scholarly journals Protocol Development for HMU! (HIV Prevention for Methamphetamine Users), a Study of Peer Navigation and Text Messaging to Promote Pre-Exposure Prophylaxis Adherence and Persistence Among People Who Use Methamphetamine: Qualitative Focus Group and Interview Study

10.2196/18118 ◽  
2020 ◽  
Vol 4 (9) ◽  
pp. e18118
Author(s):  
Vanessa M McMahan ◽  
Noah Frank ◽  
Smitty Buckler ◽  
Lauren R Violette ◽  
Jared M Baeten ◽  
...  

Background Cisgender men who have sex with men (MSM) and transgender people (TGP) who use methamphetamine are disproportionately impacted by HIV acquisition. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV, and interventions that support PrEP persistence and adherence should be evaluated among MSM and TGP who use methamphetamine. Objective We conducted formative work to inform the development of text messaging and peer navigation interventions to support PrEP persistence and adherence among MSM and TGP who use methamphetamine. In this paper, we describe how the findings from these focus groups and interviews were used to refine the study interventions and protocol for the Hit Me Up! study (HMU!; HIV Prevention in Methamphetamine Users). Methods Between October 2017 and March 2018, we conducted two focus groups and three in-depth interviews with MSM and TGP who use methamphetamine or who have worked with people who use methamphetamine. During these formative activities, we asked participants about their opinions on the proposed interventions, education and recruitment materials, and study design. We focused on how we could develop peer navigation and text messaging interventions that would be culturally appropriate and acceptable to MSM and TGP who use methamphetamine. Transcripts were reviewed by two authors who performed a retrospective content analysis to describe which specific opinions and recommendations influenced protocol development and the refinement of the interventions. Results Overall, participants thought that MSM and TGP would be interested in participating in the study, although they expected recruitment and retention to be challenging. Participants thought that the peer navigator should be someone who is nonjudgmental, has experience with people who use methamphetamine, and is patient and flexible. There was consensus that three text messages per day were appropriate, adherence reminders should be straightforward, all messages should be nonjudgmental, and participants should be able to tailor the timing and content of the text messages. These suggestions were incorporated into the study interventions via the hiring and training process and into the development of the text library, platform selection, and customizability of messages. Conclusions It is important to include the opinions and insights of populations most impacted by HIV to develop PrEP interventions with the greatest chance of success. Our formative work generated several recommendations that were incorporated into the interventions and protocol development for our ongoing study. Trial Registration ClinicalTrials.gov NCT03584282; https://clinicaltrials.gov/ct2/show/NCT03584282

2020 ◽  
Author(s):  
Vanessa M McMahan ◽  
Noah Frank ◽  
Smitty Buckler ◽  
Lauren R Violette ◽  
Jared M Baeten ◽  
...  

BACKGROUND Cisgender men who have sex with men (MSM) and transgender people (TGP) who use methamphetamine are disproportionately impacted by HIV acquisition. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV, and interventions that support PrEP persistence and adherence should be evaluated among MSM and TGP who use methamphetamine. OBJECTIVE We conducted formative work to inform the development of text messaging and peer navigation interventions to support PrEP persistence and adherence among MSM and TGP who use methamphetamine. In this paper, we describe how the findings from these focus groups and interviews were used to refine the study interventions and protocol for the Hit Me Up! study (HMU!; HIV Prevention in Methamphetamine Users). METHODS Between October 2017 and March 2018, we conducted two focus groups and three in-depth interviews with MSM and TGP who use methamphetamine or who have worked with people who use methamphetamine. During these formative activities, we asked participants about their opinions on the proposed interventions, education and recruitment materials, and study design. We focused on how we could develop peer navigation and text messaging interventions that would be culturally appropriate and acceptable to MSM and TGP who use methamphetamine. Transcripts were reviewed by two authors who performed a retrospective content analysis to describe which specific opinions and recommendations influenced protocol development and the refinement of the interventions. RESULTS Overall, participants thought that MSM and TGP would be interested in participating in the study, although they expected recruitment and retention to be challenging. Participants thought that the peer navigator should be someone who is nonjudgmental, has experience with people who use methamphetamine, and is patient and flexible. There was consensus that three text messages per day were appropriate, adherence reminders should be straightforward, all messages should be nonjudgmental, and participants should be able to tailor the timing and content of the text messages. These suggestions were incorporated into the study interventions via the hiring and training process and into the development of the text library, platform selection, and customizability of messages. CONCLUSIONS It is important to include the opinions and insights of populations most impacted by HIV to develop PrEP interventions with the greatest chance of success. Our formative work generated several recommendations that were incorporated into the interventions and protocol development for our ongoing study. CLINICALTRIAL ClinicalTrials.gov NCT03584282; https://clinicaltrials.gov/ct2/show/NCT03584282


2019 ◽  
Author(s):  
Denis Nash ◽  
Matthew Stief ◽  
Caitlin MacCrate ◽  
Chloe Mirzayi ◽  
Viraj V Patel ◽  
...  

BACKGROUND Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years. OBJECTIVE The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. METHODS We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment. RESULTS The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years. CONCLUSIONS A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions. INTERNATIONAL REGISTERED REPORT RR1-10.2196/13715


Sexual Health ◽  
2019 ◽  
Vol 16 (1) ◽  
pp. 56 ◽  
Author(s):  
Laia Fina ◽  
Amy L. Phillips ◽  
Adam T. Jones ◽  
Zoë M. Couzens ◽  
Rachel Drayton ◽  
...  

Background Pre-exposure prophylaxis (PrEP) was introduced in Sexual Health Services of the Welsh National Health Service (NHS Wales) in July 2017 as a 3-year pilot service. Methods: Data were collected through the pre-existing Sexual Health in Wales Surveillance System, to which codes were added to capture PrEP eligibility, outcome of offer of PrEP, reasons for declining and adherence. Eligibility categories were defined based on nationally agreed criteria: men who have sex with men (MSM) and transgender people at high risk of HIV acquisition; partners of HIV-positive individuals not known to be virally suppressed; and heterosexuals reporting condomless intercourse with a HIV-positive individual not known to be virally suppressed. Results: During the first 6 months, 516 people were eligible, 96% of which were MSM. Overall, 57% of those eligible (296/516) started PrEP. Reasons for declining PrEP were given by 88 (56%) of 157 people; 50 (57%) of whom did not believe themselves to be at risk. Of the available adherence assessments, 89% considered that all risk episodes had been covered. Persistence at 3 months was assessed for 141 people, of which 93 (66%) were still using PrEP. There were no HIV diagnoses in people taking PrEP during the first 6 months. Twenty-nine people were diagnosed with 37 episodes of sexually transmissible infections (STIs) while on PrEP. STI incidence was 105.7 per 100 person-years. Conclusions: The early trend indicates that implementation of PrEP is progressing as planned, and the service has been utilised by clients. This analysis can help refine implementation, inform planning and research around uptake, use and effect in Wales and internationally.


2020 ◽  
Vol 24 (11) ◽  
pp. 3056-3070
Author(s):  
Alyson Hillis ◽  
Jennifer Germain ◽  
Vivian Hope ◽  
James McVeigh ◽  
Marie Claire Van Hout

Abstract Pre-exposure prophylaxis (PrEP) is an evidence-based new biomedical HIV prevention intervention, which involves the pre-emptive use of daily (or event-based) antiretroviral drugs, to reduce risk of HIV acquisition if exposed. PrEP has recently been positioned as an integral prevention tool to reduce HIV acquisition risk among men who have sex with men (MSM) at country-level and within global prevention strategies. Given this global scale up of PrEP, we conducted a scoping review of extant international literature documenting service related perspectives, models and lessons learnt in PrEP programming for MSM. A systematic search of literature was conducted, and restricted to English language records in the timeframe 2008 to February 2019. Eligibility criteria centered on whether studies broadly described PrEP programming and service delivery for MSM as well as health communication. Following exclusion of ineligible records and removal of duplicates, 84 records were charted and thematically analysed according to scoping review methods. Four themes emerged from the thematic analysis of data; ‘PrEP service aspects, settings and staff’; ‘PrEP prescriber experiences, therapeutic alliance and care planning’; ‘PrEP adherence within formal service structures’; and ‘Multi-disciplinary and innovative PrEP care pathways’. The review highlights the complexities in providing optimal PrEP services for MSM by mapping and illustrating the importance of understanding the informal and formal routes to PrEP use among this HIV risk population; the barriers to uptake; the requirement for the presence of a positive therapeutic alliance between patient and prescriber in supporting patient initiation and adherence to PrEP regimes; and the need for availability in different culturally and ethnically sensitive models of PrEP service delivery according to low to high risk groups within the MSM communities.


2019 ◽  
Author(s):  
Jade Pagkas-Bather ◽  
Jahn Jaramillo ◽  
Jsani Henry ◽  
Vanessa Grandberry ◽  
Luis F. Ramirez ◽  
...  

Abstract Background: Peer navigation is a promising strategy to link at-risk minority men who have sex with men (MSM) to HIV prevention services including pre-exposure prophylaxis (PrEP). Methods: Thirty-two Black and 63 Latinx HIV-negative MSM living in western Washington completed a survey examining attitudes towards peer navigation and PrEP. Factor analysis derived a score for peer navigator acceptability, and linear regression identified associations with this outcome . Results: Forty-eight percent were interested in peer navigation. Being insured, higher sexual stigma, and higher PHQ-9 score were associated with higher acceptability, while higher income and having a regular medical provider were associated with lower acceptability. In multivariable analysis, higher sexual stigma predicted higher acceptability, while higher income predicted lower acceptability. Conclusion: Men preferred that peers be matched on sexual orientation, race, age and culture. Peer navigation interventions to reach minority men should address stigma, focus on lower-income men, and try to match peers to clients to the extent possible. Key words: HIV prevention, pre-exposure prophylaxis, Black, Latinx, men who have sex with men


2019 ◽  
Author(s):  
Laura Whiteley ◽  
Anne-Emilie Rouffiac ◽  
Larry Brown ◽  
Leandro Mena ◽  
Lacey Craker ◽  
...  

BACKGROUND The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, MS (the site of this proposed project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost- effective mobile messaging intervention to improve engagement in PrEP care for BMSM (18-35 yrs) living in Jackson, MS. OBJECTIVE The goals of this project are 1) to conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, 2) to assemble a PrEP Mobile Messaging Intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and 3) to evaluate the preliminary efficacy of a text messaging intervention composed of publicly available internet content in a randomized controlled study with PrEP eligible BMSM receiving care in STI/HIV testing clinics located in Jackson, MS. METHODS This research protocol will be conducted in 2 phases: a development phase involving in-depth interviews (n = 30) with PrEP eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of a small randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention (compared to enhanced standard of care) on attendance at a PrEP Services Appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription. The publicly available material will be sent to PrEP eligible BMSM in 8- 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks post-enrollment. RESULTS IRB approval was received on January 16, 2017. Research activities began in February 2018 and are still ongoing. CONCLUSIONS This PrEP Mobile Messaging Intervention aims to increase uptake of PrEP by BMSM in the Southern United States. This intervention uses interactive, tailored text messaging and appealing free web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective digital PrEP Mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care. CLINICALTRIAL Trial Registration: NCT03308097 International Registered Report Identifier (IRRID): NCT03308097


10.2196/13715 ◽  
2019 ◽  
Vol 8 (9) ◽  
pp. e13715 ◽  
Author(s):  
Denis Nash ◽  
Matthew Stief ◽  
Caitlin MacCrate ◽  
Chloe Mirzayi ◽  
Viraj V Patel ◽  
...  

Background Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years. Objective The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. Methods We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment. Results The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years. Conclusions A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions. International Registered Report Identifier (IRRID) RR1-10.2196/13715


2018 ◽  
Vol 12 (6) ◽  
pp. 1824-1834 ◽  
Author(s):  
Akshay Sharma ◽  
Erin M. Kahle ◽  
Stephen P. Sullivan ◽  
Rob Stephenson

Gay, bisexual, and other men who have sex with men (GBMSM) in the United States remain heavily impacted by HIV. The purpose of this study was to describe intergenerational differences in functional knowledge of HIV prevention strategies, perceived risk, recent condomless anal sex (CAS), and HIV testing behavior. Eight hundred sexually active GBMSM were recruited via Facebook from August to September 2015, and administered a Web-based survey which included 12 multiple-choice questions to elicit data regarding functional knowledge of different HIV prevention approaches (e.g., condom use, pre-exposure prophylaxis post-exposure prophylaxis, treatment as prevention, circumcision). Cumulative logit and multivariable logistic models were formulated to examine birth cohort variations across four analytic outcomes. Younger generations were significantly more knowledgeable, as were GBMSM with higher education. Non-Hispanic non-White GBMSM and those reporting a bisexual/other sexual orientation had lower functional knowledge. Younger generations were equally concerned about contracting HIV as their older counterparts. Perceived risk was significantly higher among non-Hispanic non-White and Hispanic GBMSM, but lower among those with higher education and those in a relationship. Finally, birth cohort variations with respect to engaging in CAS with ≥2 men in the past 3 months and testing for HIV in the past year were not markedly pronounced. Younger GBMSM might be more knowledgeable about HIV prevention strategies compared to their predecessors, but are equally concerned about contracting HIV. Researchers and practitioners should consider intergenerational and other demographic differences while designing multifaceted HIV prevention programs for GBMSM.


2020 ◽  
Author(s):  
Britta Larsen ◽  
Emily D. Greenstadt ◽  
Brittany L. Olesen ◽  
Bess H. Marcus ◽  
Job Godino ◽  
...  

BACKGROUND Adolescent girls report the lowest levels of physical activity (PA) of any demographic group, with rates especially low for racial/ethnic minority girls. Only 3% of Latina teens meet national PA guidelines, and these habits appear to persist into adulthood. Developing effective interventions to increase PA in Latina teens is necessary for preventing disease and reducing disparities. OBJECTIVE The study objective was to develop a mHealth PA intervention for Latina adolescents using a multi-stage iterative process based on an adaptation of the IDEAS (Integrate, DEsign, Assess, Share) framework. METHODS Development of the intervention was accomplished through three iterations: 1) feedback from a previous web-based pilot study, Niñas Saludables; 2) conducting focus groups with the target population; and, 3) vetting the final materials with a youth advisory board (YAB) comprising Latina adolescents. Based on feedback from participants in the Niñas Saludables study, plans to improve the intervention included incorporating visual social media posts and text messaging, adding a commercial wearable tracker, and revising the existing website to be primarily visual; proposed procedures and material were then refined through focus groups. Participants for focus groups (N=50) were girls age 13-18 who could speak and read in English who were recruited from local high schools and after school programs serving a high proportion of Latinos. Facilitated discussions focused on experience with PA and social media apps, and specific feedback on intervention material prototypes and possible names and logos. Materials were refined based on their feedback, then were beta tested by the YAB. YAB members (N=4) were Latinas age 13-18 who were not regularly active and were recruited via word of mouth and selected through an application process. RESULTS The focus group discussions yielded the following findings: PA preferences included walking, running and group fitness classes, while the least popular activities were running, swimming, and biking. Most participants used some form of social media, with Instagram being the most favored. Participants preferred text messages be sent no more than once a day, be personalized, and be positively worded. Focus group participants preferred an intervention directly targeting Latinas, and social media posts that were brightly colored, included girls of all body types, and provided specific tips and information. Modified intervention materials were generally perceived favorably by the YAB members, who provided suggestions for further refinements including incorporation of some Spanish phrases. CONCLUSIONS Latina teens were generally enthusiastic about an mHealth PA intervention, provided the materials were targeted specifically to them and their preferences. Through multiple iterations of development and feedback with the target population, we gained insight into the needs of Latina teens and joined with industry partners to build a viable final product.


Author(s):  
Southern African HIV Clinicians Society Consensus Committee

Background. The use of oral antiretrovirals to prevent HIV infection among HIV-negative men who have sex with men (MSM) has been shown to be safe and efficacious. A large, randomised, placebo-controlled trial showed a 44% reduction in the incidence of HIV infection among MSM receiving a daily oral fixed-dose combination of tenofovir disoproxil fumarate and emtricitabine (Truvada) in combination with an HIV prevention package. Improved protection was seen with higher levels of adherence. Aim. The purpose of this guideline is to: (i) explain what pre-exposure prophylaxis (PrEP) is; (ii) outline current indications for its use; (iii) outline steps for appropriate client selection; and (iv) provide guidance for monitoring and maintaining clients on PrEP. Method. PrEP is indicated for HIV-negative MSM who are assessed to be at high risk for HIV acquisition and who are willing and motivated to use PrEP as part of a package of HIV prevention services (including condoms, lubrication, sexually transmitted infection (STI) management and risk reduction counselling). Recommendations. HIV testing, estimation of creatinine clearance and STI and hepatitis B screening are recommended as baseline investigations. Daily oral Truvada, along with adherence support, can then be prescribed for eligible MSM. PrEP should not be given to MSM with abnormal renal function, nor to clients who are unmotivated to use PrEP as part of an HIV prevention package; nor should it be commenced during an acute viral illness. Three-monthly follow-up visits to assess tolerance, renal function, adherence and ongoing eligibility is recommended. Six-monthly STI screens and annual creatinine levels to estimate creatinine clearance are recommended. Hepatitis B vaccination should be provided to susceptible clients. Gastro-intestinal symptoms and weight loss are common side-effects, mostly experienced for the first 4 - 8 weeks after initiating PrEP. There is a risk of the development of antiretroviral resistance among those with undiagnosed acute HIV infection during PrEP initiation and among those with sub-optimal adherence who become HIV infected while on PrEP. Risk compensation (increasing sexual behaviours that can result in exposure to HIV) while on PrEP may become a concern, and clinicians should continue to support MSM clients to continue to use condoms, condom-compatible lubrication and practice safer sex. Research is ongoing to assess optimum dosing regimens, potential long-term effects and alternative PrEP medications. Recommendations for the use of PrEP among other at-risk individuals, and the components of these recommendations, will be informed by future evidence. S Afr J HIV Med 2012;13(2):40-55.


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