Interest in I-PrEP and Willingness to Participate in Clinical Trials Among Men and Transfeminine Persons Who have Sex with Men in Sub-Saharan Africa: Quantitative and Qualitative Findings from HPTN 075.

This study explored interest in injectable PrEP (I-PrEP) and willingness to participate in clinical trials testing new biomedical HIV prevention strategies among men and transfeminine persons who have sex with men (MSM & TGP), using data collected in the HIV Prevention Trials Network (HPTN) 075 study, which took place at sites in Kenya, Malawi, and South Africa. Data result from a survey among 267 18-44 years old HIV negative participants, complemented with semi-structured interviews with 80 purposively recruited persons. Correlations coefficients were calculated to identify demographic and psychosocial factors associated with interest in I-PrEP. Qualitative interviews were analyzed using concept-driven and subsequent data-driven coding. Most surveyed participants expressed an interest in I-PrEP. Quantitatively, only being interested in other HIV prevention measures was associated with interest in I-PrEP. Qualitatively, most participants preferred I-PrEP to O-PrEP and remained interested in I-PrEP despite barriers such as the somewhat invasive nature of the procedure and potential side effects of I-PrEP. Interest in I-PrEP was driven by the possibility of avoiding sexual or HIV stigma. Access to healthcare and altruism-such as assisting in the development of new HIV prevention methods-positively impacted willingness to participate in clinical trials. With I-PrEP favored by most participants, it is potentially a critical tool to prevent HIV infection among MSM & TGP in sub-Saharan Africa, with the mitigation of stigma as a major advance. Recruitment of MSM & TGP in biobehavioral clinical trials seems feasible, with altruistic reasons and receiving I-PrEP and free medical care as major motivators.

RESUMEN: Este estudio exploró el interés en la PrEP inyectable (I-PrEP) y la voluntad de participar en ensayos clínicos que prueban nuevas estrategias biomédicas de prevención del VIH entre hombres y personas transfemeninas que tienen sexo con hombres (HSH y TGP), utilizando datos recopilados en la Red de Ensayos de Prevención del VIH. (HPTN) 075, que se llevó a cabo en sitios de Kenia, Malawi y Sudáfrica. Los datos son el resultado de una encuesta entre 267 participantes VIH negativos de entre 18 y 44 años, complementada con entrevistas semiestructuradas con 80 personas reclutadas intencionalmente. Se calcularon coeficientes de correlación para identificar factores demográficos y psicosociales asociados con el interés en la I-PrEP. Las entrevistas cualitativas se analizaron mediante codificación basada en conceptos y, posteriormente, basada en datos. La mayoría de los participantes encuestados expresaron interés en la I-PrEP. Cuantitativamente, sólo estar interesado en otras medidas de prevención del VIH se asoció con el interés en la I-PrEP. Cualitativamente, la mayoría de los participantes prefirieron la I-PrEP a la O-PrEP y siguieron interesados en la I-PrEP a pesar de barreras como la naturaleza algo invasiva del procedimiento y los posibles efectos secundarios de la I-PrEP. El interés en la I-PrEP fue impulsado por la posibilidad de evitar el estigma sexual o del VIH. El acceso a la atención sanitaria y el altruismo (como la asistencia en el desarrollo de nuevos métodos de prevención del VIH) tuvieron un impacto positivo en la voluntad de participar en ensayos clínicos. Dado que la mayoría de los participantes prefieren la I-PrEP, es potencialmente una herramienta crítica para prevenir la infección por VIH entre HSH y TGP en el África subsahariana, con la mitigación del estigma como un avance importante. El reclutamiento de HSH y TGP en ensayos clínicos bioconductuales parece factible, con razones altruistas y recibir I-PrEP y atención médica gratuita como principales motivadores.

Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study.

BACKGROUND: Low adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use. METHODS: All sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Residual dapivirine remaining in the last ring returned by each participant was used to estimate drug released from the ring, which was then adjusted for time participants had the ring to calculate probable use categorized into three levels (low/intermittent/high). Product use was connected to PEA attendance using participant identification numbers. We used multivariate Poisson regression with robust standard errors to explore differences in ring use between PEA attendance groups and reviewed qualitative reports for illustrative quotes highlighting participant experiences with PEAs. RESULTS: 2312 of 2629 study participants attended at least one of 389 PEAs conducted across sites. Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05). When controlling for these variables, participants who attended at least one event were more likely to return a last ring showing at least some use (RR = 1.40) than those who never attended an event. There was a stronger correlation between a last returned ring showing use and participant attendance at multiple events (RR = 1.52). CONCLUSIONS: Our analysis supports the growing body of work illustrating the importance of meaningfully engaging research participants to achieve study success and aligns with other analyses of adherence support efforts during ASPIRE. While causation between PEA attendance and product use cannot be established, residual drug levels in returned rings strongly correlated with participant attendance at PEAs, and the benefits of incorporating PEAs should be considered when designing future studies of investigational products.

Community-researcher partnerships at NIAID HIV/AIDS clinical trials sites: insights for evaluation and enhancement.

BACKGROUND: Community engagement has been a cornerstone of National Institute of Allergy and Infectious Diseases (NIAID)'s HIV/AIDS clinical trials programs since 1990. Stakeholders now consider this critical to success, hence the impetus to develop evaluation approaches. OBJECTIVES: The purpose was to assess the extent to which community advisory boards (CABs) at HIV/AIDS trials sites are being integrated into research activities. METHODS: CABs and research staff (RS) at NIAID research sites were surveyed for how each viewed (a) the frequency of activities indicative of community involvement, (b) the means for identifying, prioritizing, and supporting CAB needs, and (c) mission and operational challenges. RESULTS: Overall, CABs and RS share similar views about the frequency of community involvement activities. Cluster analysis reveals three groups of sites based on activity frequency ratings, including a group notable for CAB-RS discordance. CONCLUSIONS: Assessing differences between community and researcher perceptions about the frequency of and challenges posed by specific engagement activities may prove useful in developing evaluation tools for assessing community engagement in collaborative research settings.