Abstract
Young, Black, gay and bisexual men who have sex with men (GBMSM) experience disproportionate HIV incidence and are a priority population for pre-exposure prophylaxis (PrEP). In addition to understanding barriers to PrEP initiation, it is imperative that we also understand patterns of adherence and persistence on PrEP among young, Black GBMSM who have started PrEP. Understanding factors associated with PrEP adherence and persistence will facilitate the development of interventions to encourage effective PrEP use. We conducted a study to examine the feasibility and acceptability of using frequent, online, self-administered surveys to assess recent sexual behavior and PrEP use over six months among young, Black GBMSM on PrEP. Participants completed brief surveys weekly for three months followed by monthly surveys through month six. They were also asked to submit a self-collected dried blood spot to provide a biological measure of PrEP adherence at months three and six. Feasibility was measured via completion percentages for the surveys and dried blood spot collection; acceptability was measured via qualitative data collected during in-depth interviews. Overall, 71% of participants completed at least 80% of study surveys and 64% returned at least one dried blood spot specimen. Most study procedures were reported to be acceptable, although some participants did have some difficulties using the study app to complete surveys. Short, frequent, self-administered surveys and self-collected dried blood spots were found to be feasible and acceptable methods to measure PrEP adherence and persistence among young, Black GBMSM and might form the basis for future adherence interventions.
Keywords: preexposure prophylaxis, men who have sex with men, adherence, feasibility
Introduction
Young, Black, gay and bisexual men who have sex with men (GBMSM) are disproportionately affected by the HIV epidemic in the United States (Centers for Disease Control and Prevention 2021), but they are less likely than other GBMSM to use pre-exposure prophylaxis (PrEP) (Centers for Disease Control and Prevention 2023). Based on estimates from the Centers for Disease Control and Prevention, only 11% of Black people with indications for PrEP used PrEP in 2021 compared to 19% of Hispanic/Latino people and 78% of White people (Centers for Disease Control and Prevention 2023). PrEP is a highly effective biomedical HIV prevention intervention available via oral medication that can be taken daily (Grant et al. 2010) or at the time of sexual activity (Molina et al. 2015) or as a long-acting injection every two months (Landovitz et al. 2021). Increasing PrEP use to reduce new HIV infections is a key pillar of the Ending the HIV Epidemic campaign (U.S. Department of Health and Human Services 2020), and young, Black GBMSM are a priority population given their increased lifetime risk of HIV compared to other groups (Hess et al. 2017).
PrEP effectiveness requires both initiation of PrEP and adherence to PrEP. Daily oral PrEP provides essentially complete protection against HIV transmission via anal sex when users take at least 4 out of 7 daily doses per week (Grant et al. 2014). Event-based dosing requires that a user take two pills between 2 and 24 hours prior to having sex and one pill daily thereafter as long as they continue to have sex and provides a similar level of protection as daily dosing (Molina et al. 2015). Long-acting injectable PrEP provides even greater protection than oral PrEP but requires more frequent healthcare provider visits (Landovitz et al. 2021).
Multiple approaches to measuring PrEP adherence have been developed, ranging from direct measurement via blood samples to indirect methods via electronic pill bottles.(Haberer 2016; Spinelli et al. 2020) Laboratory testing is expensive and labor-intensive to conduct. Electronic pill bottles are also expensive and require that PrEP users change their routines to incorporate the pill bottle into their medication regimen. Self-reported adherence via short, frequent surveys can be collected at a large scale for low marginal costs, and similar approaches have been found to be effective in other settings.(Curran et al. 2013) A study conducted among GBMSM in the United States found that self-report of PrEP adherence was feasible via a mobile app; however, the study sample included few Black GBMSM and participants were not required to complete regular self-assessments of PrEP use and sexual behavior.(Horvath et al. 2024)
Several barriers to PrEP adherence among Black GBMSM have been identified. Stimulant use concurrent with sex has been found to be associated with lower adherence (Okafor et al. 2020). Structural factors have also been identified as barriers to adherence and persistence, including housing insecurity and transportation issues (LeMasters et al. 2021). Lack of transportation is a particular barrier for GBMSM in rural areas because they often do not have access to PrEP providers nearby (Siegler et al. 2018). Stigma is also a major barrier to engagement in HIV prevention and overall awareness of PrEP, and intersectional stigma – in which stigmatizing experiences resulting from different aspects of one’s identity combine to increase negative effects on health outcomes – compounds the barriers experienced by Black GBMSM (Quinn et al. 2019; Ezennia et al. 2019; Babel et al. 2021). Developing a full understanding of the psychosocial barriers and facilitators of PrEP adherence among young, Black GBMSM will be necessary to develop effective interventions to ensure optimal implementation of PrEP.
PrEP adherence can be challenging to monitor because, unlike antiretrovirals for the treatment of HIV infection that require continuous adherence, PrEP is only necessary when there is ongoing risk of HIV transmission (e.g., via condomless anal sex). For example, a period in which a PrEP user stops taking their medication regularly will not affect their HIV risk if it coincides with a hiatus from condomless sex. Thus, contemporaneous measurements of PrEP use and sexual behavior are necessary to properly characterize effective PrEP adherence. We conducted a study to understand the feasibility and acceptability of conducting frequent, remote self-assessments of PrEP use and sexual behavior to granularly assess the alignment between PrEP use and sexual risk among young, Black GBMSM and to evaluate the role of psychosocial factors in facilitating or inhibiting PrEP adherence.
Methods
Participants and Recruitment
Recruitment occurred from April 2021 – December 2022. Participants were recruited from the southern United States via online advertisements on social and sexual networking apps and websites and in-person posters and flyers in community-based organizations that provide HIV prevention services. We also sent emails to men who previously participated in HIV-related research studies at Emory University and provided consent to be re-contacted about research opportunities. Unique links were used to identify the recruitment source from which a potential participant was recruited. For screening surveys with recruitment source information available, the largest number of participants were referred from ads on GROWLr (n = 521), Grindr (n = 300), and previous research study participants (n = 243). After clicking on an online advertisement or following a link from a QR code on a physical advertisement, potential participants were directed to an online eligibility screener.
After providing informed consent to screen, participants completed a brief eligibility screener. Eligible participants were cisgender male; were age 18–34 years; identified as Black or African American; reported a history of sex with cisgender men or transgender women; never tested positive for HIV; were currently taking PrEP or recently received a PrEP prescription; had an Android smartphone or iPhone; and were willing to self-collect a dried blood spot (DBS) sample for PrEP adherence. Eligible participants who provided informed consent were enrolled in the study. All study activities were approved by the University of Pittsburgh and the University of Maryland at Baltimore Institutional Review Boards.
Study Design
Participants were followed for a total of 6 months. After providing informed consent, participants could immediately complete an online baseline survey hosted on a HIPAA-compliant survey platform (Alchemer.com). Participants then download the mEMA (Ilumivu) app which was used to conduct subsequent data collection. The mEMA app is designed to conduct ecological momentary assessments and allows researchers to program specific days and times for participants to complete surveys. Participants received prompts at designated times and had 24 hours to complete the survey; they were able to select which day of the week their surveys would become available to increase the likelihood that they would be able to complete them. Participants in the current study completed weekly surveys for a total of three months (n = 11 weekly surveys) followed by monthly surveys through six months (n = 4 monthly surveys). At months 3 and 6, participants were asked to self-collect a DBS sample and return it via pre-addressed and prepaid envelope to the study laboratory for testing to determine the concentration of tenofovir diphosphate as a measure of PrEP adherence (Molecular Testing Labs, Vancouver, Washington). Participants were provided with a graphical insert and video, each of which provided instructions for completing the DBS self-collection. On each survey, participants reported sexual behavior and PrEP use in the preceding period. Participants were compensated $20 for the baseline survey, $5 for each weekly survey, $20 for each monthly survey, and $15 for each DBS specimen returned.
In addition to the activities above, some participants were invited to participate in in-depth interviews via HIPAA-compliant Zoom at either the 3- or 6-month time point. These time points were selected so that we would obtain feedback from participants after completing only weekly surveys and after completing both weekly and monthly surveys. Study staff, rather than participants, determined if a participant was eligible for an interview at the 3- or 6-month time point. Participants were purposively sampled to obtain a balance of those who were adherent and those who were not. Interviews followed a semi-structured guide, were approximately 45 minutes in duration, and were transcribed verbatim. Interview topics included acceptability of the mEMA app and study procedures, experiences using PrEP, barriers to and facilitators of PrEP adherence, and future plans for PrEP use. Transcripts were analyzed using a constant comparative thematic analysis approach under the supervision of the senior author in collaboration with study staff
Measures
Feasibility was assessed via overall study retention and completion rates for each study activity (weekly surveys, monthly surveys, DBS collection). The viability of returned DBS samples was also assessed.
Acceptability was assessed via qualitative data collected during in-depth interviews. Specifically, at the beginning of each interview, participants were asked to describe their feelings about the mEMA app and study procedures.
Participants self-reported demographic information in the baseline survey including age, ethnicity, cultural background, education and employment status, income, and health insurance. They also completed the following psychosocial scales: PHQ-9 to measure depression, Multidimensional Scale of Perceived Social Support (Zimet et al. 1990), AUDIT-C to assess alcohol use and misuse, DAST-10 to assess substance use and misuse, Brief Resilience Scale (Smith et al. 2008), and Coping Self-Efficacy Scale (Chesney et al. 2006).
Statistical Analysis
We calculated the proportion of participants who completed all study activities and the proportion of study activities completed by each participant. Participants who completed at least 80% of study surveys were defined as fully retained. The association between two outcomes -- retention and DBS completion – was assessed by demographic and psychosocial factors using Fisher’s exact test.
Acceptability was assessed using excerpts from the in-depth interviews that were relevant to participants’ feelings about participating in the study and using the study app.
Results
Feasibility
A total of 1431 eligibility screeners were initiated, of which 1265 (88%) were completed. Of those completed screeners, 146 (12%) men were eligible, 138 (11%) provided contact info, 127 (10%) provided informed consent, and 69 (6%) completed the baseline survey and were enrolled in the study. The most common reasons for ineligibility were not meeting the criteria for race (n = 657), age (n = 376), PrEP use (n = 328), and sexual behavior (n = 108). Most enrolled participants were age 25–34 (n = 56, 81%, Table 1), non-Hispanic (n = 60, 87%), and had a college education or higher (n = 45, 66%). Most participants reported private health insurance (n = 43, 62%), but 17 (25%) had no health insurance. Most participants completed at least half of the study surveys, with 49 (71%) completing 80% or more (Table 2). Fewer participants completed all weekly surveys (n = 31, 45%) compared to the number who completed all monthly surveys (n =41, 59%).
Table 1.
Demographic characteristics of participants in a longitudinal study of pre-exposure prophylaxis adherence and persistence among young, Black men who have sex with men, United States, 2021–2023.
| N | Percent | |
|---|---|---|
|
| ||
| Age Group | ||
| 18–24 years old | 13 | 19 |
| 25–34 years old | 56 | 81 |
| Ethnicity | ||
| Hispanic | 9 | 13 |
| Not Hispanic | 60 | 87 |
| Cultural Background | ||
| African American Black | 63 | |
| African | 4 | |
| Afro-Caribbean | 6 | |
| Afro-Latino | 7 | |
| Education | ||
| High School or Less | 6 | 9 |
| Some college, Associate's degree, and/or Technical School | 17 | 25 |
| College, post graduate, or professional school | 45 | 66 |
| Current Student | ||
| Yes | 19 | 28 |
| No | 50 | 73 |
| Employment Status | ||
| Employed full-time | 53 | 77 |
| Employed part-time | 8 | 12 |
| Self-employed | 1 | 2 |
| Unemployed or between jobs | 6 | 9 |
| Unable to work due to disability | 1 | 2 |
| Annual Income | ||
| $0–19,999/year | 13 | 19 |
| $20,000–49,999/year | 27 | 39 |
| $50,000-$74,999/year | 18 | 26 |
| $75,000/year or more | 11 | 16 |
| Health Insurance | ||
| Private | 43 | 62 |
| Public | 6 | 9 |
| None | 17 | 25 |
| Other | 3 | 4 |
Table 2.
Retention over six months in a longitudinal study of pre-exposure prophylaxis adherence and persistence among young, Black men who have sex with men, United States, 2021–2023.
| n | % | |
|---|---|---|
|
| ||
| Proportion of Total Surveys Completed | ||
| >=80% | 49 | 71 |
| 50–80% | 11 | 16 |
| <50% | 9 | 13 |
|
| ||
| Weekly Surveys Completeda | ||
| 11 | 31 | 45 |
| 10 | 15 | 22 |
| 9 | 4 | 6 |
| 8 | 4 | 6 |
| <8 | 15 | 22 |
| Monthly Surveys Completedb | ||
| 4 | 41 | 59 |
| 3 | 10 | 14 |
| 2 | 5 | 7 |
| 1 | 4 | 6 |
| 0 | 9 | 13 |
There were a total of 11 weekly surveys in the first three months of follow-up;
There were a total of 4 monthly surveys across the last three months of follow-up
There were no statistically significant differences in retention in survey activities, as measured by survey completion, based on any measured demographic or psychosocial factors (Table 3). Although the results were not statistically significant, point estimates of survey completion rates were somewhat higher among participants reporting higher annual incomes. Social support scores were consistently higher for those who completed ≥80% of surveys compared to those who did not.
Table 3.
Correlates of survey completion over six months of follow-up in a study of pre-exposure prophylaxis adherence and persistence among young, Black men who have sex with men, United States, 2021–2023.
| >= 80% Surveys Completed | <80% of Surveys Completed | ||
|---|---|---|---|
| Characteristic | n (percent) | n (percent) | Fisher exact p-value |
|
| |||
| Demographics | |||
| Age Group | 0.5001 | ||
| 18–24 years old | 8 (62) | 5 (38) | |
| 25–34 years old | 41 (73) | 15 (27) | |
| Education | 0.9175 | ||
| College, post graduate, or professional school | 31 (69) | 14 (31) | |
| Some college, Associates degree, and/or Technical school | 12 (71) | 5 (29) | |
| High School or Less | 5 (83) | 1 (17) | |
| Current Student | >0.99 | ||
| No | 35 (70) | 15 (30) | |
| Yes | 14 (74) | 5 (26) | |
| Employment Status | 0.0795 | ||
| Employed full-time | 38 (72) | 15 (28) | |
| Employed part-time | 5 (63) | 3 (38) | |
| Self-employed | 0 (0) | 1 (100) | |
| Unable to work due to a disability | 0 (0) | 1 (100) | |
| Unemployed or between jobs | 6 (100) | 0 (0) | |
| Annual Income | 0.1147 | ||
| $0–19,999 | 8 (62) | 5 (38) | |
| $20,000–49,999 | 16 (59) | 11 (41) | |
| $50,000-$74,999 | 16 (89) | 2 (11) | |
| $75,000 or more | 9 (82) | 2 (18) | |
| Sexual Behavior | |||
| Condomless Insertive | 0.4185 | ||
| No | 18 (64) | 10 (36) | |
| Yes | 31 (76) | 10 (24) | |
| Condomless Receptive | 0.7965 | ||
| No | 25 (69) | 11 (31) | |
| Yes | 24 (73) | 9 (27) | |
| Condomless Sex | 0.751 | ||
| No | 10 (67) | 5 (33) | |
| Yes | 39 (72) | 15 (28) | |
| Mean (s.d.) | Mean (s.d.) | Kruskal-Wallis p-value | |
| Psychosocial Factors a | |||
| Patient Health Questionnaire-9 | 5.8 (5.9) | 7.6 (7.6) | 0.3918 |
| AUDIT-C | 3.3 (2.3) | 3.2 (2.2) | 0.9415 |
| DAST-10 | 0.9 (1.0) | 1.6 (2.2) | 0.5919 |
| Resilience | 3.5 (.8) | 3.4 (.9) | 0.8372 |
| Perceived Social Support - Significant Other | 5.5 (1.3) | 4.9 (1.8) | 0.3029 |
| Perceived Social Support - Family | 4.9 (1.5) | 4.2 (1.7) | 0.0799 |
| Perceived Social Support - Friends | 5.8 (1.2) | 5.6 (1.6) | 0.9787 |
| Coping Self-Efficacy Scale Sum | 179.1 (49.7) | 168.5 (41.9) | 0.3212 |
Maximum and mimimum values for the scales are as follows: Patient Health Questionnaire-9: 0–27; AUDIT-C: 0–12; DAST-10: 0–10; Perceived Social Support – Significant Other: 1–7; Perceived Social Support – Family: 1–7; Perceived Social Support – Friends: 1–7; Coping Self-Efficacy Scale: 0–286
There were no differences in retention in specimen collection, as measured by completion of at least one of two DBS samples, based on any measured demographic or psychosocial factors except for annual household income (Table 4). Those with incomes between $50,000 and $74,999 were much more likely to return at least one DBS sample (n = 16, 89%) compared to those earning $0-$19,999 (n = 6, 46%), $20,000-$49,999 (n = 15, 56%), and $75,000 or more (n = 7, 64%).
Table 4.
Correlates of returning at least one of two dried blood spot samples for laboratory measurement of adherence over six months of follow-up in a study of pre-exposure prophylaxis adherence and persistence among young, Black men who have sex with men, United States, 2021–2023.
| Returned at Least 1 DBS | No DBS Returned | ||
|---|---|---|---|
| Characteristic | n (percent) | n (percent) | Fisher exact p-value |
| Demographics | |||
| Age Group | 0.5243 | ||
| 18–24 years old | 7 (54) | 6 (46) | |
| 25–34 years old | 37 (66) | 19 (34) | |
| Education | 0.2500 | ||
| College, post graduate, or professional school | 30 (67) | 15 (33) | |
| Some college, Associates degree, and/or Technical school | 8 (47) | 9 (53) | |
| High School or Less | 5 (83) | 1 (17) | |
| Current Student | >0.99 | ||
| No | 32 (64) | 18 (36) | |
| Yes | 12 (63) | 7 (37) | |
| Employment Status | 0.1774 | ||
| Employed full-time | 35 (66) | 18 (34) | |
| Employed part-time | 3 (38) | 5 (63) | |
| Self-employed | 1 (100) | 0 (0) | |
| Unable to work due to a disability | 0 (0) | 1 (100) | |
| Unemployed or between jobs | 5 (83) | 1 (17) | |
| Annual Income | 0.0461 | ||
| $0–19,999 | 6 (46) | 7 (54) | |
| $20,000–49,999 | 15 (56) | 12 (44) | |
| $50,000-$74,999 | 16 (89) | 2 (11) | |
| $75,000 or more | 7 (64) | 4 (36) | |
| Sexual Behavior | |||
| Condomless insertive | 0.3164 | ||
| No | 20 (71) | 8 (29) | |
| Yes | 24 (59) | 17 (41) | |
| Condomless receptive | 0.2098 | ||
| No | 20 (56) | 16 (44) | |
| Yes | 24 (73) | 9 (27) | |
| Condomless sex | 0.7674 | ||
| No | 9 (60) | 6 (40) | |
| Yes | 35 (65) | 19 (35) | |
| Mean (s.d.) | Mean (s.d.) | Kruskal-Wallis p-value | |
| Psychosocial Factors a | |||
| Patient Health Questionnaire-9 | 5.8 (5.4) | 7.3 (7.9) | 0.7023 |
| AUDIT-C | 3.3 (2.1) | 3.2 (2.4) | 0.6321 |
| DAST-10 | 0.8 (.9) | 1.6 (2.0) | 0.2058 |
| Resilience | 3.5 (.8) | 3.5 (.8) | 0.9601 |
| Perceived Social Support - Significant Other | 5.4 (1.4) | 5.2 (1.6) | 0.8116 |
| Perceived Social Support - Family | 4.7 (1.7) | 4.7 (1.3) | 0.7212 |
| Perceived Social Support - Friends | 5.8 (1.3) | 5.8 (1.3) | 0.9749 |
| Coping Self-Efficacy Scale Sum | 172.5 (50.9) | 179.9 (41.0) | 0.5448 |
Maximum and mimimum values for the scales are as follows: Patient Health Questionnaire-9: 0–27; AUDIT-C: 0–12; DAST-10: 0–10; Perceived Social Support – Significant Other: 1–7; Perceived Social Support – Family: 1–7; Perceived Social Support – Friends: 1–7; Coping Self-Efficacy Scale: 0–286
A total of 75 DBS kits were returned by participants. Of these, 56 (76%) samples were properly collected and shipped and able to be tested for tenofovir levels. Among those that were not eligible for testing, 14 (78%) were subject to shipping delays that placed them outside of the acceptable window for testing and 4 (22%) had insufficient quantity for testing.
Acceptability
A total of 14 in-depth interviews were completed. Overall, participants found the study procedures acceptable and easy to comply with. Several participants noted that the regularity of the study assessments facilitated their participation in the study, as did the automated reminders that prompted them to complete each survey. For example, one participant noted that both having the ability to decide when their surveys would be due, and the brevity of the surveys were particularly helpful:
“Um, scheduled surveys, so I just kind of knew when to expect it. Um, easy to do, would take a few seconds, a minute or so.”
(33 years old)
Another participant commented that the regularity of the surveys made them easy to plan for and complete. When asked what facilitated completion of the surveys, he said:
“The fact that it was every week, the same time every week, the regimen was the same.”
(33 years old)
However, another participant reported that the window for responding to the survey was too short and caused them to be concerned about whether they would be able to submit the survey on time:
“I think I was a little concerned about was the, the time window, the time frame of completing the surveys. Um, I kept getting reminders that was like, you know, ‘You gotta do it now. You gotta do it now.’ And sometimes, I may not be in a position or place where I can do them. And so I was always kinda concerned that, like, ‘Well, if I don’t do it right now, then I might lose out on this gift card, etc.’ I’d be like that. So, um, it was kinda hard to, like, find time to, like, stop, sit down, do a quick, I mean, survey, and then getting back to what I was doing. So that was probably the hardest, I would say.”
(31 years old)
One participant commented on the relevance and relatability of the questions and how that increased the relevance of the study to him:
“I think the study was good because some of the questions that y’all asked was kinda like, “Did you forget? Or did you forget ‘cause you was high? Did you forget ‘cause you was drink--” like, that’s, that’s, that’s real. That’s so real, and I feel like just having that straight-forward answer for people to kinda be like, “You know what? Well, I was drinking that day, so I p-- yeah, I probably did forget because of that,” and I just felt like that’s something that can resonate more with just reality, not just feel like that’s, that’s something we need-- if people wanna do st-- surveys or studies, you gotta kinda find some type of relation with the person that you’re, you know, working with.”
(27 years old)
Some participants reported difficulty figuring out how to use the smartphone app used to administer surveys; however, they were usually able to remedy any questions and did not report subsequent problems. For example:
“In the beginning, I guess it was kinda, I didn’t… It took a second to figure out what to do the first time, but once I figured it out it was easy, like where to go from a weekly assessment.”
(33 years old)
Discussion
In this pilot study of survey and laboratory measures to assess PrEP adherence and persistence among young, Black GBMSM, we observed high levels of participant retention and survey completion, indicating that these are feasible methods for studying PrEP use in this population. Overall, 71% of participants completed at least 80% of study surveys, with another 16% completing at least 50% of study surveys. Completion rates were higher for the monthly surveys compared to the weekly surveys, which might reflect a difference in the compensation available for each ($5 for each weekly survey, $20 for each monthly survey). The monthly surveys were longer in duration than the weekly surveys because they included psychosocial assessments, but the ratio of incentive to time commitment was greater for monthly compared to weekly surveys. Most participants also returned at least one DBS sample, although some DBS samples were not received in time or were not of sufficient quantity for laboratory testing.
Prior research suggests Black/African American individuals are less likely to enroll in and complete HIV clinical research studies due to structural and psychosocial factors (Sullivan et al. 2007; Gwadz et al. 2010; Castillo-Mancilla et al. 2014), specifically economic status, mistrust in research, stigma, educational level, and intrinsic motivators. Of the demographic, behavioral, and psychosocial factors considered, none was found to be associated with feasibility as measured by survey completion. Only annual income was associated with return of at least one DBS sample, with those earning $50,000–74,999 USD/year more likely to return a DBS sample than those in other income categories. Participants were able to drop their sample at a FedEx store or dropbox or schedule a pickup from FedEx, but differences in work schedules and housing stability might affect the ability of participants to take advantage of this service. These findings are consistent with previous research that found economic factors were both facilitators and barriers to study enrollment and completion. A systematic review found that individuals with lower socioeconomic status were more likely to participate in Phase 1 studies due to compensation but also less likely to complete study activities due to financial challenges (Sheridan et al. 2020). While not significant, our findings demonstrated individuals who reported greater social support were more likely to complete study surveys. Similar findings were observed in an analysis of enrollment in clinical trials, where enrollment was influenced by relationships with physicians, family members, or friends (Sheridan et al. 2020). Nevertheless, these results indicate that these methods are feasible across a wide range of PrEP-using, young, Black GBMSM. Future research should examine factors associated with engagement in clinical research by Black GBMSM as there is a gap in the existing literature.
The in-depth interviews revealed that, overall, the study design was acceptable to the planned study population. Most participants reported few or no problems using the study app, and many appreciated the notifications that were delivered via the app and text messages to remind them to complete their study activities. The survey questions were also perceived as relevant to participants’ experiences, which served as a motivation for continued participation. One participant commented on the relatively short window of time that was available to complete each survey; although this issue was not raised in other interviews, it is possible that this was a contributing factor to some of the surveys that were not completed. Some participants also had difficulty navigating the study app at first, but this was generally resolved early in the study with no subsequent issues reported. It is possible that some participants had problems with the app that were not reported to the study team, which might also have contributed to lack of retention for some participants.
This is a convenience sample of young, Black GBMSM who responded to online ads or ads in PrEP-prescribing venues. These results might not be generalizable to all young, Black GBMSM, and it is possible that there are additional barriers and facilitators of studying PrEP adherence and persistence that we did not identify. Participants were also recruited from the US South, the region with the highest HIV incidence in the United States (Centers for Disease Control and Prevention 2024) and with the greatest disparities in PrEP uptake (Sullivan et al. 2024). Our sample size limits statistical power to assess associations between demographic and psychosocial characteristics and feasibility and acceptability.
There is a need for additional studies to identify correlates and predictors of suboptimal PrEP adherence and persistence among young, Black GBMSM to identify potential indicators and/or targets for interventions to increase PrEP adherence and persistence among this key population. We demonstrated that frequent, short surveys delivered via a smartphone study app are a feasible and acceptable method for collecting granular data on contemporaneous sexual behavior and PrEP use. Although successful completion rates for DBS sample collection were somewhat lower than the surveys, self-collection and mail submission of DBS samples are also feasible methods of obtaining laboratory-based measurements of PrEP use to validate self-report.
Conclusions
This mixed methods study demonstrated via qualitative and quantitative data that conducting brief, weekly assessments of recent PrEP use and sexual behavior is both acceptable and feasible among young, Black GBMSM who use PrEP. Such assessments, conducted remotely via smartphone app, could form the basis of a scalable digital intervention to increase PrEP adherence and persistence among those most vulnerable to HIV.
Acknowledgements
The authors are grateful to Ivana Alexander for her support in conducting the study and to all of the participants for their time and contributions.
Funding:
Research reported in this publication was supported by the National Institute Of Mental Health of the National Institutes of Health under Award Number R21MH121120. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Footnotes
Declarations
Conflicts of Intertest: Not applicable
Ethics approval: All study activities were reviewed and approved by the Institutional Review Board at the University of Maryland, Baltimore.
Consent to participate: This study was reviewed and approved by the Institutional Review Boards at the University of Pittsburgh and the University of Maryland at Baltimore. All participants provided informed consent prior to participation in study activities.
Consent for publication: All participants provided informed consent that their study data might be used in research publications.
Availability of Data:
Data are available from the first author upon request.
Code availability:
Not applicable.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data are available from the first author upon request.
