Browsing by Author "Mansoor, Leila E."

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    Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
    (BMC public health, 2021) Garcia, Morgan; Luecke, Ellen; Mayo, Ashley J.; Scheckter, Rachel; Ndase, Patrick; Matovu Kiweewa, Flavia; Kemigisha, Doreen; Musara, Petina; Singh, Nishanta; Palanee-Phillips, Thesla; Baeten, Jared M.; Torjesen, Kristine; Mansoor, Leila E.
    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, placebocontrolled 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).
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    The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence
    (AIDS and Behavior, 2013) Stoner, Marie C. D.; Brown, Elizabeth R.; Palanee‑Phillips, Thesla; Mansoor, Leila E.; Tembo, Tchangani; Nair, Gonasagrie; Akello, Carolyne; Seyama, Linly; Jeenarain, Nitesha; Naidoo, Logashvari; Mgodi, Nyaradzo; Hunidzarira, Portia; Chitukuta, Miria; Straten, Ariane van der
    We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women’s internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence
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    Social harms in female-initiated HIV prevention method research: state of the evidence
    (AIDS (London, England), 2019) Montgomerya, Elizabeth T.; Robertsa, Sarah T.; Nelb, Annalene; Malherbeb, Mariette; Torjesenc, Kristine; Bunged, Katherine; Singhd, Devika; Baetene, Jared M.; Marrazzof, Jeanne; Chirenjeg, Z. Mike; Kabwigu, Samuel; Beigi, Richard; Riddler, Sharon A.; Gaffour, Zakir; Reddy, Krishnaveni; Mansoor, Leila E.; Nair, Gonasagrie; Woeberi, Kusbashni; Moodley, Jayajothi; Jeenaraini, Nitesha; Siva, Samantha; Naidoo, Logashvari; Govender, Vaneshree; Palanee-Phillips, Thesla
    Assessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for ‘social harms’, generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts. Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.