Optimised prevention of postnatal HIV transmission in Zambia and Burkina Faso (PROMISE-EPI): a phase 3, open-label, randomised controlled trial.

BACKGROUND: Transmission through breastfeeding accounts for more than half of the unacceptably high number of new paediatric HIV infections worldwide. We hypothesised that, in addition to maternal antiretroviral therapy (ART), extended postnatal prophylaxis with lamivudine, guided by point-of-care assays for maternal viral load, could reduce postnatal transmission. METHODS: We did a phase 3, open-label, randomised controlled trial at four health-care facilities in Zambia and four health-care facilities in Burkina Faso. Mothers with HIV and their breastfed infants without HIV attending the second visit of the Expanded Programme of Immunisation (EPI-2; infant age 6-8 weeks) were randomly assigned 1:1 to intervention or control groups. In the intervention group, maternal viral load was measured using Xpert HIV viral load assay at EPI-2 and at 6 months, with results provided immediately. Infants whose mothers had a viral load of 1000 copies per mL or higher were started on lamivudine syrup twice per day for 12 months or 1 month after breastfeeding discontinuation. The control group followed national guidelines for prevention of postnatal transmission of HIV. The primary outcome assessed by modified intention to treat was infant HIV infection at age 12 months, with HIV DNA point-of-care testing at 6 months and at 12 months. This trial is registered with ClinicalTrials.gov (NCT03870438). FINDINGS: Between Dec 12, 2019 and Sept 30, 2021, 34 054 mothers were screened for HIV. Among them, 1506 mothers with HIV and their infants without HIV, including 1342 mother and infant pairs from Zambia and 164 from Burkina Faso, were eligible and randomly assigned 1:1 to the intervention (n=753) or control group (n=753). At baseline, the median age of the mothers was 30·6 years (IQR 26·0-34·7), 1480 (98·4%) of 1504 were receiving ART, and 169 (11·5%) of 1466 had a viral load ≥1000 copies/mL. There was one case of HIV transmission in the intervention group and six in the control group, resulting in a transmission incidence of 0·19 per 100 person-years (95% CI 0·005-1·04) in the intervention group and 1·16 per 100 person-years (0·43-2·53) in the control group, which did not reach statistical significance (p=0·066). HIV-free survival and serious adverse events were similar in both groups. INTERPRETATION: Our intervention, initiated at EPI-2 and based on extended single-drug postnatal prophylaxis guided by point-of-care maternal viral load could be an important strategy for paediatric HIV elimination. FUNDING: The EDCTP2 programme with the support of the UK Department of Health & Social Care.

Using adult care visits to diagnose HIV infection in children, Burkina Faso.

Objective: To estimate the feasibility, positivity rate and cost of offering child testing for human immunodeficiency virus (HIV) to mothers living with HIV attending outpatient clinics in Burkina Faso. Methods: We conducted this implementation study in nine outpatient clinics between October 2021 and June 2022. We identified all women ≤ 45 years who were attending these clinics for their routine HIV care and who had at least one living child aged between 18 months and 5 years whose HIV status was not known. We offered these mothers an HIV test for their child at their next outpatient visit. We calculated intervention uptake, HIV positivity rate and costs. Findings: Of 799 eligible children, we tested 663 (83.0%) and identified 16 new HIV infections: 2.5% (95% confidence interval, CI: 1.5-4.1). Compared with HIV-negative children, significantly more HIV-infected children were breastfed beyond 12 months (P-value: 0.003) and they had not been tested before (P-value: 0.003). A significantly greater proportion of mothers of HIV-infected children were unaware of the availability of child testing at 18 months (P-value: < 0.001) and had more recently learnt their HIV status (P-value: 0.01) than mothers of HIV-negative children. The intervention cost 98.1 United States dollars for one child testing HIV-positive. Barriers to implementing this strategy included shortages of HIV tests, increased workload for health-care workers and difficulty accessing children not living with their mothers. Conclusion: Testing HIV-exposed children through their mothers in outpatient clinics is feasible and effective in a low HIV-prevalence setting such as Burkina Faso. Implementation of this strategy to detect undiagnosed HIV-infected children is recommended.

An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV).

BACKGROUND: Mother-to-child transmission of HIV during breastfeeding remains a challenge in low- and middle-income countries (LMIC). A prevention package was initiated during the highly attended 2nd visit of the Expanded Program of Immunisation (EPI-2) to identify the undiagnosed infants living with HIV and reduce the postnatal transmission of infant exposed to HIV. METHODS: PREVENIR-PEV is a non-randomized phase II clinical trial conducted at two health centres in Bobo Dioulasso (Burkina Faso). The study recruited mothers living with HIV aged 15 years and older with their singleton breastfed infants. During EPI-2 (at 8 weeks) and upon signature of the informed consent, a point-of-care early infant diagnosis (EID) was performed. HIV exposed uninfected (HEU) infants were followed-up until 12 months of age. High risk HEU infants (i.e., whose maternal viral load ≥ 1000 cp/mL at EPI-2 or M6) received an extended postnatal prophylaxis (PNP) with lamivudine until end of follow-up or the end of breastfeeding. RESULTS: Between 4 December 2019 and 4 December 2020, 118 mothers living with HIV-1 were identified, and 102 eligible mother/infant pairs had their infants tested for HIV EID. Six infants were newly diagnosed with HIV, and 96 HEU infants were followed-up for 10 months. Among the participants followed-up, all mothers were prescribed antiretrovirals. All 18 infants eligible for PNP at either EPI-2 or 6 months (M6) were initiated on lamivudine. No HIV transmission occurred, and no serious adverse events were reported in infants receiving lamivudine. CONCLUSIONS: The PREVENIR-PEV prevention package integrated into existing care is safe and its implementation is feasible in a LMIC with a low HIV prevalence. More research is needed to target mother/infant pairs not adhering to the intervention proposed in this trial. TRIAL REGISTRATION: NCT03869944; first registered on 11/03/2019.

Facteurs structurels et communautaires augmentant la vulnérabilité des hommes ayant des relations sexuelles avec des hommes dans la riposte au virus de l'immunodéficience humaine au Burkina Faso.

INTRODUCTION: Worldwide and particularly in Africa, Men who have sex with men (MSM) can play a significant role in response to the Human Immunodeficiency Virus (HIV). In Burkina Faso the fight against HIV within this population seems to be limited by violence towards MSM. PURPOSE OF RESEARCH: The goal of this study was to identify the social obstacles to HIV response among MSM in Burkina Faso. METHODS: It has been a descriptive study with an exploratory aim in a mainly qualitative approach. It was conducted in the two biggest cities as well as two border ones of the country. Nonstructural interviews have been conducted with the help of prevention MSM actors. The data have been thematically analyzed. RESULTS: In the structural level, homosexuality is publically condemned by politicians some of whom seeking its criminalization. According to them it has "come from elsewhere" and is "contrary to morals". Even though there is no legally punishing regulation against it, political and administrative authorities and security forces do not protect MSM against homophobic violence. There is not enough care structures for MSM in the country. At the community level, many religious leaders condemn homosexuality, considered as a sin; they view homosexuality as an "abomination". MSM feel that they are victims of homophobic violence. CONCLUSIONS: The MSM are victims of violence from populations and state institutions too. To reach MSM by activities in response to HIV these obstacles must necessarily be removed.

Prevention of mother-to-child transmission of HIV at the second immunization visit: a cross-sectional study, Burkina Faso.

Objective: To evaluate the performance of the cascade of activities for prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV) at the second immunization visit in Burkina Faso. Methods: In a cross-sectional study, we recruited mothers attending the second immunization visit for their infant in 20 health centres of Bobo-Dioulasso city, Burkina Faso over 12 months (2019-2020). We administered a short questionnaire to 14 176 mothers and performed HIV serological tests on mothers who had not been tested in the last 3 months. All mothers were asked about their attendance for antenatal care and HIV rapid testing. HIV-infected mothers were also asked about the timing of their HIV diagnosis, antiretroviral therapy, pre-exposure prophylaxis initiation at birth and infant diagnosis of HIV. Findings: Of 14 136 respondents, 13 738 (97.2%) had at least one HIV serological test in their lifetime. Of 13 078 mothers who were never tested or were HIV-negative, 12 454 (95.2%) were tested during or after their last pregnancy. Among HIV-infected mothers already aware of their status, 110/111 (99.1%) women were on antiretroviral therapy. Among HIV-exposed infants, 84/101 (83.2%) babies received 6 weeks of antiretroviral prophylaxis at birth and 58/110 (52.7%) had a blood sample collected for early infant diagnosis. Only two mothers received their child's test results at the time of the second immunization visit. Four mothers were newly diagnosed as HIV-positive during the study. Conclusion: Collecting data at the second immunization visit, a visit rarely missed by mothers, could be useful for identifying gaps in the PMTCT cascade in settings where mothers are difficult to reach, such as in low-income countries with intermediate or low HIV prevalence.

Immunovirological discordance among female sex workers who start antiretroviral therapy in Burkina Faso.

BACKGROUND: In people living with HIV/AIDS (PLWHA), initiation of antiretroviral therapy (ART) leads to sustained effective suppression of viral replication and increasing CD4 + T cell count. However, a fraction of ART-treated patients still fail to reach adequate CD4 + T cell number despite a suppressed viral load (VL), and this phenomenon is defined as immunovirological discordance (IVD). In Africa, several studies have reported immunovirological outcomes of antiretroviral therapy, but little is known about IVD occurrence in Female sex workers (FSW). This study aimed to assess the prevalence of IVD and associated factors among a cohort of HIV infected FSW in Burkina Faso. METHODS: We conducted a cohort study from December 2003 to October 2016. Immunovirological discordance was defined as CD4 + T cell gain < 100 cells/µL despite a suppressed VL (VL < 1000 copies/mL) 12 months after ART initiation. The CD4 + T cells were counted using BD FACSCount™ System and point of care Pima™ CD4 + Analyzer. HIV-1 RNA was quantified by real-time polymerase-chain-reaction assay with the use of the ABI 7000 system. We conducted a logistic regression to identify factors associated with discordant responses. RESULTS: Among the 123 HIV-1 infected FSW having at least 12 months follow-up on ART, 105 (85.4%) achieved HIV-1 RNA suppression. Among the latter 25 gained less than 100 CD4 + T cells within 12 months follow-up. The IVD rate was 23.8% (95%CI 16.04%-33.11%). After adjustment for age, WHO clinical stage and ART regimen including nucleoside/nucleotide reverse transcriptase inhibitors, only baseline CD4 + T cell count between 200 to 350 cells/µL (adjusted OR: 4.15; 95%CI 1.13-15.22) and 350 to 500 cells/µL (adjusted OR: 17.50; 95%CI 2.68-114.31) remain significantly associated with IVD occurrence. CONCLUSIONS: Immunovirological discordance response was common in FSW with proportions close to those observed in the general population. A diagnosis and personalized follow-up of patients who do not achieve full immune reconstitution would make it possible to avoid complications in terms of morbidity and mortality.

Representations of HIV/AIDS and HIV status disclosure among serodifferent couples in Burkina Faso / Représentations du VIH/Sida et partage de l'information sur la sérologie dans les couples sérodifférents au Burkina Faso

BACKGROUND: In Burkina Faso, the prevalence of HIV in serodifferent couples is comparable to that of some key populations. Our aim was to show the influence of HIV representation on the disclosure of HIV information in serodifferent couples. METHODS: A cross-sectional qualitative study was carried out from January to September 2019 in the city of Bobo-Dioulasso in Burkina Faso. In-depth individual interviews and focus groups were conducted with each partner of the couple using interview guides. The data was subject to thematic content analysis. RESULTS: The results show that more than three-quarters of the respondents did not share their HIV status. Those who had a negative attitude towards PLWHIV were less keen to share the information, considering that that HIV would transform the infected person negatively in the eyes of others. Also, sharing information was seen as a risk to the couple’s peace and stability. Others found the suffering of HIV so personal that it was difficult to share with others. CONCLUSION: People living with HIV, who see AIDS as a bad disease, fear the social effects of HIV and are therefore less favorable to disclose their HIV status. On the other hand, those who equated HIV with an illness like any other were keen to share information about their status.

Introduction: Au Burkina Faso, la prévalence du VIH dans les couples sérodifférents est comparable à celle des travailleuses de sexe et des hommes ayant des rapports sexuels avec d'autres hommes considérés comme des populations clés dans la lutte contre le VIH. Notre objectif était de montrer l'influence des représentations du VIH sur le partage de l'information sur la sérologie dans les couples sérodifférents. Méthodes: Nous avons réalisé une étude qualitative transversale de janvier à septembre 2019 dans la ville de Bobo-Dioulasso au Burkina Faso. Des entretiens individuels approfondis et des focus groups ont été menés auprès de chaque partenaire du couple au moyen de guides d'entretien. Les données ont fait l'objet d'une analyse de contenu thématique. Résultats: Les résultats révèlent que plus de trois quarts des enquêtés n'avaient pas partagé leur statut sérologique. Ceux qui avaient une attitude négative envers le VIH partageaient moins l'information. Ces enquêtés pensaient que le VIH transformait négativement la personne infectée aux yeux des autres ; aussi, le partage de l'information était considéré comme un risque pour la paix et la stabilité du couple. D'autres considéraient que la souffrance liée au VIH est si personnelle qu'il était difficile de la partager avec les autres. Conclusion: Les personnes Vivant avec le VIH (PVVIH) qui considèrent le sida comme une mauvaise maladie redoutent les effets sociaux du VIH donc sont moins favorables au partage de l'information sur la sérologie. Par contre, celles qui assimilent le VIH à une maladie comme les autres, étaient enclines à partager l'information sur leur sérologie.

Evaluation of the prevention of mother-to-child transmission of HIV programs at the second immunization visit in Burkina Faso and Zambia.

OBJECTIVE: Our study aimed to assess the PMTCT indicators in Burkina Faso and Zambia using a patient-orientated innovative strategy based on the second visit in the Expanded Program on Immunization (EPI-2) visit at 6-8 weeks. DESIGN: This was a cross sectional study. METHODS: We assessed women attending EPI-2 at primary healthcare facilities in Burkina Faso and Zambia with their children about their exposure to PMTCT interventions. For women living with HIV (WLHIV), viral load was measured and their children were tested for HIV DNA using point of care devices. RESULTS: Overall, 25 093 were enrolled from Burkina Faso and 8961 women from Zambia. Almost, all women attended at least one antenatal care visit. Among those aware of their HIV-positive status, 95.8 and 99.2% were on antiretroviral therapy (ART) in Burkina Faso and Zambia, respectively. Among WLHIV on ART, 75 and 79.2% achieved a viral load suppression (viral load <1000 copies/ml) in Burkina Faso and Zambia, respectively. Infant postnatal prophylaxis was administered from birth until EPI-2 to 60.9 and 89.7% of HIV-exposed children in Burkina Faso and Zambia, respectively. In Burkina Faso, only 60 of 192 (31.3%) of HIV-exposed children were sampled at day 42 for early infant diagnosis (EID) and 3 (1.6%) received a result by EPI-2. In Zambia, these figures were 879 of 1465 (64.0%) and 9.9% (145/1465), respectively for HIV-exposed children sampled at birth. CONCLUSION: This evaluation strategy at EPI-2 visit could strengthen program monitoring and help identifying gaps to be addressed on the last mile towards elimination of MTCT of HIV.

Cervical pre-cancer screening by visual inspection of the cervix after application of acetic acid in rural Burkina Faso: evaluation of women's knowledge, screening practice habits, acceptability and prevalence of risk factors and lesions in Boussé health district.

Introduction: cervical cancer is a major public health problem among women in sub-Saharan Africa. The disease can be controlled through early diagnosis through simple cost-effective methods such as visual inspection of the cervix after application of acetic acid or lugol´s iodine. However, screening for cervical cancer is still underused particularly in rural areas of Burkina Faso. The objective was to estimate the prevalence of cervical pre-cancer cancer in rural health district of Boussé, Burkina Faso. Methods: we conducted a cross-sectional study in the health district of Boussé in Northern-Central Burkina Faso from July to August 2014. Women aged 23-50 years were interviewed about their knowledge of cervical cancer and their screening practice and subsequently screened for cervical cancer by VIA. Results: a total of 418 participants were included with a median age of 34 years IQR (30-40 years). Two2 hundred participants (48%) had never heard about cervical cancer. About 134 participants (32%) knew at least one risk factor of cervical cancer. Only 37 women (9%) reported ever being screened for cervical cancer. Twenty-two percent reported concurrent sexual partnerships. The majority of the women (92%) are willing to pay to get screened for cervical pre-cancer by VIA. Overall, 21 participants (5%) were diagnosed with a cervical lesion by VIA and all of them accepted treatment with Loop electro surgical procedure. Conclusion: screening by VIA is feasible in rural Burkina Faso, but there is a poor knowledge on cervical cancer amongst the women. There is a need to set up a comprehensive, systematic, affordable and efficient cervical cancer program including an information campaign and making screening accessible in rural remote areas.

Alcohol consumption and associated risk factors in Burkina Faso: results of a population-based cross-sectional survey.

OBJECTIVES: Lifestyle modifiable risk factors are a leading preventable cause of non-communicable diseases, with alcohol consumption among the most important. Studies characterising the prevalence of alcohol consumption in low-income countries are lacking. This study describes the prevalence of different levels of alcohol consumption in Burkina Faso and its associated factors. DESIGN: Data from the 2013 Burkina Faso WHO STEPwise Approach to Surveillance survey were analysed. The prevalence of alcohol consumption over the last 30 days was recoded into categories according to WHO recommendations: low, mid or abusive alcohol consumption. Multinomial logistic regression analyses identified factors associated with the different levels of alcohol consumption. SETTING: Population-based cross-sectional survey in Burkina Faso. PARTICIPANTS: 4692 participants of both sexes aged 25-64 years were included in the study. RESULTS: In the whole sample, 3559 participants (75.8% (72.5%-78.7%)) were not consuming any alcohol, 614 (12.9% (10.9%-15.3%)) had low alcohol consumption, 399 (8.5% (7.1%-10.1%)) had mid alcohol consumption and 120 (2.7% (2.0%-3.7%)) had abusive consumption. Age was associated with alcohol intake with a gradient effect and older people having a higher level of consumption (adjusted OR (AOR): 2.36, 95% CI (1.59 to 3.51) for low consumption, 2.50 (1.54 to 4.07) for mid consumption and 2.37 (1.01 to 5.92) for abusive consumption in comparison with no consumption). Tobacco consumption was also significantly associated with alcohol intake with a gradient effect, those with higher tobacco consumption being at higher risk of abusive alcohol intake (AOR: 6.08 (2.75 to 13.4) for moderate consumption and 6.58 (1.96 to 22.11) for abusive consumption). CONCLUSION: Our data showed an important burden of alcohol consumption in Burkina Faso, which varied with age and tobacco use. To effectively reduce alcohol consumption in Burkina Faso, comprehensive control and prevention campaigns should consider these associated factors.

Design and challenges of a large HIV prevention clinical study on mother-to-child transmission: ANRS 12397 PROMISE-EPI study in Zambia and Burkina Faso.

Post-natal HIV infection through breastfeeding remains a challenge in many low and middle-income countries, particularly due to non-availability of alternative infant feeding options and the suboptimal Prevention of Mother to Child Transmission of HIV-1 (PMTCT) cascade implementation and monitoring. The PROMISE-EPI study aims to address the latter by identifying HIV infected mothers during an almost never-missed visit for their infant, the second extended program on immunization visit at 6-8 weeks of age (EPI-2). The study is divided into 3 components inclusive of an open-label randomized controlled trial aiming to assess the efficacy of a responsive preventive intervention compared to routine intervention based on the national PMTCT guidelines for HIV-1 uninfected exposed breastfeeding infants. The preventive intervention includes: a) Point of care testing for early infant HIV diagnosis and maternal viral load; b) infant, single-drug Pre-Exposure Prophylaxis (PrEP) (lamivudine) if mothers are virally unsuppressed. The primary outcome is HIV-transmission rate from EPI-2 to 12 months. The study targets to screen 37,000 mother/infant pairs in Zambia and Burkina Faso to identify 2000 mother/infant pairs for the clinical trial. The study design and challenges faced during study implementation are described, including the COVID-19 pandemic and the amended HIV guidelines in Zambia in 2020 (triple-drug PrEP in HIV exposed infants guided by quarterly maternal viral load). The changes in the Zambian guidelines raised several questions including the equipoise of PrEP options, the standard of care-triple-drug (control arm in Zambia) versus the study-single-drug (intervention arm). Trial registration number (www.clinicaltrials.gov): NCT03869944. Submission category: Study Design, Statistical Design, Study Protocols.

Growth, clinical and neurodevelopmental outcomes at school age are similar for children who received 1-year lamivudine or lopinavir/ritonavir HIV prophylaxis in early life.

In the ANRS 12174 trial, HIV-exposed uninfected African neonates who received lopinavir-ritonavir (LPV/r) prophylaxis for 1 year exhibited slower growth from birth to week 50 compared with those receiving lamivudine (3TC). We assessed whether this difference in growth persisted over time, and was accompanied by differences in neuropsychological and clinical outcomes. Between February 2017 and February 2018, we conducted a cross-sectional clinical evaluation among former trial participants who completed the 50-week follow-up and who were not HIV-infected. In addition to clinical examination, neuropsychological outcomes were assessed using the tests Kaufman-ABCII, Test of Variables of Attention, Movement Assessment Battery for Children and the Strengths and Difficulties questionnaire, parent version. Of 1101 eligible children, aged 5-7 years, 553 could be traced and analysed (274 in the LPV/r and 279 in the 3TC groups). Growth, clinical and neuropsychological outcomes did not differ between treatment groups. At school age, children exposed to LPV/r and 3TC at birth for 1 year had comparable growth and neuropsychological outcomes without evidence of long-term side-effects of LPV/r. It provides reassuring data on clinical outcomes for all HIV-infected children treated with this antiretroviral drug in early life.

Hepatitis E Virus Infections among Patients with Acute Febrile Jaundice in Burkina Faso.

Hepatitis E virus infection is a significant public health problem in many parts of the world including Africa. We tested serum samples from 900 patients in Burkina Faso presenting with febrile icterus. They all tested negative for yellow fever, but those from 23/900 (2.6%) patients contained markers of acute HEV infection (anti-HEV IgM and HEV RNA positive). Genotyping indicated that 14 of the strains were HEV genotype 2b. There was an overall HEV IgG seroprevalence of 18.2% (164/900). In a bivariate analysis, the factors linked to HEV exposure were climate and patient age. Older patients and those living in arid regions were more likely to have HEV infection. HEV genotype 2b circulating only in humans can be involved in some acute febrile icterus cases in Burkina Faso. Better access to safe water, sanitation, and improved personal hygiene should improve control of HEV infection in this country.

Factors associated with tuberculosis treatment failure in the Central East Health region of Burkina Faso.

INTRODUCTION: Tuberculosis treatment failure results in increased risk of morbidity, drug resistance, transmission and mortality. There are few data about tuberculosis treatment outcomes in Burkina Faso. The current study investigated the factors associated with tuberculosis treatment failure in the central east health region of Burkina Faso. METHODS: We conducted a case-control study. All cases of pulmonary tuberculosis failing first-line treatment matched to those who were cured (controls) in the Central Eastern Region were sampled from January 2010 to December 2014. Predictors of treatment failure were determined using multiple conditional logistic regression. RESULTS: A total of 381 patients with positive microscopic pulmonary tuberculosis were included. Of these 76 cases failed first-line treatment while 305 controls were cured. Weight loss between diagnosis and first sputum-smear examination was significantly associated with the tuberculosis treatment failure [aOR: 2.5, 95% CI: 1.3-4.7]. In addition, the delay from between treatment initiation to first sputum-smear examination, and high bacillary load at the first sputum-smear examination were significantly associated with treatment failure (p<0.001). CONCLUSION: Strengthening the relationship between health care services and local communities to improve the follow-up of tuberculosis patients, and improving adherence to tuberculosis treatment among tuberculosis patients with weight loss between treatment initiation and 2-month sputum-smear examination could be useful to reduce the risk of unsuccessful outcome.