Reasons for using traditional and complementary care by people living with HIV on antiretroviral therapy and association with interrupted care: a mixed methods study in Eswatini.

The use of traditional, complementary, and alternative medicine (TCAM) can lead to delays and interruptions in the HIV continuum of care. This study explores reasons for TCAM use in people living with HIV on antiretroviral therapy (ART) in Eswatini and compares interrupted care between different types of TCAM users. Data were collected using surveys in the MaxART study (a test-and-treat trial) between 2014 and 2017 to assess the exposure, namely visiting a TCAM provider. Additionally, visit dates were retrieved from clinic records to assess the outcome, interrupted care. Open-ended questions were analysed with qualitative content analysis (n = 602) and closed questions with bivariable and multivariable analysis (n = 202). Out of 202 participants, 145 (72%) never used TCAM, 40 (20%) ever used, and 17 (8%) is currently using TCAM (diviners, herbalists, and religious healers). No differences in interrupted care were found comparing never (reference category), past (Odds Ratio: 1.31, 95% confidence interval: 0.63-2.72), and current users (1.34, 0.47-3.77), while adjusting for gender, time since HIV diagnosis, and time on ART. Contextual factors affecting the choice for TCAM were the influence of family, advice from the health facility, and religious beliefs. Individual factors include trust in biomedical care, type of illness, no need for additional care, and practical reasons such as financial means. In conclusion, individual and contextual factors influence the choice for TCAM. Interrupted care does not differ between never, past, and current users.

Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial.

BACKGROUND: Diabetes and hypertension are increasingly important population health challenges in Eswatini. Prior to this project, healthcare for these conditions was primarily provided through physician-led teams at tertiary care facilities and accessed by only a small fraction of people living with diabetes or hypertension. This trial tests and evaluates two community-based healthcare service models implemented at the national level, which involve health care personnel at primary care facilities and utilize the country's public sector community health worker cadre (the rural health motivators [RHMs]) to help generate demand for care. METHODS: This study is a cluster-randomized controlled trial with two treatment arms and one control arm. The unit of randomization is a primary healthcare facility along with all RHMs (and their corresponding service areas) assigned to the facility. A total of 84 primary healthcare facilities were randomized in a 1:1:1 ratio to the three study arms. The first treatment arm implements differentiated service delivery (DSD) models at the clinic and community levels with the objective of improving treatment uptake and adherence among clients with diabetes or hypertension. In the second treatment arm, community distribution points (CDPs), which previously targeted clients living with human immunodeficiency virus, extend their services to clients with diabetes or hypertension by allowing them to pick up medications and obtain routine nurse-led follow-up visits in their community rather than at the healthcare facility. In both treatment arms, RHMs visit households regularly, screen clients at risk, provide personalized counseling, and refer clients to either primary care clinics or the nearest CDP. In the control arm, primary care clinics provide diabetes and hypertension care services but without the involvement of RHMs and the implementation of DSD models or CDPs. The primary endpoints are mean glycated hemoglobin (HbA1c) and systolic blood pressure among adults aged 40 years and older living with diabetes or hypertension, respectively. These endpoints will be assessed through a household survey in the RHM service areas. In addition to the health impact evaluation, we will conduct studies on cost-effectiveness, syndemics, and the intervention's implementation processes. DISCUSSION: This study has the ambition to assist the Eswatini government in selecting the most effective delivery model for diabetes and hypertension care. The evidence generated with this national-level cluster-randomized controlled trial may also prove useful to policy makers in the wider Sub-Saharan African region. TRIAL REGISTRATION: NCT04183413. Trial registration date: December 3, 2019.

Reasons for, and factors associated with, positive HIV retesting: a cross-sectional study in Eswatini.

Eswatini has a high HIV prevalence but has made progress towards improving HIV-status awareness, ART uptake and viral suppression. However, there is still a delay in ART initiation, which could partly be attributed to positive HIV-retesting. This study examines reasons for, and factors associated with, positive HIV-retesting among MaxART participants in Eswatini. Data from 601 participants is included in this cross-sectional study. Descriptive statistics and logistic regressions were used. Of the participants, 32.8% has ever retested after a previous positive result. Most participants who retested did this because they could not accept their results (61.9% of all retesters). Other main reasons are related to external influences, gender or the progression of their HIV infection (respectively 18.3%, 10.2%, and 6.1% of all retesters). Participants without a current partner and participants with less time since their first positive test have lower odds of retesting. To decrease retesting and reduce the delay in ART initiation resulting from it, efforts could be made on increasing the acceptance of positive HIV results. Providing more information on the process of testing and importance of early ART initiation, could be part of the solution.

Neighbourhood risk factors of recurrent tuberculosis in Cape Town: a cohort study using geocoded notification data.

BACKGROUND: Individuals with a history of tuberculosis (TB) disease are at higher risk of developing a subsequent episode than those without. Considering the role of social and environmental factors in tuberculosis, we assessed neighbourhood-level risk factors associated with recurrent tuberculosis in Cape Town, South Africa. METHODS: This cohort consisted of patients who completed treatment for their first drug-sensitive TB episode between 2003 and 2015. Addresses were geocoded at neighbourhood level. Data on neighbourhood-level factors were obtained from the Census 2011 (household size, population density) and the City of Cape Town (Socio-Economic Index). Neighbourhood-level TB burden was calculated annually by dividing the number of notified TB episodes by the population in that neighbourhood. Multilevel survival analysis was performed with the outcome recurrent TB, defined as a second episode of TB, and controlling for individual-level risk factors (age, gender and time since first episode in years). Follow-up ended at the second episode, or on 31 December 2015, whichever came first. RESULTS: The study included 173 421 patients from 700 neighbourhoods. Higher Socio-Economic Index was associated with a lower risk of recurrence compared with average Socio-Economic Index. An increased risk was found for higher household size and TB burden, with an increase of 20% for every additional person in mean household size and 10% for every additional TB episode/100 inhabitants. No association was found with population density. CONCLUSION: Recurrent TB was associated with increased household size and TB burden at neighbourhood level. These findings could be used to target TB screening activities.

Safety and immunogenicity of co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in Gabonese adults: a randomised, controlled, double-blind, phase 1 dose-escalation trial.

BACKGROUND: Hookworms cause substantial morbidity in children and women of reproductive age. The control strategy of mass drug administration is suboptimal, hence the need for a vaccine. Necator americanus aspartic protease-1 (Na-APR-1) and N americanus glutathione S-transferase-1 (Na-GST-1) are involved in the digestion and detoxification of haemoglobin in the hookworm digestive tract. In animal models, vaccination against these antigens resulted in protection from challenge infection. Both vaccine candidates were shown to be safe and well tolerated when administered separately to healthy adults. We assessed the safety and immunogenicity of co-administered Na-GST-1 and Na-APR-1 (M74) vaccines in healthy Gabonese adults. METHODS: This randomised, controlled, double-blind, phase 1, dose-escalation trial was done at the Centre de Recherches Médicales de Lambaréné, in a region of Gabon where N americanus and other helminths are prevalent. Healthy adults aged 18-50 years and living in Lambaréné or the surrounding areas were recruited to the study. Participants were enrolled consecutively into two dose cohorts (30 µg or 100 µg of the experimental vaccines) and randomly assigned in blocks (block size four) to receive three doses of either co-administered Na-GST-1 plus Na-APR-1 (M74; 30 µg or 100 µg of each), adjuvanted with Alhydrogel (aluminium hydroxide gel suspension) together with an aqueous formulation of glucopyranosyl lipid A, or hepatitis B vaccine plus saline (control group). Vaccines were administered intramuscularly on days 0, 28, and 180. The primary endpoint was safety, with immunogenicity a secondary endpoint. The intention-to-treat population was used for safety analyses, whereas for immunogenicity analyses, the per-protocol population was used (participants who received all scheduled vaccinations). Control vaccine recipients for both dose cohorts were combined for the analyses. The trial is registered with ClinicalTrials.gov, NCT02126462. FINDINGS: Between Oct 27, 2014, and Jan 31, 2015, 56 individuals were screened for eligibility, of whom 32 were enrolled and randomly assigned to one of the three study groups (12 each in the 30 µg and 100 µg experimental vaccine groups and eight in the control group). Both study vaccines were well tolerated in both dose groups. The most common adverse events were mild-to-moderate injection-site pain, headache, myalgia, and nausea. No severe or serious adverse events related to the vaccines were recorded. 52 unsolicited vaccine-related adverse events occurred during the study, but there was no difference in frequency between vaccine groups. IgG antibodies were induced to each of the vaccine antigens, with mean IgG levels increasing after each vaccination. Vaccination with 100 µg of each vaccine antigen consistently induced IgG seroconversion (IgG levels above the reactivity threshold). Peak IgG responses were observed 2 weeks after the third vaccine dose for both antigens, with all participants who received the 100 µg doses seroconverting at that timepoint. IgG levels steadily declined until the final study visit 6 months after the third vaccination, although they remained significantly higher than baseline in the 100 µg dose group. INTERPRETATION: Vaccination with recombinant Na-GST-1 and Na-APR-1 (M74) in healthy adults living in N americanus-endemic areas of Gabon was safe and induced IgG to each antigen. To our knowledge, this study is the first to report results of Na-APR-1 (M74) co-administered with Alhydrogel in participants from an N americanus-endemic area. Further clinical development of these vaccines should involve efficacy studies. FUNDING: European Union Seventh Framework Programme.

Changes in disclosure, adherence and healthcare interactions after the introduction of immediate ART initiation: an analysis of patient experiences in Swaziland.

INTRODUCTION: There are concerns that immediate ART initiation (regardless of CD4 count) negatively affects HIV status disclosure, ART adherence and healthcare interactions. We assessed changes in these factors after the 'Early access to ART for all' intervention, a universal test-and-treat study in Swaziland. METHODS: We recruited two samples of participants between 2014 and 2017. The first group was interviewed before the intervention (control); the second group at the implementation and 6 months thereafter (intervention). RESULTS: High levels of disclosure to partners (controls and intervention: 94%) and family members (controls: 78%, intervention: 79%) were reported, and high levels of adherence (85% did not miss a dose among the controls, 84% in the intervention group). There were no changes in patients reporting feeling pressured to initiate ART (controls: 10%, intervention: 11%). The quality of interaction with healthcare workers improved after the intervention; healthcare workers explained more often the choice of ART initiation (controls: 88%, intervention: 93%) and the meaning of both CD4 and viral load test results (controls: 15%, intervention: 47%). More patients in the intervention group reported receiving test results (controls: 13%, intervention: 46%). We observed no changes in disclosure, adherence or patient experiences 6 months into the intervention compared to its start. CONCLUSION: Our results suggest that both reported adherence and disclosure levels remain high after the introduction of immediate ART in Swaziland. We observed an improvement in the healthcare interactions, possibly due to training at participating facilities, which will be an important element for a successful roll-out of immediate ART.

OBJECTIF: Il y a des craintes que l'initiation de l'ART immédiat (quel que soit la numération des CD4) affecte négativement la divulgation du statut VIH, l'adhésion au traitement et les interactions avec les soins de santé. Nous avons évalué les modifications de ces facteurs après l'intervention «Accès précoce à l'ART pour tous¼, une étude universelle de dépistage et traitement au Swaziland. MÉTHODES: Nous avons recruté deux échantillons de participants entre 2014 et 2017. Le premier groupe a été interviewé avant l'intervention (témoins), le deuxième groupe lors de l'implémentation et six mois après (intervention). RÉSULTATS: Des niveaux élevés de divulgation aux partenaires (témoin et intervention: 94%) et aux membres de la famille (témoins: 78%, intervention: 79%) ont été rapportés, ainsi que des taux élevés d'adhésion (85% n'ont pas oublié une dose chez les témoins, 84% dans le groupe d'intervention). Aucun changement n'a été observé chez les patients déclarant se sentir poussés à commencer l'ART (témoins: 10%, intervention: 11%). La qualité de l'interaction avec les agents de la santé s'est améliorée après l'intervention; les agents de santé expliquent plus souvent le choix de l'initiation de l'ART (témoins: 88%, intervention: 93%) et la signification des résultats des tests de CD4 et de la charge virale (témoins: 15%, intervention: 47%). Plus de patients du groupe d'intervention ont déclaré avoir reçu les résultats des tests (témoins: 13%, intervention: 46%). Nous n'avons observé aucun changement dans la divulgation, l'adhésion ou l'expérience des patients six mois après le début de l'intervention par rapport à son début. CONCLUSION: Nos résultats suggèrent que les taux d'adhésion et de divulgation rapportés restent élevés après l'introduction de l'ART immédiat au Swaziland. Nous avons observé une amélioration des interactions avec les soins de santé, probablement due à la formation dispensée dans les établissements participants, ce qui constituera un élément important pour le succès du déploiement de l'ART immédiat.