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An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

ABSTRACT: BACKGROUND:Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to male-to-male sexual contact among adolescents and young adults aged 13 to 24 years. However, such disparities cannot be attributed to individual-level factors alone but rather are situated within larger social and structural contexts that marginalize and predispose YMSM, YTW, and GNC youth of color to increased HIV exposure. Addressing social and structural risk factors requires intervention on distal drivers of HIV risk, including employment and economic stability. The Work2Prevent (W2P) study aims to target economic stability through job readiness and employment as a structural-level intervention for preventing adolescent and young adult HIV among black and Latinx YMSM, YTW, and GNC youth. This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors. OBJECTIVE:The goal of the research is to pilot-test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color. This intervention was adapted from Increased Individual Income and Independence, an existing evidence-based employment program for HIV-positive adults during phase 1 of the W2P study. METHODS:The employment intervention will be pilot-tested among vulnerable YMSM, YTW, and GNC youth of color in a single-arm pre-post trial to assess feasibility, acceptability, and preliminary estimates of efficacy. RESULTS:Research activities began in March 2018 and were completed in November 2019. Overall, 5 participants were enrolled in the pretest and 51 participants were enrolled in the pilot. CONCLUSIONS:Interventions that address the social and structural drivers of HIV exposure and infection are sorely needed in order to successfully bend the curve in the adolescent and young adult HIV epidemic. Employment as prevention has the potential to be a scalable intervention that can be deployed among this group. TRIAL REGISTRATION:ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16401.

SUBMITTER: Hill BJ

PROVIDER: S-EPMC7445605 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

Hill Brandon J BJ Motley Darnell N DN Rosentel Kris K VandeVusse Alicia A Garofalo Robert R Schneider John A JA Kuhns Lisa M LM Kipke Michele D MD Reisner Sari S Rupp Betty M BM Sanchez Maria M McCumber Micah M Renshaw Laura L West Goolsby Rachel R Loop Matthew Shane MS

JMIR research protocols 20200810 8

<h4>Background</h4>Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to male-to-male sexual contact among adolescents and young adults aged 13 to 24 years. However, such disparities cannot be attributed to individual-le ...[more]

PMID: 32773376

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Project description:BACKGROUND:In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2. OBJECTIVE:This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting. METHODS:The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy. RESULTS:Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot. CONCLUSIONS:This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned. TRIAL REGISTRATION:ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/18051.

Project description:BACKGROUND:HIV continues to have a disparate impact on young cisgender men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth who are assigned male at birth. Outcomes are generally worse among youth of color. Experiences of discrimination and marginalization often limit educational attainment and may even more directly limit access to gainful employment. Though seemingly distal, these experiences influence young people's proximity to HIV risk by limiting their access to health care and potentially moving them toward sex work as a means of income as well as increased substance use. Work2Prevent (W2P) aims to achieve economic stability through employment as a structural-level intervention for preventing adolescent and young adult HIV infection. The study will pilot-test an effective, theoretically driven employment program (increased individual income and independence [iFOUR]), for HIV-positive adults, and adapt it to the needs of black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years who are vulnerable to HIV exposure. OBJECTIVE:This paper aimed to describe the protocol for the exploratory phase of W2P. The purpose of this phase was to determine the essential components needed for a structural-level employment intervention aimed at increasing job-seeking self-efficacy and career readiness among black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years. METHODS:The exploratory phase of the W2P study consisted of in-depth interviews and focus groups with members of the target community as well as brief interviews with lesbian, gay, bisexual, transgender, and queer (LGBTQ)-inclusive employers. The study team will conduct in-depth interviews with up to 12 YMSM and 12 YTW and GNC youth, up to 10 focus groups with a maximum of 40 YMSM and 40 YTW and GNC youth, and up to 40 brief interviews with LGBTQ-inclusive employers. Participants will be recruited through a community-based recruiter, passive recruitment in community spaces and on social media, and active recruitment by research staff in community spaces serving LGBTQ youth. RESULTS:In-depth interviews were conducted with 21 participants, and 7 focus groups were conducted with 46 participants in total. In addition, 19 brief interviews with LGBTQ-inclusive employers were conducted. The analysis of the data is underway. CONCLUSIONS:Preliminary findings from the formative phase of the study will be used to inform the tailoring and refinement of the iFOUR adult-based intervention into the youth-focused W2P intervention curriculum. Perspectives from YMSM, YTW, GNC youth, and LGBTQ-inclusive employers offer a multidimensional view of the barriers and facilitators to adolescent and young adult LGBTQ employment. This information is critical to the development of a culturally appropriate and relevant youth-focused intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16384.

Project description:BackgroundDiet and exercise may be associated with quality of life and survival in men with prostate cancer.ObjectiveThis study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer.MethodsWe conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ?18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls-one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes.ResultsIn total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1.ConclusionsA web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations.Trial registrationClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.

Project description:BACKGROUND:Caregiver involvement is critical for supporting positive behavioral health and legal outcomes for justice-involved youth; however, recruiting this population into clinical research studies and engaging them in treatment remain challenging. Technology-based approaches are a promising, yet understudied avenue for recruiting and intervening with caregivers of justice-involved youth. OBJECTIVE:This mixed methods study aimed to assess the feasibility of recruiting caregivers of justice-involved youth using social media into clinical research and to understand caregivers' perceptions of the acceptability of digital health interventions. METHODS:Caregivers of justice-involved youth were recruited through paid Facebook advertisements to participate in a Web-based survey. Advertisement design was determined using Facebook A/B split testing, and the advertisement with the lowest cost per link click was used for the primary advertisement campaign. Survey participants were offered the option to participate in a follow-up qualitative phone interview focused on the perceived feasibility and acceptability of digital health interventions. RESULTS:Facebook advertisements were successful in quickly recruiting a diverse set of caregivers (80/153, 52.3% female; mean age 43 years, SD 7; 76/168, 45.2% black, 34/168, 20.2% white, and 28/168, 16.7% Latinx; and 97/156, 62.2% biological parents); cost per click was US $0.53, and conversion rate was 11.5%. Survey participants used multiple social media platforms; 60.1% (101/168) of the participants indicated they would participate in a digital health intervention for caregivers of justice-involved youth. Survey respondents' most preferred intervention was supportive and motivational parenting messages via SMS text message. Of the survey respondents, 18 completed a phone interview (12/18, 67% female; mean age 45 years, SD 10; 10/18, 56% black, 7/18, 39% white, and 1/18, 6% Latinx; and 16/18, 89% biological parents). Interview participant responses suggested digital health interventions are acceptable, but they expressed both likes (eg, alleviates barriers to treatment access) and concerns (eg, privacy); their most preferred intervention was video-based family therapy. CONCLUSIONS:Recruiting and intervening with caregivers of justice-involved youth through social media and other digital health approaches may be a feasible and acceptable approach to overcoming barriers to accessing traditional in-person behavioral health care.

Project description:Developing an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine.One hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination (at 12 months) to investigate feasibility and acceptability of a future HIV vaccine trial in this population. Adverse events, changes in risk behaviour, acceptability of trial procedures and motivations for participation in future trials were assessed.Men were a median 25 years old (inter-quartile range?=?23-29), 53% were employed, 90% secondary school educated and 67% uncircumcised. Of the 900 scheduled study visits, 90% were completed in the immediate vaccination arm (405/450) and 88% (396/450) in the delayed arm (P?=?0.338). Acceptability of trial procedures and services was very high overall. However, only 65% of the deferred group strongly liked being randomised compared to 90% in the immediate group (P?=?0.001). Informed consent processes were viewed favourably by 92% of the delayed and 82% of the immediate group (P?=?0.080). Good quality health services, especially if provided by a male nurse, were rated highly. Even though almost all participants had some concern about the safety of a future HIV vaccine (98%), the majority were willing to participate in a future trial. Future trial participation would be motivated mainly by the potential for accessing an effective vaccine (81%) and altruism (75%), rather than by reimbursement incentives (2%).Recruitment and retention of men into vaccine trials is feasible and acceptable in our setting. Findings from this surrogate vaccine trial show a high willingness to participate in future HIV vaccine trials. While access to potentially effective vaccines is important, quality health services are an equally compelling incentive for enrolment.

Project description:BackgroundHIV self-testing (HIVST) is an innovative HIV testing approach that effectively reaches those who do not otherwise test, including key populations (KPs). Despite potential benefits, HIVST is not currently implemented in Pakistan. The high risk of HIV among transgender (TGs) persons is among the highest risk group for HIV in Pakistan, yet knowledge of HIV status remains low in this key population group. We conducted a pilot project to assess the acceptability and feasibility of distributing HIVST to TGs in Larkana.MethodsEligible participants were 18 years or above and self-identified as transgender ("hijra"). One oral fluid HIVST kit per person was distributed free of cost in the community by trained transgender peer outreach workers (ORW). Participants could request a demonstration of the HIVST procedure before performing self-testing which was provided by the trained ORW. Demographic characteristics of participants were collected. The ORW followed up with phone calls two days later to record if HIVST kits were used, the results, and whether assistance was required.ResultsBetween November 2020 and February 2021, 150 HIVST kits were distributed to eligible TGs. The average age of participants was 25.5 years (standard deviation: 7.0). Over a third (52, 34.7%) had no formal education, while (16, 10.6%) had attended at least five years of schooling. Over one-third (58, 38.6%) of participants were first-time testers. One hundred and thirty-nine (92.7%) participants reported their results within two days. For the remaining 11 participants, ORWs had to contact them. All participants reported using HIVST kits within three days. A majority (141, 94%) used the kit in their homes, and the remaining nine (6%) used it at the community-based organization's office. Overall, a small proportion (11, 7.3%) of participants requested a demonstration of the test procedure before performing HIVST. Four (2.7%) participants who had performed unsupervised self-tests reported reactive HIVST results; all were linked to treatment within five working days once their HIV result was confirmed. The majority (136, 90.6%) of participants felt that self-testing was easy to perform independently, and 143 (95%) reported that they would recommend HIVST to their peers.ConclusionHIVST is acceptable among TGs and identified by first-time testers as undiagnosed infections. Peer-led distribution appears to be a feasible approach for implementation in this setting. HIVST should be considered for routine implementation and scale up to reduce testing gaps among Pakistan's key population, particularly TGs.

Dataset Information

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

Publications

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

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