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.

Long-term persistence of mitochondrial dysfunctions after viral infections and antiviral therapies: A review of mechanisms involved.

Mitochondria are vital for most cells' functions. Viruses hijack mitochondria machinery for misappropriation of energy supply or to bypass defense mechanisms. Many of these mitochondrial dysfunctions persist after recovery from treated or untreated viral infections, particularly when mitochondrial DNA is permanently damaged. Quantitative defects and structural rearrangements of mitochondrial DNA accumulate in post-mitotic tissues as recently reported long after SARS-CoV-2 or HIV infection, or following antiviral therapy. These observations are consistent with the "hit-and-run" concept proposed decades ago to explain viro-induced cell transformation and it could apply to delayed post-viral onsets of symptoms and advocate for complementary supportive care. Thus, according to this concept, following exposure to viruses or antiviral agents, mitochondrial damage could evolve into an autonomous clinical condition. It also establishes a pathogenic link between communicable and non-communicable chronic diseases.

Combination of serological and cytokine release assays for improved diagnosis of childhood tuberculosis in Zambia (PROMISE-TB).

OBJECTIVES: The diagnostic gaps for childhood tuberculosis (TB) remain considerable in settings with high TB incidence and resource constraints. We established and evaluated the performance of a scoring system based on a combination of serological tests and T-cell cytokine release assays, chosen for their ability to detect immune responses indicative of TB, in a context of high prevalence of pediatric HIV infection. METHODS: We enrolled 628 consecutive children aged ≤15 years, admitted for TB suspicion. Multiple cytokine levels in QuantiFERON Gold In-Tube supernatants and antigen 85B (Ag85B) antibodies were assessed in children who tested positive with either Xpert TB or mycobacterial culture. The results were compared with those of control children. RESULTS: Among the biomarkers most strongly associated with TB, random forest classification analysis selected Ag85B antibodies, interleukin-2/interferon-γ ratio, and monokine induced by interferon-γ for the scoring system. The receiver operating characteristic curve derived from our scoring system showed an area under the curve of 0.95 (0.91-0.99), yielding 91% sensitivity and 88% specificity. The internal bootstrap validation gave the following 95% confidence intervals for the score performance: sensitivity 71%-97% and specificity 79%-99%. CONCLUSIONS: This study suggests that supplementing the QuantiFERON assay with a combination of serological and T-cell markers could enhance childhood TB screening regardless of HIV status and age. Further validation among the target population is necessary to confirm the performance of this scoring system.

Safety and pharmacokinetics of subcutaneous administration of broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs), given to HIV-1 exposed, uninfected neonates and infants: study protocol for a phase I trial.

BACKGROUND: The ambitious goal to eliminate new pediatric HIV infections by 2030 requires accelerated prevention strategies in high-risk settings such as South Africa. One approach could be pre-exposure prophylaxis (PrEP) with broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs). The aim of our study is to define the optimal dose(s), the ideal combination(s) of bNAbs in terms of potency and breadth, and timing of subcutaneous (SC) administration(s) to prevent breast milk transmission of HIV. METHODS: Two bNAbs, CAP256V2LS and VRC07-523LS, will be assessed in a sequential and randomized phase I, single-site, single-blind, dose-finding trial. We aim to investigate the 28-day safety and pharmacokinetics (PK) profile of incrementally higher doses of these bNAbs in breastfeeding HIV-1 exposed born without HIV neonates alongside standard of care antiretroviral (ARV) medication to prevent (infants) or treat (mothers) HIV infection. The trial design includes 3 steps and 7 arms (1, 2, 3, 4, 5, 6 and 6b) with 8 infants in each arm. The first step will evaluate the safety and PK profile of the bNAbs when given alone as a single subcutaneous (SC) administration at increasing mg/kg body weight doses within 96 h of birth: arms 1, 2 and 3 at doses of 5, 10, and 20 mg/kg of CAP256V2LS, respectively; arms 4 and 5 at doses of 20 and 30 mg/kg of VRC07-523LS, respectively. Step two will evaluate the safety and PK profile of a combination of the two bNAbs administered SC at fixed doses within 96 h of birth. Step three will evaluate the safety and PK profile of the two bNAbs administered SC in combination at fixed doses, after 3 months. Arms 1 and 6 will follow sequential recruitment, whereas randomization will occur sequentially between arms (a) 2 & 4 and (b) 3 & 5. Before each randomization, a safety pause will allow review of safety data of the preceding arms. DISCUSSION: The results of this trial will guide further studies on bNAbs to prevent breast milk transmission of HIV. PROTOCOL VERSION: Version 4.0 dated 15 March 2024. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR): PACTR202205715278722, 21 April 2022; South African National Clinical Trial Registry (SANCTR): DOH-27-062022-6058.

Screening for hepatitis C virus at the time of mammography using rapid diagnostic tests in women aged between 50 and 74 years (Mamm'OC NCT05067374).

Chronic hepatitis C Virus (HCV) infection presents a global health challenge, with significant morbidity and mortality worldwide. Despite remarkable progress in treatment options, achieving elimination targets by 2030, as set by the World Health Organization, remains elusive. Our study aimed to address this gap by integrating HCV screening into a national breast cancer screening program. Between March 2022 and March 2023, a prospective cross-sectional multicenter study was conducted in four radiology centers in Montpellier, France. We proposed HCV screening to consecutive women undergoing mammography, targeting 1,500 participants aged 50-74 years. A rapid diagnostic test (RDT) for HCV antibodies (HCV Ab) was performed on capillary whole blood, with positive cases undergoing serological and RNA confirmation. Participants also completed a questionnaire on demographic data and risk factors. Acceptance rates, HCV prevalence, and linkage to care were assessed. The acceptance rate for this integrated screening approach was 82.4%. Notably, the seroprevalence of HCV was found to be 0.65%. Linkage to care was prompt, and the cascade of care demonstrated successful treatment outcomes. Importantly, the majority of detected infections were successfully resolved. These findings underscore the feasibility and acceptability of integrating HCV screening with breast cancer screening programs providing updated prevalence data and valuable insights for refining future screening strategies.

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.

Early temporary mechanical circulatory support for cardiogenic shock: Real-life data from a regional cardiac assistance network.

BACKGROUND: Temporary mechanical circulatory support as well as multidisciplinary team approach in a regional care organization might improve survival of cardiogenic shock. No study has evaluated the relative effect of each temporary mechanical circulatory support on mortality in the context of a regional network. METHODS: Prospective observational data were retrieved from patients consecutively admitted with cardiogenic shock to the intensive care units in 3 centers organized into a regional cardiac assistance network. Temporary mechanical circulatory support indication was decided by a heart team, based on the initial shock severity or if shock was refractory to medical treatment within 24 hours of admission. A propensity score for circulatory support use was used as an adjustment co-variable to emulate a target trial. The primary endpoint was in-hospital mortality. RESULTS: Two hundred and forty-six patients were included in the study (median age: 59.5 years, 71.9% male): 121 received early mechanical assistance. The main etiologies were acute myocardial infraction (46.8%) and decompensated heart failure (27.2%). Patients who received early mechanical assistance had more severe conditions than other patients. Their crude in-hospital mortality was 38% and 22.4% in other patients but adjusted in-hospital mortality was not different (hazard ratio 0.91, 95% CI:0.65-1.26). Patients with mechanical assistance had a higher rate of complications than others with longer Intensive Care Unit and hospital stays. CONCLUSIONS: In the conditions of a cardiac assistance regional network, in-hospital mortality was not improved by early mechanical assistance implantation. A high incidence of complications of temporary mechanical circulatory support may have jeopardized its potential benefit.

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.

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.

Adherence to option B + antiretroviral therapy and associated factors in pregnant and breastfeeding women in Sub-Saharan Africa: a systematic review and meta-analysis.

BACKGROUND: To assess the adherence to option B + antiretroviral therapy (ART) and associated factors in pregnant and breastfeeding women in Sub-Saharan Africa (SSA). METHODS: We conducted a comprehensive search from 01st January 2012 to 03rd October 2022, across four databases: PubMed, Scopus, Proquest Central, and Index Medicus Africain, to identify studies focused on pregnant and/or breastfeeding women living with HIV and receiving option B+ ART in SSA. Studies reporting adherence data were included in the meta-analysis. Were excluded studies published before 01st January 2012, grey literature, systematic reviews, and meta-analysis studies. Articles selection and data extraction were performed independently by two reviewers. We evaluated pooled adherence and pooled association between various factors and adherence using a random-effects model. RESULTS: Overall, 42 studies involving 15,158 participants across 15 countries contributed to the meta-analysis. The overall pooled adherence was 72.3% (95% CI: 68.2-76.1%). Having high education level (pooled odds ratio (OR): 2.25; 95% CI: 1.57-3.21), living in urban area (pooled OR: 1.75; 95% CI: 1.10-2.81), disclosing status to a family/partner (pooled OR: 1.74; 95% CI: 1.27-2.40), having a support system (pooled OR: 3.19; 95% CI: 1.89-5.36), receiving counseling (pooled OR: 3.97; 95% CI: 2.96-5.34), initiating ART at early clinical HIV stage (pooled OR: 2.22; 95% CI: 1.08-4.56), and having good knowledge on PMTCT/HIV (pooled OR: 2.71; 95% CI: 1.40-5.25) were factors significantly associated with adherence to option B + ART. CONCLUSIONS: Despite the implementation of option B+ ART, the level of adherence among pregnant and breastfeeding women in SSA falls short of meeting the critical thresholds for viral load suppression as outlined in the 95-95-95 objectives set for 2025. These objectives are integral for achieving HIV elimination, and in turn, preventing HIV mother-to-child transmission. To bridge this gap, urgent tailored interventions based on individual and structural factors are essential to enhance adherence within these subgroups of women. This targeted approach is crucial in striving towards the HIV elimination target in SSA.

Utility of self-report antiretroviral adherence for predicting HIV viral load among persons who inject drugs in Hai Phong Vietnam: assessing differences by methamphetamine use.

ABSTRACTIn resource-limited settings, alternatives to HIV viral load testing may be necessary to monitor the health of people living with HIV. We assessed the utility of self-report antiretroviral therapy (ART) to screen for HIV viral load among persons who inject drugs in Hai Phong Vietnam, and consider differences by recent methamphetamine use. From 2016 to 2018 we recruited PWID through cross sectional surveys and collected self-report ART adherence and HIV viral load to estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) and likelihood ratios (LR+, LR-) for self-reported ART adherence as a screening test for HIV viral load. We used three HIV viral load thresholds: < 1000, 500 and 250 copies/mL; laboratory-confirmed HIV viral load was the gold standard. Among 792 PWID recruited, PPV remained above 90% regardless of recent methamphetamine use with slightly higher PPV among those not reporting recent methamphetamine use. The results remained consistent across all three HIV viral load thresholds. Our findings suggest that when HIV viral load testing is not possible, self-reported ART adherence may inform decisions about how to prioritize HIV viral load testing among PWID. The high PPV values suggest self-reported high ART adherence indicates likely HIV viral suppression, irrespective of methamphetamine use.

Gender, homelessness, hospitalization and methamphetamine use fuel depression among people who inject drugs: implications for innovative prevention and care strategies.

Background: The co-occurrence of substance use disorder and mental disorder, known as dual diagnosis, has a distressingly high prevalence among individuals grappling with either of these conditions. Mood disorders, especially depression, constitute a substantial burden for People Who Inject Drugs (PWID) and a significant public health concern in Vietnam. Identifying risk factors for depression in PWID is imperative for the development of targeted interventions. Methods: We enrolled PWID into a cohort using the respondent-driven sampling method. Over a 36-month period, we systematically tracked the emergence of depression and employed multiple imputation in conjunction with a mixed nonlinear model to pinpoint risk factors for depression in this demographic. At inclusion, depression was screened using the PHQ-2 questionnaire, and subsequent episodes of depression were assessed semi-annually using the CES-D8. Results: Three hundred and ninety-one PWID (26.6%) were depressed. Major risk factors for depression included being female, not having a permanent residency, having been hospitalized and using methamphetamine more than weekly. Other risk factors included age, being single, not having a health insurance card and not being on methadone. Limitations: The exclusion of missing visits and social desirability could have led to selection and information biases. In this observational study, confusion biases are possible despite our best efforts. Conclusion: Depression is alarmingly frequent in PWID. In this study taking in account the chronological relationship between sociodemographic and clinical factors and depression, risk factors were identified in this specific setting of low-to-middle income country. The findings highlight the need to develop innovative targeted psychiatric interventions with the help of supporting peers.

HCV RNA Quantification by a Domestic Commercial Assay: A Case Study among People Who Inject Drugs in Vietnam.

The desired performance of nucleic acid testing (NAT) may vary if used for disease diagnosis or for the evaluation of the therapeutic efficacy of a treatment, although in most cases, the same assay is used. However, these tests may not be affordable in many situations including in low/middle income countries that in response have developed domestic assays. Given the example of HCV NAT among people who inject drugs in Vietnam, we aimed at evaluating a domestic assay versus an FDA- and CE-approved assay. This cross-evaluation revealed that (i) the domestic assay had a poorer sensitivity with a threshold of detection above 104 IU/mL, and (ii) the FDA-approved assay had a percentage of false negative results close to 1%. Together, in the present study, the domestic assay had a performance compatible with diagnosis purposes (given that this population was 70% HCV seropositive) but not compatible with HCV treatment monitoring (given that treatment failures are rare and the observed viremia frequently below the threshold of detection). This study highlights the need for a proper evaluation of HCV RNA domestic assays in order to efficiently contribute to the WHO HCV elimination target by 2030.

A community-based strategy to eliminate hepatitis C among people who inject drugs in Vietnam.

Background: Towards hepatitis C elimination among people who inject drugs (PWID), we assessed the effectiveness of a strategy consisting of a community-based respondent-driven sampling (RDS) as wide screening, a simplified and integrated hospital-based care, and prevention of reinfection supported by community-based organisations (CBO), in Hai Phong, Vietnam. Methods: Adults who injected heroin were enrolled in a RDS survey implemented in two CBO premises. Rapid HIV and HCV tests were done on site, and blood was taken for HCV RNA testing. Those with detectable HCV RNA were referred with CBO support to three public hospitals for 12-week sofosbuvir/daclatasvir, plus ribavirin for patients with cirrhosis. Participants were followed-up 12 weeks post-treatment (SVR12) and 48 weeks after enrolment. The primary endpoint was the rate of undetectable HCV RNA participants at 48 weeks. Findings: Among the 1444 RDS survey participants, 875 had hepatitis C. Their median age was 41 years (IQR 36-47), 96% were males, 36% were HIV-coinfected. Overall, 686 (78.4%) started sofosbuvir/daclatasvirs, and 629 of the 647 (97.2%) patients tested at SVR12 were cured. At week 48 (581/608) 95.6% had undetectable HCV RNA, representing 66.4% of all PWID identified with hepatitis C. The reinfection rate after SVR12 was 4/100 person-years (95% CI: 2-7). Interpretation: Our strategy, involving CBO and addressing all steps from wide HCV screening to prevention of reinfection, stands as a promising approach to eliminate HCV among PWID in low and middle-income countries. Funding: France ANRS|MIE (#ANRS12380). The RDS survey was implemented with grants from the NIDA (#R01DA041978) and ANRS|MIE (#ANRS12353).

Facilitators and barriers to infant post-natal HIV prophylaxis, a qualitative sub-study of the PROMISE-EPI trial in Lusaka, Zambia.

Background: Infant post-natal prophylaxis (PNP) is used to prevent HIV transmission through breastfeeding. The WHO edited recommendations but so far there is no consensus on the duration of prophylaxis and the type of drug used depends on national guidelines. In Zambia, the national recommendations include a three-drug prophylaxis, composed of a dispersible combined tablet of zidovudine (AZT) and lamivudine (3TC) and an oral suspension of nevirapine (NVP) for 12 weeks or until the mother's viral load is <1,000 cp/mL. The PROMISE-EPI study, modified the PNP regimen to lamivudine only, initiated at 6 weeks and continued until 12 months to all HIV exposed uninfected infants of virally unsuppressed mothers. Our aim in this analysis was to identify barriers and facilitators to this extended PNP, the keystone toward an effective prevention. Methods: Individual interviews and focus group discussion (FGD) were conducted with PROMISE-EPI participants who had received prophylaxis for their children from the national program up to 6 weeks and then lamivudine oral solution in PROMISE-EPI study. Health care providers and PROMISE-EPI staff were also interviewed. Sessions were recorded, transcribed verbatim and translated from local languages into English. An initial code-book was designed and then adapted on the basis of the emerging themes, to allow a descriptive thematic analysis. Results: More barriers to PNP adherence were identified with triple drug prophylaxis than with lamivudine. These barriers were related to the formulation and bitter taste of AZT/3TC tablets. The ready to use formulation and sweet taste of lamivudine syrup were appreciated by mothers. Extended PNP proposed in the PROMISE-EPI study was globally well accepted and strategies were found to increase adherence. Adherence to lamivudine appeared to be better than the mothers' adherence to their own antiretroviral therapy. Conclusion: Accompanying mothers living with HIV and giving them the choice of the PNP to prevent transmission via breastfeeding (type of PNP regimen and extended PNP in non-adherent mothers), may be one of the keys to reducing the burden of pediatric HIV acquisition in low and middle income countries.

Effectiveness of a Community Empowerment Intervention to Improve Access to Pre-exposure Prophylaxis in Migrant Women Sex Workers: Protocol for a Mixed Methods Implementation Study.

BACKGROUND: The World Health Organization recommends pre-exposure prophylaxis (PrEP) for all populations at substantial risk of HIV infection. However, at-risk women very rarely use PrEP in France-this represents a critical issue among migrant women sex workers (MWSWs). Previous studies on PrEP use among women sex workers or migrants focused on individual or social determinants of motivation. However, operational studies in real-word settings using a holistic population approach to maximize PrEP adherence among MWSWs are lacking. OBJECTIVE: FASSETS (ie, "Favoriser l'Accès à la Santé Sexuelle des Travailleuses du Sexe"; English: "facilitate the access to Sexual Health in women sex workers") is a participative, multilevel, mixed methods study aiming to improve global knowledge of and access to sexual health care and PrEP among MWSWs through targeted empowerment strategies. METHODS: This study comprises several phases: (1) phase 1: an initial qualitative study combining semistructured interviews, informal interviews, and participative observations will be performed among MWSWs, local community nongovernmental organizations, and institutions providing sexual reproductive health services to identify the determinants of PrEP access among MWSWs and for respondent-driven sampling (RDS); (2) phase 2: the size of the hidden MWSW population is estimated in Marseille through capture-recapture (the RDS survey will serve as "recapture"); (3) phase 3: a longitudinal cohort will be formed through RDS to represent the MWSW population with a goal of 150 inclusions-this cohort will be followed up for 12 months, and sequential questionnaires exploring medical history; knowledge of sexual health, HIV, and sexually transmitted infections; migration route; and current living conditions will be administered at inclusion (month 0) and months 3, 6, and 12 to measure the following interventional phase's outcomes; and (4) phase 4: an interventional study with community empowerment actions about sexual health and PrEP will be conducted with community health workers; standardized questionnaires and semistructured interviews, observations, and focus groups will highlight MWSWs' experiences with empowerment resources, concerns about sexual health, and especially PrEP use or uptake, and we will evaluate whether and how community-adapted empowerment actions conducted by community health workers are effective in increasing access to sexual health, prevention and screening of sexually transmitted infections, and PrEP knowledge and access among MWSWs. RESULTS: Recruitment commenced on March 1, 2022. We estimate the follow-up period to end on September 30, 2023. CONCLUSIONS: This multiphase study will provide robust evidence about the magnitude of the MWSW population in Marseille (the second largest town in France) and their current conditions of living, access to and knowledge of sexual health, and PrEP access. Using a mixed methods analysis, we will investigate whether individual and collective community health empowerment approaches can facilitate access to PrEP and its initiation, use, and adherence in this vulnerable population. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42844.

Availability and readiness of the health facilities to provide HIV counseling and testing and prevention of mother-to-child transmission services in Burkina Faso: a trend analysis from 2012 to 2018.

BACKGROUND: Provider-Initiated HIV Testing and Counseling (PITC) and Prevention of Mother-To-Child Transmission (PMTCT) are key services for achieving the goal of complete elimination of HIV. However, there is limited evidence on the ability of health facilities to provide these services in Burkina Faso. Therefore, we aimed to assess the trends and disparities in the availability and readiness of health facilities to provide PITC and PMTCT services in Burkina Faso between 2012 and 2018. METHODS: We performed a secondary analysis of facility-level data from the World Health Organization's Service Availability and Readiness Assessment (SARA) surveys conducted in 2012, 2014, 2016, and 2018 in Burkina Faso. The availability and readiness of health facilities were assessed using SARA's manual, and linear regressions were used to examine trends. RESULTS: Between 2012 and 2018, the mean proportion of health facilities providing PITC services increased, but not significantly, from 82.9% to 83.4% (p = 0.11), with the mean readiness index significantly decreasing from 71.5% to 65.4% (p < 0.001). This decrease concerned the staff and guidelines (73.8% to 50.5%; p < 0.001), equipment (79.0% to 77.4%; p < 0.001), and medicines and commodities (54.2% to 45.2%; p < 0.001) domains. Regarding the PMTCT services, the mean proportion of health facilities globally providing the service significantly decreased from 83.7% in 2012 to 67.7% (p = 0.030) in 2018, and the mean readiness significantly decreased from 53.2% in 2012 to 50.9% in 2018 (p = 0.004). This decreasing trend was related to the staff and training (80.3% to 57.6%; p < 0.001) and medicines and commodities (9.2% to 6.5%; p < 0.001) domains. The global significant negative trend of readiness was mainly observed at the primary level of healthcare (52.7% to 49.4%; p = 0.030). Four regions experienced a significant decrease in the readiness index of health facilities to provide PMTCT services: Cascades, Centre, Centre-Sud, and Sud-Ouest, while Haut-Bassins and Nord regions showed increasing trends. CONCLUSION: Availability and readiness of health facilities to provide PITC and PMTCT remain suboptimal in Burkina Faso. Actions to strengthen the skills of professionals and enhance the availability of medicines and commodities while focusing more on health regions with significant decreasing trends are urgently needed to improve the quality of services for HIV.