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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...

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.

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.