Development of a digital pill and respondent behavioral intervention (PrEPSteps) for HIV pre-exposure prophylaxis adherence among stimulant using men who have sex with men

Author(s):  
Peter R Chai ◽  
Yassir Mohamed ◽  
Georgia Goodman ◽  
Maria J Bustamante ◽  
Matthew C Sullivan ◽  
...  

Abstract The efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention in men who have sex with men (MSM) is contingent upon consistent adherence. Digital pill systems (DPS) provide real-time, objective measurement of ingestions and can inform behavioral adherence interventions. Qualitative feedback was solicited from MSM who use stimulants to optimize a cognitive behavioral therapy (CBT)-based intervention (LifeSteps), used in conjunction with a DPS, to promote PrEP adherence (PrEPSteps). Seven focus groups and one individual qualitative interview were conducted in Boston, MA with cisgender, HIV-negative MSM who reported stimulant use and current PrEP use or interest. Focus groups and interviews explored reactions to the DPS and PrEPSteps messaging components: contingent reinforcement (CR), corrective feedback (CF), LifeSteps, and substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT). Quantitative assessments were administered. Qualitative data were analyzed using applied thematic analysis. Twenty MSM participated. Most were White (N = 12), identified as homosexual or gay (N = 15), and college-educated (N = 15). Ages ranged from 24 to 68 years (median 35.5). Participants were willing to engage with the DPS and viewed it as beneficial for promoting adherence. Confirmatory CR messages were deemed acceptable, and a neutral tone was preferred. CF messages were viewed as most helpful and as promoting individual responsibility. LifeSteps was perceived as useful for contextualizing nonadherence. However, SBIRT was a barrier to DPS use; concerns around potential substance use stigma were reported. MSM who use stimulants were accepting of the DPS and PrEPSteps intervention. CR, CF, and LifeSteps messages were viewed as helpful, with modifications pertaining to tone and content; SBIRT messages were not preferred.

Iproceedings ◽  
10.2196/15273 ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e15273
Author(s):  
Georgia Goodman ◽  
Conall O'Cleirigh ◽  
Kenneth H Mayer ◽  
Edward W Boyer ◽  
Rochelle K Rosen ◽  
...  

Background Digital pills contain a radiofrequency emitter and gelatin capsule that over-encapsulate a study medication. The radiofrequency emitter, activated by the chloride ion gradient in the stomach, transmits a signal to a wearable Reader device following ingestion. The Reader relays ingestion data to a smartphone app and cloud-based server, allowing for real-time verification of ingestion events and adherence measurement. Digitized pre-exposure prophylaxis (PrEP) may improve outcomes in populations with suboptimal adherence related to substance use. Stimulant use is particularly prevalent among men who have sex with men (MSM) and is associated with increased HIV risk behavior and transmission. We conducted seven focus groups with MSM who use stimulants (N=16) to inform the development of PrEPsteps, a novel smartphone-based adherence intervention respondent to data from digitized PrEP and designed to augment adherence. Objective To inform the specification of the design, content, and delivery of the smartphone-based PrEPsteps adherence system via focus groups with HIV-negative MSM who use stimulants. Methods Seven focus groups were conducted with HIV-negative MSM reporting stimulant use (eg, cocaine, methamphetamine) in the past six months. Participants self-reported medical history, substance use and sexual activity. Focus groups explored responses to digital pill technology, willingness and barriers to use, content and timing of adherence messaging, and three intervention components: (1) abbreviated cognitive behavioral therapy (CBT) adherence counseling (LifeSteps); (2) contingent reinforcement/corrective feedback; and (3) substance use-related Screening, Brief Intervention and Referral to Treatment (SBIRT). Focus groups were transcribed and analyzed using applied thematic analysis. Results Sixteen individuals participated in focus groups. All were male; age ranged from 24 to 63 (mean 39.9, SD 14.1) and most self-identified as gay (N=13). Participants were primarily non-Hispanic or Latino (N=12); 10 identified as white, two as black, and four as multiracial. Most had at least a college degree (N=14). Twelve participants were taking PrEP, 5 of whom reported missed doses in the past two weeks. Number of sexual partners in the past three months ranged from 1 to 200 (M=28.1; SD=50.9). Fifteen participants reported using stimulants during the last 30 days. Participants viewed digital pills as a tool to enhance PrEP adherence and accountability. They expressed a willingness to use the digital pill and identified physicians, family members, and partners as people with whom they would share adherence data. The Reader was viewed as the most difficult technological component to use, although participants also described the device as itself an adherence reminder. Participants identified customizability as a valuable aspect of the technology; message and reminder content, structure, and scheduling were all considered customizable. With regard to the intervention, participants were accepting of and willing to interact with corrective feedback messages linked to a brief CBT LifeSteps booster session. Conclusions PrEPsteps, a smartphone-based adherence intervention, was viewed as acceptable by HIV-negative MSM who use stimulants. Individuals perceived corrective feedback notifications to be the most helpful component of the system, and expressed a strong preference for customizability across the intervention.


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 ◽  
Vol 13 (1) ◽  
pp. 49-58 ◽  
Author(s):  
Sara Jeanne Pelletier ◽  
Marie-Pierre Gagnon ◽  
Souleymane Diabaté ◽  
Ouffoué Kra ◽  
Yadjoro Josué Biékoua ◽  
...  

Background: HIV remains an important public health issue throughout the world. In Côte d’Ivoire, a high burden of HIV is observed in men who have sex with men (MSM). Objective: We assessed the acceptability of Pre-Exposure Prophylaxis (PrEP) among men who have sex with men (MSM) in Bouaké, Côte d’Ivoire. Methods: We conducted and analysed four focus groups with 31 HIV-negative MSM and eight in-depth individual interviews with participants recruited from the focus groups. Results: Four MSM (13%) were aware of PrEP before participating in the study. All the participants were interested in taking PrEP if available: 19 (61.3%) would prefer the daily regimen and 12 (38.7%) would opt for the on-demand regimen. Many advantages of PrEP were mentioned: protection in case of a condom break, protection in case of high-risk sexual behaviour, self-reliance, decreasing HIV fear and ease of use. Barriers to the use of PrEP included: it does not protect against other Sexually Transmitted Tnfections (STIs), taking a pill regularly is necessary, the size of the pill, possibility of side effects, the cost and accessibility. Six participants (19.3%) admitted that they would use condoms less if they take PrEP. Conclusion: Findings indicate that PrEP is acceptable within the MSM community. Implementation should be done rapidly, and PrEP should be part of a global prevention program which includes counselling, STI screening and promotion of safe sex practices. Health authorities should consider PrEP for all high-risk groups to avoid worsening stigmatization by targeting MSM only.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Paul A. Shuper ◽  
Narges Joharchi ◽  
Isaac I. Bogoch ◽  
Mona Loutfy ◽  
Frederic Crouzat ◽  
...  

Abstract Background Although HIV pre-exposure prophylaxis (PrEP) substantially diminishes the likelihood of HIV acquisition, poor adherence can decrease the HIV-protective benefits of PrEP. The present investigation sought to identify the extent to which alcohol consumption, substance use, and depression were linked to PrEP nonadherence among gay, bisexual, and other men-who-have-sex-with-men (gbMSM). Methods gbMSM (age ≥ 18, prescribed PrEP for ≥3 months) were recruited from two clinics in Toronto, Canada for an e-survey assessing demographics; PrEP nonadherence (4-day PrEP-focused ACTG assessment); hazardous and harmful alcohol use (AUDIT scores of 8–15 and 16+, respectively); moderate/high risk substance use (NIDA M-ASSIST scores > 4); depression (CESD-10 scores ≥10); and other PrEP-relevant factors. The primary outcome, PrEP nonadherence, entailed missing one or more PrEP doses over the past 4 days. A linear-by-linear test of association assessed whether increasing severity of alcohol use (i.e., based on AUDIT categories) was linked to a greater occurrence of PrEP nonadherence. Univariate logistic regression was employed to determine factors associated with PrEP nonadherence, and factors demonstrating univariate associations at the p < .10 significance level were included in a multivariate logistic regression model. Additive and interactive effects involving key significant factors were assessed through logistic regression to evaluate potential syndemic-focused associations. Results A total of 141 gbMSM (Mean age = 37.9, white = 63.1%) completed the e-survey. Hazardous/harmful drinking (31.9%), moderate/high risk substance use (43.3%), and depression (23.7%) were common; and one in five participants (19.9%) reported PrEP nonadherence. Increasing alcohol use level was significantly associated with a greater likelihood of nonadherence (i.e., 15.6, 25.0, and 44.4% of low-risk, hazardous, and harmful drinkers reported nonadherence, respectively (χ2(1) = 4.79, p = .029)). Multivariate logistic regression demonstrated that harmful alcohol use (AOR = 6.72, 95%CI = 1.49–30.33, p = .013) and moderate/high risk cocaine use (AOR = 3.11, 95%CI = 1.01–9.59, p = .049) independently predicted nonadherence. Furthermore, an additive association emerged, wherein the likelihood of PrEP nonadherence was highest among those who were hazardous/harmful drinkers and moderate/high risk cocaine users (OR = 2.25, 95%CI = 1.19–4.25, p = .013). Depression was not associated with nonadherence. Conclusions Findings highlight the need to integrate alcohol- and substance-focused initiatives into PrEP care for gbMSM. Such initiatives, in turn, may help improve PrEP adherence and reduce the potential for HIV acquisition among this group.


2020 ◽  
Vol 32 (2) ◽  
pp. 152-168 ◽  
Author(s):  
Errol L. Fields ◽  
Amanda Long ◽  
Kehinde Bademosi ◽  
Ricky Granderson ◽  
Christina M. Schumacher ◽  
...  

LGBTQ populations, particularly Black men who have sex with men and transgender women, experience significant HIV disparities; public health messages may inadvertently stigmatize LGBTQ populations. We sought to use qualitative methods to inform a PrEP campaign. Unstructured focus groups were conducted among predominantly Black LGBTQ persons recruited through social media and events. Discussions were audio-recorded, transcribed, and analyzed in NVivo using categorical analysis. Eighty individuals participated in 13 focus groups; 80% (64) identified as sexual or gender minorities. Eighty-eight percent (70) identified as Black/African American. Four themes emerged: (1) culturally competent, community-informed, locally relevant messaging, (2) avoiding stigmatizing language or images, (3) inaccessibility of clinical language, and (4) using identity labels representing local communities and their diversity. Findings suggest PrEP campaigns need to be developed through community-informed processes to engage and avoid stigmatizing priority populations. Ongoing partnerships between public health and LGBTQ communities can facilitate development of campaigns with engaging, acceptable language.


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


2018 ◽  
Vol 94 (7) ◽  
pp. 508-514 ◽  
Author(s):  
Adiba Hassan ◽  
Jill S Blumenthal ◽  
Michael P Dube ◽  
Eric Ellorin ◽  
Katya Corado ◽  
...  

ObjectivesRectal douching/enema (RD) is a common practice among men who have sex with men (MSM) in preparation for sex. RD can break down the rectal mucosal barrier and potentially affect the rectal microbiome. The objective of this study was to understand if RD is associated with acquiring rectal infections (RI) with rectal gonorrhoea (NG) and/or chlamydia (CT).MethodsFrom 2013 to 2015, 395 adult HIV-uninfected MSM were enrolled in a randomised controlled study for pre-exposure prophylaxis (PrEP) adherence with routine sexual risk survey and testing. Using data from this cohort, baseline differences by RI were assessed using Pearson’s χ² and Wilcoxon-Mann-Whitney test. Association between RD and RI was modelled using multivariable logistic regression adjusted for potential confounders (sexual behaviour, substance use and age) selected a priori. Effect modification by number of male partners and sensitivity analysis to rule out reverse causality were also conducted.ResultsOf 395 participants, 261 (66%) performed RD and 133 (33%) had at least one NG/CT RI over 48 weeks. Number of condomless anal receptive sex (med: 4, p<0.001), male partners (med:6, p<0.001) and substance use (any of methamphetamine/hallucinogens/dissociative/poppers) (p<0.001) were associated with increased odds of RI. Controlling for potential confounders, odds of prevalent RI were 3.59 (p<0.001, 95% CI 1.90 to 6.78) and incident RI 3.87 (p=0.001, 95% CI 1.78 to 8.39) when douching weekly or more compared with not douching. MSM with more than six male partners had 5.34 (p=0.002, 95% CI 1.87 to 15.31) increased odds of RI when douching weekly or more compared with not douching.ConclusionRectal hygiene with RD is a common practice (66%) among HIV-uninfected MSM on PrEP in this study, which increases the odds of acquiring rectal NG and/or CT independent of sexual risk behaviour, substance use and other factors. This suggests interventional approaches targeting rectal hygiene products and practices could reduce sexually transmitted infections.


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


2021 ◽  
pp. sextrans-2020-054629
Author(s):  
Louis MacGregor ◽  
Manik Kohli ◽  
Katharine J Looker ◽  
Ford Hickson ◽  
Peter Weatherburn ◽  
...  

IntroductionIn the last decade diagnoses of most STIs have risen among men who have sex with men (MSM). Although a significant proportion of this is likely due to increased STI screening, understanding the role of behavioural drivers remains critical. We measure the associations between stimulant use to enhance and prolong sexual experiences (chemsex) and bacterial STI diagnoses in UK MSM, individually considering HIV-diagnosed MSM, pre-exposure prophylaxis (PrEP) users and other MSM.MethodsWe used the UK 2017–2018 European MSM Internet Survey data (n=9375). We constructed causal inference models using multivariable logistic regression, calculating adjusted OR (aOR) and 95% CI of the associations between participation in recent (≤12 months) exclusively dyadic or multipartner chemsex versus no chemsex and recent self-reported diagnoses of syphilis, gonorrhoea and chlamydia.ResultsAmong MSM with an HIV diagnosis, 25% of users indicated recent multipartner chemsex, vs 28% of PrEP users and 5% of other MSM. Adjusting for age, ethnicity, UK birth, cis-trans status, sexual identity, education, settlement size and relationship status, participation in recent multipartner chemsex versus no chemsex was associated with greater odds of recent syphilis, gonorrhoea and chlamydia diagnosis. aORs for recent syphilis, gonorrhoea and chlamydia diagnoses were 2.6 (95% CI 1.7 to 4.1), 3.9 (95% CI 2.6 to 5.8) and 2.9 (95% CI 1.9 to 4.3), respectively, in HIV-diagnosed MSM; 1.9 (95% CI 1.1 to 3.3), 2.9 (95% CI 2.0 to 4.2) and 1.9 (95% CI 1.3 to 2.8), respectively, in PrEP users; and 4.0 (95% CI 2.3 to 6.9), 2.7 (95% CI 1.9 to 3.8) and 2.3 (95% CI 1.6 to 3.4), respectively, in other MSM. Conversely, exclusively dyadic chemsex had no significant associations with bacterial STI diagnoses among HIV-diagnosed MSM, only gonorrhoea (aOR 2.4, 95% CI 1.2 to 4.7) among PrEP users and syphilis (aOR 2.8, 95% CI 1.4 to 5.6) among other MSM.DiscussionMultipartner chemsex may drive the association between chemsex and bacterial STI diagnoses and thus should be the focus of future tailored chemsex interventions. Additionally, PrEP acceptability among MSM and particularly chemsex participants has generated an emergent group suitable for such interventions.


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