Perceptions and Experiences of Returning Self-collected Specimens for HIV, Bacterial STI and Potential PrEP Adherence Testing among Sexual Minority Men in the United States.

Few studies among gay, bisexual and other men who have sex with men (GBMSM) have examined facilitators and barriers to self-collecting specimens for extragenital STI screening, and none have evaluated attitudes towards self-collecting hair samples that can be utilized for PrEP drug level testing to assess adherence. To address this gap, we interviewed 25 sexually active GBMSM who were offered a choice to self-collect and return finger-stick blood samples (for actual HIV testing), pharyngeal swabs, rectal swabs and urine specimens (for actual gonorrhea and chlamydia testing), and hair samples (to visually determine their adequacy for PrEP drug level testing): 11 who returned all, 4 who returned some, and 10 who did not return any. Participants found self-collecting finger-stick blood samples and rectal swabs more challenging than other specimens. Frequently discussed facilitators of return included an opportunity to confirm one's HIV or STI status, limited access to a healthcare provider and a desire to advance research focusing on home-based testing. Commonly cited barriers to return included low self-efficacy pertaining to self-collection and apprehension around the possibility of delay or loss of specimens during transit. Offering additional support such as real-time video conferencing may prove helpful in future field-based research with GBMSM.

Willingness to Participate in and Preferences for Studies of mHealth HIV Prevention Interventions: Cross-Sectional Study Among Sexual and Gender Minority Groups in the Southern United States.

A number of mobile HIV prevention interventions have been developed to increase uptake of HIV prevention services such as HIV testing and pre-exposure prophylaxis (PrEP). Most of these interventions have been tested among urban populations. However, sexual and gender minority (SGM) groups in rural areas might also benefit from mobile HIV prevention interventions. These groups have heightened experiences of stigma and discrimination and have limited access to culturally competent healthcare. We conducted a survey of SGM participants in the southern United States to assess willingness to use the common features of mobile HIV prevention interventions and to participate in research studies of these interventions and to compare the results between rural and non-rural respondents. We found few differences in willingness to use common features of mobile HIV prevention interventions based on rurality and high levels of cellular connectivity across participants. Based on these results, rural residence is not a barrier to using mobile HIV prevention interventions.

Distance as a barrier to HIV testing among sexual and gender minority populations in the rural southern US: a cross-sectional study.

INTRODUCTION: Sexual and gender minority people who live in rural areas are less likely to have had a HIV test in the previous 12 months compared with those who live in non-rural areas. We assessed the independent contribution of distance and time required to travel to receive a HIV test on recent uptake of HIV testing. METHODS: We conducted a cross-sectional survey of sexual and gender minority populations in the southern US. We used Poisson regression with robust standard errors to estimate prevalence ratios to compare uptake of HIV testing in the previous 12 months among those who traveled more than 20 miles (~32 km) and more than 30 minutes to their most recent HIV test compared with those who traveled less distance and time to their most recent test, respectively. RESULTS: A total of 508 (n=155 rural, n=348 non-rural) participants completed the survey. Of these, 398 (78.5%) had received a HIV test in the previous 12 months. Those who traveled more than 20 miles (~32 km) to their most recent test were more likely to have not received a HIV test in the previous 12 months compared with those who traveled 20 miles (~32 km) or less (adjusted prevalence ratio 2.25; 95% confidence interval 1.22-4.17). There were no differences based on travel time to the most recent test. CONCLUSION: Distance, but not time, to travel to receive a HIV test is independently associated with reduced HIV testing. More geographically proximal options or access to home-based testing might reduce this barrier.

Lessons Learned From the Implementation of a Pilot Study on Self-collected Specimen Return by Sexual Minority Men (Project Caboodle!): Qualitative Exploration.

BACKGROUND: Self-collection of specimens at home and their return by mail might help reduce some of the barriers to HIV and bacterial sexually transmitted infection (STI) screening encountered by gay, bisexual, and other men who have sex with men (GBMSM). To evaluate the benefits and challenges of bringing this approach to scale, researchers are increasingly requesting GBMSM to return self-collected specimens as part of web-based sexual health studies. Testing self-collected hair samples for preexposure prophylaxis drug levels may also be a viable option to identify GBMSM who face adherence difficulties and offer them support. OBJECTIVE: Project Caboodle! sought to evaluate the acceptability and feasibility of self-collecting at home and returning by mail 5 specimens (a finger-stick blood sample, a pharyngeal swab, a rectal swab, a urine specimen, and a hair sample) among 100 sexually active GBMSM in the United States aged between 18 and 34 years. In this manuscript, we aimed to describe the key lessons learned from our study's implementation and to present recommendations offered by participants to maximize the rates of self-collected specimen return. METHODS: Following the specimen self-collection phase, a subset of 25 participants (11 who returned all 5 specimens, 4 who returned between 1 and 4 specimens, and 10 who did not return any specimens) was selected for in-depth interviews conducted via a videoconferencing platform. During the session, a semistructured interview guide was used to discuss the factors influencing decisions regarding returning self-collected specimens for laboratory processing. The transcripts were analyzed using template analysis. RESULTS: University branding of web-based and physical materials instilled a sense of trust in participants and increased their confidence in the test results. Shipping the specimen self-collection box in plain unmarked packaging promoted discretion during transit and on its receipt. Using different colored bags with matching color-coded instructions to self-collect each type of specimen minimized the potential for confusion. Participants recommended including prerecorded instructional videos to supplement the written instructions, providing information on the importance of triple-site bacterial STI testing, and adding a reminder of the types of testing that would and would not be conducted on hair samples. Participants also suggested tailoring the specimen self-collection box to include only the tests that they might be interested in completing at that time, adding real-time videoconferencing to the beginning of the study to introduce the research team, and sending personalized reminders following the delivery of the specimen self-collection box. CONCLUSIONS: Our results offer valuable insights into aspects that facilitated participant engagement in self-collected specimen return, as well as areas for potential improvement to maximize return rates. Our findings can help guide the design of future large-scale studies and public health programs for home-based HIV, bacterial STI, and preexposure prophylaxis adherence testing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13647.

Willingness to use and preferences for long-acting injectable PrEP among sexual and gender minority populations in the southern United States, 2021-2022: cross-sectional study.

INTRODUCTION: Long-acting injectable (LAI) pre-exposure prophylaxis (PrEP) for HIV prevention was approved by the U.S. Food and Drug Administration in 2021. LAI PrEP is more effective than oral PrEP. However, it is not clear whether the groups most at risk of HIV in the United States will use LAI PrEP. Willingness to use LAI PrEP and preference for LAI versus oral PrEP has not been reported for sexual and gender minority (SGM) people in the southern United States, where the HIV epidemic is concentrated. Our goal was to assess willingness to use LAI PrEP and preference for oral versus LAI PrEP among SGM people in the southern United States and to assess differences in willingness by demographics and sexual behaviour. METHODS: We conducted an online, cross-sectional survey of SGM people aged 15-34 years in the southern United States (n = 583). Participants reported willingness to use LAI PrEP and preferences for LAI PrEP versus daily oral PrEP. We assessed bivariate associations and adjusted prevalence ratios for the LAI-PrEP-related outcomes and key demographic and behavioural characteristics. RESULTS: Overall, 68% of all participants (n = 393) reported being willing to use LAI PrEP that provides protection against HIV for 3 months. Of those, most (n = 320, 81%) indicated a preference for using LAI PrEP, compared to a daily oral pill or no preference. Willingness to use LAI PrEP was more common among transgender and non-binary participants and participants who engaged in condomless anal intercourse in the last 6 months. Hispanic participants were more likely and non-Hispanic Black participants were less likely to report willingness to use LAI PrEP compared to non-Hispanic White participants. CONCLUSIONS: Willingness to use LAI PrEP was high among SGM people in the southern United States, although there were some important differences in willingness based on demographic characteristics. Decreased willingness to use LAI PrEP among groups who are disproportionately affected by the HIV epidemic, such as non-Hispanic Black SGM people, could exacerbate existing disparities in HIV incidence. LAI PrEP is an acceptable option among SGM populations in the southern United States, but strategies will be needed to ensure equitable implementation.

Study Evaluating Self-Collected Specimen Return for HIV, Bacterial STI, and Potential Pre-Exposure Prophylaxis Adherence Testing Among Sexual Minority Men in the United States.

Web-based HIV and sexually transmitted infection (STI) prevention studies are increasingly requesting gay, bisexual, and other men who have sex with men (GBMSM) to return self-collected specimens for laboratory processing. Some studies have solicited self-collected extragenital swabs for gonorrhea and chlamydia testing, but to date, none have solicited self-collected hair samples for pre-exposure prophylaxis (PrEP) adherence testing. Project Caboodle! offered 100 racially/ethnically diverse GBMSM aged 18 to 34 years residing across the United States a choice to self-collect at home and return by mail any of the following: a finger-stick blood sample (for HIV testing), a pharyngeal swab, a rectal swab and a urine specimen (for gonorrhea and chlamydia testing), and a hair sample (to visually assess its adequacy for PrEP drug level testing). Despite not incentivizing specimen return, 51% mailed back at least one type of specimen within 6 weeks (1% returned three specimens, 11% returned four specimens and 39% returned all five specimens). The majority of returned specimens were adequate for laboratory processing. Significantly more participants without a college education (p = .0003) and those who were working full-time or part-time (p = .0070) did not return any specimens. In addition, lower levels of HIV-related knowledge (p = .0390), STI-related knowledge (p = .0162), concern about contracting HIV (p = .0484), and concern about contracting STIs (p = .0108) were observed among participants who did not return any specimens. Self-collection of specimens holds promise as a remote monitoring strategy that could supplement testing in clinical settings, but a better understanding of why some GBMSM may choose to fully, partially, or not engage in this approach is warranted.

Interest in HIV Prevention Mobile Phone Apps: Focus Group Study With Sexual and Gender Minority Persons Living in the Rural Southern United States.

BACKGROUND: Mobile health (mHealth) interventions, including smartphone apps, have been found to be an effective means of increasing the uptake of HIV prevention tools, including HIV and sexually transmitted infection (STI) tests and pre-exposure prophylaxis. However, most HIV prevention mHealth apps tested in the United States have been tested among populations living in areas surrounding urban centers. Owing to reduced access to broadband internet and reliable cellular data services, it remains unclear how accessible and effective these interventions will be in rural areas. In addition, gay and bisexual men who have sex with men and gender minority populations in rural areas experience enhanced stigma when compared with their more urban counterparts, and these experiences might affect their willingness and interest in mHealth apps. OBJECTIVE: This study aimed to conduct online focus groups with men who have sex with men and transgender and gender diverse populations in the rural southern United States to assess their interest in mHealth HIV prevention apps and the features that they would be the most interested in using. METHODS: Focus group participants were recruited from a larger pool of sexual and gender minority respondents to a web-based research survey. The participants indicated that they would be willing to participate in an online focus group discussion. Focus groups were conducted via secure Zoom (Zoom Video Communications Inc) videoconferencing. During the focus group discussions, participants were asked to discuss their experiences with HIV and STI prevention and how these experiences were affected by living in a rural area. They were then shown screenshots of a new app to promote HIV and STI prevention among rural populations and asked to provide their opinions on the app's features. The transcripts of the discussions were reviewed and coded using a constant comparative approach. RESULTS: A total of 6 focus groups were conducted with 26 participants. Most participants were cisgender gay and bisexual men who have sex with men (19/26, 73%); the remaining participants were transgender men (2/26, 8%), were nonbinary people (2/26, 8%), or had multiple gender identities (3/26, 12%). Participants reported numerous barriers to accessing HIV and STI prevention services and accurate information about HIV and STI prevention options. Overall, the participants reported a high degree of interest in mHealth interventions for HIV and STI prevention and suggested several recommendations for the features of an app-based intervention that would be the most useful for rural residents. CONCLUSIONS: These focus group discussions indicate that rural residence is not a major barrier to mHealth HIV and STI prevention intervention implementation and that there is a high degree of interest in these approaches to HIV and STI prevention.

Acceptability and Feasibility of Self-Collecting Biological Specimens for HIV, Sexually Transmitted Infection, and Adherence Testing Among High-Risk Populations (Project Caboodle!): Protocol for an Exploratory Mixed-Methods Study.

BACKGROUND: Men who have sex with men (MSM) in the United States experience a disproportionate burden of HIV and bacterial sexually transmitted infections (STIs), such as gonorrhea and chlamydia. Screening levels among MSM remain inadequate owing to barriers to testing such as stigma, privacy and confidentiality concerns, transportation issues, insufficient clinic time, and limited access to health care. Self-collection of specimens at home and their return by mail for HIV and bacterial STI testing, as well as pre-exposure prophylaxis (PrEP) adherence monitoring, could be a resource-efficient option that might mitigate some of these barriers. OBJECTIVE: Project Caboodle! is a mixed-methods study that explores the acceptability and feasibility of self-collecting and returning a bundle of 5 different specimens for HIV and bacterial STI testing, as well as PrEP adherence monitoring, among sexually active HIV-negative or unknown status MSM in the United States aged 18 to 34 years. METHODS: Participants will be recruited using age, race, and ethnicity varied advertising on social networking websites and mobile gay dating apps. In Phase 1, we will send 100 participants a box containing materials for self-collecting and potentially returning a finger-stick blood sample (for HIV testing), pharyngeal swab, rectal swab, and urine specimen (for gonorrhea and chlamydia testing), and hair sample (to assess adequacy for potential PrEP adherence monitoring). Specimen return will not be incentivized, and participants can choose to mail back all, some, or none of the specimens. Test results will be delivered back to participants by trained counselors over the phone. In Phase 2, we will conduct individual in-depth interviews using a video-based teleconferencing software (VSee) with 32 participants from Phase 1 (half who returned all specimens and half who returned some or no specimens) to examine attitudes toward and barriers to completing various study activities. RESULTS: Project Caboodle! was funded in May 2018, and participant recruitment began in March 2019. The processes of designing a study logo, creating advertisements, programming Web-based surveys, and finalizing step-by-step written instructions accompanied by color images for specimen self-collection have been completed. The boxes containing 5 self-collection kits affixed with unique identification stickers are being assembled, and shipping procedures (for mailing out boxes to participants and for specimen return by participants using prepaid shipping envelopes) and payment procedures for completing the surveys and in-depth interviews are being finalized. CONCLUSIONS: Self-collection of biological specimens at home and their return by mail for HIV and bacterial STI testing, as well as PrEP adherence monitoring, might offer a practical and convenient solution to improve comprehensive prevention efforts for high-risk MSM. The potentially reduced time, expense, and travel associated with this approach could facilitate a wider implementation of screening algorithms and remote monitoring strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13647.