scholarly journals Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial (Preprint)

2018 ◽  
Author(s):  
Jeffrey T Parsons ◽  
Tyrel Starks ◽  
Sitaji Gurung ◽  
Demetria Cain ◽  
Jonathan Marmo ◽  
...  

BACKGROUND Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men’s Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. OBJECTIVE This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. METHODS This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats—clinic-based versus remote delivery—offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. RESULTS Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. CONCLUSIONS We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery. CLINICALTRIAL ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11184

Sexual Health ◽  
2020 ◽  
Vol 17 (1) ◽  
pp. 87
Author(s):  
C. Kelsie Dodson ◽  
D'Netria Jackson ◽  
Christina A. Muzny ◽  
Ellen F. Eaton

Background Young Black men who have sex with men (YBMSM) in the Deep South are at increased risk of sexually transmissible infections (STIs) and HIV. The present two-phase study evaluated the recruitment of YBMSM, both HIV infected and uninfected, for a sexual health study in Birmingham (AL, USA) from 2017 to 2019 and explored alternative patient-centred recruitment methods. Methods: In Phase 1, YBMSM were recruited to participate in focus groups related to STI testing. To recruit participants, flyers were displayed in businesses, clinics and lesbian, gay, bisexual and transgender (LGBT)-friendly organisations. In addition, research staff at an HIV clinic referred participants and a recruiter attended community events. In Phase 2, YB men were asked, in an electronic survey, ‘What is the best way to recruit young, Black men for surveys about sexual health?’ and ‘If you selected ‘social media’, which social media sites or ‘apps’ do you think are best to recruit young, Black men?’. Results: In Phase 1, 38 YBMSM participated in focus groups. Twelve (32%) were recruited by referral, 9 (24%) were recruited from an HIV clinic and 11 (29%) were recruited from an LGBT organisation. The recruiter was unable to recruit any participants. In Phase 2, 55 YBMSM completed the electronic survey. Twenty-six (48%) selected social media as the best way to recruit young Black men for surveys about sexual health, and their suggested platforms included Instagram, Facebook, Twitter, Snapchat, Kik and dating apps. Seventeen (31%) selected ‘Having young gay black men recruit from their friends and acquaintances’ as the ideal recruitment strategy. Conclusion: Challenges persist when recruiting YBMSM for sexual health research. Social media may provide better access to this vulnerable population.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Stijn Hogervorst ◽  
Marcel Adriaanse ◽  
Hella Brandt ◽  
Marcia Vervloet ◽  
Liset van Dijk ◽  
...  

Abstract Purpose The purpose of this feasibility study was to improve and implement an intervention aimed at enhancing medication adherence in sub-optimally controlled and non-adherent type 2 diabetes (T2DM) patients in primary care. Methods Four phases were completed: (1) context analysis, (2) collaboration protocol development, (3) digitalization, and (4) process evaluation. Two community pharmacies and seven general practices participated. In phase 1, two focus groups were conducted, of which one with healthcare providers (HCP, N = 5) and one with patients (N = 11). In phase 4, four semi-structured interviews and one focus group (N = 6) were conducted with healthcare providers. The goal of these focus groups and interviews was to obtain insights into current care to support medication adherence (phase 1), opportunities for collaboration (phase 2) and process evaluation (phase 4). Data were analyzed in Atlas.ti using thematic analyses. Results Both T2DM patients and HCPs considered medication adherence vital. Suboptimal collaboration between HCPs and unreliable ways to monitor medication non-adherence appeared important barriers for adequate care to support medication adherence (phase 1). The nurse practitioner (NP) was chosen as the interventionist with supportive roles for other HCPs (phase 2). All components of the intervention were digitalized (phase 3). The implementation of the digitalized intervention was reported to be suboptimal (phase 4). Main reasons were that pharmacy refill data were unreliable, NPs experienced difficulties addressing medication non-adherence adequately and collaboration between HCPs was suboptimal. Conclusions The medication adherence enhancing intervention was successfully digitalized, but implementation of the digitalized intervention appeared not feasible as of yet.


2015 ◽  
Vol 11 (3) ◽  
pp. 498-507 ◽  
Author(s):  
José A. Bauermeister ◽  
Lisa Eaton ◽  
Steven Meanley ◽  
Emily S. Pingel ◽  

Transactional sex refers to the commodification of the body in exchange for shelter, food, and other goods and needs. Transactional sex has been associated with negative health outcomes including HIV infection, psychological distress, and substance use and abuse. Compared with the body of research examining transactional sex among women, less is known about the prevalence and correlates of transactional sex among men. Using data from a cross-sectional survey of young men who have sex with men (ages 18-29) living in the Detroit Metro Area ( N = 357; 9% HIV infected; 49% Black, 26% White, 16% Latino, 9% Other race), multivariate logistic regression analyses examined the association between transactional sex with regular and casual partners and key psychosocial factors (e.g., race/ethnicity, education, poverty, relationship status, HIV status, prior sexually transmitted infections [STIs], mental health, substance use, and residential instability) previously identified in the transactional sex literature. Forty-four percent of the current sample reported engaging in transactional sex. Transactional sex was associated with age, employment status, relationship status, and anxiety symptoms. When stratified, transactional sex with a regular partner was associated with age, educational attainment, employment status, relationship status, anxiety, and alcohol use. Transactional sex with a casual partner was associated with homelessness, race/ethnicity, employment status, and hard drug use. The implications of these findings for HIV/STI prevention are discussed, including the notion that efforts to address HIV/STIs among young men who have sex with men may require interventions to consider experiences of transactional sex and the psychosocial contexts that may increase its likelihood.


2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Hector Garcia-Alcala ◽  
Celia Isabel Santos Vichido ◽  
Silverio Islas Macedo ◽  
Christelle Nathalie Genestier-Tamborero ◽  
Marissa Minutti-Palacios ◽  
...  

Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety ofα-lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd;n=16) or to ALA withdrawal (n=17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p<0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p<0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier:NCT02439879.


2019 ◽  
Author(s):  
Elizabeth McConnell

Black men who have sex with men (MSM), especially young MSM, are more likely to contract Human Immunodeficiency Virus (HIV) than MSM of other races. However, Black MSM consistently report comparable or fewer individual risk behaviors than MSM of other races. Research thus far has largely targeted individual risk factors and has been unable to account for the mechanisms driving this racial disparity. In addition, although individual risk behaviors occur within particular risk environments, little research examining HIV racial disparities has acknowledged that substance use and other HIV risk behaviors are socially and spatially dependent. Emerging research with Black MSM documents racial/ethnic differences in the individual, venue, and neighborhood level networks of young men who have sex with men (YMSM). These findings suggest that although rates of drug use and other individual risk behaviors may be lower among Black YMSM than other racial/ethnic groups, their consequences may be different due to the nature of the risk environments experienced by these young men. The overall objective of this project was to contribute to knowledge about structural mechanisms (e.g., stigma, discrimination, and resource inequality) that shape risk environments, which in turn shape consequences of substance use and other HIV risk behaviors for YMSM of different races/ethnicities. However, quantitative data describing these social and spatial contexts (i.e., the structure of individual, venue, and neighborhood networks) has limited capacity to explore and explain these complex phenomena, and interpreting these data is problematic without the incorporation of the voices, lived experiences, and insights of YMSM themselves. Therefore, thisstudy used an innovative mixed methods approach to visualize and guide the interpretation of individual, venue, and neighborhood level networks captured within an existing NIH-funded cohort of YMSM. Using an explanatory sequential design, multilevel network and geospatial data were visualized (Phase 1) and subsequently used to guide interviews with YMSM (Phase 2). Grounded theory was used to analyze interview data, leading to a theory of mechanisms that shape HIV racial disparities in this population. The overall project had two aims: 1) demonstrate several mechanisms through networks at the individual, venue, and neighborhood levels form risk environments that shape substance use and HIV risk for White, Black, and Hispanic/Latino YMSM, and 2) demonstrate several structural mechanisms, such as stigma, discrimination, and resource inequality, that shape the individual, venue, and neighborhood level networks and risk environments of White, Black, and Hispanic/Latino YMSM.


2017 ◽  
Author(s):  
Melinda S Bender ◽  
Bruce A Cooper ◽  
Linda G Park ◽  
Sara Padash ◽  
Shoshana Arai

BACKGROUND Filipino Americans have a high prevalence of obesity, type 2 diabetes (T2D), and cardiovascular disease compared with other Asian American subgroups and non-Hispanic whites. Mobile health (mHealth) weight loss interventions can reduce chronic disease risks, but these are untested in Filipino Americans with T2D. OBJECTIVE The objective of this study was to assess feasibility and potential efficacy of a pilot, randomized controlled trial (RCT) of a culturally adapted mHealth weight loss lifestyle intervention (Pilipino Americans Go4Health [PilAm Go4Health]) for overweight Filipino Americans with T2D. METHODS This was a 2-arm pilot RCT of the 3-month PilAm Go4Health intervention (phase 1) with an active waitlist control and 3-month follow-up (phase 2). The waitlist control received the PilAm Go4Health in phase 2, whereas the intervention group transitioned to the 3-month follow-up. PilAm Go4Health incorporated a Fitbit accelerometer, mobile app with diary for health behavior tracking (steps, food/calories, and weight), and social media (Facebook) for virtual social support, including 7 in-person monthly meetings. Filipino American adults ≥18 years with T2D were recruited from Northern California. Feasibility was measured by rates of recruitment, engagement, and retention. Multilevel regression analyses assessed within and between group differences for the secondary outcome of percent weight change and other outcomes of weight (kg), body mass index (BMI), waist circumference, fasting plasma glucose, HbA1c, and steps. RESULTS A total of 45 Filipino American adults were enrolled and randomized. Mean age was 58 (SD 10) years, 62% (28/45) were women, and mean BMI was 30.1 (SD 4.6). Participant retention and study completion were 100%, with both the intervention and waitlist group achieving near-perfect attendance at all 7 intervention office visits. Groups receiving the PilAm Go4Health in phase 1 (intervention group) and phase 2 (waitlist group) had significantly greater weight loss, −2.6% (−3.9 to −1.4) and −3.3% (−1.8 to −4.8), respectively, compared with the nonintervention group, resulting in a moderate to small effect sizes (d=0.53 and 0.37, respectively). In phase 1, 18% (4/22) of the intervention group achieved a 5% weight loss, whereas 82% (18/22) maintained or lost 2% to 5% of their weight and continued to maintain this weight loss in the 3-month follow-up. Other health outcomes, including waist circumference, BMI, and step counts, improved when each arm received the PilAm Go4Health, but the fasting glucose and HbA1c outcomes were mixed. CONCLUSIONS The PilAm Go4Health was feasible and demonstrated potential efficacy in reducing diabetes risks in overweight Filipino Americans with T2D. This study supports the use of mHealth and other promising intervention strategies to reduce obesity and diabetes risks in Filipino Americans. Further testing in a full-scale RCT is warranted. These findings may support intervention translation to reduce diabetes risks in other at-risk diverse populations. CLINICALTRIAL Clinicaltrials.gov NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived by WebCite at http://www.webcitation.org/6vDfrvIPp)


2018 ◽  
Vol 22 (7) ◽  
pp. 2284-2295 ◽  
Author(s):  
Michael E. Newcomb ◽  
Gregory Swann ◽  
David Mohr ◽  
Brian Mustanski

2021 ◽  
Author(s):  
Brian Suffoletto ◽  
Tina Goldstein ◽  
David Brent

BACKGROUND Many adolescents with depression do not pursue mental health (MH) treatment following referral by a heathcare provider. We developed a theory-based automated text message intervention (Text to Connect, T2C) that attempts to reduce cognitive barriers to initiation of MH care. OBJECTIVE In this 2-phase study, we sought to first understand potential for T2C and then test engagement, usability, and potential efficacy of T2C among adolescents with depression and their parent/caregiver. METHODS In phase 1, we conducted focus groups with adolescents with depression (n=9) and their parent/caregiver (n=9) separately and transcripts were examined for themes. In phase 2, we conducted an open trial of T2C with adolescents with depression referred to MH care (n=43) and their parent/caregiver (n=28). We assessed usability by examining program engagement, usability ratings and qualitative feedback at 4-weeks follow-up. We assessed potential effectiveness by examining change in perceived barriers to treatment and MH care initiation from baseline to 4-weeks. RESULTS In phase 1, we found that themes supported the T2C approach. In phase 2, we found high engagement with daily negative affect check-ins, high usability ratings, and self-reported decreases in barriers to MH treatment over time among adolescents. At 4-weeks follow-up, most adolescents reported either having initiated MH care (52%) or pending scheduling (15%), leaving only 15% of adolescents still not interested in MH care. CONCLUSIONS Findings from this study suggest that T2C is acceptable to adolescents with depression and most parent/caregivers, is used at high rates, and may be helpful to reduce cognitive barriers to MH care initiation. CLINICALTRIAL NCT04560075


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