NRU :: Browsing by Author "Etima, Juliane"

Browsing by Author "Etima, Juliane"

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Acceptability and use of a dapivirine vaginal ring in a phase III trial
(AIDS (London, England), 2017) Montgomery, Elizabeth T.; Straten, Ariane van der; Chitukuta, Miria; Reddy, Krishnaveni; Woeber, Kubashni; Atujuna, Millicent; Bekker, Linda-Gail; Etima, Juliane; Nakyanzi, Teopista; Mayo, Ashley J.; Katz, Ariana; Laborde, Nicole; Grossman, Cynthia I.; Soto-Torres, Lydia; Palanee-Phillips, Thesla; Baeten, Jared M.
The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring. Method—Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed. Results—We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring. Conclusion—It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.
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.
Ethical considerations for involving adolescents in biomedical HIV prevention research
(BMC Medical Ethics, 2021) Nakalega, Rita; Akello, Carolyne; Gati, Brenda; Nakabiito, Clemensia; Nolan, Monica; Kamira, Betty; Etima, Juliane; Nakyanzi, Teopista; Kemigisha, Doreen; Nanziri, Sophie C.; Nanyonga, Stella; Nambusi, Maria Janine; Mulumba, Emmie; Biira, Florence; Nabunya, Hadijah Kalule; Akasiima, Simon Afrika; Nansimbe, Joselyne; Maena, Joel; Babirye, Juliet Allen; Ngure, Kenneth; Mujugira, Andrew
Background: Involvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda. Methods: From August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions. Results: Most community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention. Conclusions: Stakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining
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.
Negative rumors about a vaginal ring for HIV-1 prevention in sub-Saharan Africa
(HHS Public Access, 2019) Chitukuta, Miria; Duby, Zoe; Katz, Ariana; Nakyanzi, Teopista; Reddy, Krishnaveni; Palanee-Phillips, Thesla; Tembo, Tchangani; Etima, Juliane; Musara, Petina; Mgodi, Nyaradzo M.; Straten, Ariane van der
Rumours may influence health-related behaviours, including uptake and adherence to HIV prevention products. This ASPIRE study assessed the safety and effectiveness of a vaginal ring delivering the antiretroviral dapivirine for HIV prevention in Africa. We explored negative rumours about study participation and the vaginal ring amongst study participants and their communities in Malawi, Uganda, South Africa and Zimbabwe. Two hundred and fourteen women participated in either single or serial in-depth interviews, or a focus group discussion. Three key findings emerged in the data. Firstly, rumours reflected fears concerning the ring and trial participation. Given the historical-political context of the countries in which the trial was conducted, the ring’s investigational nature and its foreign origin, ring use was rumoured to cause negative health outcomes such as cancer and infertility and was also associated with practices such as witchcraft or Satanism; salience of these rumours varied by country. Secondly, rumours reportedly affected participants’ adherence to the ring, and other women’s willingness to participate in the study. Finally, participants reported that participant engagement activities helped address rumours, resulting in enhanced trust and rapport between staff and participants.
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.
Use Of Peers, Community Lay Persons And Village Health Team (VHT) Members Improves Six-Week Postnatal Clinic (PNC) Follow-Up And Early Infant HIV Diagnosis (EID) In Urban And Rural Health Units In Uganda: A One-Year Implementation Study
(BMC Health Services Research, 2015) Namukwaya, Zikulah; Mosha, Linda Barlow; Mudiope, Peter; Kekitiinwa, Adeodata; Matovu, Joyce Namale; Musingye, Ezra; Ssebaggala, Jane Ntongo; Nakyanzi, Teopista; Abwooli, Jubilee John; Mirembe, Dorothy; Etima, Juliane; Bitarakwate, Edward; Fowler, Mary Glenn; Musoke, Philippa Martha; Peer-senga study Group at Mulago; Mengo, Rubaga and Mpigi Health Units
Effective Prevention of Mother to child Transmission of HIV (PMTCT) relies heavily on follow-up of HIV-infected women and infants from antenatal, through postnatal, to the end of the breastfeeding period. In Uganda, postnatal (PNC) follow-up remains below 50 % creating a missed opportunity for linkage to comprehensive HIV care and early infant diagnosis (EID). We evaluated the use of HIV infected peer mothers (peers), community lay persons and Village health team (VHT) members to improve PNC follow up and EID in urban and rural health units.Study participants were HIV-infected women recruited from antenatal clinics at three urban clinics (Mulago, Rubaga and Mengo hospitals) and one rural health centre (Mpigi Health centre IV) between January and September 2010. The women were followed through delivery and the mother-infant pairs for the 6-week postnatal visit and up to 14 weeks for EID. Peers, community lay persons and VHT members were identified and trained in basic PMTCT and reproductive health (RH). They were then assigned to study clinic to support and follow study participants, their partners and infants through provision of health education, counseling, home visits, and phone call reminders. Six week PNC attendance was measured as a proportion of mother-infant pairs that returned for the 6-week postnatal follow up visit (5–8 weeks) while EID was measured as the proportion of HIV-exposed live birth that had an HIV test done by 14 weeks of age. Data at baseline (one year before the intervention) was compared with that during the one year study period among study participants and HIV infected women and their HIV-exposed infants in the whole clinic population.A total of 558 HIV-infected pregnant women were recruited for the study, 47 mother-infant pairs were censured before 6 weeks due to stillbirth (14), infant death < 6 weeks (23), death of participant (04) and loss to follow up before delivery (6). 401/511 (78.5 %) of mother-infant pairs returned to the study clinics at six-week, while 441/511 (86.3 %) infants were tested for HIV infection by 14 weeks of age. The baseline six-week PNC follow up was 37.7 % and increased during the study period to 78.5 % and 39.1 % among study participants and whole clinic population respectively, an incremental difference of 39.4 % (P < 0.001). EID increased from a baseline of 53.6 % to 86.3 % and 65.8 % among study and whole clinic population respectively during the study period, an incremental difference of 20.5 % (P < 0.001).Use of peers, community lay persons and VHT members led to a significant increase in six-week postnatal follow up of HIV infected women and EID among HIV exposed infants in the four study clinics. Our study supports the use of peers to improve early postnatal follow up and EID and should be implemented in other health units to support the PMTCT cascade.

Browsing by Author "Etima, Juliane"

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