Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are ...the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women.
This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits.
Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population.
ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of ...critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group.
This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up.
Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group.
ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
IMPORTANCE: The incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk ...behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group. OBJECTIVE: To determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach. INTERVENTIONS: Participants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time- and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board’s recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period. MAIN OUTCOMES AND MEASURES: Primary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits. RESULTS: Of the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 0.40 at baseline vs 1.22 0.22 at 4 months) compared with the standard of care group (2.69 0.59 at baseline vs 2.10 0.47 at 4 months) (risk ratio RR, 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 0.13 vs 1.40 0.32; RR, 0.60; 95% CI, 0.50-0.72; P < .001). CONCLUSIONS AND RELEVANCE: Among YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01575938
HIV incidence among young adult men who have sex with men (MSM), particularly among black and Latino men, continues to rise. As such, continued HIV prevention interventions for young MSM of color are ...of utmost importance. Male Youth Pursuing Empowerment, Education and Prevention around Sexuality (MyPEEPS) Mobile is a comprehensive HIV prevention and sexual health education smartphone app initially created to promote sexual health and HIV prevention among adolescent sexual minority young men aged 13 to 18 years.
The objective of this study was to critically appraise the acceptability and usability of MyPEEPS Mobile for young adult MSM aged 19 to 25 years.
Study participants used the mobile app, completed usability questionnaires and in-depth interviews, and reported their experience using the app. Analysis of interview data was guided by the Unified Theory of Acceptance and Use of Technology (UTAUT) to better understand the usability and acceptability of this intervention for young adults. Interview data were coded using the following constructs from the UTAUT model: performance expectancy, effort expectancy, and social influence.
A total of 20 young adult MSM (n=10 in Chicago, Illinois, and n=10 in New York, New York) were enrolled in the study. Participants reported that MyPEEPS Mobile was free of functional problems (Health Information Technology Usability Evaluation Scale scores and Post-Study System Usability Questionnaire scores consistent with high usability), easy to use, and useful, with an engaging approach that increased acceptability, including the use of avatars and animation, and inclusive representation of the diverse identities by race and ethnicity, gender identity, and sexual orientation. Recommended areas for improving MyPEEPS Mobile for the target demographic included more adult-oriented graphics, advanced educational content, scenarios for youth with more sexual experience, and search function to increase accessibility of key content.
Overall, young adult MSM aged 19 to 25 years described the MyPEEPS Mobile as educational, informative, and usable for their sexual health education and HIV prevention needs, and they provided actionable recommendations to optimize its use and applicability for this age group.
Young men who have sex with men are at increased risk for HIV. Research with older men and high-risk populations suggests that network dynamics may contribute to the spread of infectious disease and ...HIV, but little is known about the sexual networks of young men who have sex with men. Utilizing a unique dataset, this study presents novel descriptive data about the sexual networks of racially diverse 17- to 23-year-old young men who have sex with men. Additionally, individual, partner, and network characteristics of these young men who have sex with men were examined as potential drivers of HIV, STI, and unprotected intercourse. Results indicated several partner- and network-level factors associated with HIV and associated outcomes.
The rate of chronic health conditions (CHCs) in children and adolescents has doubled in the past 20 years, with increased health care costs. Technology-based interventions have demonstrated efficacy ...to improving medication adherence. However, data to support the cost effectiveness of these interventions are lacking.
The objective of this study is to conduct an economic evaluation of text-messaging and smartphone-based interventions that focus on improving medication adherence in adolescents with CHCs.
Searches included PubMed MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science, and Inspec. Eligibility criteria included age (12-24 years old), original articles, outcomes for medication adherence, and economic outcomes.
Our search identified 1118 unique articles that were independently screened. A total of 156 articles met inclusion criteria and were then examined independently with full-text review. A total of 15 articles met most criteria but lacked economic outcomes such as cost effectiveness or cost-utility data. No articles met all predefined criteria to be included for final review. Only 4 articles (text messaging n=3, electronic directly observed therapy n=1) described interventions with possible future cost-saving but no formal economic evaluation.
The evidence to support the cost effectiveness of text-messaging and smartphone-based interventions in improving medication adherence in adolescents with CHCs is insufficient. This lack of research highlights the need for comprehensive economic evaluation of such interventions to better understand their role in cost-savings while improving medication adherence and health outcomes. Economic evaluation of technology-based interventions can contribute to more evidence-based assessment of the scalability, sustainability, and benefits of broader investment of such technology tools in adolescents with CHCs.
Worldwide, transgender women are at disproportionately higher risk of HIV infection, with the primary mode of infection being condomless anal intercourse. Although very few HIV prevention ...interventions have been developed and tested specifically for transgender women, growing evidence suggests that behavioral HIV risk reduction interventions for other marginalized groups are efficacious. We outline the current state of knowledge and areas in need of further development in this area.
Mobile health (mHealth) apps have the potential to be a useful mode of delivering HIV prevention information, particularly for young men (13-24 years) who account for 21% of new HIV diagnoses in the ...United States. We translated an existing evidence-based, face-to-face HIV prevention curriculum into a portable platform and developed a mobile Web app: MyPEEPS Mobile.
The purpose of this study was to assess the usability of MyPEEPS Mobile from both expert and end user perspectives.
We conducted a heuristic evaluation with five experts in informatics to identify violations of usability principles and end user usability testing with 20 young men aged 15 to 18 years in New York, NY, Birmingham, AL, and Chicago, IL to identify potential obstacles to their use of the app.
Mean scores of the overall severity of the identified heuristic violations rated by experts ranged from 0.4 and 2.6 (0=no usability problem to 4=usability catastrophe). Overall, our end users successfully completed the tasks associated with use case scenarios and provided comments/recommendations on improving usability of MyPEEPS Mobile. The mean of the overall Post-Study System Usability Questionnaire scores rated by the end users was 1.63 (SD 0.65), reflecting strong user acceptance of the app.
The comments made by experts and end users will be used to refine MyPEEPS Mobile prior to a pilot study assessing the acceptability of the app across diverse sexual minority young men in their everyday lives.
To address poor outcomes among adolescents and young adults living with HIV (AYA-HIV), iCARE Nigeria successfully piloted two-way text message antiretroviral therapy (ART) reminders together with ...peer navigation. Study participants had significant improvement in ART adherence and viral suppression at 48 weeks. Understanding facto of this intervention. We used explanatory, mixed methods to assess implementation outcomes (feasibility, acceptability, and adoption) and identify implementation strategies used or adapted to promote intervention success. Quantitative data included participant surveys, program records, and back-end mHealth data, and were summarized using descriptive statistics. Qualitative data were collected from key informants and focus group discussions with program staff and summarized using directed content analysis. iCARE Nigeria was feasible as evidenced by ease of recruitment, high retention of patients and peer navigators (PN), and successful deployment of initial text message reminders (99.9%). Most participants (95%) and PN (90%) found text message reminders were not bothersome or intrusive. Implementation strategies employed to facilitate intervention success included: (1) selecting, training, supervising, and matching of PN to patients; (2) tailoring frequency (daily to weekly) and mode of communication between PN and patients according to patient need; (3) routine screening for adherence challenges; (4) changing phone airtime stipends from monthly to weekly in response to rapid depletion; and (5) conducting telecommunication needs assessments, to identify and troubleshoot implementation barriers (issues with mobile devices, power availability). iCARE Nigeria was feasible and acceptable with high adoption by stakeholders. The implementation strategies identified here can be tailored for intervention scale-up in similar environments to promote ART adherence for AYA-HIV.