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.

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.

Prediction of HIV drug resistance based on virologic, immunologic, clinical, and/or adherence criteria in the Stratall ANRS 12110/ESTHER trial in Cameroon.

Our study in Cameroonian rural district hospitals showed that the immunologic and clinical failure criteria had poor performance to identify human immunodeficiency virus drug resistance in a timely manner. Switching to second-line antiretroviral therapy after 2 consecutive viral loads ≥5000 copies/mL, as recommended by the World Health Organization, appeared to be the most appropriate strategy.

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.

[Perceptions and use of Universal Health Coverage (Plan Sésame) among the elderly in Dakar (Senegal), impacts on health expenditure related to diabetes and hypertension]. / Perceptions et utilisation de la Couverture Maladie Universelle (Plan Sésame) par les personnes âgées à Dakar (Sénégal), impacts sur les dépenses de santé liées au diabète et à l'hypertension.

Introduction/rationale: In 2006, the Senegalese government set up a health coverage programme for people aged 60 and over - the Plan Sésame - to provide free medical care in all the country's public health facilities. This scheme has been integrated into the Universal Health Coverage (CMU) promoted from 2013. The objective of the study was to describe and analyse the knowledge and representations of professionals and users about health coverage and the Plan Sésame, the use of the scheme by the elderly, to evaluate the amount of medical expenses incurred during a routine medical consultation for the monitoring of their illness (hypertension and diabetes), and to calculate the out-of-pocket expenses related to the consultation. Material and methods: Study conducted between July 2020 and October 2021 in two public health facilities in Dakar. Mixed approach: 1/ qualitative study by semi-directive interviews, informal interviews, observations and field diary with 35 people selected according to a reasoned choice procedure with the aim of diversifying gender, age, social status, therapeutic itineraries for 23 people (including 12 women, ages between 60 and 85 years), and professional activities for 12 health actors; 2/ quantitative cross-sectional study by questionnaire of 225 people (including 141 women) aged 60 and over; we calculated the total cost of the consultation and associated prescriptions (complementary examinations and medicines) as well as the remaining medical expenses (out-of-pocket) and the cost of transporting patients. This is a descriptive exploratory study of a non-representative sample of the elderly population in Senegal. Results: The health professionals interviewed supported the principle of health coverage, but most of them had limited and sometimes imprecise knowledge of the existing schemes and the methods of access or the services covered. Their point of view about the consequences of the Plan Sésame on their practice reveals some contradictions: some complain about the increase in workload, the criticism is extended to all the free schemes which would have a negative impact on daily practice because of the increase in the number of consultations which would be linked to abuse by patients.The interviews highlight the heterogeneity of the knowledge of elderly people about the health coverage intended for them, even though the Plan Sésame has been in place for over ten years. The interviews clearly show that the use of the health coverage system by the elderly depends closely on the information they have and their ability to use it, both for women and men. There is a close link between the level of social integration of people and their use of health coverage: the most socially integrated people are those who know how to use CMU services best. The use of health coverage by the elderly appears to vary according to the individual.Although Plan Sésame is defined as part of a national strategy, its implementation varies according to the health structures and the periods; in the two study sites, the range of services covered by Plan Sésame is very limited, so the coverage provided by Plan Sésame is only partial: between 30 and 50% of the medical costs; the remaining cost of a consultation for elderly patients with hypertension and/or diabetes varies between 24,000 and 28,000 CFA francs.These amounts must be put into perspective with the resources available to people. Statistical studies published in 2021 report that in Senegal the average daily expenditure is 1,390 CFA francs/person/day; and that almost 38% of the population lives on 913 CFA francs/person/ day, which is the poverty line calculated in 2019. Thus, the average out-of-pocket expenses for a follow-up consultation for hypertension, diabetes or a combination of the two diseases represent 15 to 30 days of daily expenditure. While the vast majority of elderly people in Senegal do not have a retirement pension, health expenses are therefore borne by their relatives. Within households, medical expenditure for the elderly competes with basic needs, particularly food, which usually take up more than half of household resources. This indispensable family support places the elderly in a situation of total dependence. Conclusions: In 2021, Plan Sésame does not yet allow for completely free care for the elderly. However, its application, even partial, has resulted in a real reduction in health care costs for the elderly. Its use remains limited due to inconsistent application by most health structures. Its impact is insufficient in view of the amounts that users have to pay in a context of social and economic vulnerability. These observations reinforce the need to work on reducing the price of medical services and strengthening the UHC, in order to improve the equity and performance of the system, and to make it fully functional in all health structures.

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.

Improving early infant diagnosis for HIV-exposed infants using unmanned aerial vehicles for blood sample transportation in Conakry, Guinea: a comparative cost-effectiveness analysis.

BACKGROUND: Early infant diagnosis (EID) for HIV-exposed infants is essential due to high mortality during the first months of their lives. In Conakry (Guinea), timely EID is difficult as traffic congestion prevents the rapid transport of blood samples to the central laboratory. We investigated the cost-effectiveness of transporting EID blood samples by unmanned aerial vehicles (UAV), also known as drones. METHODS AND FINDINGS: Using Monte Carlo simulations, we conducted a cost-effectiveness comparative analysis between EID blood samples transportation by on-demand UAV transportation versus the baseline scenario (ie, van with irregular collection schedules) and compared with a hypothetic on-demand motorcycle transportation system. Incremental cost-effectiveness ratio (ICER) per life-year gained was computed. Simulation models included parameters such as consultation timing (eg, time of arrival), motorcycle and UAV characteristics, weather and traffic conditions. Over the 5-year period programme, the UAV and motorcycle strategies were able to save a cumulative additional 834.8 life-years (585.1-1084.5) and 794.7 life-years (550.3-1039.0), respectively, compared with the baseline scenario. The ICER per life-year gained found were US$535 for the UAV strategy versus baseline scenario, US$504 for the motorcycle strategy versus baseline scenario and US$1137 per additional life-year gained for the UAV versus motorcycle strategy. Respectively, those ICERs represented 44.8%, 42.2% and 95.2% of the national gross domestic product (GDP) per capita in Guinea-that is, US$1194. CONCLUSION: Compared with the baseline strategy, both transportation of EID blood samples by UAVs or motorcycles had a cost per additional life-year gained below half of the national GDP per capita and could be seen as cost-effective in Conakry. A UAV strategy can save more lives than a motorcycle one although the cost needed per additional life-year gained might need to consider alongside budget impact and feasibility considerations.

Queer necropolitics of asylum: Senegalese refugees facing HIV in Mauritania.

Since 2008, homosexuality has been the subject of recurrent public controversies in Senegal, sometimes accompanied by police arrests and popular violence. In this context, a migration route has opened up to Mauritania, where some are granted refugee status by the United Nations High Commissioner for Refugees (UNHCR). Among them, a few are selected for 'resettlement' in a host country in North America or Europe. Many of these Senegalese gay men residing in Mauritania are infected with HIV. In recent years, some of them have returned to Senegal in a very deteriorated condition, leading in several cases to death; others have died in exile in Nouakchott. This article reports on the living conditions and access to health care of Senegalese gay men who went to Mauritania hoping for resettlement to the Global North by the UNHCR. It is based on semi-directed interviews with Senegalese gay asylum seekers as well as members of NGOs, health structures and institutions (including the UNHCR) in Nouakchott and Dakar. It shows that, despite the UNHCR's demonstrated commitment to refugee protection, the asylum (and specifically resettlement) system exposes those who rely on it to increased, sometimes fatal, health risks.

Does universal health coverage reduce out-of-pocket expenditures for medical consultations for people living with HIV in Senegal? An exploratory cross-sectional study.

OBJECTIVES: In Senegal, a national health coverage system named Couverture Medicale Universelle (CMU) has been under development since 2013; its impact on out-of-pocket (OOP) expenses for people living with HIV (PLHIV) remains unknown. Our objective was to assess the impact of the national health coverage system on health expenses for PLHIV by measuring the OOP amount for a routine consultation for various categories of PLHIV, in Dakar and different regions in Senegal, viewed from the patients' perspective. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional survey in 2018 and 2019 using a face-to-face questionnaire with PLHIV: 344 adults followed up at Fann Regional Centre for research and training in clinical treatment in Dakar; 60 adult men who have sex with men (MSM) in 2 hospitals in Dakar and 7 facilities in the regions; and 130 children and adolescents (0-19 years) in 16 care facilities in the southern regions. We have calculated the total price of the consultation and associated prescriptions along with the patient's OOP medical and transportation contributions. The average amounts were compared using the Student's t-test. RESULTS: All patients are on antiretroviral treatment with a median duration of 6 years, 5 years and 3 years for adults, MSM and children/adolescents, respectively. The percentage of people who have health coverage is 26%, 18% and 44% for adults, MSM and children. In practice, these systems are rarely used. The OOP amount (health expenses+transportation costs) for a routine consultation is €11 for adults and children, and €32.5 for MSM. CONCLUSION: The number of PLHIV with coverage is low, and the system's effectiveness remains limited. Currently, this system has proved ineffective in implementing free healthcare, recommended by WHO since 2005.

Prevalence and molecular characterization of hepatitis B virus infection in HIV-infected children in Senegal.

BACKGROUND AND AIMS: Sub-Saharan Africa (SSA) is the region with the most patients co-infected with the human immunodeficiency virus (HIV) and the hepatitis B virus (HBV) worldwide. However, few studies have focused on SSA children who are at a higher risk of developing a chronic infection than adults. Furthermore, children on first-line antiretroviral therapy (ART) including low genetic barrier drugs may develop both HBV and HIV resistance mutations. The aim of this work was to document HIV-HBV co-infection and to characterize the HBV isolates in children in Senegal. METHODS: This is a retrospective study of 613 children infected with HIV on ART or not. Dried blood spot (DBS) specimens were used to detect hepatitis B surface antigen (HBsAg) with a rapid diagnostic test (RDT). Confirmation of HBsAg status and hepatitis B e antigen (HBeAg) detection was performed on an automated platform using the chemiluminescence assay technology. HBV viral DNA was quantified by real-time polymerase chain reaction (PCR) and the preS1/preS2/HBsAg region was genotyped by nested PCR followed by sequencing using the Sanger technique. RESULTS: The prevalence of HIV-HBV co-infection was 4.1% (25/613). The median age of co-infected children was 13 years (2 years-16 years) and 40% (10/25) were girls. Almost all 19/20 (95%) were infected with HIV-1 and 79% (19/24) were treated with 3TC-based triple combination ART. The median duration of time on ART was 15 months (3 months-80 months). More than half of the children 53% (9/17) were experiencing HIV virologic failure and 75% (6/8) had at least one HIV-related resistance-associated mutation (RAM). Of the six children with resistance, none of the three administered treatments were effective on HIV. Of the 25 co-infected children, 82% (18/22) were HBeAg-positive, while the median HBV viral load (VL) was 6.20 log10 IU/mL (24/25 patients), and 62,5% (10/16) of the children had a persistent HBV viremia. Combination of ART was the only factor associated with HBV viremia persistence. Amplification was successful in 15 out of 16 patients (rate of 94%), and the ensuing phylogenetic analysis revealed that eight strains (53%) belonged to genotype A and seven (47%) to genotype E. HBV-related 3TC RAMs were uncovered in 20% of these patients (3/15). HBsAg escape mutations were found in 20% of the children (3/15). CONCLUSIONS: Our results showed a high level of drug resistance mutations to both HIV and HBV, a significant level of HBsAg escape mutations, HBV DNA persistence and HIV virologic failure in co-infected children in Senegal. The HBV genotypes found were A and E.

WHO clinical criteria-based initiation of antiretroviral therapy: lessons from rural district hospitals in Cameroon with regard to 2009 revised WHO recommendations.

OBJECTIVE: To assess the proportion of patients infected with HIV with a CD4 count above 350 cells/mm(3) among those classified at WHO clinical stage 3 or 4 who initiated antiretroviral therapy in rural district hospitals in Cameroon to assess the 2009 revised WHO recommendations. METHODS: Cross-sectional study in nine rural district hospitals where the treatment initiation is based on the WHO clinical criteria. The proportion of patients who were classified at stage 3 or 4 and who had a CD4 count >350 cells/mm(3) was assessed. RESULTS: Of 458 patients included in 2006-2008 (women 70.5%; median age 37.0 years), 337 (73.6%) were classified at WHO clinical stage 3 and 121 (26.4%) at stage 4. Overall, 108 patients (23.6%) had a CD4 count >350 cells/mm(3). Of them, 94 patients (20.5%) were classified at WHO clinical stage 3, and 14 (3.1%) were classified at WHO clinical stage 4. CONCLUSION: The WHO clinical stages 3 and 4 were poorly correlated with the 'gold standard' of CD4 cell count. This study highlights the need to promote CD4 testing for assessing the patient eligibility.

Gender Differences in Adherence and Response to Antiretroviral Treatment in the Stratall Trial in Rural District Hospitals in Cameroon.

BACKGROUND: Evidence of gender differences in antiretroviral treatment (ART) outcomes in sub-Saharan Africa is conflicting. Our objective was to assess gender differences in (1) adherence to ART and (2) virologic failure, immune reconstitution, mortality, and disease progression adjusting for adherence. METHODS: Cohort study among 459 ART-naive patients followed up 24 months after initiation in 2006-2010 in 9 rural district hospitals. Adherence to ART was assessed using (1) a validated tool based on multiple patient self-reports and (2) antiretroviral plasma concentrations. The associations between gender and the outcomes were assessed using multivariate mixed models or accelerated time failure models. RESULTS: One hundred thirty-five patients (29.4%) were men. At baseline, men were older, had higher body mass index and hemoglobin level, and received more frequently efavirenz than women. Gender was not associated with self-reported adherence (P = 0.872, 0.169, and 0.867 for moderate adherence, low adherence, and treatment interruption, respectively) or with antiretroviral plasma concentrations (P = 0.549 for nevirapine/efavirenz). In contrast, male gender was associated with virologic failure [odds ratio: 2.18, 95% confidence interval (CI): 1.31 to 3.62, P = 0.003], lower immunologic reconstitution (coefficient: -58.7 at month 24, 95% CI: -100.8 to -16.6, P = 0.006), and faster progression to death (time ratio: 0.30, 95% CI: 0.12 to 0.78, P = 0.014) and/or to World Health Organization stage 4 event (time ratio: 0.27, 95% CI: 0.09 to 0.79, P = 0.017). CONCLUSIONS: Our study provides important evidence that African men are more vulnerable to ART failure than women and that the male vulnerability extends beyond adherence issues. Additional studies are needed to determine the causes for this vulnerability to optimize HIV care. However, personalized adherence support remains crucial.

Time patterns of adherence and long-term virological response to non-nucleoside reverse transcriptase inhibitor regimens in the Stratall ANRS 12110/ESTHER trial in Cameroon.

BACKGROUND: Although treatment adherence is a major challenge in sub-Saharan Africa, it is still unknown which longitudinal patterns of adherence are the most detrimental to long-term virological response to non-nucleoside reverse transcriptase inhibitor (NNRTI) regimens. This analysis aimed to study the influence of different time patterns of adherence on virological failure after 24 months of treatment in Cameroon. METHODS: Antiretroviral therapy (ART) adherence data were collected using face-to-face questionnaires administered at months 1, 3, 6, 12, 18 and 24. Virological failure was defined as viral load >40 copies/ml at month 18 and/or 24. Two combined indicators of early adherence (months 1, 3 and 6) and adherence during the maintenance phase (months 12, 18 and 24) were designed to classify patients as always adherent during the early or maintenance phase, non-adherent at least once and having interrupted ART for >2 days at least once at any visit during either of these two phases. RESULTS: Virological failure occurred in 107 (42%) of the 254 patients included in the analysis. In the early and maintenance phases, 84% and 76%, respectively, were always adherent, 5% and 5% were non-adherent and 11% and 20% experienced ≥ 1 treatment interruption. Early non-adherence was independently associated with virological failure (adjusted OR 7.2 [95% CI 1.5, 34.6]), while only treatment interruptions had a significant impact on virological failure during the maintenance phase (adjusted OR 2.1 [95% CI 1.1, 4.4]). CONCLUSIONS: ART NNRTI-regimens used in sub-Saharan Africa seem to 'forgive' deviations from good adherence during the maintenance phase. Optimizing adherence in the early months of treatment remains crucial, especially in a setting of poor health care infrastructure and resources.

Task shifting HIV care in rural district hospitals in Cameroon: evidence of comparable antiretroviral treatment-related outcomes between nurses and physicians in the Stratall ANRS/ESTHER trial.

BACKGROUND: Task shifting to nurses for antiretroviral therapy (ART) is promoted by the World Health Organization to compensate for the severe shortage of physicians in Africa. We assessed the effectiveness of task shifting from physicians to nurses in rural district hospitals in Cameroon. METHODS: We performed a cohort study using data from the Stratall trial, designed to assess monitoring strategies in 2006-2010. ART-naive patients were followed up for 24 months after treatment initiation. Clinical visits were performed by nurses or physicians. We assessed the associations between the consultant ratio (ie, the ratio of the number of nurse-led visits to the number of physician-led visits) and HIV virological success, CD4 recovery, mortality, and disease progression to death or to the World Health Organization clinical stage 4 in multivariate analyses. RESULTS: Of the 4141 clinical visits performed in 459 patients (70.6% female, median age 37 years), a quarter was task shifted to nurses. The consultant ratio was not significantly associated with virological success [odds ratio 1.00, 95% confidence interval (CI): 0.59 to 1.72, P = 0.990], CD4 recovery (coefficient -3.6, 95% CI: -35.6; 28.5, P = 0.827), mortality (time ratio 1.39, 95% CI: 0.27 to 7.06, P = 0.693), or disease progression (time ratio 1.60, 95% CI: 0.35 to 7.37, P = 0.543). CONCLUSIONS: This study brings important evidence about the comparability of ART-related outcomes between HIV models of care based on physicians or nurses in resource-limited settings. Investing in nursing resources for the management of noncomplex patients should help reduce costs and patient waiting lists while freeing up physician time for the management of complex cases, for mentoring and supervision activities, and for other health interventions.

Susceptibility to transmitting HIV in patients initiating antiretroviral therapy in rural district hospitals in Cameroon (Stratall ANRS 12110/ESTHER Trial).

OBJECTIVES: Using cohort data nested in a randomized trial conducted in Cameroon, this study aimed to investigate time trends and predictors of the susceptibility to transmitting HIV during the first 24 months of treatment. METHODS: The outcome, susceptibility to transmitting HIV, was defined as reporting inconsistent condom use and experiencing incomplete virological suppression. Mixed logistic regressions were performed to identify predictors of this outcome among 250 patients reporting to have had sexual relationships either with HIV-negative or unknown HIV status partner(s). RESULTS: Despite an initial decrease from 76% at M0 to 50% at M6, the rate of inconsistent condom use significantly increased from M12 (59%) to M24 (66%) (p = 0.017). However, the proportion of patients susceptible to transmitting HIV significantly decreased over follow-up from 76% at M0, to 50% at M6, 31% at M12 and 27% at M24 (p<0.001). After controlling for age, gender and intervention group, we found that perceiving healthcare staff's readiness to listen as poor (adjusted odds ratios (AOR) [95% Confidence Interval (CI)] = 1.87 [1.01-3.46]), reporting to have sexual relationships more than once per week (AOR [95%CI] = 2.52 [1.29-4.93]), having more than one sexual partner (AOR [95%CI] = 2.53 [1.21-5.30]) and desiring a/another child (AOR [95%CI] = 2.07 [1.10-3.87]) were all associated with a higher risk of being susceptible to transmitting HIV. Conversely, time since ART initiation (AOR [95%CI] = 0.66 [0.53-0.83] for an extra 6 months and ART adherence (AOR [95%CI] = 0.33 [0.15-0.72]) were significantly associated with a lower risk of being susceptible to transmitting HIV. CONCLUSIONS: The decrease observed in the susceptibility to transmitting HIV suggests that fear of behavioural disinhibition should not be a barrier to universal access to ART. However, developing adequate preventive interventions matching patients' expectations -like the desire to have children- and strengthening healthcare staff's counselling skills are urgently needed to maximize the impact of ART in slowing the HIV epidemic.

Monitoring of HIV viral load, CD4 cell count, and clinical assessment versus clinical monitoring alone for antiretroviral therapy in low-resource settings (Stratall ANRS 12110/ESTHER): a cost-effectiveness analysis.

BACKGROUND: In low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy (ART) remains controversial in view of persistent resource constraints. The Stratall trial did not show that clinical monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. We aimed to evaluate the costs and cost-effectiveness of the ART monitoring approaches assessed in the Stratall trial. METHODS: The randomised, controlled, non-inferiority Stratall trial was done in a decentralised setting in Cameroon. Between May 23, 2006, and Jan 31, 2008, ART-naive adults were randomly assigned (1:1) to clinical monitoring (CLIN) or viral load and CD4 cell count plus clinical monitoring (LAB) and followed up for 24 months. We calculated costs, number of life-years saved (LYS), and incremental cost-effectiveness ratios (ICERs) with data from patients who had been followed up for at least 6 months. We considered two cost scenarios in which viral load plus CD4 cell count tests cost either US$95 (scenario 1; Abbott RealTime HIV-1 assay) or $63 (scenario 2; generic assay). We compared ICERs with a WHO-recommended threshold of three times the per-person gross domestic product (GDP) for Cameroon ($3670-3800) and an alternative lower threshold of $2385 to determine cost-effectiveness. We assessed uncertainty with one-way sensitivity analyses and cost-effectiveness acceptability curves. FINDINGS: 188 participants who underwent LAB and 197 who underwent CLIN were followed up for at least 6 months. In scenario 1, LAB increased costs by a mean of $489 (SD 430) per patient and saved 0·103 life-years compared with CLIN (ICER of $4768 [95% CI 3926-5613] per LYS). In scenario 2, the incremental mean cost of LAB was $343 (SD 425) -ie, an ICER of $3339 (2507-4173) per LYS. A combined strategy in which LAB would only be used in patients starting ART with a CD4 count of 200 cells per µL or fewer suggests that 0·120 life-years would be saved at an additional cost of $259 per patient in scenario 1 (ICER of $2167 [95% CI 1314-3020] per LYS) and $181 in scenario 2 (ICER of $1510 [692-2329] per LYS) when compared with CLIN. INTERPRETATION: Laboratory monitoring was not cost effective in 2006-10 compared with clinical monitoring when the Abbott RealTime HIV-1 assay was used according to the $3670 cost-effectiveness threshold (three times per-person GDP in Cameroon), but it might be cost effective if a generic in-house assay is used. FUNDING: French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Ensemble pour une Solidarité Thérapeutique Hospitalière En Réseau (ESTHER).

Operational research and HIV policy and guidelines: lessons from a study of patients lost to follow-up from a public antiretroviral treatment program in Cameroon.

Can operations and implementation research guide today's unprecedented efforts to scale-up HIV/AIDS prevention, treatment, care, and support in resource-limited settings? Our study of patients with HIV/AIDS who were first seen at the Central Hospital (Yaoundé, Cameroon) to begin antiretroviral therapy demonstrates the value of using operations research to explore programs, policies, and guidelines used in health care. We studied one group of patients, those lost to follow-up. Our findings confirmed the value of early treatment, systems to follow individuals, free treatment, and resources that enable operations research. We encourage health-care workers and program managers to perform operational research in their own context, and we emphasize the importance of allocating adequate human, financial, and logistic resources for this activity. Finally, we stress that the health-care workers, program managers, and researchers must work together to better inform policy and guidelines.

Monitoring of HIV viral loads, CD4 cell counts, and clinical assessments versus clinical monitoring alone for antiretroviral therapy in rural district hospitals in Cameroon (Stratall ANRS 12110/ESTHER): a randomised non-inferiority trial.

BACKGROUND: Scaling up of antiretroviral therapy in low-resource countries is done on the basis of decentralised, integrated HIV care in rural facilities; however, laboratory monitoring is generally unavailable. We aimed to assess the effectiveness and safety of clinical monitoring alone (CLIN) in terms of non-inferiority to laboratory and clinical monitoring (LAB). METHODS: We did a randomised, open-label, non-inferiority trial in nine rural district hospitals in Cameroon. Eligible participants were adults (≥18 years) infected with HIV-1 group M (WHO disease stage 3-4) who had not previously received antiretroviral therapy, and were followed-up for 2 years by health-care workers in routine activities. We randomly assigned participants (1:1) to CLIN or LAB (counts of HIV viral load and CD4 cell every 6 months) groups with a computer-generated list. The primary outcome was non-inferiority of CLIN to LAB in terms of increase in CD4 cell count with a non-inferiority margin of 25%. We did all analyses in participants who attended at least one follow-up visit. This trial is registered with ClinicalTrials.gov, number NCT00301561. FINDINGS: 238 (93%) of 256 participants assigned to CLIN and 221 (93%) of 237 assigned to LAB were eligible for analysis. CLIN was not non-inferior to LAB; the mean increase in CD4 cell count was 175 cells per µL (SD 190, 95% CI 151-200) with CLIN and 206 (190, 181-231) with LAB (difference -31 [-63 to 2] and non-inferiority margin -52 [-58 to -45]). Furthermore, in the predefined secondary outcome of treatment changes, 13 participants (6%) in the LAB group switched to second-line regimens whereas no participants in the CLIN group did so (p<0·0001). By contrast, other predefined secondary outcomes were much the same in both groups-viral suppression (<40 copies per mL; 465 [49%] of 952 measurements in CLIN vs 456 [52%] of 884 in LAB), HIV resistance (23 [10%] of 238 participants vs 22 [10%] of 219 participants), mortality (44 [18%] of 238 vs 32 [14%] of 221), disease progression (85 [36%] of 238 vs 64 [29%] of 221), adherence (672 [63%] of 1067 measurements vs 621 [61%] of 1011), loss to follow-up (21 [9%] of 238 vs 17 [8%] of 221), and toxic effects (46 [19%] of 238 vs 56 [25%] of 221). INTERPRETATION: Our findings support WHO's recommendation for laboratory monitoring of antiretroviral therapy. However, the small differences that we noted between the strategies suggest that clinical monitoring alone could be used, at least temporarily, to expand antiretroviral therapy in low-resource settings. FUNDING: French National Agency for Research on AIDS (ANRS) and Ensemble pour une Solidarité Thérapeutique Hospitalière En Réseau (ESTHER).