Introduction
Methods
Domain | Inquiries/prompts |
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Feasibility/acceptability | Perceptions of feasibility, acceptability and ease of uptake for their assigned regimen |
Alteration of regimen | Altering the regimen to better ‘fit’ their daily life or risk behavior |
Preference for other regimens | Whether participant(s) would switch to a different regimen if available; what the ideal regimen would be |
Facilitators and barriers to adherence | Common facilitators and barriers to following assigned regimen |
Disclosure of participation | Sense of importance that others knew the participant was enrolled in the study |
Experiences with participation and study team | Feelings towards participation, the project, project-staff, and how pill-taking and condom use was supported |
Recommendations | Recommendations for change in study support or adherence support approach |
Results
Participants
Themes
Facilitators of and Barriers to Study-Provided PrEP Use
Theme | Defined as discourse on… | Example quotes |
---|---|---|
Facilitators of PrEP use | ||
Efficacy beliefs | Beliefs that PrEP works to prevent HIV | ‘What motivated me is the fact that they protect me from getting HIV, because sometimes I forget to use a condom with my boyfriend that is why I continued using the pills. I had that hope that the pills will protect me…” D IDI “The treatment made me safe so I continued taking the pills.” E IDI “I heard here at the site that these pills work and that they were being tested overseas too and that the results proved that these pills do work so that made me take the pills.” E FG |
Perceived HIV-prevention needs/risks | Risk of being exposed to HIV/desire to protect HIV-negative status; discussion of prevention in context of rape/forced sex | “As I said before, it made me want to protect myself. Before I was involved in the study, I didn’t care as much as I do now.” T IDI “… I also knew that this pill will help me in any case like if I was to be raped I would not be infected with HIV” D IDI |
Use of concrete adherence strategies | Strategies used for adherence | “I didn’t set my phone or anything like that. I knew that if Generations [a popular television series] is about to begin, I would take my pill.” D FG “I would keep the tablets in my pocket so that I always remember to drink the tablets” E IDI |
Social support for use | Support from partner/friend/family for taking PrEP | “My friends would also help me because they knew at a certain time I was supposed to take the pill. So it was those kinds of things that helped me.” T FG “The boyfriend that I was staying with was very supportive and he always encourages me to drink the tablets.” E IDI |
Barriers to PrEP use | ||
Attributes of PrEP pills (taste, smell) | Negative perceptions of pill attributes | “Yes, at the beginning I was asking myself, how am I going to be able to swallow this big pill and as time goes on, I was able to swallow them.” D IDI “What I found difficult was the way it smelled, it made me nauseous. So when the time came for me to take it, I had to think hard about it. I wasn’t too happy taking it.” D FG |
Side-effects attributed to PrEP | Negative physical experiences attributed to using PrEP in self or others | “At first it was hard because they were not good for my immune system but they have told me here that at first I might have some side effects such as always feel[ing] hungry, dizziness and they made me to have a small rush but as time goes on, I got used to it.” D IDI |
ARV-related stigma | Fears that PrEP use will be misattributed to HIV-treatment; participant will be assumed to be HIV-positive | “Plus negative response from friends … they compare Truvada® to ARVs because they know someone who was taking the same medication and ended up being HIV positive.” D IDI “We are very shy of walking around with pills in our bags, because we are scared of what people would say, because let us say you take out your pills and take them at the party, some people won’t even ask- they will just say it’s an ARV.” E FG |
Needs for privacy/non-disclosure | Non-disclosure of study participation to significant others, due to anticipated stigma, misunderstanding or lack of support | “The problem was that I didn’t tell my boyfriend that I was taking the Truvada®. So when I went to his place, I wouldn’t take it along” T FG “So you are now sitting with friends and you see that the time is about to arrive. So what will they say if I were to take these pills in front of them? My friends are going to judge me. So I end up not taking them then.” E FG |
Non-daily regimens | ||
Sex-dependent doses | Difficulty in determining whether or not sex would occur (for pre-sex dosing) and a mismatch between PrEP dosing and the post-sex milieu | “What would get me to forget is that—I live with my boyfriend, right, okay. So maybe we’re lying on the bed together and then sex just happens… Now my pills sit in a divider and sometimes they are looking at me, but I am busy at the moment… So I will have sex and then will wait for the appropriate time for me to take the after sex pills.” E FG “The regimen that we were in was very difficult. Let’s say that you are in town and your partner phones you and says: “Baby, please come this way when you’re finished in town.” Now you might not have a chance to stop off at home because it could be late.” E FG “And sometimes, after sex, you want to sleep. Maybe you’re tired. You don’t think about taking pills. Maybe you guys are sitting together and talking since you don’t see each other so often. So then you will forget the pills.” E IDI “After sex…. After I have just finished having sex, it’s nice to sit back and relax a bit.” T FG |
Facilitators of and Challenges to Study Participation
Theme | Defined as discourse on… | Example quotes |
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Facilitators of study participation | ||
Personal experiences with HIV | Desires to contribute towards HIV prevention because of negative impact of HIV on family, friends, or community | “I joined because I have a family member who passed on because of HIV, so I decided to take part because I will also benefit”. E FG |
Valuing the package of care received as a participant | The unique benefits of being in the study in terms of the medical care and screening not easily available outside of the study | “You know, when we’re in the township, it can be difficult for us to go test at the clinic and you won’t know what your status is. So at least when you come here, you can find out whether you are sick or not. So that supported me because I got to know about my health.” E IDI “Maybe you just want to be cautious about your health because here at the study they look at a lot of things you don’t drink the pills only. That is what I liked” D IDI |
Financial/economic compensation | Reimbursements as motivating participation in the study | “They [other participants] also told me about the difficulties they had but then they endured them. Another one told that she is enduring them because you get money in this study, like a lot of money.” T IDI |
Positive feelings towards the research team | Experiences, beliefs or feelings towards study team that were positive or motivating | “It’s the way they treat us here at [site name]. It’s the way the counselors also speak to us. They help you understand the way in which these pills are meant to be taken. They don’t force you.” T IDI “All the staff members were supportive I enjoy coming here.” E IDI |
Commitment to HIV prevention research | Discourse of a shared vision with the study in terms of working together to make real contributions to HIV prevention in their community | “What made it easy for me was that it’s helping the community. It’s not only helping me. So I am happy that there were people who were supporting me.” D FG “I was following the instructions and I told myself that I was doing it for a purpose. …to check as to whether this research works for other people.” D IDI |
Challenges to participation | ||
Concerns about safety | Study provided PrEP as unsafe or less safe than informed by the research team | “People were not drinking the tablets because they were flushing them down toilets because they were […] experiencing side effects like headaches, stomach ache and gaining weight.” E IDI “…I was scared of getting side effects hence I would throw the pills away….” T IDI “I was okay but got worried because people were talking about side effects.” T IDI |
Community distrust of study and/or PrEP and women’s participation in the study | Community rumors/convictions that women would get HIV through participation, have HIV, or prioritize themselves and receiving money for participation over the community | “Yoh! People say that they give you AIDS there!” E FG “…and my friend also said I am looking for trouble by joining this study she had this whole idea of how I could catch HIV.” T FG “And as for my friends… they were telling me that I am only carrying on with this study because I wanted money” D IDI “My family never encouraged me, especially my sister. She just told me that I was going to get AIDS. She said: ‘They take your blood and sell it.’” D FG |
Negative clinic experiences | Experiences at clinic site that were negative or considered burdensome; feelings of lack of transparency/feeling accused | “They irritated me because the same question is asked every day: “address, contacts, phone numbers” – all the time… He would ask the same questions. …Then when you come back you have to explain again.” T FG “…and traditionally for us black people we don’t disclose info like that easily to anyone, it’s embarrassing and especially when they ask these unexpected questions.” T FG “…it was all just irritating, and they would look you in the face plus they wouldn’t say if you right or wrong, they would just write down what you saying.” T FG “…the counselors were telling us that we are throwing the pills away, which it was not all of us.” T IDI |
Cross-Cutting Themes/Narratives Contextualizing Approach to Study-Provided PrEP
Ubuntu
Skepticism
Variable Approaches to Study-Provided PrEP
Synthesis of Findings: A Mutuality Framework
Dynamic | Approach to study and study-provided PrEP | Caused by… | Intervention implications and possible strategies |
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Distrust | Active, intentional avoidance of taking product/PrEP. “…I was scared of getting side effects hence I would throw the pills away….” T IDI “Others were just opening up the container as [proof] that they were taking them while they were not taking them at all.” D IDI | Rejection of integrity of study (goals, potential reciprocity to community) and safety of products/PrEP and efficacy. | Strategies targeting changing beliefs in safety, reciprocity, and efficacy of product or integrity/relevance of research findings (for efficacy trials) Possible change strategies: Community theatre with roles for “pro” and “cons” of drug safety or study integrity where turns are taken in giving voice to each “side”, ending with thoughts on what evidence/experiences would convince one side or the other Normalization of skepticism and overt discussion of pros/cons allowing for exploration of each Community engagement and mobilization events (i.e., CBPR strategies) Designs and programs that allow for discontinuation or not using PrEP while remaining in cohort Creating “task force” teams of participants who are tasked with and resourced to perform fact-finding missions about study and/or products |
Uncertainty | Variable persistence with study-provided PrEP- on-again/off-again engagement with trying to use study-provided PrEP. “Firstly, people say that we’re risking our lives by getting involved in HIV research.” E FG “But then I ended up thinking and thinking and thinking about this, whether there really isn’t anything [HIV] they are giving us here.” D IDI | Skeptical exploration of whether or not to trust study, PrEP, or providers of PrEP (the research study, demonstration project, or health agency) | In addition to changing beliefs (above), strategies targeting enhancing beliefs of safety, reciprocity, and efficacy Possible change strategies: PrEP study or program awareness campaigns that invite open discussion of potential medical mistrust from social–historical and political perspectives Promote exploration of ambivalence as reasonable and valid with a focus on identifying what “data” would be needed to assure participant Adopt high transparency strategies that explain aspects of procedures, protocol or PrEP programs that are uncommon in communities- for example, media providing “proof” of legitimacy of tests, samples or monitoring (video of blood collection, where it is shipped with pictures of labs, and disposal after processing) Engage peers, champions, and trusted individuals to lead debates and discussions about integrity, truth, and reciprocity If the PrEP agent is known to be effective, emphasize this aspect of potential value through multiple modalities (pictures, media, theatre and other methods of depicting efficacy) Create opportunities to build sense of ownership in trial- task participants with conducting evaluations of experiences at clinic, quality of care received, and social harms (negative experiences) in community that are fed back to the research team and acted upon |
Alignment | Whereas persistence (trying to take study-provided PrEP) is likely good; execution adherence is anticipated to vary on the basis of adherence skills (strategies) and degree of positive beliefs about value of PrEP and adherence “… I wouldn’t do any of that [not take the tablets] because I want to see if these pills really, really work” T FG “I also wanted to continue taking it to the end and if I hear that the pill did its job and helped people, I will be proud of that.” E FG | Provisional acceptance that the study and products provided by study do benefit self and community in ways that are relevant and meaningful | Support should target maintaining trust in study and positive beliefs about study-provided PrEP use and optimizing adherence. Possible change strategies: Barriers based discussions to identify adherence challenges and resources and skills that could be used to address them Peer based support for adherence and developing strategies to promote adherence Real-time monitoring may help to provide reminders and problem solving support as and when needed Exploration of collected dosing data (as available) to identify strengths, barriers and potential strategies |
Mutuality | Both persistence and execution adherence are generally high/good “… 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… to see whether the pills can protect someone from HIV.” E FG “… [people] in the study must help them. They must be proud to talk about the pills and encourage other people.” T FG | Ownership of PrEP and/or goals of the study or program to the point of advocacy | Support for uptake, persistence and adherence are not generally needed in this dynamic. Rather, avoiding eroding mutuality is essential and developing avenues for collaboration offers opportunities to mobilize participant groups and communities Possible strategies to retain women in this dynamic: Create programs for peer mentors, community champions, and other roles that facilitate advocacy Create sister-groups where women can lead discussions among women in the study or program Create and use rotating participant advisory panels where women can take on valued leadership positions within the study or program Engage women in the development of a plan for how results of the study or program will be disseminated to community and policy makers Facilitate the creation of advocacy groups that can lead local and regional efforts to enhance awareness in communities and represent community with local health ministries, feeding back to community progress and reasons for delays in rolling out diverse prevention strategies |