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Epidemiology and Social

Decision-making regarding condom use among daily and event-driven users of preexposure prophylaxis in the Netherlands

Zimmermann, Hanne M.L.a; Jongen, Vita W.a; Boyd, Andersa,b; Hoornenborg, Elskec; Prins, Mariaa,d; de Vries, Henry J.C.c,e; Schim van der Loeff, Maarten F.a,d; Davidovich, Udia,f; on behalf of the Amsterdam PrEP Project Team in the HIV Transmission Elimination Amsterdam Initiative (H-TEAM)

Author Information
doi: 10.1097/QAD.0000000000002714

Abstract

Introduction

Preexposure prophylaxis (PrEP) offers highly effective HIV infection prevention among MSM [1–3]. Since its 2016 approval by the European Medicine Agency, PrEP has been increasingly included as part of the routine HIV prevention package in European countries. Since August 2019, sexual health clinics in the Netherlands have provided PrEP care free of charge and PrEP tablets at reduced price to 6500 MSM at high-risk for HIV in a 5-year pilot PrEP program [4].

Despite the proven efficacy of PrEP, its introduction has been debated extensively in both the scientific and popular literature. The potential benefit of PrEP (i.e. reducing HIV incidence and reducing sex-related fear) has been weighed against the concern of ‘risk compensation’, in which PrEP use could result in decreased condom use and increased incidence of sexually transmitted infections (STIs). Studies have reported conflicting findings on decreasing condom use and increasing STI incidence among PrEP users after PrEP initiation [5–9]. A recent meta-analysis including more recent publications also suggested this to be the case [10], while in the Amsterdam PrEP (AMPrEP) demonstration project we observed significantly decreasing condom use with no significant rise in STIs during 2 years of PrEP use [9].

Concern about ‘risk compensation’ has made condom use among PrEP users an important public health goal and has led to the generic recommendation of condom use to be included in the Dutch PrEP-provision guidelines [11]. With PrEP protection against HIV acquisition, some users may indeed decide to use condoms differently than before PrEP initiation. However, while studies focused on overall trends have linked PrEP to decreasing condom use, the particular choices PrEP users make when they do use a condom remain largely unexplored. Whereas STI prevention among PrEP users is a public health priority, it may not be an individual priority [12]. Understanding when and why PrEP users decide to use condoms may help improve our knowledge of their sexual practices and to design counseling strategies to increase condom use during PrEP use when relevant.

In this mixed-methods study, we report on the strategies and motives for using condoms among PrEP users. We used mobile app-based diary data on daily sexual practices of MSM participating in the AMPrEP demonstration project. Using these quantitative data, we determined the frequency of the following four strategies of PrEP and condom use: PrEP only, PrEP and condoms combined, condoms only, and neither PrEP nor condoms. With additional qualitative data, we explored the motives for deploying each of these strategies.

Methods

Study setting

AMPrEP is an ongoing, longitudinal, open-label demonstration project that evaluates the acceptability and feasibility of daily (dPrEP) and event-driven PrEP (edPrEP) [13]. Full procedures and primary results have been published elsewhere [9,13]. Persons interested in participating in AMPrEP could fill out a web-based form online which examined their eligibility. HIV-negative men and transgender persons having sex with men were eligible for inclusion if they were at least 18 years old and had reported condomless anal sex (CAS) with casual partners; at least one diagnosed bacterial STI; use of postexposure prophylaxis, or sex with an HIV-positive partner with a detectable viral load in the preceding 6 months. Between August 2015 and May 2016, AMPrEP enrolled 374 HIV-negative MSM and two HIV-negative transgender women. AMPrEP participants are seen quarterly for medical monitoring, counseling, and data collection at the Public Health Service of Amsterdam, the Netherlands. Participants were free to choose between dPrEP and edPrEP at baseline and were allowed to switch between regimens at each study visit. Event-driven use is defined as taking two emtricitabine/tenofovir disoproxil tablets 2–24 h before an episode of CAS, followed by one tablet every 24 h until 48 h after the last episode of CAS [3]. Daily use is defined as taking one tablet of PrEP daily. A mobile application (app) was developed for Android and iOS, enabling participants to report daily information on PrEP use and sexual behavior.

Quantitative measures and analysis

Each day during follow-up, participants were asked to answer two questions in the AMPrEP-app: ‘Did you take a pill today?’ and ‘Did you have anal sex today?’, both questions had ‘yes’ or ‘no’ responses. If respondents answered ‘yes’ to question 2, the app prompted six additional questions regarding the partner type: steady partner, known casual partner (KCP) and/or unknown casual partner (UCP) and whether a condom was used during the sex act(s). Participants could indicate multiple partner types per day.

For the quantitative analyses, we excluded all participants who never responded to the app. Whenever participants reported multiple sex acts with KCPs and/or UCPs on the same day, we assumed that the information on condom use applied to all sex acts with these partners. We described the total number and proportion of sex acts per strategy by PrEP regimen. Baseline demographics of included versus excluded participants were compared using Pearson's chi-square, Fisher's exact, and rank sum tests, as appropriate. Participants included in the analysis were significantly younger, were more often employed, had a higher income level and more often reported an STI diagnosis at baseline compared with those excluded (Supplementary Table 1, https://links.lww.com/QAD/B856). Proportionate use of the four strategies among sex acts was plotted against the months since PrEP initiation for both dPrEP and edPrEP users. To compare the dPrEP and edPrEP users, we jointly modeled PrEP use (yes/no) and condom use (yes/no) using a bivariate probit regression model, with PrEP regimen as an independent variable. We tested overall differences in both outcomes with a joint Wald chi-square test. To correct for repeated measurements, variance was calculated to assume independently and identically distributed error across clusters of individuals. All analyses were stratified by partner type (i.e. steady partner, KCP, UCP). Data were analyzed using Stata (version 15.1; StataCorp, College Station, Texas, USA).

Qualitative measures and analysis

The current study involved secondary analysis of in-depth interviews (IDIs) conducted individually with 43 AMPrEP participants. The primary analysis aimed to gain insight into the impact of PrEP use on sexual well being. Briefly, participants were purposefully sampled on the basis of self-reported changes on several well being indicators that were integrated into the quarterly questionnaire; switching PrEP regimens; or not changing nor switching regimens during follow-up. We contacted eligible participants in batches and analyzed transcribed interviews after every second interview to establish thematic saturation in a timely manner. We stopped recruitment when thematic saturation for the primary aim was reached. IDIs lasted on average 51 (range 29–90) min and were conducted in Dutch or English by skilled qualitative researchers (including H.M.L.Z.).

Motives for PrEP and condom use were also consistently explored during the IDIs, but have not yet been separately analyzed. The aim of this secondary analysis was to analyze the motives for the deployment of the four strategies of PrEP and condom use: using only PrEP, combining PrEP with condoms, using only condoms, and using neither. For this purpose, all transcripts were recoded inductively by two independent coders who discussed all codes until reaching consensus. Subsequently, all codes were further categorized into themes (H.M.L.Z. and U.D.). We only included reasons from participants who employed the related strategy and excluded hypothetical reasoning.

Ethical considerations

The AMPrEP protocol obtained ethical approval from the ethics board of the Amsterdam UMC at the Academic Medical Center, Amsterdam, the Netherlands (NL49504.018.14). Oral informed consent was obtained from all interviewees for the recording, storage and usage of interviews. All data collected with the app were stored on a protected server at the Public Health Service of Amsterdam, using a unique study identifier.

Results

Descriptives

Of the 376 AMPrEP participants enrolled by May 2016, we included 352 (93.6%) participants who completed questions in the app at least once between 18 August 2015 and 27 February 2019. Of the included participants, 86% self-identified as white and 77% had at least college education. Median age at baseline was 39 years [interquartile range (IQR): 32–47]. Ninety-three (26.4%) chose edPrEP, and 259 (73.6%) chose dPrEP at baseline. A total of 48 949 anal sex acts were reported in the 41 953 days on which data were recorded. Of these sex acts, 11 632 were with steady partners, 19 547 with KCPs, and 17 770 with UCPs. Participants reported a median of 101.5 sex acts [IQR 40.5–211] with any partner type during the study period. A high proportion of sex acts were covered by PrEP among dPrEP users (98.4%, n = 39 597/40 254) and edPrEP users (86.4%, n = 7514/8695, Table 1). The proportions of sex acts covered by each of the condom and PrEP use strategies were statistically different between dPrEP and edPrEP users across all strata of partner type (P < 0.001 for all partner types, Table 1).

Table 1 - Preexposure prophylaxis and condom use for each individual sex act within each preexposure prophylaxis regimen (daily or event-driven) stratified by partner type within the Amsterdam preexposure prophylaxis observational cohort study, 18 August 2015 to 27 February 2019, Amsterdam, the Netherlands.
Steady partner Known casual partner Unknown casual partner



Daily, n = 9510 Event-driven, n = 2122 Daily, n = 15 838 Event-driven, n = 3709 Daily, n = 14 906 Event-driven, n = 2864
n (%) n (%) P value n (%) n (%) P value n (%) n (%) P value
PrEP only 8657 (91.0%) 1489 (70.2%) <0.001 13 008 (82.1%) 2930 (79.0%) <0.001 11 607 (77.9%) 1959 (68.4%) <0.001
PrEP and condom 555 (5.8%) 59 (2.8%) 2628 (16.6%) 505 (13.6%) 3124 (21.0%) 572 (20.0%)
Condom only 13 (0.1%) 36 (1.7%) 65 (0.4%) 132 (3.6%) 77 (0.5%) 211 (7.4%)
No PrEP, no condom 285 (3.0%) 538 (25.4%) 137 (0.9%) 142 (3.8%) 98 (0.7%) 122 (4.3%)
AMPrEP, Amsterdam PrEP Project; PrEP, preexposure prophylaxis.
Proportions of sex acts within each strategy were compared between the daily and the event-driven regime using a bivariate probit regression model with PrEP use (yes/no) and condom use (yes/no) as the outcome variables and PrEP regimen as an independent outcome. The P value was computed by testing the overall differences in the two outcomes with a joint Wald chi-square test. To correct for repeated measurements, variance was calculated to assume independently and identically distributed error across clusters of individuals.

From June 2017 to June 2018, we conducted individual, semistructured IDIs with 43 AMPrEP participants, of whom 28 were using dPrEP and 15 edPrEP. Median time on PrEP at the time of the IDI was 21 months [IQR: 20–27]. Most interviewees self-identified as white (88.4%) and had at least college education (90.7%). Median age at baseline was 41 years [IQR: 33–50].

Table 1 shows the overall numbers and proportions of the four PrEP and condom use strategies by PrEP regimen and partner type. Figure 1 shows the distribution of the four strategies per month since PrEP initiation by PrEP regimen and partner type. We added the number of reported sex acts per month on PrEP within each PrEP regimen stratified by partner type to Supplementary Table 2, https://links.lww.com/QAD/B856. Table 2 shows the themes and representative quotes identified in the IDIs. In the following, we describe the prevalence and motivation behind the practice of the four possible combinations of PrEP and condom use strategies since PrEP initiation.

F1
Fig. 1:
The distribution of the four strategies per month since preexposure prophylaxis initiation by preexposure prophylaxis regimen and partner type within the Amsterdam preexposure prophylaxis observational cohort study, 18 August 2015 to 27 February 2019, Amsterdam, the Netherlands.
Table 2 - Reasons for using or not using condoms among preexposure prophylaxis users in the Amsterdam preexposure prophylaxis observational cohort study, 2017–2018, Amsterdam, the Netherlands.
Reasons for PrEP only, n = 31

Theme Representative quotes
1A Increased trust in effectiveness of biomedical HIV prevention strategies, n = 12 PrEP: ‘If the other also uses PrEP, we don’t need a condom. It's not like that was the case from the beginning [PrEP-initiation], but it gradually became that way. I talked a lot about it with other friends who are also in the program [AMPrEP], my partner, and just also my own experience. At one point it [PrEP] became the first order of protection. It [PrEP] used to be an additional protection, but now it is the first’. (Interview 8, daily PrEP);TasP: ‘I think because I use PrEP now, but also because I know other people use PrEP as well as that I know now that with undetectable the risk of infection is limited. So also knowing this, as well as using PrEP, contributes to me being more often unsafe, it is now not an issue anymore to let go of condoms’. (Interview 18, event-driven PrEP)
1B Pleasurable sex, n = 24 ‘It is this dilemma: either you choose something that is safe but interferes with sex, or you choose for something that is more enjoyable, but more risky. So you notice during sex it doesn’t feel as nice, so you notice you don’t want to use it. But with that, I choose for the possibility of getting other STIs’. (Interview 21, daily PrEP)
1C STIs are perceived as manageable and curable, n = 21 ‘It's only about HIV… I am not afraid of STIs, they can be treated’. (Interview 6, daily PrEP)
1D Perceived low-response efficacy of condoms for STIs, n = 13 ‘Of course, I can also be infected with other [sexually transmitted] diseases, but I can also easily get those when I use a condom. A condom isn’t everything’. (Interview 9, event-driven PrEP)
1E Difficulty of returning to condom use, n = 9 ‘It is also addicting, that you think: “Oh I’m going to have enjoyable sex, let's go". You get used to that feeling. Now I have this kind of voice in my head that thinks “Why would you". Once you’re in the flow [of noncondom use] it is difficult to go back’. (Interview 37, event-driven PrEP)
Reasons for combining PrEP and condoms, n = 27

Theme Representative quotes
2A STI prevention, n = 19 In general: ‘I really don’t feel like getting infected with an STI. I use it as additional protection’ (Interview 16, daily PrEP). After contracting several STIs: ‘In Amsterdam, where I live now, the STIs are flying around, I am fed up with it. I will use condoms again’. (Interview 24, daily PrEP)
After contracting HCV: ‘Well, that hepatitis C infection was a wake-up call. You have to be careful with those kind of things. I got a bit scared, so now I am way more careful regarding condoms’ (Interview 24, daily PrEP)
2B Perceived elevated risk for HIV/STI acquisition, n = 22 Lack of control: ‘When I’m in a situation where there is a lot of sex around me, then I will choose to use a condom because I feel less in control’. (Interview 3, daily PrEP). Lack of trust: ‘[I use a condom] with people I don’t really know or only a little, or with people I don’t know anything about, specifically about their sexual health, or with those I do not have a relationship of trust yet’. (Interview 10, daily PrEP)
2C Mental reassurance, n = 9 In general: ‘Physically I enjoy condomless sex. I do however need the mental reassurance of condoms. I would not enjoy sex otherwise, even with PrEP, it is really a reassurance thing to avoid what you’re most afraid of’. (Interview 28, event-driven PrEP)
With HIV-positive partners: ‘But if I know someone has HIV, then it actually doesn’t matter anymore what condition I am in, it always pops in my mind that he has HIV and I will always use a condom when that's the case. Otherwise I wouldn’t have sex’. (Interview 11, daily PrEP)
2D Perceived suboptimal PrEP-adherence, n = 3 ‘Especially in the beginning, but sometimes this still happens, I got confused whether or not I had taken my pill [of PrEP]. I started stressing in the heat of the moment and decided to use condoms in these situations. Afterwards I used to count my pills and sometimes figured out I didn’t have to [use the condom], but within that moment of stress I felt I had to compensate my failure to be safe’. (Interview 11, daily PrEP)
2E Perceived decreased PrEP-efficacy, n = 2 ‘For example, when I was ill recently, I feel more at risk somehow. You know you’re taught it doesn’t work as good when having diarrhea or so’. (Interview 38, event-driven PrEP)
2F Sex partner's demand, n = 19 ‘Some partners are crystal clear. If I don’t want to use a condom, the deal is off’. (Interview 19, daily PrEP)
2H Avoidance of PrEP-disclosure, n = 11 Anticipated PrEP-stigma: ‘I wanted to do it without a condom and he looked at me like I was some fool. If it's like that I don’t even want to tell someone I use PrEP, so I don’t and use a condom [along with PrEP]’. (Interview 37, event-driven PrEP). Anticipated rejection: ‘I learned from previous experiences that when I told someone I used PrEP it became a “thing", and they block you [on dating apps] because they think you only do bareback, while if you just say you use a condom, there is no issue’ (Interview 42, daily PrEP)
2I Hygienic reasons, n = 2 ‘I use condoms if his bottom isn’t clean’. (Interview 37, event-driven PrEP)
Reasons for condoms only, n = 12

Theme Representative quotes
3A Event-driven use of PrEP, n = 8 Specific strategy of PrEP-use: ‘I try to use PrEP only for planned [risky] sex in the weekends. During the week I have safe sex with a condom’. (Interview 5, event-driven PrEP)
Anticipated PrEP-related stigma: ‘Online I try to figure someone's opinion about PrEP. If he is negative about it, I use a condom instead’. (Interview 37, event-driven PrEP)
PrEP is redundant if condoms are used anyway: ‘It's not for double protection’. (Interview 2, event-driven PrEP)
Sex was not planned: ‘Sometimes you’re not sure if you’re going to have sex, but then you end up with someone and it comes to anal sex. If I didn’t take PrEP in such situations, I will use a condom’. (Interview 38, event-driven PrEP)
3B Nonadherence to daily PrEP, n = 4 ‘At some time I forgot to take pills and of course it will still partly protect me, but it is not as it is prescribed. So I worried about it. The next time this happened, I used a condom instead’. (Interview 21, daily PrEP)
Reasons for not using PrEP nor condoms, n = 15

Theme Representative quotes
4A Perceived low risk for HIV, n = 14 Steady partner: ‘We repeatedly discuss our agreements for having sex with others. Therefore with my partner I do not use condoms’
Undetectable HIV-positive partner: ‘I already have this group of undetectable friends and it is completely unnecessary to take it. So I use it intermittently [event-driven] for HIV-negative men’. (Interview 20, event-driven PrEP)
No anal sex: ‘It occurred when I gave someone a blow job. I call it the department of STIs, not HIV’. (Interview 9, event-driven PrEP)
4B Forgetting either PrEP or condoms, n = 8 Forgetting PrEP shortly after PrEP initiation: ‘In the beginning I forgot sometimes, but now it's not hard at all’. (Interview 21, daily PrEP)
Forgetting to use a condom in the heat of the moment: ‘I did intend to [use a condom], but then in the moment itself that was all gone’. (Interview 37, event-driven PrEP)
AMPrEP, Amsterdam PrEP Project; HCV, hepatitis C virus; PrEP, preexposure prophylaxis; STI, sexually transmitted infection.

Preexposure prophylaxis only

PrEP only was the most commonly used strategy for sex with any partner type (81.0%, n = 39 650/48 949 anal sex acts, Table 1) regardless of PrEP regimen or time since PrEP initiation (Fig. 1). In the IDIs, almost all interviewees described how PrEP initiation had introduced a recurring dilemma in which they had to choose between pleasure and additional safety for each sex act. The increased trust in the effectiveness of biomedical HIV prevention strategies, such as treatment as prevention and PrEP, were described as motivations not to use condoms (quotes 1A, Table 2). As they were now protected by PrEP against HIV, using PrEP alone was the most preferable strategy among most interviewees and was applied most of the time. The motives for not using condoms were primarily based on the prospect of more pleasurable sex (quote 1B) and the assumption that STIs are curable (quote 1C). Many interviewees also perceived the efficacy of condoms to be low for STI protection (quote 1D). Some participants also described the difficulty of returning to condom use after becoming familiar with the pleasure of condomless sex (quote 1E).

Preexposure prophylaxis and condoms combined

Although combining PrEP and condoms was less frequent, there were scenarios in which PrEP users preferred the additional use of condoms. Combined PrEP and condoms were occasionally used in sex acts with steady partners, more often in sex acts of dPrEP (5.8%, n = 555/9510) than in sex acts of edPrEP users (2.8%, n = 59/2122, Table 1). The proportion of combined PrEP and condom use was relatively comparable between edPrEP and dPrEP users for sex acts with UCPs (Table 1; Fig. 1). Interviewees described adding condoms when their acquisition of STIs had increased since PrEP initiation, specifically when diagnosed with hepatitis C virus (HCV) (quotes 2A, Table 2), or when they perceived a sexual context as bearing extra risk for HIV or STI acquisition due to lack of control (e.g. sex parties, drug use during/before sex) or lack of trust in sex partners (quotes 2B). Some participants continued use of condoms after PrEP initiation for mental reassurance, specifically when sex partners were HIV positive (quotes 2C). Some doubted their own PrEP adherence or the efficacy of PrEP, especially if they had just started PrEP, and used condoms alongside PrEP for safety reassurance (quotes 2D and 2E). Perceptions of reduced PrEP efficacy were not based on any clinical or scientific grounds; they were often heightened at particular moments (e.g. after falling ill). Other reasons to use condoms alongside PrEP were when sex partners insisted on it (quote 2F); to avoid PrEP disclosure in case of anticipated stigma or rejection (quotes 2H), or for hygienic reasons (quote 2I).

Condom only

Condom only sex acts with any partner were uncommon, but occurred more often in sex acts of edPrEP (4.4%, n = 379/8695) than dPrEP users (<1%; n = 155/40 254) and more often with KCPs and UCPs than steady partners (Table 1; Fig. 1). In the IDIs, event-driven users described a few scenarios in which they used only condoms (quotes 3A, Table 2). For example, some interviewees restricted PrEP use to weekends and used condoms for the rest of the week, or relied on condoms only when sex was unplanned. Condoms also replaced PrEP when PrEP-related stigma was anticipated or when PrEP was perceived to be redundant (quotes 3A). Daily users reverted to condoms only when there was difficulty in adhering to PrEP (quote 3B).

Neither preexposure prophylaxis nor condoms

Using neither condoms nor PrEP occurred in 1.3% (n = 520/40 254) of sex acts among dPrEP users and in 9.2% (n = 802/8695) of sex acts among edPrEP users (Table 1). Most of these uncovered sex acts were reported in sex acts with steady partners among edPrEP users (25.4%; n = 538/2122). Figure 1 demonstrates an increase in using no protection with steady partners in sex acts of edPrEP users during follow-up. IDIs indicated that the main reason for not using either method was low perceived HIV risk, particularly with a steady partner, an HIV-positive partner with an undetectable viral load, or when the sexual activities performed were considered less risky (quotes 4A, Table 2). Other instances represented more risky situations, such as issues with adherence: forgetting to use dPrEP, especially shortly after PrEP initiation when they were not yet accustomed to taking pills (quotes 4B), or failing to plan for event-driven doses. Using neither strategy was also associated with failing to use a condom in the heat of the moment.

Discussion

In this mixed-methods study, we explored the frequency of and reasons for using condoms among PrEP users enrolled in the AMPrEP project. Data collected daily over 4 years on almost 50 000 sex acts indicated that the vast majority of anal sex acts were covered by PrEP alone, regardless of PrEP regimen or partner type. When a condom was used along with PrEP, it was mostly during sex with casual partners. We further showed that users of edPrEP more often replaced PrEP with condoms or used neither strategy compared with users of dPrEP, especially when having sex with steady partners.

Our data from the IDIs suggest that condom use decisions among PrEP users were primarily guided by balancing choices between additional HIV/STI-protection and increased sexual pleasure, as was also suggested by qualitative studies reporting on changes in sexual behavior post-PrEP initiation [14–16]. Combining condoms with PrEP was typically preferred when STI prevention other than HIV was a priority, having sex was perceived as being particularly risky, the sex partner insisted upon condom use, or PrEP stigmatizing reactions were anticipated.

Apart from the prevention of more common STIs, HCV infections were perceived as a particular motivator for concurrent condom use. Although STIs other than HCV were predominantly seen as curable and manageable, HCV was regarded as more serious and important to avoid, which is in line with risk perceptions reported among HIV-positive MSM who were previously infected with HCV [17]. After observing high incidence of HCV infections in AMPrEP [18], newsletters including this study finding were distributed to AMPrEP participants and could have affected related condom use.

PrEP-related stigma has been previously linked to temporarily or completely discontinuing PrEP use [19,20], and our findings suggest that condom use is perceived as a socially appropriate alternative when stigma is anticipated and an individual wants to avoid PrEP disclosure, or when a sex partner insists on condom use. Our participants used condoms together with PrEP in such circumstances. Efforts should therefore continue to be made to disconnect the association of PrEP use with promiscuity [21] and reframe PrEP as an opportunity to take responsibility for one's sexual health [22].

For protection against HIV, edPrEP use requires a certain degree of planning. It has been suggested that using edPrEP leads to a lower proportion of PrEP-covered sex acts compared with using dPrEP [23], although the coverage can be high if edPrEP is the only available regimen [24]. We found high proportions of PrEP-covered sex acts among edPrEP users, but even higher among dPrEP users. However, most PrEP-uncovered sex acts involved deploying condoms instead of PrEP, especially among edPrEP users.

The most frequently mentioned motive for not using PrEP during sex acts was that individuals, mostly edPrEP users, chose to use condoms instead for various of reasons, and PrEP was therefore perceived as redundant for the prevention of HIV. Such reasoning is in line with the prevention-effective paradigm [25], in which HIV-preventive behavior is seen as a dynamic process of deployment of different HIV prevention strategies. Individuals at risk for HIV can choose that is the best way to be protected as long as it leads to effective prevention of HIV acquisition.

The primary reason provided for using neither condoms nor PrEP was low perceived HIV risk, which may explain the relatively high proportion of uncovered sex acts with steady partners among edPrEP users. However, previous studies suggest that 32–68% of all HIV infections occur in steady partnerships [26,27]. Hence, it is important to inform and guide PrEP users, allowing them to discern which relationship context is indeed not risky, and to distinguish between objective, subjective, and realistic HIV risk. This could help PrEP users to select an appropriate option for HIV prevention within relationships [28].

Our study is one of the first to use daily-collected data to report on combinations of PrEP and condom use among PrEP users. An important strength of our study is that data collected daily should minimize recall bias. Other strengths are the high number of sex acts that were analyzed among both daily and edPrEP users, and our combination of both quantitative and qualitative methods. Limitations of this approach might be that not all participants reported their daily behavior through the app and that all reports came from MSM who were early PrEP adopters. App users and nonusers differed in some respects, but did not differ in sexual behavior or preference. Nonusers were more likely of older age, unemployed and had a lower income level, all of which could be reflective of differences in their affinity for digital app/phone use but could also influence condom decision-making. In addition, only 24 participants ended up being excluded because they never used the app, leaving the majority of AMPrEP participants part of our data (Supplementary Table 1, https://links.lww.com/QAD/B856). The implications of our findings may therefore be helpful for countries where PrEP is widely available among MSM and where social attitudes toward sexual preference resemble those in the Netherlands. Another limitation relating to app use might be that, for some participants, sex acts were incompletely reported in the app over time. The overall number of reported sex acts decreased over time, especially among edPrEP users (Supplementary Table 2, https://links.lww.com/QAD/B856), which may have biased the report of changes over time.

Our study carries important implications for counseling PrEP users. First, counselors should recognize that PrEP alone is often the chosen HIV-prevention strategy, and should be treated as such. Excessive focus on preventing the decreasing use of condoms could undermine the potential for counseling, as some patients can feel uncomfortable sharing information on condomless sex that may result in criticism [29,30]. Second, condom use remains an important tool for HIV/STI-prevention (including HCV) and is still applied by PrEP users in a variety of settings. It seems that most PrEP users choose to use condoms based on the following three reasons: first, reasoned choices estimating risk (especially for sex acts with UCPs and in particularly high risk contexts); second, edPrEP use (when PrEP is no longer being taken); or third, other situations that either prevent men from using PrEP or disclosing PrEP use. Taken together, we argue that health professionals should steer away from counseling based on the assumption of ‘risk compensation’. Instead, counseling should concentrate on promoting condom use as a viable option when engaging in anal sex in specific contexts such as described above. Since PrEP is usually integrated into broader HIV-prevention services, including STI testing, we further argue that PrEP care could be viewed as an opportunity for counselors to discuss individual motives for condom use and discern objective risks as a means to minimize potential STI risks.

In conclusion, condom use remains a feasible and important HIV-prevention and STI-prevention tool that is applied by PrEP users for various reasons and in a variety of contexts. Client-centered PrEP counseling should incorporate the discussion of condoms and their added value, with respect to individual motives and contexts for PrEP and condom use.

Acknowledgements

We thank all AMPrEP participants and the members of the advisory board and the community engagement group of AMPrEP and Sanne Eekman, Lisa Postma, and Thijs Reyniers as interviewers and coders of the qualitative data. We further acknowledge the following persons for their invaluable support to this study: Roel Achterbergh, Mark van den Elshout, Gerard Sonder, Yvonne van Duijnhoven, Gerben Rienk Visser, Linda May, Paul Oostvogel, Sylvia Bruisten, Adriaan Tempert, Kees de Jong, Ilya Peters, Myra van Leeuwen, Princella Felipa, Kenneth Yap, and all of those who contributed to the H-TEAM (Supplement 3, https://links.lww.com/QAD/B856). Lucy Phillips edited the final draft.

Author contributions: E.H., M.P., M.F.S.v.d.L., H.J.C.d.V., and U.D. contributed to design of the AMPrEP demonstration project and obtained funding. H.M.L.Z. and U.D. contributed to study concept and design of the current study. H.M.L.Z., V.W.J., A.B., E.H., M.F.S.v.d.L., and U.D. contributed to acquisition, analysis, or interpretation of the data. H.M.L.Z. drafted the article. All authors critically revised and approved the final version for publication.

The AMPrEP project has received funding as part of the H-TEAM initiative from ZonMw (grant number: 522002003), the National Institute for Public Health and the Environment and GGD research funds. The study drug is provided by Gilead Sciences. The H-TEAM initiative is being supported by the Aidsfonds Netherlands (grant number: 2013169), Stichting Amsterdam Diner Foundation, Gilead Sciences Europe Ltd (grant number: PA-HIV-PREP-16-0024), Gilead Sciences (protocol numbers: CO-NL-276-4222, CO-US-276-1712), Janssen Pharmaceuticals (reference number: PHNL/JAN/0714/0005b/1912fde), M.A.C. AIDS Fund, and ViiV Healthcare (PO numbers: 3000268822, 3000747780).

Conflicts of interest

Our institute received the drugs for the Amsterdam PrEP study from Gilead Sciences based on an unconditional grant. E.H. received financial reimbursement for time spent serving on advisory boards of Gilead Sciences, paid to her institute. M.P. obtained unrestricted research grants and speaker's fees from Gilead Sciences, Roche, Abbvie, and MSD, paid to her institute. U.D. obtained unrestricted research grants and speaker's fees from Gilead Sciences, paid to his institute. The remaining authors declared no potential conflicts of interests for this project.

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Keywords:

condoms; counseling; HIV infections; HIV prevention and control; MSM; preexposure prophylaxis; sexually transmitted infections

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