Browsing by Author "Meda, Nicolas"
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Item Extended Pre-Exposure Prophylaxis With Lopinavir–Ritonavir Versus Lamivudine To Prevent HIV-1 Transmission Through Breastfeeding Up To 50 Weeks In Infants In Africa (ANRS 12174): A Randomised Controlled Trial(The Lancet, 2016) Nagot, Nicolas; Kankasa, Chipepo; Tumwine, James K.; Meda, Nicolas; Hofmeyr, G. Justus; Vallo, Roselyne; Mwiya, Mwiya; Kwagala, Mary; Traore, Hugues; Sunday, Amwe; Singata, Mandisa; Siuluta, Chafye; Some, Eric; Rutagwera, David; Neboua, Desire; Ndeezi, Grace; Jackson, Debra; Maréchal, Valérie; Neveu, Dorine; Engebretsen, Ingunn M. S.; Lombard, Carl; Blanche, Stéphane; Sommerfelt, Halvor; Rekacewicz, Claire; Tylleskär, Thorkild; Perre, Philippe Van de; for the ANRS 12174 Trial GroupStrategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa, including infant prophylaxis, have never been assessed past 6 months of breastfeeding, despite breastfeeding being recommended up to 12 months after birth. We aimed to compare the efficacy and safety of infant prophylaxis with the two drug regimens (lamivudine or lopinavir–ritonavir) to prevent postnatal HIV-1 transmission up to 50 weeks of breastfeeding.We did a randomised controlled trial in four sites in Burkina Faso, South Africa, Uganda, and Zambia in children born to HIV-1-infected mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL). An independent researcher electronically generated a randomisation schedule; we then used sequentially numbered envelopes to randomly assign (1:1) HIV-1-uninfected breastfed infants aged 7 days to either lopinavir–ritonavir or lamivudine (paediatric liquid formulations, twice a day) up to 1 week after complete cessation of breastfeeding or at the final visit at week 50. We stratified the randomisation by country and used permuted blocks of four and six. We used a study label on drug bottles to mask participants, study physicians, and assessors to the treatment allocation. The primary outcome was infant HIV-1 infection between age 7 days and 50 weeks, diagnosed every 3 months with HIV-1 DNA PCR, in the modified intention-to-treat population (all who attended at least one follow-up visit). This trial is registered with ClinicalTrials.gov, number NCT00640263.Between Nov 16, 2009, and May 7, 2012, we enrolled and randomised 1273 infants and analysed 1236; 615 assigned to lopinavir–ritonavir or 621 assigned to lamivudine. 17 HIV-1 infections were diagnosed in the study period (eight in the lopinavir–ritonavir group and nine in the lamivudine group), resulting in cumulative HIV-1 infection of 1·4% (95% CI 0·4–2·5) and 1·5% (0·7–2·5), respectively. Infection rates did not differ between the two drug regimens (hazard ratio [HR] of lopinavir–ritonavir versus lamivudine of 0·90, 95% CI 0·35–2·34; p=0·83). Clinical and biological severe adverse events did not differ between groups; 251 (51%) infants had a grade 3–4 event in the lopinavir–ritonavir group compared with 246 (50%) in the lamivudine group.Infant HIV-1 prophylaxis with lopinavir–ritonavir was not superior to lamivudine and both drugs led to very low rates of HIV-1 postnatal transmission for up to 50 weeks of breastfeeding. Infant pre-exposure prophylaxis should be extended until the end of HIV-1 exposure and mothers should be informed about the persistent risk of transmission throughout breastfeeding.Item “If I have money, I cannot allow my baby to breastfeed only …” barriers and facilitators to scale-up of peer counselling for exclusive breastfeeding in Uganda(International Breastfeeding Journal, 2020) Rujumba, Joseph; Ndeezi, Grace; Nankabirwa, Victoria; Kwagala, Mary; Mukochi, Michelle; Diallo, Abdoulaye Hama; Meda, Nicolas; Engebretsen, Ingunn M. S.; Tylleskär, Thorkild; Tumwine, JamesEarly initiation and exclusive breastfeeding for 6 months reduces infant morbidity and mortality and can positively impact on cognitive function. In Uganda, exclusive breastfeeding for 6 months is recommended but many women introduce alternative feeds early. Interventions to scale-up peer support provision for exclusive breastfeeding are limited. We explored the barriers, facilitators and solutions to scaling-up of peer counselling support for exclusive breastfeeding in Uganda.A qualitative study was conducted in Mbale District and Kampala City between April and July 2014. Data were collected through 15 key informant interviews with health workers and managers of organizations involved in child and maternal health as well as seven focus group discussions with peer counsellors who took part in the PROMISE EBF Trial (2006–2008), VHT members, mothers and fathers of children aged 1 year and below. Data were analysed using the content thematic approach.The need for peer support for exclusive breastfeeding, especially for young and first-time mothers, was highlighted by most study participants. While mothers, mothers-in-law, friends and husbands were mentioned as major stakeholders regarding infant feeding, they were perceived to lack adequate information on breastfeeding. Health workers were mentioned as a key source of support, but their constraints of heavy workloads and lack of education materials on breastfeeding were highlighted. High community expectations of peer counsellors, the perceived inadequacy of breast milk, general acceptability of complimentary feeding, household food insecurity, heavy workload for women and unsupportive ‘work-places’ were key barriers to scaling-up of peer counselling support for breastfeeding. The peer counsellors who were part of the PROMISE EBF trial in Mbale, the village health team programme, health facilities, community groups, the media and professional associations emerged as potential facilitators that can aid the scaling-up of peer counselling support for breastfeeding.Peer support for breastfeeding is highly valued in this setting. The health system and health workers are regarded as the main facilitators to scaling-up of peer support for exclusive breastfeeding. Partnerships with village health teams (VHTs), community groups, role models, professional associations and the media are other potential facilitators to this scaling-up.