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IAS 2015: Pros and Cons of PrEP -- Volunteers Recount their Experiences in ADAPT Study

The reasons people come forward for pre-exposure prophylaxis (PrEP) or take it once prescribed are likely to be very mixed, and dependent as much on local political and cultural beliefs as they are on more personal factors like relationship status, researchers reported at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015) last month in Vancouver.

[Produced in collaboration with Aidsmap.com]

The HPTN 067 (ADAPT) study is a Phase 2 open-label study of Truvada PrEP based in 3 cities -- Cape Town, Bangkok, and Harlem, New York. It aims to evaluate the ease of use and feasibility of 3 different PrEP regimens: daily dosing, timed dosing (meaning 2 doses a week plus an extra dose 2 hours after sex, if it happens), and event-driven dosing (meaning 1 dose 2-24 hours ahead of anticipated sex and another dose 2 hours after, if it happens).

Study results on adherence, pill usage, and HIV infections were reported previously. Each of the 3 city studies also had qualitative studies attached so that participants could relate their experience of taking PrEP.

Cape Town

In Cape Town, 18 of the 179 women involved gave in-depth interviews to the researchers -- 6 in each regimen arm, 3 in the first half of the study, and 3 near its end. There were also 6 focus groups of 7 participants each. Thus 60 women, or about a third of study participants, gave qualitative feedback.

Rivet Amico of the University of Michigan, who headed the qualitative study, said that attitudes of participants in this and in other prevention studies ranged over a whole spectrum from full endorsement to complete distrust. Adherence (the percentage of pills taken) and persistence (the length of time participants stayed in the study as active participants) were likened to these attitudes. She said that attitudes towards the study varied from complete distrust and avoidance of pill-taking to empowerment and acting as a champion for PrEP.

Factors that might particularly influence African participants included "Ubuntu," the belief that the worth of an individual depends on the contribution they make to their surrounding community; the trial would be weighed against standards of community usefulness.

Skepticism about the trial was not necessarily unhealthy: participants might be well aware that a scientific trial’s outcome was uncertain and they might have fears about taking PrEP and distrust of the integrity and trustworthiness of the trial and its researchers. These could be amplified or diminished by the influence of the community and especially by other PrEP champions or anti-PrEP critics.

Distrust was more common in this and other PrEP studies in South Africa than in some other settings because participants were more likely to join the trial for other motives such as the medical benefits it offered, while actually not believing in the benefit of PrEP. Such participants could even act as advocates against PrEP. “I will never drink [take] these pills because I don’t trust them,” said one participant.

Cautious exploration was the term best suited to the next category, people who were not sure what they thought about PrEP and could be swayed by arguments for or against it, with resulting irregular adherence. “I was getting confused and pressured because I did not know whether to continue to take tablets or not,” said another participant.

Provisional acceptance characterized the next group, who were motivated to try to take PrEP. Their persistence was good, but they often found it challenging to actually remember to take the pills; they were characterized more by a determination to be good participants than by a feeling of empowerment. “I wouldn’t do that [i.e., not take the tablets] because I want to see if these pills really, really work,” said one.

Ownership was the best word to describe the attitude of the fourth group, who did not just feel like enrolled participants, but like partners in a joint enterprise. They often acted as champions for PrEP and saw it as their job to combat negative perceptions and beliefs. One factor that African participants in PrEP trials, in particular, have cited as a barrier to adherence is the assumption by family and friends that someone taking an antiretroviral pill must have HIV. One participant described combating such remarks: “And I said, ‘look here, ask me. And don’t you dare say I have HIV, telling everyone in this shop. We are doing research here’.”

Amico commented that depending on where participants were on this spectrum, the usual adherence counseling strategies might help, but might also have counterproductive effects. If someone was already distrustful of the trial, then asking them to address barriers to adherence might only entrench distrust: beliefs needed to be addressed rather than difficulties. Equally, people who felt like partners and advocates might feel disempowered and talked down to if constantly reminded of the importance of adherence; instead, counseling might concentrate on supporting their advocacy. “Don’t assume people enter a study ‘neutral’,” Amico said.

Bangkok

In Bangkok, 38 out of the 180 men who have sex with men (MSM) involved took part in qualitative evaluation of the study, 32 in 6 focus groups of 5 men, and 6 in 1-to-1 interviews. They were only interviewed towards the end of the study.

The men in the Bangkok study tended to talk much more specifically about the pros and cons of the 3 different PrEP regimens in terms of sex and relationships.

Presenter Tareerat Chemnasiri said that daily PrEP was preferred by many because there was no association with sex and it could be passed off as another medicine: “It would be awkward to take a tablet before or after sex. My partner would ask what the tablet was for. But for daily dose, I could say it was dietary supplement,” said one participant.

A number of participants emphasized that they did not always have control over when they had sex: “My boyfriend always controls when to have sex, even though it is not often. So, I continue to take tablets 2 days a week and just wait for the sex to happen,” said one.

With others, lack of opportunity, rather than lack of control, was the issue, and here the twice-weekly dose made the most sense: “I don’t plan for sex, [but I do] carry the tablets with me all the time,” said another.

One participant said he would prefer event-driven PrEP as he did not have enough sex to justify daily dosing. But several others had difficulty with the post-sex dose in the intermittent PrEP arms: “After coming back from the bar, I took a tablet at 2 am right before having sex and I had to wait 2 hours to take post sex dose at 4 am. I already fell asleep by then.” (This, incidentally, was a major problem cited by one of the few other studies of PrEP in MSM in a non-high-income country, a small study done in Kenya).

One participant, however, liked intermittent PrEP because it actually served as a prompt for sex, almost an aphrodisiac: “I always ask for sex from my boyfriend. Sometimes, he says yes. Sometimes, he’s tired. But, if I’m really horny I would take a tablet and get what I want.”

New York

In the New York study, 37 mostly black men who have sex with men took part in qualitative interviews including 6 in-depth interviews and 31 in focus groups.

Here, many of the participants also concentrated on the practicalities of daily or event-driven dosing. Many did not like the idea of associating pill-taking with sex, some just felt it was "awkward" if the other partner was not also taking a pill, while some encountered outright hostility: “My partners would be like, ‘Why are you taking those pills?’ [and] sometimes it would never get to the intercourse part. It would just stop the night. They would be mad and leave.”

Even some people with steady partners, however, felt they had to conceal their PrEP taking: “If you got a steady partner you know when you are going to do it or not. You can have [the pill]; ‘Hold on, let me go to the bathroom’ -- pop it. Because...some people are not ready to just accept things. They live in...in a fantasy world where you don’t think it can happen to you.”

However, New York participants were also more concerned than the Thai gay men about stigmatizing attitudes from other people including healthcare workers, relatives, and friends; again, there was a widespread assumption that the participant must have HIV if they were taking a pill. “You telling them you’re taking a pill to prevent it; they thinking you taking a pill to stop it,” said one.

The participants had encountered "slut-shaming" and the assumption that they must be promiscuous if they were taking PrEP, while others distrusted that PrEP worked and therefore assumed that a person who took PrEP was at higher risk of having HIV: “One of my partners was like, ‘Whoa. What does this mean? What are you doing?’ Indicating that taking the pill means that I’m willy-nilly having unprotected sex.” “A few of them were just like -- ‘I’d rather not have sex with you because I don’t know if PrEP works,’ or ‘You’re probably just like a big whore’.”

However, participants also described feelings of anxiety relief, protection, and empowerment from taking PrEP. One said he called it his “Superman pill,” while another rather said: “I was protected. Like that [pill] was my older brother and I was getting beat up by the bully at school.”

Presenter Julie Franks of Columbia University said that interventions to address HIV-related stigma in the context of PrEP use were needed for black men who had sex with men in the U.S. However, she added, “Our qualitative sample of mostly black MSM valued PrEP as a significant improvement over existing HIV prevention strategies.”

SEE ALSO:

IAS 2015: Non-Daily PrEP Provides Extra Options, But Adherence Often Better with Daily Dosing

IAS 2015: ADAPT Study Shows PrEP Feasibility [VIDEO]

8/5/15

References

KR Amico. PrEP experiences among South African women in the HPTN067 (ADAPT) study: Healthy paranoia (skepticism), Ubuntu, champions and challenges to resolving PrEP dissonance. 8th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Vancouver, July 19-22, 2015. Symposium presentation MOSY0106.

T Chemnasiri. Patterns of sex and PrEP in Bangkok MSM (HPTN 067/ADAPT Study). 8th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Vancouver, July 19-22, 2015. Symposium presentation MOSY0107.

J Franks. Patterns of Sex and PrEP in Harlem MSM: A qualitative study (HPTN 067). 8th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Vancouver, July 19-22, 2015. Symposium presentation MOSY0108.