When and why women might suspend PrEP use according to perceived seasons of risk: implications for PrEP-specific risk-reduction counselling.

Oral pre-exposure prophylaxis (PrEP) using the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (Truvada) has been shown to dramatically reduce the risk of HIV acquisition for women at higher risk of infection if taken daily. Understanding when and why women would intentionally stop using an efficacious oral PrEP drug within the context of their 'normal' daily lives is essential for delivering effective PrEP risk-reduction counselling. As part of a larger study, we conducted 60 qualitative interviews with women at higher risk of HIV in Bondo, Kenya, and Pretoria, South Africa. Participants charted their sexual contacts over the previous six months, indicated whether they would have taken PrEP if available and discussed whether and why they would have suspended PrEP use. Nearly all participants said they would have used PrEP in the previous six months; half indicated they would have suspended PrEP use at some point. Participants' reasons for an extended break from PrEP were related to partnership dynamics (e.g., perceived low risk of a stable partner) and phases of life (e.g., trying to conceive). Life events (e.g., holidays and travel) could prompt shorter breaks in PrEP use. These circumstances may or may not correspond to actual contexts of lower risk, highlighting the importance of tailored PrEP risk-reduction counselling.

Participants' Explanations for Nonadherence in the FEM-PrEP Clinical Trial.

BACKGROUND: FEM-PrEP-a clinical trial of daily, oral emtricitabine/tenofovir disoproxil fumarate for HIV prevention among women in sub-Saharan Africa-did not show a reduction in HIV acquisition because of low adherence to the study pill. We conducted a follow-up study to identify reasons for nonadherence. METHODS: Qualitative, semistructured interviews (n = 88) and quantitative, audio computer-assisted self-interviews (n = 224) were conducted with former FEM-PrEP participants in Bondo, Kenya, and Pretoria, South Africa. Thematic analysis was used to analyze the qualitative data, and descriptive statistics were used to describe audio computer-assisted self-interviews responses. Data are presented within the 5 categories of Ickovics' and Meisler's conceptual framework on adherence: (1) the individual, (2) trial characteristics and study pill regimen, (3) patient-provider relationship, (4) clinical setting, and (5) the disease. RESULTS: Participants' explanations for nonadherence were primarily situated within 3 of the framework's 5 categories: (1) the individual, (2) trial characteristics and study pill regimen, and (3) the disease. Concerns about the investigational nature of the drug being tested and side effects were the prominent reasons reported for nonadherence. Participants also described being discouraged from taking the study pill by members of the community, their sexual partners, and other participants, primarily because of these same concerns. Limited acceptability of the pill's attributes influenced nonadherence for some participants as did concerns about HIV-related stigma. In addition, many participants reported that others continued in FEM-PrEP while not taking the study pill because of the trial's ancillary benefits and visit reimbursement-factors related to the clinical setting. Negative patient-provider relationships were infrequently reported as a factor that influenced nonadherence. CONCLUSIONS: Despite substantial study staff engagement with participants and communities, concerns about the study pill and discouragement from others seemed to have influenced nonadherence considerably. Alternative study designs or procedures and enhanced community engagement paradigms may be needed in future studies.

Motivations for Reducing Other HIV Risk-Reduction Practices if Taking Pre-Exposure Prophylaxis: Findings from a Qualitative Study Among Women in Kenya and South Africa.

Findings from a survey conducted among women at high risk for HIV in Bondo, Kenya, and Pretoria, South Africa, demonstrated that a substantial proportion would be inclined to reduce their use of other HIV risk-reduction practices if they were taking pre-exposure prophylaxis (PrEP). To explore the motivations for their anticipated behavior change, we conducted qualitative interviews with 60 women whose survey responses suggested they would be more likely to reduce condom use or have sex with a new partner if they were taking PrEP compared to if they were not taking PrEP. Three interrelated themes were identified: (1) "PrEP protects"--PrEP was perceived as an effective HIV prevention method that replaced the need for condoms; (2) condoms were a source of conflict in relationships, and PrEP would provide an opportunity to resolve or avoid this conflict; and (3) having sex without a condom or having sex with a new partner was necessary for receiving material goods and financial assistance--PrEP would provide reassurance in these situations. Many believed that PrEP alone would be a sufficient HIV risk-reduction strategy. These findings suggest that participants' HIV risk-reduction intentions, if they were to use PrEP, were based predominately on their understanding of the high efficacy of PrEP and their experiences with the limitations of condoms. Enhanced counseling is needed to promote informed decision making and to ensure overall sexual health for women using PrEP for HIV prevention, particularly with respect to the prevention of pregnancy and other sexually transmitted infections when PrEP is used alone.

Preparing for the Rollout of Pre-Exposure Prophylaxis (PrEP): A Vignette Survey to Identify Intended Sexual Behaviors among Women in Kenya and South Africa if Using PrEP.

INTRODUCTION: Several clinical trials have demonstrated the efficacy of pre-exposure prophylaxis (PrEP) in reducing HIV risk. One concern with introducing PrEP is whether users will engage in riskier sexual behaviors. METHODS: We assessed the effect that PrEP may have on sexual risk behaviors by administering a survey to 799 women in Bondo, Kenya, and Pretoria, South Africa. Participants were asked about their sexual behavior intentions twice--once as if they were taking PrEP and once as if they were not taking PrEP--within four risk situations (vignettes). They responded using a 5-point ordinal scale. We used a series of linear mixed effects models with an unstructured residual covariance matrix to estimate the between- and within-subject differences in the mean likelihood of engaging in risky sexual behavior across the PrEP and non-PrEP contexts. We also calculated the total percentage of participants who reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP, by vignette. RESULTS: We found statistically significant differences in the mean likelihood of engaging in risky sexual behavior with the between-subject comparison (-0.17, p < 0.01) and with the within-subject comparison (-0.31, p < 0.001). Depending on the vignette, 27% to 40% of participants reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP. CONCLUSIONS: Our findings indicate that modest increases in risky sexual behavior could occur with PrEP. Although responses from the majority of participants suggest they would not be more likely to engage in risky sexual behavior if they took PrEP, a substantial proportion might. Programs rolling out PrEP should be prepared to assist similar women in making informed choices about reducing their risk of HIV and about their sexual health beyond HIV prevention.

The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.

BACKGROUND: FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use. We conducted a follow-up study with former participants in Bondo, Kenya, and Pretoria, South Africa, to understand factors that had influenced overreporting of adherence and to learn the whereabouts of unused pills. METHODS: Qualitative, semistructured interviews were conducted with 88 participants, and quantitative, audio computer-assisted self-interviews were conducted with 224 participants. We used thematic analysis and descriptive statistics to analyze the qualitative and quantitative data, respectively. RESULTS: In audio computer-assisted self-interviews, 31% (n = 70) said they had overreported adherence; the main reason was the belief that nonadherence would result in trial termination (69%, n = 48). A considerable percentage (35%, n = 78) acknowledged discarding unused pills. Few acknowledged giving their pills to someone else (4%, n = 10), and even fewer acknowledged giving them to someone with HIV (2%, n = 5). Many participants in the semistructured interviews said other participants had counted and removed pills from their bottles to appear adherent. CONCLUSIONS: Despite repeated messages that nonadherence would not upset staff, participants acknowledged several perceived negative consequences of reporting nonadherence, which made it difficult to report accurately. Uneasiness continued in the follow-up study, as many said they had not overreported during the trial. Efforts to improve self-reported measures should include identifying alternative methods for creating supportive environments that allow participants to feel comfortable reporting actual adherence.

The sexual risk context among the FEM-PrEP study population in Bondo, Kenya and Pretoria, South Africa.

BACKGROUND: Incidence rates in the FEM-PrEP and VOICE trials demonstrate that women from diverse sub-Saharan African communities continue to be at substantial HIV risk. OBJECTIVE: To describe and compare the sexual risk context of the study population from two FEM-PrEP trial sites-Bondo, Kenya, and Pretoria, South Africa. METHODS: At baseline we collected information about demographics, sexual behaviors, and partnership beliefs through quantitative questionnaires with all participants (Bondo, n = 720; Pretoria, n = 750). To explore the sexual risk context, we also conducted qualitative, semi-structured interviews with HIV-negative participants randomly selected at several time points (Bondo, n = 111; Pretoria, n = 69). RESULTS: Demographics, sexual behavior, and partnership beliefs varied significantly between the sites. Bondo participants were generally older, had fewer years of schooling, and were more likely to be employed and married compared to Pretoria participants. Bondo participants were more likely to report multiple partners and not knowing whether their partner had HIV than Pretoria participants. A significantly higher percentage of Bondo participants reported engaging in sex without a condom with their primary and other partners compared to Pretoria participants. We found a borderline association between participants who reported not using condoms in the 4 weeks prior to baseline and lower risk of HIV infection, and no association between having more than one sexual partner at baseline and HIV infection. DISCUSSION: Despite significantly different demographics, sexual behaviors, and partnership beliefs, many women in the FEM-PrEP trial were at risk of acquiring HIV as demonstrated by the sites' high HIV incidence. Though gender dynamics differed between the populations, they appear to play a critical role in women's sexual practices. The findings highlight different ways women from diverse contexts may be at-risk for HIV and the importance of providing HIV prevention options that are both effective and feasible given personal and social circumstances.

A descriptive analysis of perceptions of HIV risk and worry about acquiring HIV among FEM-PrEP participants who seroconverted in Bondo, Kenya, and Pretoria, South Africa.

INTRODUCTION: Risk perception is a core construct in many behaviour change theories in public health. Individuals who believe they are at risk of acquiring an illness may be more likely to engage in behaviours to reduce that risk; those who do not feel at risk may be unlikely to engage in risk reduction behaviours. Among participants who seroconverted in two FEM-PrEP sites - Bondo, Kenya, and Pretoria, South Africa - we explored perceived HIV risk and worry about acquiring HIV prior to HIV infection. METHODS: FEM-PrEP was a phase III clinical trial of once-daily, oral emtricitabine and tenofovir disoproxil fumarate for HIV prevention among women in sub-Saharan Africa. We asked all participants about their perceived HIV risk in the next four weeks, prior to HIV testing, during a quantitative face-to-face interview at enrolment and at quarterly follow-up visits. Among participants who seroconverted, we calculated the frequencies of their responses from the visit conducted closest to, but before, HIV acquisition. Also among women who seroconverted, we conducted qualitative, semi-structured interviews (SSIs) at weeks 1, 4 and 8 after participants' HIV diagnosis visit to retrospectively explore feelings of HIV worry. Applied thematic analysis was used to analyse the SSI data. RESULTS: Among participants who seroconverted in Bondo and Pretoria, 52% reported in the quantitative interview that they had no chance of acquiring HIV in the next four weeks. We identified four processes of risk rationalization from the SSI narratives. In "protective behaviour," participants described at least one risk reduction behaviour they used to reduce their HIV risk; these actions made them feel not vulnerable to HIV, and therefore they did not worry about acquiring the virus. In "protective reasoning," participants considered their HIV risk but rationalized, based on certain events or beliefs, that they were not vulnerable and therefore did not worry about getting HIV. In "recognition of vulnerability," participants described reasons for being worried about getting HIV but said no or limited action was taken to reduce their perceived vulnerability. Participants with "no rationalization or action" did not describe any HIV worry or did not engage in HIV risk reduction behaviours. CONCLUSIONS: Women who are at substantial risk of acquiring HIV may underestimate their actual risk. Yet, others who accurately understand their HIV risk may be unable to act on their concerns. Perceived HIV risk and risk rationalization are important concepts to explore in risk reduction counselling to increase the use of HIV prevention strategies among women at risk of HIV.