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Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial.

ABSTRACT: INTRODUCTION:Strategies are needed to curb the increasing HIV incidence in young men who have sex with men (YMSM) and transgender women (YTGW) worldwide. We assessed the impact of youth-friendly services (YFS) and a mobile phone application (app) on adherence to pre-exposure prophylaxis (PrEP) in YMSM and YTGW in Thailand. METHODS:A randomized control trial was conducted in YMSM and YTGW aged 15 to 19 years. Participants were provided daily oral tenofovir disoproxil fumerate/emtricitabine (TDF/FTC), condoms and randomized to receive either YFS or YFS plus a PrEP app (YFS + APP), whose features included self-assessment of HIV acquisition risk, point rewards and reminders for PrEP and clinic appointments. Clinic visits occurred at zero, one, three and six months and telephone contact at two, four and five months. HIV testing was performed at every clinic visit. PrEP adherence was evaluated with intracellular tenofovir diphosphate (TFV-DP) concentrations in dried blood spot (DBS) samples at months 3 and 6. The primary endpoint assessed was "PrEP adherence" defined as TFV-DP DBS concentrations ?700 fmol/punch (equivalent to ?4 doses of TDF/week). RESULTS:Between March 2018 and June 2019, 489 adolescents were screened at three centres in Bangkok. Twenty-seven (6%) adolescents tested positive for HIV and 200 (41%) adolescents participated in the study. Of these, 147 were YMSM (74%) and 53 YTGW (26%). At baseline, median age was 18 years (IQR 17 to 19), 66% reported inconsistent condom use in the past month. Sexually transmitted infection prevalence was 23%. Retention at six months was 73%. In the YFS + APP arm, median app use duration was three months (IQR 1 to 5). PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p-value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p-value 0.54). No HIV seroconversions occurred during 75 person years of follow-up. CONCLUSIONS:Youth-friendly PrEP services enabled good adherence among half of adolescent PrEP users. However, the mobile phone application tested did not provide additional PrEP adherence benefit in this randomized trial. Adolescent risk behaviours are dynamic and require adaptive programmes that focus on "prevention-effective adherence."

SUBMITTER: Songtaweesin WN

PROVIDER: S-EPMC7459171 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial.

Songtaweesin Wipaporn Natalie WN Kawichai Surinda S Phanuphak Nittaya N Cressey Tim R TR Wongharn Prissana P Saisaengjan Chutima C Chinbunchorn Tanat T Janyam Surang S Linjongrat Danai D Puthanakit Thanyawee T Puthanakit Thanyawee T

Journal of the International AIDS Society 20200901

<h4>Introduction</h4>Strategies are needed to curb the increasing HIV incidence in young men who have sex with men (YMSM) and transgender women (YTGW) worldwide. We assessed the impact of youth-friendly services (YFS) and a mobile phone application (app) on adherence to pre-exposure prophylaxis (PrEP) in YMSM and YTGW in Thailand.<h4>Methods</h4>A randomized control trial was conducted in YMSM and YTGW aged 15 to 19 years. Participants were provided daily oral tenofovir disoproxil fumerate/emtri ...[more]

PMID: 32869511

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Project description:BackgroundWidespread smartphone use provides opportunities for mobile health HIV prevention strategies among at-risk populations.ObjectiveThis study aims to investigate engagement in a theory-based (information-motivation-behavioral skills model) mobile phone app developed to support HIV pre-exposure prophylaxis (PrEP) adherence among Thai young men who have sex with men (YMSM) and young transgender women (YTGW) in Bangkok, Thailand.MethodsA randomized controlled trial was conducted among HIV-negative YMSM and YTGW aged 15-19 years initiating daily oral PrEP. Participants were randomized to receive either youth-friendly PrEP services (YFS) for 6 months, including monthly contact with site staff (clinic visits or telephone follow-up) and staff consultation access, or YFS plus use of a PrEP adherence support app (YFS+APP). The target population focus group discussion findings and the information-motivation-behavioral skills model informed app development. App features were based on the 3Rs-risk assessment of self-HIV acquisition risk, reminders to take PrEP, and rewards as redeemable points. Dried blood spots quantifying of tenofovir diphosphate were collected at months 3 and 6 to assess PrEP adherence. Tenofovir diphosphate ≥350-699 fmol/punch was classified as fair adherence and ≥700 fmol/punch as good adherence. Data analysis on app use paradata and exit interviews were conducted on the YFS+APP arm after 6 months of follow-up.ResultsBetween March 2018 and June 2019, 200 participants with a median age of 18 (IQR 17-19) years were enrolled. Overall, 74% (148/200) were YMSM; 87% (87/100) of participants who received YFS+APP logged in to the app and performed weekly HIV acquisition risk assessments (log-in and risk assessment [LRA]). The median duration between the first and last log-in was 3.5 (IQR 1.6-5.6) months, with a median frequency of 6 LRAs (IQR 2-10). Moreover, 22% (22/100) of the participants in the YFS+APP arm were frequent users (LRA≥10) during the 6-month follow-up period. YMSM were 9.3 (95% CI 1.2-74.3) times more likely to be frequent app users than YTGW (P=.04). Frequent app users had higher proportions (12%-16%) of PrEP adherence at both months 3 and 6 compared with infrequent users (LRA<10) and the YFS arm, although this did not reach statistical significance. Of the 100 participants in the YFS+APP arm, 23 (23%) were interviewed. The risk assessment function is perceived as the most useful app feature. Further aesthetic adaptations and a more comprehensive rewards system were suggested by the interviewees.ConclusionsHigher rates of PrEP adherence among frequent app users were observed; however, this was not statistically significant. A short app use duration of 3 months suggests that they may be useful in establishing habits in taking daily PrEP, but not long-term adherence. Further studies on the specific mechanisms of mobile phone apps that influence health behaviors are needed.Trial registrationClinicalTrials.gov NCT03778892; https://clinicaltrials.gov/ct2/show/NCT03778892.

Project description:BackgroundAdolescents face socio-structural, personal and programmatic barriers to HIV prevention services, highlighting the importance of understanding knowledge and acceptability as essential aspects to promote their broader access to pre-exposure prophylaxis (PrEP). We analyzed the acceptability of PrEP among adolescent men who have sex with men (MSM), travestis and transgender women (TGW).MethodsA qualitative investigation was conducted as part of the formative research of the PrEP15-19 study, an ongoing demonstration study that analyzes the effectiveness of daily PrEP among adolescent MSM, travestis and TGW aged 15-19 in three Brazilian cities. A total of 37 semi-structured interviews and 6 focus groups were conducted. Building from thematic analysis focusing on participants' sexual encounters, perceptions about PrEP efficacy, and vulnerability contexts, we analyzed prospective acceptability of PrEP.FindingsKnowledge about PrEP was incipient and characterized by adolescents' frequent doubts about its prescription and efficacy. The 'ideal' use of PrEP appeared together with consistent condom use, especially in casual sex. PrEP use was also mentioned as depending on increased learning about prevention management over time. Main barriers to PrEP use included the incorporation of a daily medication into participants' routine and its impact on their social lives, especially related to stigma. Concerns over short- and long-term side effects were also reported as barriers to PrEP use. TGW and travestis contrasted using PrEP with the precarity of their life conditions, and some expressed a critical vision about PrEP by associating it with pharmaceuticalization and trans necropolitics.ConclusionsParticipants' low knowledge and acceptability of PrEP are circumscribed by a rigid perception of condom as the ideal prevention method and the context of their sexual relations. Prospective acceptability highlights that the successful uptake of PrEP depends on overcoming barriers of access to health services and confronting transphobia and homophobia as part of care.

Project description:BACKGROUND:We identified correlates of sex-related pre-exposure prophylaxis (PrEP) adherence in HPTN067/ADAPT, a phase 2, open-label feasibility study of daily and nondaily regimens of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)-based PrEP, among Thai men who have sex with men (MSM), and transgender women (TGW), Bangkok. METHODS:Participants were randomly assigned to one of three self-administered dosing regimens for 24 weeks: daily, time-driven, or event-driven. Demographic and behavioral information was obtained at screening. Pill-container opening was recorded with electronic dose monitoring, and self-reported information on PrEP use, sex events, and substance use was obtained during weekly interviews to confirm dose data. Sex-related PrEP adherence was calculated as the proportion of sex events covered by PrEP use (at least one tablet taken within 4 days before sex and at least one tablet taken within 24 hours after sex) to total sex events. We used multivariate modeling with sex event as the unit of analysis to evaluate correlates associated with sex-related PrEP adherence. RESULTS:Among 178 MSM and TGW, sex-related PrEP adherence was similar in the daily and time-driven arms (P = 0.79), both significantly greater than the event-driven arm (P = 0.02 compared to daily). Sex-related PrEP adherence by those reporting stimulant use (74.2%) was similar to those reporting other nonalcohol drug use (76.3%, P = 0.80), but lower than those reporting no substance use (84.6%, P = 0.04). In a multivariable model, randomization to the event-driven arm, a higher prestudy number of reported sex events, and use of stimulant drugs were associated with significantly lower sex-related PrEP adherence. CONCLUSION:Adherence was influenced by treatment schedule and adversely affected by nonalcoholic substance use. Regardless of these factors, Thai MSM and TGW maintained high adherence levels to oral PrEP dosing regimens and coverage of sexual exposures.

Project description:BackgroundIn the United States, young men who have sex with men (YMSM) and transgender women who have sex with men (YTWSM) bear a disproportionate burden of prevalent and incident HIV infections. Once diagnosed, many YMSM and YTWSM struggle to engage in HIV care, adhere to antiretroviral therapy (ART), and achieve viral suppression. Computer-based interventions, including those focused on behavior change, are recognized as effective tools for engaging youth.ObjectiveThe purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies, a theory-based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care, ART uptake, ART adherence, and viral suppression among HIV-positive YMSM and YTWSM. The study also qualitatively assesses intervention acceptability, perceived impact, and sustainability.MethodsThis is a two-group, active-control randomized controlled trial of the Epic Allies app. YMSM and YTWSM aged 16 to 24 inclusive, with detectable HIV viral load are randomized 1:1 within strata of new to care (newly entered HIV medical care ≤12 months of baseline visit) or ART-nonadherent (first entered HIV medical care >12 months before baseline visit) to intervention or control conditions. The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring, tracking of select adherence-related behaviors (eg, alcohol and marijuana use), an interactive dashboard that displays the participant's adherence-related behaviors and provides tailored feedback, encouragement messages from other users, daily HIV/ART educational articles, and gamification features (eg, mini-games, points, badges) to increase motivation for behavior change and app engagement. The control condition features weekly phone-based notifications to encourage participants to view educational information in the control app. Follow-up assessments are administered at 13, 26, and 39 weeks for each arm. The primary outcome measure is viral suppression. Secondary outcome measures include engagement in care, ART uptake, ART adherence, and psychosocial barriers to engagement in care and ART adherence, including psychological distress, stigma, and social support.ResultsBaseline enrollment began in September 2015 and was completed in September 2016 (n=146), and assessment of intervention outcomes continued through August 2017. Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials.gov by April 30, 2018.ConclusionsIf successful, Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States. Adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections, thereby reducing health care costs and HIV transmission. Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM, other HIV-positive populations, and for those diagnosed with other chronic diseases such as diabetes and hypertension.Trial registrationClinicalTrials.gov NCT02782130; https://clinicaltrials.gov/ct2/show/NCT02782130 (Archived by Webcite at http://www.webcitation.org/6yGODyerk).

Project description:IntroductionEfficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for PrEP is strongly dependent on the adherence. We examined the concordance between indirect adherence measures and protective drug levels among participants retained through 48 weeks in the PrEP Brasil Study.MethodsPrEP Brasil was a prospective, multicenter, open-label demonstration project evaluating PrEP provision for men who have sex with men (MSM) and transgender women (TGW) at higher risk for HIV infection within the setting of Brazilian Public Health System. Three indirect adherence measures were obtained at week 48: medication possession ratio (MPR), pill count and self-report (30-days recall). Tenofovir diphosphate (TFV-DP) concentration in Dried Blood Spot (DBS) was measured at week 48. Areas under (AUC) the receiver operating characteristics (ROC) curve were used to evaluate the concordance between achieving protective drug levels (TFV-DP≥700fmol/punch) and the indirect adherence measures. Youden's index and distance to corner were used to determine the optimal cutoff points for each indirect adherence measure. We calculated sensitivity, specificity, negative (NPV) and positive (PPV) predictive values for the found cutoff points. Finally, Delong test was used to compare AUCs.Results and discussionFrom April, 2014 to July, 2016, 450 participants initiated PrEP, 375(83.3%) were retained through 48 weeks. Of these, 74% (277/375) had TFV-DP ≥700fmol/punch. All adherence measures discriminated between participants with and without protective drug levels (AUC>0.5). High indirect adherence measure was predictive of protective drug levels (PPV>0.8) while low indirect adherence measure was not predictive of lack of protective drug levels (NPV<0.5). No significant differences were found between the adherence methods (p = 0.44).ConclusionsLow-burden measurements such as MPR and self-report can be used to predict PrEP adherence in a public health context in Brazil for MSM and TGW retained through 48 weeks. Clinical Trial Number: NCT01989611.

Project description:Suicide is a leading cause of death among 10- to 19-year-olds in the United States, with 5% to 8% attempting suicide each year. Suicide risk rises significantly during early adolescence and is higher in rural and underserved communities. School-based universal prevention programs offer a promising way of reducing suicide by providing strategies for emotion regulation and encouraging help-seeking behaviors and youth-adult connectedness. However, such programs frequently run into difficulties in trying to engage a broad range of students. Text messaging is a dominant medium of communication among youths, and studies show both efficacy and uptake in text messaging interventions aimed at adolescents. Text-based interventions may, thus, offer a means for school-based universal prevention programs to engage adolescents who would otherwise be difficult to reach.We field tested Text4Strength, an automated, interactive text messaging intervention that seeks to reach a broad range of early adolescents in rural communities. Text4Strength extends Sources of Strength, a peer-led school suicide prevention program, by encouraging emotion regulation, help-seeking behaviors, and youth-adult connectedness in adolescents. The study tested the appeal and feasibility of Text4Strength and its potential to extend universal school-based suicide prevention.We field tested Text4Strength with 42 ninth-grade students. Over 9 weeks, students received 28 interactive message sequences across 9 categories (Sources of Strength introduction, positive friend, mentors, family support, healthy activities, generosity, spirituality, medical access, and emotion regulation strategies). The message sequences included games, requests for advice, questions about students' own experiences, and peer testimonial videos. We measured baseline mental health characteristics, frequency of replies, completion of sequences and video viewing, appeal to students, and their perception of having benefited from the program.Of the 42 participating students, 38 (91%) responded to at least one sequence and 22 (52%) responded to more than a third of the sequences. The proportion of students who completed multistep sequences they had started ranged from 35% (6/17) to 100% (3/3 to 28/28), with responses dropping off when more than 4 replies were needed. With the exception of spirituality and generosity, each of the content areas generated at least a moderate number of student replies from both boys and girls. Students with higher and lower levels of risk and distress interacted with the sequences at similar rates. Contrary to expectations, few students watched videos. Students viewed the intervention as useful-even those who rarely responded to messages. More than 70% found the texts useful (3 items, n range 29-34) and 90% (36) agreed the program should be repeated.Text4Strength offers a potentially engaging way to extend school-based interventions that promote protective factors for suicide. Text4Strength is ready to be revised, based on findings and student feedback from this field test, and rigorously tested for efficacy.

Project description:BackgroundDaily and on-demand pre-exposure prophylaxis (PrEP) has been well demonstrated to effectively prevent HIV acquisition for men who have sex with men (MSM). More than half of the MSM PrEP users in Taiwan prefer on-demand PrEP; however, on-demand PrEP involves a complicated dosing regimen because it requires precoital and postcoital dosing and sex events are hard to anticipate. Although there are a growing number of mobile apps designed to improve access to HIV prevention services and HIV medication adherence, few mobile apps focus on adherence to PrEP or are designed to accommodate a complicated, on-demand PrEP dosing schedule.ObjectiveThe aim of this project is to evaluate the usability of a newly developed mobile app (UPrEPU) to assist MSM PrEP users to self-monitor their adherence to either daily or on-demand PrEP using a user-centered scheme.MethodsThis research will be conducted in 2 phases: app development and usability study. In the app development phase, we will first conduct formative research with end users and stakeholders through in-depth interviews; the results will provide PrEP users' and PrEP navigators' personas as material used in the app conceptualization stage. PrEP navigators are individuals in the health care system that help HIV-negative individuals who need assistance in accessing PrEP care. A low-fidelity prototype of the app feature will be formatted by applying a participatory design approach to engage PrEP users, designers, and app developers in the design process of the app. Then, a high-fidelity prototype of the app will be developed for the usability study and refined iteratively by the multidisciplinary team and new internal testers. Internal testers include the research team consisting of experts in public health, infectious disease, and industrial design and a close network of the research team that is taking PrEP. In the usability study phase, we will enroll 70 MSM PrEP users and follow them up for 4 months. Usability, feasibility, and effectiveness of adherence monitoring will be evaluated.ResultsRefinement of the UPrEPU app is currently ongoing. The usability study commenced in May 2020.ConclusionsThe UPrEPU app is one of the first apps designed to help MSM PrEP users to self-manage their PrEP schedule better regardless of dosing modes. With a design-thinking approach and adapting to the cultural context in Taiwan's MSM population, this novel app will have substantial potential to be acceptable and feasible and contribute to the reduction of new HIV infections.Trial registrationClinicalTrials.gov NCT04248790; https://clinicaltrials.gov/ct2/show/NCT04248790.International registered report identifier (irrid)PRR1-10.2196/20360.

Project description:BackgroundRegular human immunodeficiency virus (HIV) testing of persons at risk is critical to HIV prevention. Infrequent HIV testing and late diagnosis of HIV infection have been observed among young black men who have sex with men (MSM) and transwomen (transgender women)-two groups overrepresented in the HIV epidemic.ObjectiveThe objective of this study was to inform the development of a brief mobile phone intervention to increase HIV testing among young black MSM and transwomen by providing a tailored recommendation of an optimal HIV testing approach. We identified demographic, behavioral, psychosocial, and sociostructural factors associated with intentions to use three specific HIV testing approaches: self-testing, testing at a clinic or other provider, and couples HIV testing and counseling (CHTC).MethodsIndividuals were eligible for a Web-based survey if they were male at birth; were between the ages of 16 and 29 years; self-identified as black, African American, Caribbean black, African black, or multiethnic black; were not known to be HIV-infected; and reported insertive or receptive anal intercourse with a man or transwoman in the last 12 months. Recruitment occurred via banner advertisements placed on a range of social and sexual networking websites and apps in New York City and nationally, and via events attended by young black MSM and transwomen in New York City. Intention to test by each testing method was analyzed using logistic regression with best subset models and stepwise variable selection.ResultsAmong 169 participants, intention to use a self-test was positively associated with comfort in testing by a friend or a partner at home (Adjusted odds ratio, AOR, 2.40; 95% CI 1.09-5.30), and stigma or fear as a reason not to test (AOR 8.61; 95% CI 2.50-29.68) and negatively associated with higher social support (AOR 0.48; 95% CI 0.33-0.72) and having health insurance (AOR 0.21; 95% CI 0.09-0.54). Intention to test at a clinic or other provider was positively associated with self-efficacy for HIV testing (AOR 2.87; 95% CI 1.48-5.59) and social support (AOR 1.98; 95% CI 1.34-2.92), and negatively associated with a lifetime history of incarceration (AOR 0.37; 95% CI 0.16-0.89). Intention to test by CHTC was negatively associated with higher educational level (Some college or Associate's degree vs high school graduate or less [AOR 0.81; 95% CI 0.39-1.70]; Bachelor's degree or more vs high school graduate or less [AOR 0.28; 95% CI 0.11-0.70]).ConclusionsUnique factors were associated with intention to test using specific testing approaches. These data will be critical for the development of a tailored intervention that shows promise to increase comfort and experiences with a variety of testing approaches among young black MSM and transwomen.

Dataset Information

Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial.

Publications

Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial.

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