NRU :: Browsing by Author "Kabwigu, Samuel"

Browsing by Author "Kabwigu, Samuel"

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Case Study: Converting Paper-based Case Report Forms to an Electronic Format (e-CRF) with ACASI Self-Report Integration
(Online journal of public health informatics, 2017) Mierzwa, Stan; Souidi, Samir; Akello, Carolyne; Etima, Juliane; Ssebagala, Richard; Nolan, Monica; Kabwigu, Samuel; Nakablito, Clemensia
This paper will discuss the integration of electronic Case Report Forms (e-CRFs) into an already existing Android-based Audio Computer-Assisted Self-Interview (ACASI) software solution that was developed for a public health project in Kampala, Uganda, the technical outcome results, and lessons learned that may be useful to other projects requiring or considering such a technology solution. The developed product can function without a connection to the Internet and allows for synchronizing collected data once connectivity is possible. Previously, only paper-based CRFs were utilized at the Uganda project site. A subset or select group of CRFs were targeted for integration with ACASI in order to test feasibility and success. Survey volume, error rate, and acceptance of the system, as well as the operational and technical design of the solution, will be discussed.
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.
HIV disease progression among women following seroconversion during a tenofovirbased HIV prevention trial
(PLoS ONE, 2017) Riddler, Sharon A.; Husnik, Marla; Gita, Ramjee; Anamika, Premrajh; Onini Tutshana, Bomkazi; Arendevi, Pather; Siva, Samantha; Jeenarain, Nitesha; Nair, Gonasagrie; Selepe, Pearl; Kabwigu, Samuel; Palanee-Phillips, Thesla; Panchia, Ravindre; Mhlanga, Felix; Lisa, Levy; Livant, Edward; Patterson, Karen; Elharrar, Vanessa; Balkus, Jennifer
Little is known regarding HIV disease outcomes among individuals who become infected with HIV while receiving antiretroviral medications for prevention. We compared HIV disease parameters among women who seroconverted while receiving tenofovir-containing oral or vaginal pre-exposure prophylaxis (PrEP) to placebo. Methods Participants with HIV seroconversion in a randomized placebo-controlled trial of oral tenofovir, oral tenofovir/emtricitabine, and vaginal tenofovir gel (MTN-003) were followed in a longitudinal cohort study (MTN-015). The effect of oral and vaginal tenofovir-containing PrEP on HIV disease progression was compared to placebo using linear mixed effects and Cox proportional hazard models, as appropriate. Additional analyses were performed to compare the outcomes among participants with detectable tenofovir or emtricitabine in plasma at the first quarterly visit in MTN-003. Results A total of 224 participants were included in the analysis; 93% from South Africa and 94% clade C virus. No differences in HIV RNA at steady state or the trajectory over 12 months were observed for each active arm compared to placebo; tenofovir gel recipients had higher CD4+ T cell counts (722 vs 596 cells/mm3; p = 0.02) at 90 days after estimated HIV seroconversion and higher average rates of change over 12 months compared to placebo (-181 vs -92 cells/mm3 per year; p = 0.08). With a median follow-up of 31 months, no significant differences were observed for time to CD4+ T cell count 350 cells/mm3, or the composite endpoint of CD4+ T cells 350 cells/mm3, initiation of antiretroviral therapy or death for each active arm compared to placebo. Additionally, there were no significant differences in the HIV RNA or CD4+ T cell counts at baseline, the change to month 12, or any disease progression outcomes among participants with oral drug detected and no oral drug detected compared to placebo. Conclusions No clinically significant differences in HIV seroconversion outcomes were observed among women randomized to tenofovir-containing oral or vaginal PrEP regimens, however low overall adherence limits the generalizability of these findings.
How Community Education Tools Facilitated Understanding of the ASPIRE Vaginal Ring Study: Kampala Experience
(AIDS Research and Human Retroviruses, 2014) Ndawula, Patrick; Nakyanzi, Teopista; Etima, Juliane; Kabwigu, Samuel; Matovu, Flavia K.; Nanziri, Sophie C.; Kemigisha, Doreen; Nanyonga, Stella; White, Rhonda; Cokley, Cheryl; Nakabiito, Clemesia
UNAIDS Good participatory practice guidelines for biomedical HIV prevention trials recommends that sufficient trial information, such as study objectives, procedures, risks, benefits, and what is expected of participants, is provided for potential participants to make informed decisions. We describe how ASPIRE community education tools increased study awareness and enabled literacy regarding research, reproductive health, family planning, and HIV prevention.
Impact of DSMB Outcomes on Participation in HIV Prevention Trials: The VOICE Study Experience in Kampala, Uganda
(AIDS Research and Human Retroviruses, 2014) Etima, Juliane; Nakyanzi, Teopista; Kabwigu, Samuel; Kiweewa, Flavia M.; Mirembe, Brenda G.; Akello, Carolyne A.; Rossi, Lisa; Nakabiito, Clemensia
Clinical trials are monitored and regulated by independent bodies to ensure participants’ safety and ethical conduct. Depending on study progress, these bodies may recommend a trial to continue as is, be modified or stopped. Six such reviews were conducted during the implementation of the VOICE study. We describe the impact of Data & Safety Monitoring Board (DSMB) recommendations on continued study participation in Kampala, Uganda, including retention, researchers’ motivation to continue the study, and community perceptions and attitudes about the study.
Impact of Male Partner Involvement on Women’s Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial
(AIDS and Behavior, 2020) Roberts, Sarah T.; Nair, Gonasagrie; Baeten, Jared M.; Palanee‑Philips, Thesla; Schwartz, Katie; Reddy, Krishnaveni; Kabwigu, Samuel; Matovu Kiweewa, Flavia; Govender, Vaneshree; Gaffoor, Zakir; Singh, Nishanta; Siva, Samantha; Naidoo, Kalendri; Montgomery, Elizabeth T.
identified as one of the most significant factors impacting women’s willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women’s adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64–80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03–1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38–35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70–6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36–10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention.
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.
Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study
(HIV Clinical Trials, 2018) Wynne, Joshua; Muwawu, Rosemary; Mubiru, Michael C.; Kamira, Betty; Kemigisha, Doreen; Nakyanzi, Teopista; Kabwigu, Samuel; Nakabiito, Clemensia; Kiweewa Matovu, Flavia
The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. This paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda. Once enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Challenges to retention included a mobile population, non-disclosure of study participation to spouse/family, and economic constraints. Strategies used to maintain high participation rates included the use of detailed locator information, a participant tracking database, regular HIV/STI testing, and the formation of close bonds between staff and subjects. We enrolled 322 women out of the 637 screened. The overall retention rate was 95% over a 3 year follow up period. Only 179 (3%) out of the 6124 expected visits were missed throughout study implementation. Reasons for missed visits included: participants thinking that they did not need frequent visits due to their HIV negative status, time constraints due to commercial sex work, and migration for better employment. With the implementation of multi-faceted comprehensive follow-up and retention strategies, we achieved very high retention rates in the MTN-003 study. This paper provides a blueprint for effective participant retention strategies for other longitudinal HIV prevention studies in resource-limited settings in Sub-Saharan Africa.
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.
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.
Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site
(AIDS Research and Human Retroviruses, 2014) Nanziri, Sophie Clare; Ndawula, Patrick; Nakyanzi, Teopista; Gati, Brenda; Matovu, Flavia K.; Etima, Juliane; Kabwigu, Samuel; Kemigisha, Doreen; Nanyonga, Stella; Nakabiito, Cleemensia
Recruitment of participants is labor intensive and a critical aspect of prevention research. It is important to incorporate early retention techniques into recruitment strategies during the planning phase to ensure that retention targets are met. The Kampala team describes the strategies, process, and challenges in ensuring retainable participants are recruited into the study.
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.

Browsing by Author "Kabwigu, Samuel"

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