Browsing by Author "Scheckter, Rachel"

Now showing 1 - 4 of 4
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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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    Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials
    (HIV Clinical Trials, 2018) Mhlanga, Felix G.; Noguchi, Lisa; Balkus, Jennifer E.; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O’Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R.; Hillier, Sharon L.; Beigi, Richard
    Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. Results: To date, participants from two phase I studies and two effectiveness trials have participated in MTN- 016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.
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    The MTN-016 Pregnancy Registry: Baseline Characteristics of Enrollees from the VOICE Study and Reasons for Non-enrollment of Eligible Women
    (AIDS Research and Human Retroviruses, 2014) Kabwigu, Samuel; Noguchi, Lisa; Moodley, Jothi; Palanee, Thes; Kintu, Kenneth; Nair, Lulu; Panchia, R.; Selepe, Pearl; Balkus, Jennifer E.; Torjesen, Kristine; Piper, Jeanna; Scheckter, Rachel; Hazra, Rohan; Beigi, Richard
    As pregnant women are at risk for HIV and women at risk of HIV may become pregnant, it is important to assess the safety of candidate HIV prevention products in both non-pregnant and pregnant women. The MTN-016 pregnancy registry is a prospective observational cohort in which participants who became pregnant during MTN effectiveness studies or those with planned exposures in pregnancy safety studies are monitored for adverse obstetric outcomes; infants from these pregnancies are followed through the first year of life. Registry enrollment systematically excludes termination of pregnancy and early pregnancy loss, including early non-viable pregnancies with a transient positive test at a monthly visit, as these data are captured in parent protocols. For VOICE participants enrolled into the registry from Uganda, Zimbabwe and South Africa, we describe baseline demographic characteristics and key reasons for non-enrollment as reported by site investigators.
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    Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy
    (Journal of acquired immune deficiency syndromes, 2018) Makanani, Bonus; Balkus, Jennifer E.; Jiao, Yuqing; Noguchi, Lisa M.; Palanee-Phillips, Thesla; Mbilizi, Yamikani; Moodley, Jothi; Kintu, Kenneth; Reddy, Krishnaveni; Kabwigu, Samuel; Jeenariain, Nitesha; Harkoo, Ishana; Mgodi, Nyaradzo; Piper, Jeanna; Rees, Helen; Scheckter, Rachel; Beigi, Richard; Baeten, Jared M. ,
    Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1–uninfected women who became pregnant while participating in MTN-020/ASPIRE. ASPIRE was a randomized, double-blind, placebocontrolled phase III safety and effectiveness study of the dapivirinering for HIV-1 prevention. Sexually active women aged 18–45 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled. Urine pregnancy tests were performed monthly, and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included the following: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, and congenital anomalies), and infant growth.