island.ApproachThematic analysis identified barriers and facilitators to primary care utilization at the individual, interpersonal, and systemic levels.Key resultsAmong 78 PWID, 48 described recent primary care experiences; 33 had positive experiences and 15 described negative experiences involving discrimination or mistrust. Individual-level barriers to primary care utilization included perceived lack of need and competing priorities (e.g., avoiding opioid withdrawal, securing shelter beds). Interpersonal-level barriers included stigma and perceived low quality of care for PWID. Systemic-level barriers included difficulty navigating healthcare systems, inadequate transportation, long wait times, and frequent provider turnover. Participants with positive primary care experiences explained how appointment reminders, flexible hours, addiction medicine-trained providers, case management services, and transportation support facilitated primary care utilization and satisfaction.ConclusionsFindings regarding the multilevel barriers and facilitators to accessing primary care among PWID identify potential targets for programmatic interventions to improve primary care utilization in this population. Based on these findings, we make recommendations for improving the engagement of PWID in primary care as a means to advance individual and public health outcomes.

Background Stigma is associated with poor health among sexual minority individuals. However, no studies have examined the relationship between stigma and problematic drinking among male sex workers (MSWs). This study examined the relationship between sex work stigma and problematic alcohol use among MSWs.MethodsUsing baseline data from a cohort of 98 MSWs in the US Northeast enrolled between 2015 and 2016, we used logistic regression to examine associations between sex work stigma and hazardous drinking (Alcohol Use Disorders Identification Test (AUDIT) score ≥8) and sex work while drunk, and tested whether sexual orientation (gay vs non-gay identified) and social network size moderated these associations.ResultsAlmost half the sample (n = 46; 44%) reported hazardous drinking and 56 MSWs (57%) reported engaging in sex work while drunk. Sex work stigma was associated with hazardous drinking (adjusted odds ratio (aOR) 1.2, 95% confidence interval (CI) 1.05-1.36). Sexual orientation marginally moderated this relationship (P = 0.07), such that it was only significant among gay-identified MSWs (aOR 1.91, 95% CI 1.11-3.28), not among non-gay MSW. Similarly, sexual orientation moderated the effect of sex work stigma on sex work while drunk (P = 0.02), which was only significant among gay-identified MSWs (aOR 1.65, 95% CI 1.05-1.60). Social network size also moderated the effect of sex work stigma on sex work while drunk (P = 0.02), which was only significant among MSWs with small networks (aOR 1.26, 95% CI 1.00-1.58), suggesting large networks can be protective.ConclusionsGay MSWs may be particularly vulnerable to alcohol-related effects of stigma. Future interventions should consider engaging social networks to curb problematic drinking among MSWs.

Purpose: We assessed if young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents. Methods: This study analyzed baseline findings from a diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015. Bivariate and multivariable logistic regression were used to assess if parental support was associated with a decreased odds of suicidal ideation. Results: Nearly one-fifth (18.9%) of YTW reported suicidal ideation at baseline. In our adjusted multivariable model, YTW with supportive mothers had 0.37 (95% confidence interval = 0.15-0.90) times the odds of having suicidal ideation compared with YTW with unsupportive mothers. Conclusion: This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity. Our results suggest that parent-focused interventions to improve the relationships between YTW and their parents may lower the odds of YTW having suicidal ideation. Clinical Trial Registration Identifier: NCT01575938.

BackgroundPeople who inject drugs (PWID) are at increased risk for HIV acquisition and could benefit from antiretroviral pre-exposure prophylaxis (PrEP). However, PrEP has been underutilized in this population, and PrEP adherence intervention needs are understudied.MethodsTo inform PrEP intervention development, we reviewed evidence on antiretroviral therapy (ART) adherence among HIV-infected PWID. Guided by a behavioral model of healthcare utilization and using the PICOS framework, we conducted a systematic review in four electronic databases to identify original research studies of ART adherence in HIV-infected PWID in the United States and Canada between Jan 1, 2006-Dec 31, 2016. We synthesized and interpreted findings related to developing recommendations for PrEP adherence interventions for PWID.ResultsAfter excluding 618 duplicates and screening 1049 unique records, we retained 20 studies of PWID (mean n = 465) with adherence-related outcomes (via pharmacy records: n = 9; self-report: n = 8; biological markers: n = 5; electronic monitoring: n = 2). Predisposing factors (patient-level barriers to adherence) included younger age, female sex, and structural vulnerability (e.g., incarceration, homelessness). Enabling resources (i.e., facilitators) that could be leveraged or promoted by interventions included self-efficacy, substance use treatment, and high-quality patient-provider relationships. Competing needs that require specific intervention strategies or adaptations included markers of poor physical health, mental health comorbidities (e.g., depression), and engagement in transactional sex.ConclusionsHIV treatment adherence research carries important lessons for efforts to optimize PrEP adherence among PWID. Despite limitations, this systematic review suggests that strategies are needed to engage highly vulnerable and marginalized sub-groups of this underserved population (e.g., younger PWID, women who inject drugs) in PrEP adherence-related research and programming.

BackgroundHepatitis C virus (HCV) infection is increasingly prevalent among people who inject drugs (PWID) in the context of the current US opioid crisis. Although curative therapy is available and recommended as a public health strategy, few PWID have been treated. We explore PWID narratives that explain why they have not sought HCV treatment or decided against starting it. We then compare these narratives to evidence-based and guideline-concordant information to better enable health, social service, harm reduction providers, PWID, and other stakeholders to dispel misconceptions and improve HCV treatment uptake in this vulnerable population.MethodsWe recruited HIV-uninfected PWID (n = 33) through community-based organizations (CBOs) to participate in semi-structured, in-depth qualitative interviews on topics related to overall health, access to care, and knowledge and interest in specific HIV prevention methods.ResultsIn interviews, HCV transmission and delaying or forgoing HCV treatment emerged as important themes. We identified three predominant narratives relating to delaying or deferring HCV treatment among PWID: (1) lacking concern about HCV being serious or urgent enough to require treatment, (2) recognizing the importance of treatment but nevertheless deciding to delay treatment, and (3) perceiving that clinicians and insurance companies recommend that patients who currently use or inject drugs should delay treatment.ConclusionsOur findings highlight persistent beliefs among PWID that hinder HCV treatment utilization. Given the strong evidence that treatment improves individual health regardless of substance use status while also decreasing HCV transmission in the population, efforts are urgently needed to counter the predominant narratives identified in our study. We provide evidence-based, guideline-adherent information that counters the identified narratives in order to help individuals working with PWID to motivate and facilitate treatment access and uptake. An important strategy to improve HCV treatment initiation among PWID could involve disseminating guideline-concordant counternarratives to PWID and the providers who work with and are trusted by this population.

BackgroundMen who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India.MethodsFunded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months.DiscussionHIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group.Trial registrationClinicalTrials.gov Identifier: NCT02556294 , registered 22 September 2015.

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

BackgroundHIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, "adaptive" ART adherence intervention protocol for HIV-infected adolescents and young adults.MethodsThis is a randomized controlled trial (RCT) to establish the efficacy of "Positive STEPS," a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report.DiscussionBehavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings.Trial registrationClinicalTrials.gov number NCT03092531 , registered March 28, 2017.

BackgroundCross-sectional studies have suggested that co-occurring epidemics or "syndemics" of psychosocial health problems may accelerate HIV transmission among men who have sex with men (MSM) in the United States. We aimed to assess how 5 syndemic conditions (depressive symptoms, heavy alcohol use, stimulant use, polydrug use, and childhood sexual abuse) affected HIV incidence and sexual risk behavior over time.MethodsEligible men in a large prospective cohort of sexually active HIV-uninfected MSM completed HIV testing and behavioral surveys at baseline and every 6 months for 48 months. We examined interrelationships between psychosocial problems and whether these interactions increased the odds of HIV risk behaviors and risk of seroconversion over study follow-up.ResultsAmong 4295 men, prevalence of psychosocial conditions was substantial at baseline and was positively associated with each other. We identified a statistically significant positive dose-response relationship between numbers of syndemic conditions and HIV seroconversion for all comparisons (with the greatest hazard among those with 4-5 conditions, adjusted hazard ratio = 8.69; 95% confidence interval: 4.78 to 15.44). The number of syndemic conditions also predicted increased HIV-related risk behaviors over time, which mediated the syndemic-HIV seroconversion association.ConclusionsThe accumulation of syndemic psychosocial problems predicted HIV-related sexual risk behaviors and seroconversion in a large sample of US MSM. Given the high prevalence of syndemic conditions among MSM and the moderate effect sizes attained by traditional brief behavioral interventions to date, the HIV prevention agenda requires a shift toward improved assessment of psychosocial comorbidities and stronger integration with mental health and substance abuse treatment services.