Implementing long-acting injectable antiretroviral treatments in Senegal: issues, challenges and conditions for introducing them. Qualitative study with healthcare providers and patients.

Long-acting injectable antiretroviral therapy (LAI-ART) can offer people living with HIV (PLWH) a promising alternative to daily oral therapy. This article highlights the issues, challenges and conditions related to introducing LAI-ART into the social lives of PLWH and HIV-care practices in Senegal. Semi-structured interviews were conducted with 42 PLWH in two hospital care units in Dakar and with 13 healthcare providers and 6 peer educators. Interviews were transcribed, thematically coded and analysed using a cross-sectional approach. We found three key issues. First, simplifying living with HIV: PLWH respondents perceive LAI-ART as an opportunity to ease the burden associated with taking tablets. This enthusiasm may however be qualified by an ambivalent relationship with injections and is subject to certain conditions. Second, certain constraints linked to the medicalisation of care are to be anticipated, including the obligation to go to the hospital every two months for injections. These findings foreshadow the new management work for medical follow-up expected to fall on PLWH and caregivers. Third, the challenges of introducing LAI-ART in Senegal are to ensure adequate organisation of care and supply and sustainability of the program. These results clarify how to implement programs to introduce LAI-ART into real life in the West African context.

m-PIMA™ HIV1/2 VL: A suitable tool for HIV-1 and HIV-2 viral load quantification in West Africa.

Point-of-Care for HIV viral RNA quantification seems to be a complementary strategy to the existing conventional systems. This study evaluated the performance of the m-PIMA™ HIV1/2 Viral Load for the quantification of both HIV-1 and HIV-2 RNA viral load. A total of 555 HIV-1 and 90 HIV-2 samples previously tested by Abbott RealTime HIV-1 (Abbott, Chicago, USA) and Generic HIV-2® Charge virale (Biocentric, France) were tested using the m-PIMA™ HIV1/2 Viral Load at the HIV National Reference lab in Senegal. For HIV-1, Pearson correlation and Bland-Altman plots showed a coefficient r = 0.97 and a bias of -0.11 log10 copies/ml (95% confidence interval [CI]: -0.086 to -0.133 log10 copies/ml) for the m-PIMA™ HIV1/2 Viral Load, respectively. Sensitivity and specificity at 3 log10 copies/ml (threshold of virological failure) were 93.6% (95%[CI]: 91.5% to 95.6%) and 99.1% (95%[CI]: 98.3% to 99.9%), respectively. For HIV-2, a correlation of r = 0.95 was also noted with a bias of - 0.229 log10 copies/ml (95%[CI]: -0.161 to -0.297 log10 copies/ml). Sensitivity and specificity at 3 log10 copies/ml were 97.6% (95%[CI]: 94.3% to 100%) and 93.9% (95%[CI]: 88.9% to 98.8%), respectively. These results confirmed that m-PIMA™ HIV1/2 VL could be a good alternative for HIV-1 and HIV-2 viral load testing in decentralized settings in Senegal.

Sexuality of adolescent girls born with HIV in Senegal: an anthropological analysis.

Objectives: In Senegal, the dominant social norm upholds virginity before marriage and edifies abstinence for adolescents as a cardinal moral value. Currently, sex outside of marriage remains socially condemned. The onset of sex for adolescent girls born with HIV in Senegal brings up several challenges. In Dakar, initiatives, especially through digital applications, are being developed to support these young people. These programs are much rarer in rural settings. A study conducted in 2021 explored how adolescent girls born with HIV who live outside of Dakar experience sexuality, what socio-health constraints they face, and what support they receive from the healthcare system. Method: An anthropological study titled 'Treatment Failure among Children and Adolescents Living with HIV in Senegal, Outside Dakar' (ETEA-VIH, ANRS 12421) was conducted in 2021 in 14 regional hospitals and health centers. Semi-structured interviews were conducted with 87 HIV-positive children and adolescents, 95 parents/guardians, and 47 health care workers. Adolescent girls' onset of sexuality was specifically analyzed for 40 adolescent girls age 12-19 years old. Results: Generally, parents feign oblivion about their children's sexual lives. Mothers dread a pregnancy out of marriage because they are responsible for overseeing sex education and would be 'blamed' for the transgression. The occurrence of an unintended pregnancy can lead to exclusion from the family and a risk of transmitting HIV to the child due to the lack of medical and social support. HIV remains a stigmatizing disease that families keep secret. The risk of disclosure is a major concern. Despite sexual and reproductive health (SRH) programs, most healthcare workers are reluctant to discuss sexuality or to offer contraception to adolescent girls. Information spaces have been set up in some regional hospitals by associations trained in SRH. They are rarer in health centers. Accessibility to digital applications and discussion forums is limited due to the lack of smartphones and Internet access. Conclusion: In rural settings, HIV-positive adolescent girls are confronted with the silence that surrounds sexuality and HIV. An individualized approach and confidential access to contraception should be prioritized to support them with assistance from PLHIV associations.

Treatment success or failure in children and adolescents born with HIV in rural Senegal: An anthropological perspective.

Due to the efficacy of antiretrovirals (ARVs), mortality and morbidity related to the AIDS epidemic has declined considerably in recent decades. Nevertheless in Africa, the persistence of new infections and the concerning development of ARV drug resistance reflect the challenges in preventing and treating HIV infection. These problems are especially affecting children and adolescents living with HIV (CALHIV). In 1998, Senegal was the first West African country to implement a government program for access to ARV drugs. However, care for CALHIV remains challenging. A national survey conducted in 2015 showed that 64% of CALHIV (0-19 years) in follow-up in sites outside of Dakar were in treatment failure. The article presents the results of an anthropological study that aims to examine the modalities of medical and social care for CALHIV, identify the various structural and social determinants of treatment failure or success, and ascertain their respective influence. The ethnographic survey was conducted between July 2020 and November 2021 in 11 of the 14 regions of Senegal and in 15 health facilities (11 health centers and 4 regional hospitals). The interviews and observations were conducted with 65 children and adolescents, 63 parents or guardians, and 47 health workers providing their care. The results show that situations of treatment failure or success are the result of favorable or unfavorable configurations that bring into play various actors-children, parents, health care professionals-and their interactions with and in varying sociocultural and structural contexts. This research underscores the contribution of anthropology to the analysis and understanding of care systems. From a public health perspective, our analyses argue for a differentiated approach to strengthening the skills of health facility staff, taking into account the specificity of each site.

Validation of the point-of-care (POC) technologies Xpert HIV-1 Qual and m-PIMA HIV 1/2 detect for early diagnosis of HIV-1 and HIV-2 in Senegal.

Introduction: early infant diagnosis (EID) is crucial in the prevention of mother to child transmission (PMTCT) of human immunodeficiency virus (HIV) and is an essential component for the elimination of HIV. EID can be strengthened in resource-limited countries by the introduction and the roll out of real-time polymerase chain reaction (PCR) technologies via point-of-care (POC) devices which improves treatment in remote areas and reduces turnaround time for clinicians and patients to receive results and linkage to care. The objective of this study was to evaluate the performance of Xpert® HIV-1 Qual Assay (Cepheid) and m-PIMA™ HIV 1/2 Detect (ABBOTT) for EID of HIV-1 and HIV-2. Methods: the performance of the Xpert® HIV-1 qual device was evaluated with 192 samples including 100 dried blood spot (DBS) samples from the National Reference Laboratory biobank (71 negative and 29 positive samples) and an additional 92 whole blood samples collected from infants from neonatal departments. These infants from seven treatment centers in the Dakar region were born to mothers infected with HIV-1 (n=91), HIV-2 (n= 8) or HIV-1/2 (n=1). The m-PIMA™ HIV 1/2 detect assay was evaluated on whole blood samples (n=100) with 92 HIV-1 samples and 8 HIV-2 samples from children born to HIV-infected mothers. The Cobas AmpliPreP/Cobas TaqMan (CAP/CTM) platform from Roche Diagnostic Laboratories was used as a reference for HIV-1 diagnosis and the Generic HIV-2 Viral Load Assay (Biocentric) was used as a reference for HIV-2 diagnosis. Performance was evaluated by calculating sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and Cohen's kappa coefficient. Results: for HIV-1 detection on GeneXpert and m-PIMA, no discordance was found on the samples tested, i.e. a sensitivity of 100% (95% CI: 93.9-100%), a specificity of 100% (95% CI: 97.5-100%), a positive predictive value (PPV) of 100% (95% CI: 93.9-100%) and a negative predictive value (NPV) of 100% (95% CI: 97.5-100%). Agreement with Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) was 100% with a Kappa coefficient of 1 (p<0.001, 95% CI) for both techniques. Similarly, the comparison between m-PIMA and generic biocentric for the detection of HIV-2 on the 8 samples tested showed perfect agreement. Conclusion: these results confirm the excellent performance of the Xpert® HIV-1 qual and m-PIMA™ HIV1/2 detect tests for the detection of HIV-1 and HIV-2 and encourage the extension of POC tests to improve access to EID in Senegal.

Adherence to ready-to-use food and acceptability of outpatient nutritional therapy in HIV-infected undernourished Senegalese adolescents: research-based recommendations for routine care.

BACKGROUND: Ready-to-use food (RUF) is increasingly used for nutritional therapy in HIV-infected individuals. However, practical guidance advising nutrition care to HIV-infected adolescents is lacking, so that little is known about the acceptability of such therapy in this vulnerable population. This study assesses the overall acceptability and perception of a RUF-based therapy and risk factors associated with sub-optimal RUF intake in HIV-infected undernourished adolescents in Senegal. METHODS: Participants 5 to 18 years of age with acute malnutrition were enrolled in 12 HIV clinics in Senegal. Participants were provided with imported RUF, according to WHO prescription weight- and age-bands (2009), until recovery or for a maximum of 9-12 months. Malnutrition and recovery were defined according to WHO growth standards. Adherence was assessed fortnightly by self-reported RUF intake over the period. Sub-optimal RUF intake was defined as when consumption of the RUF provision was < 50%. RUF therapy acceptability and perceptions were assessed using a structured questionnaire at week 2 and focus group discussions (FGDs) at the end of the study. Factors associated with sub-optimal RUF intake at week 2 were identified using a stepwise logistic regression model. RESULTS: We enrolled 173 participants, with a median age of 12.5 years (Interquartile range: 9.5-14.9), of whom 61% recovered from malnutrition within the study period. Median follow-up duration was 66 days (21-224). RUF consumption was stable, varying between 64 and 57% of the RUF provided, throughout the follow-up. At week 2, sub-optimal RUF intake was observed in 31% of participants. Dislike of the taste of RUF (aOR = 5.0, 95% CI: 2.0-12.3), HIV non-disclosure (5.1, 1.9-13.9) and food insecurity (2.8, 1.1-7.2) were the major risk factors associated with sub-optimal RUF intake at week 2. FGDs showed that the need to hide from others to avoid sharing and undesirable effects were other constraints on RUF feeding. CONCLUSIONS: This study revealed several factors reducing the acceptability and adherence to RUF therapy based on WHO guidelines in HIV-infected adolescents. Tailoring prescription guidance and empowering young patients in their care are crucial levers for improving the acceptability of RUF-based therapy in routine care. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03101852, 04/04/2017.

High level of treatment failure and drug resistance to first-line antiretroviral therapies among HIV-infected children receiving decentralized care in Senegal.

BACKGROUND: In Senegal in 2015, an estimated 4800 children were living with HIV, with 1200 receiving ARV treatment, of whom half had follow-up care in decentralized sites outside Dakar. However, until now no studies have determined the efficacy of pediatric treatment in decentralized settings, even though the emergence of viral resistance, particularly among children in Africa, is a well-known phenomenon. This study aimed to assess the virological status of HIV-infected children in all decentralized facilities to help improve access to quality care. METHODS: A cross-sectional epidemiological and virological study was conducted in all of Senegal's regions, except Dakar, between March and June 2015 and sought to include all HIV-infected children and adolescents (0-19 years), treated or not with ARVs. Socio-demographic and clinical data and a blood sample on blotting paper were collected for children from treatment sites. Samples were routed on public transportation, assisted by a network of community health workers. A viral load (VL) assay was performed for each child, followed by genotyping when it exceeded 1000 copies/mL (3 log10). RESULTS: Of the 851 identified children, 666 (78%) were enrolled in the study. Half of the children were girls, and the average age was 8 years (6 months-19 years). Most of the children (96.7%) were infected with HIV-1, and 90% were treated with ART, primarily with AZT + 3TC + NVP/EFV therapeutic regimen. The median duration of time on ART was 21 months (1-129). VL was measured for 2% of children before this study. Almost two-thirds (64%) of the children are experiencing virological failure. Among them, there was resistance to at least one drug for 86.5% of cases. Also, 25% children presented resistance to one drug and 40% to two out of three. For nearly one-third of the children presenting resistance, none of the three drugs of the treatment was active. Factors associated with virological failure were male sex, follow-up by a generalist rather than a specialist, and treatment interruptions. CONCLUSIONS: We observed a high level of virological failure and a high percentage of viral resistance among children receiving health care in decentralized facilities in Senegal.

Improving the informed consent process among HIV-infected undisclosed minors participating in a biomedical research: insights from the multicentre nutritional SNACS study in Senegal.

OBJECTIVES: Providing research information in a manner accessible to minors participating in biomedical research is a major challenge. Guidance is dramatically lacking regarding best practices for seeking informed consent among undisclosed minors enrolled in HIV-related research. We implemented an improved informed consent process (IICP) and identified factors associated with understanding of the information presented to HIV-infected minors prior to their enrolment in a study. METHODS: We enrolled study participants attending 12 paediatric HIV clinics in Senegal. Children ≥7 years were provided with standardised research information using the IICP, which involves viewing a video and taking part in extended group discussions. Understanding was assessed by seven basic questions scored 1 or 2 points, with a maximum score of 11 points. A score of 9 or more points was defined as satisfactory understanding. Factors associated with understanding were identified using a stepwise logistic regression model. RESULTS: Overall, 112 children, with a median age of 12.9 years (IQR: 10.2-15.0), participated in the IICP, of whom 37% were HIV disclosed. 71% achieved a satisfactory understanding score and all gave consent to participate in the research. HIV-disclosed children were more likely to demonstrate satisfactory understanding than undisclosed children (aOR = 3.2, 95% CI: 1.1-9.6). Age, study setting and education level were not associated with satisfactory understanding. CONCLUSION: These findings provide practical guidance for the development of improved and friendly informed consent processes in research involving minors. The implementation of the paediatric HIV research agenda will require a standardised and operational definition of informed consent, integrating the issue of HIV disclosure.

OBJECTIFS: Fournir des informations sur la recherche d'une manière accessible aux mineurs participant à la recherche biomédicale est un défi majeur. Les guidances font cruellement défaut en ce qui concerne les meilleures pratiques pour obtenir le consentement éclairé des mineurs non dévoilés, inscrits dans des recherches sur le VIH. Nous avons mis en place un processus de consentement éclairé amélioré (PCEA) et identifié les facteurs associés à la compréhension des informations présentées aux mineurs infectés par le VIH avant leur inscription à une étude. MÉTHODES: Nous avons recruté des participants à l'étude dans 12 cliniques pédiatriques de traitement du VIH au Sénégal. Les enfants de 7 ans et plus ont reçu des informations de recherche standardisées à l'aide du PCEA, qui consiste à visionner une vidéo et à participer à des discussions de groupe prolongées. La compréhension a été évaluée par 7 questions de base notées 1 ou 2 points, avec un score maximum de 11 points. Un score de 9 points ou plus a été défini comme une compréhension satisfaisante. Les facteurs associés à la compréhension ont été identifiés à l'aide d'un modèle de régression logistique par étapes. RÉSULTATS: Au total, 112 enfants âgés de 12,9 ans en moyenne (IQR: 10,2-15,0) ont participé au PCEA, dont 37% avaient leur statut VIH dévoilé. 71% ont obtenu un score de compréhension satisfaisant et tous ont consenti à participer à la recherche. Les enfants avec un statut VIH dévoilé étaient plus susceptibles de démontrer une compréhension satisfaisante que ceux avec un statut non dévoilé (aOR: 3,2; IC95%: 1,1-9,6). L'âge, le cadre de l'étude et le niveau d'éducation n'étaient pas associés à une compréhension satisfaisante. CONCLUSION: Ces résultats fournissent des guidances pratiques pour la mise au point de processus de consentement éclairé améliorés et conviviaux dans la recherche impliquant des mineurs. La mise en œuvre du programme de recherche pédiatrique sur le VIH nécessitera une définition normalisée et opérationnelle du consentement éclairé, intégrant la question de la révélation du VIH.

Potential Impact of Integrated Stigma Mitigation Interventions in Improving HIV/AIDS Service Delivery and Uptake for Key Populations in Senegal.

BACKGROUND: Men who have sex with men (MSM) and female sex workers (FSW) are consistently shown to have a higher burden of HIV compared with other adults in Senegal. This study, HIV Prevention 2.0, evaluates the impact of the 3-tiered integrated stigma mitigation interventions (ISMIs) approach to optimizing HIV service delivery for key populations in Senegal. METHODS: Baseline assessment includes a questionnaire and biological testing for HIV. A proportion of participants enrolled into a 24-month longitudinal cohort with questionnaires and biological testing every 3 months. In these preliminary analyses, ISMIs are evaluated from participants in the cohort through uptake of HIV services and implementation outcomes. RESULTS: Overall, 724 MSM and 758 FSW participated in the baseline assessment. HIV prevalence is 30.2% (n = 219/724) among MSM and 5.3% (n = 40/758) among FSW. Fear of seeking health services among MSM is 17.7% (n = 128/724) at baseline, 10.5% (n = 18/172) at month 3, and 9.8% (n = 10/102) at month 6 (P < 0.004); and among FSW is 21.9% (n = 166/758) at baseline, 8.1% (n = 15/185) at month 3, and 10.7% (n = 18/168) at month 6 (P < 0.001). Overall, 63.9% (n = 62/97) of MSM and 82.5% (n = 118/143) of FSW agreed that the intervention is effective in addressing stigma; however, loss to follow-up was 41.1% among MSM and 10% among FSW. CONCLUSION: Baseline data reinforce the need for stigma mitigation interventions, combined with enhanced linkage and retention to optimize HIV treatment. Preliminary results show high levels of HIV-related risk determinants and suggest the potential utility of the ISMI to decrease perceived stigma relating to engagement in HIV prevention, treatment, and care services among key populations in Senegal.

A 84-month follow up of adherence to HAART in a cohort of adult Senegalese patients.

OBJECTIVES: To assess long-term adherence of the first HIV-1 patients receiving highly active antiretroviral therapy (HAART) in Senegal, and to identify the main determinants of adherence. METHODS: The first 180 patients enrolled in the Senegalese HAART initiative between August 1998 and April 2001 followed up for at least 30 days were eligible. Adherence was assessed monthly at each drug dispensation between November 1999 and November 2006 by a pharmacist using a pill count completed by a questionnaire. Adherence was expressed as the proportion of tablets taken to prescribed tablets. An adherence of 95% was considered to be good. A random-intercept logit model was fitted to identify the main determinants of adherence. RESULTS: Adherence data were available for 158 of 167 eligible patients. Twenty-nine patients died during the study period and 10 were lost to follow-up. Median treatment duration was 78 months, accruing to 6657 person-months of observation. Overall, mean adherence reached 91% [median: 100%, interquartile range (IQR) 96-100%] and adherence exceeded 95% in 78% [95% CI 77-79%] of observations. After 4 years of treatment mean adherence stabilized around 90% and adherence > or =95% stabilized around 70%. Treatment duration and protease inhibitor (PI)-based regimen (indinavir) had a negative effect on adherence, but adherence tended to improve with time for patients receiving a PI. Patient-level variance was highly significant and accounted for a third of total variance. CONCLUSIONS: This work demonstrates that good long-term adherence can be achieved in the sub-Saharan context given close monitoring and adherence support measures, confirms the worse adherence for indinavir and underlines the importance of patient heterogeneity.

Adherence to HAART and its principal determinants in a cohort of Senegalese adults.

BACKGROUND: Access to programmes providing highly active antiretroviral therapy (HAART) is recent in Africa. In Senegal, a national initiative was launched in 1998. The capacity of African patients to adhere to complex antiretroviral treatments (ARV) is largely unknown. METHODS: We assessed adherence and identified the main reasons for treatment interruption in a prospective observational cohort of patients participating in an ARV access programme in Dakar, Senegal. Adherence was estimated each month on the basis of the patients' stated consumption and on the proportion of the prescribed dose returned unused to the dispensing pharmacy. A total of 158 patients were studied between November 1999 and October 2001. RESULTS: A cross-section analysis showed that the stated level of adherence was high: on average, over the study period, the patients said they had taken 91% of each monthly dose and that they had taken the full monthly dose during two-thirds of the months studied. Adherence tended to be better among patients who were required to make little or no contribution to the cost of their treatment, through an appropriate pricing structure. Adherence was also better with efavirenz-containing regimens than with indinavir-containing regimens. CONCLUSION: These results show that adherence to HAART can be as high in Africa as that generally observed in industrialized countries, and that the cost and type of drug regimen must be taken into account when designing ARV access programmes for poor communities.