Participant views and experiences of sexual health research: The Contraception Choices online trial

Qualitative interviews

Interviews were conducted by telephone or face-to-face by KB or AG, either at University College London or in clinic settings. We used a semi-structured topic guide to explore participants' views on the online trial design, their views of the Contraception Choices website, and digital interventions for contraception. The topic guide covered reasons for taking part in the study, understanding of the purpose of the research, online registration and consent process, acceptability of contact/follow-up via email, views about incentives and the Contraception Choices website (e.g. preference for an access point, relevance and usefulness of the website). We tried to mitigate social desirability bias by asking open questions and encouraging participants to express their views, whether positive or negative. Interviews were audio-recorded and transcribed verbatim.¹⁴ KB was an independent researcher, whilst AG was involved in the Contraception Choices website development. Participants were offered £5 online shopping vouchers for completing the 1-week follow-up questionnaire and £15 for taking part in a post-study interview.

Free-text comments on RCT follow-up surveys

Participants in the main Contraception Choices RCT were followed up by email 3 and 6-months post-randomisation and invited to complete an online outcome questionnaire. For the present study, we analysed participants' answers to two free-text questions: ‘What did you like or dislike about the website’ (asked to intervention group participants only) and ‘Has being in the study had any good or bad effects on your life?’ (asked to all trial participants).

Qualitative interview data

Interviews were audio-recorded, transcribed verbatim and checked for accuracy. The quality of interview data was reviewed by the research group as the study progressed by listening to audio-recordings and discussion of two early transcripts. Following this, the topic guide was revised in minor ways. Data were analysed using thematic analysis, using both deductive and inductive approaches.¹⁵ KB and AG independently coded interview data, using Atlas.ti™ software to facilitate data retrieval, coding and linkage, and to record analytic notes.

Free-text comments

Free-text comments on RCT follow-up surveys were collated and coded in an Excel file, and analytic notes were added. AG and JSh coded the free-text data.

Pre-trial feasibility study participants

Twenty-eight women were recruited to the online pre-trial feasibility study. Of these, 18 agreed to be interviewed, seven declined and three were uncontactable. We do not know the number of potentially eligible participants in the six research settings or the number who declined to participate. Participants were interviewed from all six settings (community pharmacy, n = 4; antenatal clinic, n = 2; abortion clinic, n = 3; young person's sexual health clinic, n = 4; sexual health clinic, n = 3; general practice, n = 2).

Participants ranged in age from 17 to 34 years. One participant over the age of 30 years had joined the study despite the age of 15–30 years eligibility requirement. Two women were currently pregnant, six were not using contraception and were not wanting to conceive, and 10 were using at least one method of contraception. Most women were of White ethnicity and were educated to at least A/AS level. Characteristics of participants recruited to the pre-trial feasibility study are shown in Table 1.

Contraception choices main RCT participants

The median age of the RCT participants (n = 927) was 24 years, with 50% aged 21–27 years.⁵ Most women were of White ethnicity (68%). The remaining participants were of mixed heritage (11%), Asian (9%) and Black (9%). Around half were educated to degree level (51%).

Of the 464 intervention group participants, 387 (83%) provided free-text comments at the 3-month follow-up, and 414 (89%) provided free-text comments at the 6-month follow-up.

Being approached about the study in a clinic waiting room

The majority of participants felt it was appropriate and acceptable to have been approached about the study in the waiting area of a clinic or pharmacy:

I thought that was good, because it gives you something to do when you’re just sitting there waiting, rather than just worrying about what's going on or anything. It comes as a nice distraction to be honest. (20 years, young person's sexual health clinic, interviewed)

A couple of participants thought that clinic-based recruitment could be sensitive for some:

I think some people would’ve found that uncomfortable to talk about, yes. Some people, when they go to these clinics, just want complete, like want to be really anonymous. (20 years, young person's sexual health clinic, interviewed)

Being invited to participate in contraception research prior to an abortion was problematic because of the stigma connected with attending an abortion clinic, and feeling distracted and concerned by the procedure itself. One participant said:

It was quite embarrassing being there and then I think being approached by two people you don't know is – I don't know how to say it I guess it's like, because I appreciate what you’re doing […..] But I think for some people that would just be quite maybe like I use the word offensive – I don't mean that it's offensive because I don't find it offensive, but I think maybe some people would, yes.

If you try to get information out of people on the day your mind is just not on that subject like you’re not thinking about somebody else's research study. You’re thinking about oh my God am I going to die? (26 years, abortion clinic, interviewed)

Attitudes towards participating in contraception research

The perceived credentials of the research team were important in establishing trust (i.e. NHS or a university):

It was important that it was someone that I sort of knew. Wasn't just a random person, but someone I could trust with information … if it's the hospital and the university then they’re going to be the best people that know most about it, probably. (20 years, young person's sexual health clinic, interviewed)

Most participants found it unproblematic and appropriate being asked about contraception and pregnancy in the online survey:

I don't feel uncomfortable talking about contraceptives … Whereas people might feel more uncomfortable talking about their sexual life in itself, where contraceptive is kind of, yes, nothing embarrassing. (23 years, community pharmacy, interviewed)

In contrast, one participant recruited from the abortion service felt ambivalent about being asked about contraception and pregnancy at that time:

I don't really know I think I was quite mixed there because I was definitely like not, well I guess I was just like cursing myself at the time I was like this is something I should have thought about before. (26 years, abortion clinic, interviewed)

Several women said that the research sounded interesting and that they wanted information about contraception and felt they may learn more by seeing the Contraception Choices website. A number of participants wanted to help others by contributing to research:

I feel really proud of myself for contributing to improving health information in a small way. Family planning/contraception are health issues I really care about – it's nice to ‘give back’. It's great that I’ve been able to contribute. It has made me feel like I’m doing something worthy. (30 years, sexual health clinic, free-text comment)

Some women felt that the voucher was an incentive to take part in the study and a nice reward for their time, but for others, the voucher was not important. All but one participant said that they would have taken part in the research even if a voucher was not offered:

The questionnaire isn't invasive or lengthy and the voucher is nice little incentive to take part. (27 years, general practice, free-text comment)

Views of online trial procedures

Online trial registration was self-directed using a tablet computer in clinic waiting rooms. Women found it quick and easy to register for the study and found the information clear, such that they largely understood what the study was about and what they were agreeing to. Women did not have any concerns about giving their contact details (telephone number and email address) and understood these were so the research team could send them the follow-up questionnaire and to contact them to arrange an interview:

… the information I gave I felt was standard for what I was about to participate in. It was what you would expect when signing up to anything online … (21 years, community pharmacy, interviewed)

… it's a kind of tablet [computer] I haven't used before. But despite that, it, because tablets are made quite user friendly and the questionnaire was very user-friendly, so even for me, never seeing that kind of tablet before, that was very easy [……] you can sit with a tablet in a way that actually achieves more privacy than if you had a computer you had to go over to. (23 years, community pharmacy, interviewed)

Views of electronic follow-up procedures

Participants were followed up by email with a weblink to the online follow-up questionnaire. Non-responders were also contacted by text message and by phone, if needed. Participants were positive about being contacted by email for the follow-up survey because of the convenience:

… it's less personal … if people feel a certain type of way about it … it's easy. It comes in. Boom. It's on my phone. It's on my laptop. So it's quick. It's accessible. So it's probably the best way. (27 years, community pharmacy, interviewed)

… I like being contacted by email because it gives me a lot of … I can kind of control when I have the time for it … So I think it's a good way at least for surveys, etc., where it doesn't, you don't have to respond now. You can respond tomorrow or the day after, if that's when you got time, so, yes, emails are good. (23 years, community pharmacy, interviewed)

One participant said that she liked being contacted by email since she could immediately see who the email was from. While none of the participants minded receiving the follow-up survey by email, some felt that text messages might be more likely to be read:

With emails, I tend to just skim through them very quickly. So I might not pay attention to the content in the email … And with texts … People use texts … People text often, so you, kind of … You’re most likely to view the message than just leave it there. (19 years, young person's sexual health clinic, interviewed)

Email reminders to engage with the Contraception Choices website

The main trial intervention group were sent emails every two weeks to encourage them to revisit the Contraception Choices website, and these prompts were mostly positively received:

If anything the emails have been a helpful reminder to sort a more permanent solution for my contraception needs. (22 years, sexual health clinic, free-text comment)

A minority of participants felt that there were too many prompts to visit the website (although every reminder email offered a link to ‘unsubscribe’ if unwanted).

Adverse impacts of the research or the Contraception Choices website

One person recruited through the abortion clinic described an adverse impact of being in the study:

I was asked to do the survey on the day of my abortion so the timing was not ideal and emails about this survey remind me of that day. (23 years, abortion clinic, free-text comment)

There were no other reported adverse impacts concerning either the research or the Contraception Choices website.

The place of digital interventions for Contraception Choice

Participants were positive about the Contraception Choices website and suggested a number of places where they felt the website could be offered, including healthcare settings such as general practice, hospitals, antenatal or post-natal clinics, pharmacies, sexual health clinics and walk-in centres. Participants also felt the website would be useful in schools, colleges and universities, on social media (e.g. Facebook and Twitter), and also advertised on public transport and in women's magazines.

I think it's very useful, because it gives you so much information than you’re [not] going to get from anywhere else, and especially is all in one place that it's really accessible and easy to understand. (20 years, young person's sexual health clinic, interviewed)

Some said that a website would be more attractive than leaflets:

I think it would be very useful. Last year I had to go several times to a walk-in clinic … in the office I was in there was, maybe, like, pamphlets, but, like, who actually goes through, like brochures nowadays? (21 years, community pharmacy, interviewed)

One participant felt that a website was useful because it meant people could access information without having to speak to someone:

… it's a way that you can access information without asking or speaking to people, I think that people so often just don't want to do that. (26 years, abortion clinic, interviewed)

Participants had differing opinions on when the website would be most useful: before, during or after a clinic appointment. Some suggested that it would be useful to receive a link to the website when making an appointment or along with text message appointment reminders:

… when you were making an appointment and they asked you what it was about maybe being redirected to the website then would have been really good. (19 years, abortion clinic, interviewed)

… I know that we get, from my sex health clinic, text messages about our appointments. If that could include, if I’m female, a link to that, that would be, I’m thinking excellent. (23 years, community pharmacy, interviewed)

Many participants said that the waiting room of a sexual health clinic or antenatal clinic was a good time to offer web-based information on contraception:

I think [it was] a really good idea […] in the waiting room, especially in the antenatal part because that is the time when women would be thinking about, maybe, when they give birth, what to go on and all their options. (22 years, antenatal clinic, interviewed).

Participants also suggested that the Contraception Choices website could be a useful tool for clinicians to share in a consultation:

I think it would be a good thing for the nurse to show, like, you know, well, yes, look here, so here we have all, instead of just talking, it's good to have it written down and then I think the website's great. (22 years, young person's sexual health clinic, interviewed).

Some women thought the website would be useful after a contraception appointment, to look-up information another time and to review options following emergency contraception:

… sometimes, when you leave the clinic, you’ve, kind of, forgotten, or you don't … You’re not really clear on everything that you’ve been told by the doctor. So it just … it allows you to, kind of, brush up on any, like knowledge. (19 years, young person's sexual health clinic, interviewed)

… if you’re going to a sexual health clinic for a morning after pill or anywhere for a morning after pill if they like talked to you about that, about this website then that would be really useful. (19 years, abortion clinic, interviewed)

Recruitment

Online recruitment to online trials can be quick and easy, for example, via social media¹⁸ but face-to-face recruitment in clinic settings can enhance participation in digital health research.^11,12 We recruited participants face-to-face for the main Contraception Choices RCT, and also via an online booking system (sending an invitation within a text message confirming a contraception appointment).⁵ Automated online recruitment was much quicker and less resource-intensive than face-to-face recruitment and is highly appropriate in the context of the coronavirus pandemic.¹⁹ The credentials of a research team are important to participants,²⁰ and should feature on online recruitment adverts.

Recruitment in the abortion clinic setting was more difficult for participants who may experience negative feelings such as guilt, shame or self-blame,²¹ and who may feel distracted and concerned about the procedure itself.

Online trial procedures

Online questionnaires and online trials are now very well-established methods for sexual health research, including national surveys of sexual behaviour, interventions for sexually transmitted infection (STI) and human immunodeficiency virus (HIV) prevention and for sexual difficulties, and sex and relationship education.^{7,9,12,18,22–24} Our research confirms that participants are not concerned about an online environment for sexual health research as long as they are given information about what is involved and they trust the research team.^20,25 Participants can be offered a choice of mode of contact (e.g. by email, phone, text message and/or post).¹²

Online sexual health research could incur unanticipated harms, for example, if others glean private information from study emails or text messages.²⁶ Mobile phone use is not private in many situations, for example, phones may be shared within families in low-income countries^26,27 and friends, parents or partners may see young people's phone content.^28,29 Abusive partners may exert control through violation of digital privacy (e.g. monitoring emails, social media accounts and text messages).^26,28 It is reassuring that none of the RCT participants or pre-trial feasibility study interviewees reported adverse events of this nature. It is important to strike a balance between describing research procedures in enough detail so that participants can evaluate potential risks and ensuring that information is clear, concise and easy to understand.^13,30