Sylvie Boyer

Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial

BackgroundAntiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial’s secondary outcomes.Methods/designA cluster-randomised trial in 34 (2 × 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 × 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/μL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters.DiscussionWe aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability.Trial registrationClinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.

Scaling up access to antiretroviral treatment for HIV infection : the impact of decentralization of healthcare delivery in Cameroon

Background:The independent evaluation of the Cameroonian antiretroviral therapy (ART) Programme, which reached one of the highest coverage in the eligible HIV-infected population (58%) in Sub-Saharan Africa, offered the opportunity to assess ART outcomes in the context of the decentralization of HIV care delivery. Materials and methods:A cross-sectional survey (EVAL, ANRS 12-116, 2007) was carried out in a random sample of 3151 HIV-positive patients (response rate 90%) attending 27 treatment centres at the different level of the healthcare delivery (central, provincial and district), as well as in the exhaustive sample of doctors in charge of HIV care in these centres (response rate 92%, n = 97). Multivariate two-level analyses were conducted to assess the impact of the level of healthcare delivery on CD4 cell gains since initiation of treatment and adherence to treatment in the subsample of patients who were ART-treated for 6 months or more (n = 1985). Results:District treatment centres were characterized by more limited technical and human resources but a lower workload. ART-treated patients followed up in these centres had significantly lower socioeconomic status. After adjustment for other explanatory factors, immunological improvement was similar in patients followed up at the central and district level, whereas adherence to ART was better both at provincial and district levels. Conclusion:Success in scaling-up access to ART in Cameroon has been facilitated by decentralization of the healthcare system. Long-term sustainability urgently implies better integration of this HIV-targeted programme in the global healthcare reform of financing mechanisms, management of human resources and drug procurement systems.

Financial barriers to HIV treatment in Yaoundé, Cameroon: first results of a national cross-sectional survey

OBJECTIVE To assess the extent to which user fees for antiretroviral therapy (ART) represent a financial barrier to access to ART among HIV-positive patients in Yaoundé, Cameroon. METHODS Sociodemographic, economic and clinical data were collected from a random sample of 707 HIV-positive patients followed up in six public hospitals of the capital city (Yaoundé) and its surroundings through face-to-face interviews carried out by trained interviewers independently from medical staff and medical questionnaires filled out by prescribing physicians. Logistic regression models were used to identify factors associated with self-reported financial difficulties in purchasing ART during the previous 3 months. FINDINGS Of the 532 patients treated with ART at the time of the survey, 20% reported financial difficulty in purchasing their antiretroviral drugs during the previous 3 months. After adjustment for socioeconomic and clinical factors, reports of financial difficulties were significantly associated with lower adherence to ART (odds ratio, OR: 0.24; 95% confidence interval, CI: 0.15-0.40; P < 0.0001) and with lower CD4+ lymphocyte (CD4) counts after 6 months of treatment (OR: 2.14; 95% CI: 1.15-3.96 for CD4 counts < 200 cells/microl; P = 0.04). CONCLUSION Removing a financial barrier to treatment with ART by eliminating user fees at the point of care delivery, as recommended by WHO, could lead to increased adherence to ART and to improved clinical results. New health financing mechanisms based on the public resources of national governments and international donors are needed to attain universal access to drugs and treatment for HIV infection.

HIV disclosure and unsafe sex among HIV-infected women in Cameroon: Results from the ANRS-EVAL study

Encouraging seropositive people to voluntarily disclose their serostatus has been promoted as a key component of HIV prevention. Among other reasons, HIV disclosure to ones main partner is believed to be an incentive for serodiscordant couples to practice safe sex. The present article investigated this issue by conducting a cross-sectional survey of a large sample of HIV-infected women attending HIV care centers in Cameroon (N=1014). Overall, 86.3% of these women had disclosed their serostatus to their main partner. With respect to sexual activity with their main partner during the previous three months, 35.0% had practiced abstinence and 47.4% only safe sex, whereas 17.6% had engaged in unsafe sex at least once. HIV disclosure to ones main partner was related to safe sexual practices in multivariate analysis. Some of the factors associated with disclosure and safe sex were illustrative of the positive roles of improved access to care and womens empowerment. On the contrary, beliefs overestimating the effectiveness of antiretroviral therapies were quite widespread among respondents and predictive of both concealment of HIV status and unsafe sex.

Determinants of unplanned antiretroviral treatment interruptions among people living with HIV in Yaoundé, Cameroon (EVAL survey, ANRS 12-116)

Objective  To identify correlates of self‐reported antiretroviral therapies (ART) interruptions among people living with HIV and AIDS (PLWHA) in Cameroon.

The Point-of-Care Laboratory in Clinical Microbiology

SUMMARY Point-of-care (POC) laboratories that deliver rapid diagnoses of infectious diseases were invented to balance the centralization of core laboratories. POC laboratories operate 24 h a day and 7 days a week to provide diagnoses within 2 h, largely based on immunochromatography and real-time PCR tests. In our experience, these tests are conveniently combined into syndrome-based kits that facilitate sampling, including self-sampling and test operations, as POC laboratories can be operated by trained operators who are not necessarily biologists. POC laboratories are a way of easily providing clinical microbiology testing for populations distant from laboratories in developing and developed countries and on ships. Modern Internet connections enable support from core laboratories. The cost-effectiveness of POC laboratories has been established for the rapid diagnosis of tuberculosis and sexually transmitted infections in both developed and developing countries.

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

Adherence to antiretroviral treatment in HIV-positive patients in the Cameroon context: promoting the use of medication reminder methods.

95 (scenario 1; Abbott RealTime HIV-1 assay) or

Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal

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 (

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.

3670-3800) and an alternative lower threshold of