Outcomes of patients failing first-line antiretroviral treatment in a decentralised programme led by nurses in the Democratic Republic of Congo

Background: Task-shifting of care and first-line treatment for people living with HIV (PLHIV) from doctors to nurses is feasible, effective and acceptable in sub-Saharan Africa. Since first-line resistance to antiretroviral therapy (ART) is increasing, comprehensive HIV care should be informed by viral load (VL) monitoring to ensure timely detection of treatment failure and switch to second-line ART if appropriate. Patients identified with a first elevated VL (FEVL) enter a cycle with extra counselling sessions, VL re-testing, and potential regimen switch, putting additional strain on scarce human resources. However, identification of treatment failure and its management remains largely doctor-led and there are limited results from programmes with nurse-led management of treatment failure. Health service-delivery in the Democratic Republic of Congo (DRC) is challenging in a weak health system, pressured by epidemics and political unrest. Despite low HIV prevalence in the capital Kinshasa (1.6%), many PLHIV present with advanced disease and early mortality is high. HIV care and treatment, VL testing and second-line switch in decentralised facilities in Kinshasa is exclusively managed by nurses, but results have so far not been documented. Methods Patient outcome data in three primary care facilities in Kinshasa, were routinely collected since ART introduction in 2002 and entered in the national Tier.net database. A protocol (Section A: Study protocol) was developed with detailed methods and procedures for a retrospective analysis of patient outcomes after having had a FEVL (≥1000 copies/ml). The protocol includes analysis of predictors for favourable outcomes (i.e. retained and with VL re-suppressed at 12 months after first high VL or administratively censored or transferred with suppressed VL), and analysis of compliance to existing protocols. The protocol received approval by ethics boards of the Ministry of Health of the DRC and the University of Cape Town. A structured literature review was conducted (Section B: Literature review), critically appraising peer-reviewed publications describing outcomes of PLHIV on ART after first-line failure in sub-Saharan Africa under programmatic conditions. The review included studies where treatment failure and switch were managed by medical doctors, due to paucity of data of nurse-led management of treatment failure. Predictors for outcomes after failure and switch to secondline were also extracted from available literature. A journal-ready manuscript (Section C: Manuscript) presents the findings of the analysis conducted on patients with a FEVL in three decentralised nurse-led facilities in Kinshasa, and predictors for favourable outcomes. Results Of 294 adults with FEVL who did not switch to second-line before confirmatory VL, 82% had a second VL (VL2) done within 24 months of FEVL at a median (interquartile range [IQR]) of 4.0 (3.1-5.6) months) after FEVL. Among patients with VL2 done, 69% had VL2 ≥1000copies/ml, of whom 75% switched to second-line a median of 1.1 (IQR, 0.7-2.0) months after VL2. Among the 85% of patients who were not deceased, LTFU or transferred out by 6 months after second-line switch, 82% had VL6 versus ≤3 months after FEVL and switching 1-3 versus ≤1 month after VL2 ≥ 1000copies/ml were independently associated with lower odds of a favourable outcome. Conclusion Exclusively nurse-managed detection of virologic failure and switch to second-line ART in decentralised health facilities yielded acceptable outcomes in our cohort in urban Kinshasa. Early detection and fast switch can help improve retention and viral suppression following virologic failure. Task-shifting along the viral load cascade is a feasible and safe strategy in settings with limited human resources and growing viral resistance

Improving access to antiretrovirals in rural South Africa – a call to action

South Africa already has the world’s biggest antiretroviral (ARV) programme. With the introduction of extended criteria for initiating ARVs, the National Department of Health wishes to increase the number of people on ARVs by around two million over the next 2 years. Adoption of a chronic disease management model, with extended task shifting, decentralisation and new approaches to distribution of ARVs, must be embraced if this is to be successfully achieved without huge increases in resources. In this editorial we discuss the need for change, and the current substantial blocks to progress (principally in prescribing and dispensing legislation) that contradict national treatment guidance and should be addressed as a matter of urgency. In addition, we draw attention to threatened regulatory changes that may further worsen the situation.

Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey.

BACKGROUND: HIV and TB programs have rapidly scaled-up over the past decade in Sub-Saharan Africa and uninterrupted supplies of those medicines are critical to their success. However, estimates of stock-outs are largely unknown. This survey aimed to estimate the extent of stock-outs of antiretroviral and TB medicines in public health facilities across South Africa, which has the world's largest antiretroviral treatment (ART) program and a rising multidrug-resistant TB epidemic. METHODS: We conducted a cross-sectional telephonic survey (October-December 2015) of public health facilities. Facilities were asked about the prevalence of stock-outs on the day of the survey and in the preceding three months, their duration and impact. RESULTS: Nationwide, of 3547 eligible health facilities, 79% (2804) could be reached telephonically. 88% (2463) participated and 4% (93) were excluded as they did not provide ART or TB treatment. Of the 2370 included facilities, 20% (485) reported a stock-out of at least 1 ARV and/or TB-related medicine on the day of contact and 36% (864) during the three months prior to contact, ranging from 74% (163/220) of health facilities in Mpumalanga to 12% (32/261) in the Western Cape province. These 864 facilities reported 1475 individual stock-outs, with one to fourteen different medicines out of stock per facility. Information on impact was provided in 98% (1449/1475) of stock-outs: 25% (366) resulted in a high impact outcome, where patients left the facility without medicine or were provided with an incomplete regimen. Of the 757 stock-outs that were resolved 70% (527) lasted longer than one month. INTERPRETATION: There was a high prevalence of stock-outs nationwide. Large interprovincial differences in stock-out occurrence, duration, and impact suggest differences in provincial ability to prevent, mitigate and cope within the same framework. End-user monitoring of the supply chain by patients and civil society has the potential to increase transparency and complement public sector monitoring systems

data_CS SAT.xls

Characteristics and treatment outcomes from TB patients in Guinea, Conakry. </p

Near point-of-care HIV viral load testing: Cascade after high viral load in suburban Yangon, Myanmar

Introduction HIV viral load (VL) testing in resource-limited settings is often centralised, limiting access. In Myanmar, we assessed outcomes according to VL access and the VL cascade (case management after a first high VL result) before and after near point-of-care (POC) VL was introduced. Methods Routine programme data from people living with HIV (PLHIV) on antiretroviral therapy (ART) were used. We assessed the odds of getting a VL test done by year. Attrition and mortality two years after ART initiation were compared between three groups of PLHIV with different access to VL testing using Kaplan-Meier analysis. We compared VL cascades in those with a first VL result before and after near POC VL testing became available. With logistic regression, predictors of confirmed virological failure after a first high VL in the POC era were explored. Results Among 4291 PLHIV who started ART between July 2009 and June 2018, 794 (18.5%) became eligible for VL testing when it was not available, 2388 (55.7%) when centralised laboratory-based VL testing was available, and 1109 (25.8%) when near POC VL testing was available. Between 2010 and 2019, the odds of getting a VL test among those eligible increased with each year (OR: 5.21 [95% CI: 4.95–5.48]). Attrition and mortality were not different in the three groups. When comparing PLHIV with a first VL result before and after implementation of the near POC VL testing, in the latter, more had a first VL test (92% versus 15%, pConclusion Near POC VL testing enabled rapid increase of VL coverage and a well-managed VL cascade in Myanmar

Near point-of-care HIV viral load testing: Cascade after high viral load in suburban Yangon, Myanmar.

IntroductionHIV viral load (VL) testing in resource-limited settings is often centralised, limiting access. In Myanmar, we assessed outcomes according to VL access and the VL cascade (case management after a first high VL result) before and after near point-of-care (POC) VL was introduced.MethodsRoutine programme data from people living with HIV (PLHIV) on antiretroviral therapy (ART) were used. We assessed the odds of getting a VL test done by year. Attrition and mortality two years after ART initiation were compared between three groups of PLHIV with different access to VL testing using Kaplan-Meier analysis. We compared VL cascades in those with a first VL result before and after near POC VL testing became available. With logistic regression, predictors of confirmed virological failure after a first high VL in the POC era were explored.ResultsAmong 4291 PLHIV who started ART between July 2009 and June 2018, 794 (18.5%) became eligible for VL testing when it was not available, 2388 (55.7%) when centralised laboratory-based VL testing was available, and 1109 (25.8%) when near POC VL testing was available. Between 2010 and 2019, the odds of getting a VL test among those eligible increased with each year (OR: 5.21 [95% CI: 4.95-5.48]). Attrition and mortality were not different in the three groups. When comparing PLHIV with a first VL result before and after implementation of the near POC VL testing, in the latter, more had a first VL test (92% versus 15%, pConclusionNear POC VL testing enabled rapid increase of VL coverage and a well-managed VL cascade in Myanmar

Community-supported self-administered tuberculosis treatment combined with active tuberculosis screening: a pilot experience in Conakry, Guinea

Directly observed treatment (DOT) for tuberculosis (TB) is recommended by the World Health Organization. However, DOT does not always meet patients’ preferences, burdens health facilities, and is hard to implement in settings where access to healthcare services is regularly interrupted. A model addressing these limitations of DOT is community-supported self-administered treatment (CS-SAT), in which patients who self-administer TB treatment receive regular visits from community members. Guinea is a country with a high TB burden, recurrent epidemics, and periodic socio-political unrest. We piloted a CS-SAT model for drug-susceptible TB patients in Conakry, led by community volunteers, who also conducted active TB case finding among household contacts and referrals for isoniazid preventive treatment (IPT) in children below 5 years old. We aimed to assess TB treatment outcomes of patients on CS-SAT and describe the number of patients identified with TB case finding and IPT provision. Prospectively enrolled bacteriologically confirmed TB patients, presenting to two facilities, received monthly TB medication. Community volunteers performed bi-weekly (initiation phase) and later monthly (continuation phase) home visits to verify treatment adherence, screen household contacts for TB, and assess IPT uptake in children under five. Among 359 enrolled TB patients, 237 (66.0%) were male, and 37 (10.3%) were HIV-positive. Three hundred forty (94.7%) participants had treatment success, seven (1.9%) died, seven (1.9%) experienced treatment failure, and five (1.4%) were lost-to-follow-up. Among 1585 household contacts screened for TB, 26 (1.6%) had TB symptoms, of whom five (19.2%) were diagnosed with pulmonary TB. IPT referral was done for 376 children from 198 households. In a challenging setting, where DOT is often not feasible, CS-SAT led to successful TB treatment outcomes and created an opportunity for active TB case finding and IPT referral. We recommend the Guinean CS-SAT model for implementation in similar settings