Browsing by Author "Balkus, Jennifer E."

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    Dapivirine vaginal ring use does not diminish the effectiveness of hormonal contraception
    (Journal of acquired immune deficiency syndromes, 2017) Balkus, Jennifer E.; Palanee-Phillips, Thesla; Reddy, Krishnaveni; Siva, Samantha; Harkoo, Ishana; Nakabiito, Clemensia; Kintu, Kenneth; Nair, Gonasangrie; Chappell, Catherine; Matovu Kiweewa, Flavia; Kabwigu, Samuel; Naidoo, Logashvari; Jeenarain, Nitesha; Marzinke, Mark; Soto-Torres, Lydia; Brown, Elizabeth R.; Baeten, Jared M.
    To evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use. A secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention. Methods: Use of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection. Of 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm, 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods. Use of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially due to poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy.
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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.