Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda.

INTRODUCTION: Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease. METHODS AND ANALYSIS: This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner's ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension. ETHICS AND DISSEMINATION: The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications. TRIAL REGISTRATION NUMBER: ISRCTN15319595.

Implementing integrated care clinics for HIV-infection, diabetes and hypertension in Uganda (INTE-AFRICA): process evaluation of a cluster randomised controlled trial.

BACKGROUND: Sub-Saharan Africa is experiencing a dual burden of chronic human immunodeficiency virus and non-communicable diseases. A pragmatic parallel arm cluster randomised trial (INTE-AFRICA) scaled up 'one-stop' integrated care clinics for HIV-infection, diabetes and hypertension at selected facilities in Uganda. These clinics operated integrated health education and concurrent management of HIV, hypertension and diabetes. A process evaluation (PE) aimed to explore the experiences, attitudes and practices of a wide variety of stakeholders during implementation and to develop an understanding of the impact of broader structural and contextual factors on the process of service integration. METHODS: The PE was conducted in one integrated care clinic, and consisted of 48 in-depth interviews with stakeholders (patients, healthcare providers, policy-makers, international organisation, and clinical researchers); three focus group discussions with community leaders and members (n = 15); and 8 h of clinic-based observation. An inductive analytical approach collected and analysed the data using the Empirical Phenomenological Psychological five-step method. Bronfenbrenner's ecological framework was subsequently used to conceptualise integrated care across multiple contextual levels (macro, meso, micro). RESULTS: Four main themes emerged; Implementing the integrated care model within healthcare facilities enhances detection of NCDs and comprehensive co-morbid care; Challenges of NCD drug supply chains; HIV stigma reduction over time, and Health education talks as a mechanism for change. Positive aspects of integrated care centred on the avoidance of duplication of care processes; increased capacity for screening, diagnosis and treatment of previously undiagnosed comorbid conditions; and broadening of skills of health workers to manage multiple conditions. Patients were motivated to continue receiving integrated care, despite frequent NCD drug stock-outs; and development of peer initiatives to purchase NCD drugs. Initial concerns about potential disruption of HIV care were overcome, leading to staff motivation to continue delivering integrated care. CONCLUSIONS: Implementing integrated care has the potential to sustainably reduce duplication of services, improve retention in care and treatment adherence for co/multi-morbid patients, encourage knowledge-sharing between patients and providers, and reduce HIV stigma. TRIAL REGISTRATION NUMBER: ISRCTN43896688.

Culturally adapted motivational interviewing with cognitive behavior therapy and mindfulness-based relapse prevention for substance use disorder in Pakistan (CAMAIB): protocol for a feasibility factorial randomised controlled trial.

BACKGROUND: The use of psychoactive substances significantly impacts the health, social and economic aspects of families, communities and nations. There is a need to develop and test psychological interventions aimed for individuals with substance use disorder (SUD) in lower- and middle-income countries (LMICs), such as in Pakistan. The aim of this exploratory trial is to test the feasibility and acceptability of two culturally adapted psychological interventions in a factorial randomised controlled trial (RCT). METHODS: The proposed project will be conducted in three phases. The first phase of the study will focus on cultural adaptation of the interventions through qualitative interviews with key stakeholders. The second phase will be to refine and produce manually assisted interventions. Third and last stage would be to assess the feasibility of the culturally adapted interventions through a factorial RCT. The study will be carried out in Karachi, Hyderabad, Peshawar, Lahore and Rawalpindi, Pakistan. Recruitment of participants will take place from primary care and volunteer organisations/drug rehabilitation centres. A total of 260 individuals diagnosed with SUD (n = 65) in each of the four arms will be recruited. The intervention will be delivered weekly over a period of 12 weeks in both individual and group settings. Assessments will be carried out at baseline, at 12th week (after completion of intervention) and 24th week post-randomisation. The analysis will determine the feasibility of recruitment, randomisation, retention and intervention delivery. Acceptability of intervention will be determined in terms of adherence to intervention, i.e. the mean number of sessions attended, number of home assignments completed, attrition rates, as well as through process evaluation to understand the implementation process, context, participants' satisfaction, and impact of the study intervention. The health resource use and impact on the quality of life will be established through health economic data. DISCUSSION: This study will provide evidence for feasibility and acceptability of culturally adapted manually assisted psychological interventions for individuals with SUD in the context of Pakistan. The study will have clinical implications if intervention is proven feasible and acceptable. TRIAL REGISTRATION: Name of the registry: ClinicalTrials.gov, Trial registration number: NCT04885569 , Date of registration: 25th April 2021.

The acceptability of integrated healthcare services for HIV and non-communicable diseases: experiences from patients and healthcare workers in Tanzania.

BACKGROUND: In sub-Saharan Africa, the prevalence of non-communicable diseases (NCDs) has risen sharply amidst a high burden of communicable diseases. An integrated approach to HIV and NCD care offers the potential of strengthening disease control programmes. We used qualitative methods to explore patients' and care-providers' experiences and perspectives on the acceptability of integrated care for HIV-infection, diabetes mellitus (DM), and hypertension (HT) in Tanzania. METHODS: A qualitative study was conducted in selected health facilities in Dar es Salaam and Coastal regions, which had started to provide integrated care and management for HIV, DM, and HT using a single research clinic for patients with one or more of these conditions. In-depth interviews were held with patients and healthcare providers at three time points: At enrolment (prior to the patient receiving integrated care, at the mid-line and at the study end). A minimum of 16 patients and 12 healthcare providers were sampled for each time point. Observation was also carried out in the respective clinics during pre- and mid-line phases. The Theoretical Framework of Acceptability (TFA) underpinned the structure and interpretation of the combined qualitative and observational data sets. RESULTS: Patients and healthcare providers revealed a positive attitude towards the integrated care delivery model at the mid-line and at study end-time points. High acceptability was related to increased exposure to service integration in terms of satisfaction with the clinic setup, seating arrangements and the provision of medical care services. Satisfaction also centred on the patients' freedom to move from one service point to another, and to discuss the services and their own health status amongst themselves. Adherence to medication and scheduling of clinic appointments appeared central to the patient-provider relationship as an aspect in the provision of quality services. Multi-condition health education, patient time and cost-saving, and detection of undiagnosed disease conditions emerged as benefits. On the other hand, a few challenges included long waiting times and limited privacy in lower and periphery health facilities due to infrastructural limitations. CONCLUSION: The study reveals a continued high level of acceptability of the integrated care model among study participants in Tanzania. This calls for evaluation in a larger and a comparative study. Nevertheless, much more concerted efforts are necessary to address structural challenges and maximise privacy and confidentiality.

Integrated healthcare services for HIV, diabetes mellitus and hypertension in selected health facilities in Kampala and Wakiso districts, Uganda: A qualitative methods study.

Health policies in Africa are shifting towards integrated care services for chronic conditions, but in parts of Africa robust evidence on effectiveness is limited. We assessed the integration of vertical health services for HIV, diabetes and hypertension provided in a feasibility study within five health facilities in Uganda. From November 2018 to January 2020, we conducted a series of three in-depth interviews with 31, 29 and 24 service users attending the integrated clinics within Kampala and Wakiso districts. Ten healthcare workers were interviewed twice during the same period. Interviews were conducted in Luganda, translated into English, and analysed thematically using the concepts of availability, affordability and acceptability. All participants reported shortages of diabetes and hypertension drugs and diagnostic equipment prior to the establishment of the integrated clinics. These shortages were mostly addressed in the integrated clinics through a drugs buffer. Integration did not affect the already good provision of anti-retroviral therapy. The cost of transport reduced because of fewer clinic visits after integration. Healthcare workers reported that the main cause of non-adherence among users with diabetes and hypertension was poverty. Participants with diabetes and hypertension reported they could not afford private clinical investigations or purchase drugs prior to the establishment of the integrated clinics. The strengthening of drug supply for non-communicable conditions in the integrated clinics was welcomed. Most participants observed that the integrated clinic reduced feelings of stigma for those living with HIV. Sharing the clinic afforded privacy about an individual's condition, and users were comfortable with the waiting room sitting arrangement. We found that integrating non-communicable disease and HIV care had benefits for all users. Integrated care could be an effective model of care if service users have access to a reliable supply of basic medicines for both HIV and non-communicable disease conditions.

Integrating diabetes, hypertension and HIV care in sub-Saharan Africa: a Delphi consensus study on international best practice.

BACKGROUND: Although HIV continues to have a high prevalence among adults in sub-Saharan Africa (SSA), the burden of noncommunicable diseases (NCD) such as diabetes and hypertension is increasing rapidly. There is an urgent need to expand the capacity of healthcare systems in SSA to provide NCD services and scale up existing chronic care management pathways. The aim of this study was to identify key components, outcomes, and best practice in integrated service provision for the prevention, identification and treatment of HIV, hypertension and diabetes. METHODS: An international, multi stakeholder e-Delphi consensus study was conducted over two successive rounds. In Round 1, 24 participants were asked to score 27 statements, under the headings 'Service Provision' and 'Benefits of Integration', by importance. In Round 2, the 16 participants who completed Round 1 were shown the distribution of scores from other participants along with the score that they attributed to an outcome and were asked to reflect on the score they gave, based on the scores of the other participants and then to rescore if they wished to. Nine participants completed Round 2. RESULTS: Based on the Round 1 ranking, 19 of the 27 outcomes met the 70% threshold for consensus. Four additional outcomes suggested by participants in Round 1 were added to Round 2, and upon review by participants, 22 of the 31 outcomes met the consensus threshold. The five items participants scored from 7 to 9 in both rounds as essential for effective integrated healthcare delivery of health services for chronic conditions were improved data collection and surveillance of NCDs among people living with HIV to inform integrated NCD/HIV programme management, strengthened drug procurement systems, availability of equipment and access to relevant blood tests, health education for all chronic conditions, and enhanced continuity of care for patients with multimorbidity. CONCLUSIONS: This study highlights the outcomes which may form key components of future complex interventions to define a model of integrated healthcare delivery for diabetes, hypertension and HIV in sub-Saharan Africa.

Strengthening integration of chronic care in Africa: protocol for the qualitative process evaluation of integrated HIV, diabetes and hypertension care in a cluster randomised controlled trial in Tanzania and Uganda.

INTRODUCTION: In sub-Saharan Africa, the burden of non-communicable diseases (NCDs), particularly diabetes mellitus (DM) and hypertension, has increased rapidly in recent years, although HIV infection remains a leading cause of death among young-middle-aged adults. Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV. There is an urgent need to expand healthcare capacity to provide integrated services to address these chronic conditions. METHODS AND ANALYSIS: This protocol describes procedures for a qualitative process evaluation of INTE-AFRICA, a cluster randomised trial comparing integrated health service provision for HIV infection, DM and hypertension, to the current stand-alone vertical care. Interviews, focus group discussions and observations of consultations and other care processes in two clinics (in Tanzania, Uganda) will be used to explore the experiences of stakeholders. These stakeholders will include health service users, policy-makers, healthcare providers, community leaders and members, researchers, non-governmental and international organisations. The exploration will be carried out during the implementation of the project, alongside an understanding of the impact of broader structural and contextual factors. ETHICS AND DISSEMINATION: Ethical approval was granted by the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania) and TASO Research Ethics Committee (Uganda) in 2020. The evaluation will provide the opportunity to document the implementation of integration over several timepoints (6, 12 and 18 months) and refine integrated service provision prior to scale up. This synergistic approach to evaluate, understand and respond will support service integration and inform monitoring, policy and practice development efforts to involve and educate communities in Tanzania and Uganda. It will create a model of care and a platform of good practices and lessons learnt for other countries implementing integrated and decentralised community health services. TRIAL REGISTRATION NUMBER: ISRCTN43896688; Pre-results.

Home Manufacture of Drugs: An Online Investigation and a Toxicological Reality Check of Online Discussions on Drug Chemistry.

Emerging trends in market dynamics and the use of new psychoactive substances are both a public health concern and a complex regulatory issue. One novel area of investigation is the availability of homemade opioids, amphetamines and dissociatives, and the potential fueling of interest in clandestine home manufacture of drugs via the Internet. We illustrate here how online communal folk pharmacology of homemade drugs on drug website forums may actually inform home manufacture practices or contribute to the reduction of harms associated with this practice. Discrepancies between online information around purification and making homemade drugs safer, and the synthesis of the same substances in a proper laboratory environment, exist. Moderation and shutdown of synthesis queries and discussions online are grounded in drug websites adhering to harm-reduction principles by facilitating discussions around purification of homemade drugs only. Drug discussion forums should consider reevaluating their policies on chemistry discussions in aiming to reach people who cannot or will not refrain from cooking their own drugs with credible information that may contribute to reductions in the harms associated with this practice.

"Trip-Sitting" in the Black Hole: A Netnographic Study of Dissociation and Indigenous Harm Reduction.

An array of dissociative novel psychoactive substances, including "methoxetamine," "3-MeO-PCP," and "methoxphenidine," have emerged as substitutes for the illicit substance "ketamine." A netographic research methodology aimed to describe online, dissociative novel psychoactive substance users' perceptions of risk, informed knowledge around use, and indigenous harm-reduction practices as advocated within online drug fora, so as to provide credible information which can be used to inform public online health education and drug prevention. Systematic Internet searches were performed using the terms "synthetic dissociative," "methoxetamine," "methoxphenidine," "diphenidine," "3-MeO-PCP," "4-MeO-PCP," "2-MDP," and "dissociative research chemical" in combination with "forum." Following screening of 3,476 forum threads with removal of duplicates and exclusion criteria, 90 user trip reports and 115 fora threads from seven drug fora websites were analyzed by conducting content analysis. Five themes emerged with 43 categories. The findings illustrated how forum activity within the cyber drug user community disseminated and exchanged "communal folk pharmacology" relating to the use of dissociative novel psychoactive substances. Further research and consistent monitoring of Internet drug fora are advised to explore variations in harm-reduction tactics throughout dissociative NPS populations, and to consider how existing harm-reduction initiatives are influencing these hard-to-reach groups.

Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions.

BACKGROUND: Communal online folk pharmacology fuels the drive for short cuts in attaining muscle enhancement, fat loss, and youthful skin. OBJECTIVES: The study used "netnography" to explore female use of CJC-1295, a synthetic growth hormone analogue from the perspectives contained in Internet forum activity. METHODS: A systematic Internet search was conducted using variation of the term "CJC-1295"; and combined with "forum." Ninety-six hits related to bodybuilding websites where CJC-1295 was mentioned. Following application of exclusion criteria to confine to female use and evidence of forum activity, 9 sites remained. These were searched internally for reference to CJC-1295. Twenty-three discussion threads relating to female use of CJC-1295 formed the end data set, and analyzed using the Empirical Phenomenological Psychological method. RESULTS: Forum users appeared well versed and experienced in the poly use of performance and image drug supplementation. Choice to use CJC-1295 centered on weight loss, muscle enhancement, youthful skin, improved sleep, and injury healing. Concerns were described relating to female consequences of use given gender variations in growth hormone pulses affecting estimation of dosage, cycling, and long-term consequences. CONCLUSIONS: Public health interventions should consider female self-medicating use of synthetic growth hormone within a repertoire of product supplementation, and related adverse health consequences.

"Vintage meds": a netnographic study of user decision-making, home preparation, and consumptive patterns of laudanum.

BACKGROUND: Reviews have commented on rising clandestine manufacture of opiate drug solutions for injecting, and to a lesser extent for oral use. Very little is known about user attempts to culture poppy seeds, widely available on the internet for manufacture of long acting medium-high potency oral solutions, both as poppy seed tea or as opium tincture (laudanum). OBJECTIVES: A netnographic research methodology aimed to provide online consumer insight into user sourcing and decision influences, experiences of home manufacture of laudanum, utilization of opium tincture recipes, and consumptive patterns. METHODS: A systematic internet search was conducted using the terms: "Laudanum," "Opium tincture," and "Tincture of Opium" in combination with "forum." Following screening of 810 forum threads with exclusion criteria and removal of duplicates, 75 fora threads on 6 online drug fora were analyzed using the empirical phenomenological psychological method. Four themes were generated. RESULTS: Findings illustrated the underpinning of user reminiscing about Victorian use of standardized laudanum, long duration shelf life, and medicinal use for opiate withdrawals with intentions to prepare. Preparation of famous recipes and use of authentic storage bottles boosted nostalgia. Participants appeared well versed in kitchen chemistry processes. Discussions centered on type and amount of alcohol used, use of additives to promote palatability and intoxication effect, homogenization of poppy seeds, and double extraction using opium tincture. Lack of detail available on intoxication experiences, with tentative dosage advised. CONCLUSIONS: Development of targeted and credible "counterpublic" harm reduction initiatives situated within online consumerism of communal drug knowledge is warranted.

An in-depth case examination of an exotic dancer's experience of melanotan.

BACKGROUND: Cultural values placed on tanned skin equating with perceived health and attractiveness in the Western world have stimulated the development, sale and use of synthetic tanning agents. These agents are synthetic analogues of the naturally occurring melanocyte-stimulating hormones (α-MSHs) which stimulate melanogenesis or pigmentation of the skin. There is a lack of research on prevalence of use, user experiences and outcomes, despite evident 'health marketability' and diffusion of use via the Internet. METHODS: We present a unique, intensive, holistic and exploratory single case study analysis of an active user's experiences of synthetic tanning product's labelled as melanotan, with rich description of the case's meanings and identities attached to being tanned, motives for use, injecting experiences and practices, sourcing routes, outcomes and future intentions to use. RESULTS: The case, an exotic dancer, had no prior drug injecting experience and did not identify as 'injecting drug user'. Introduction to injecting of synthetic tanning products occurred with peer assistance. She was conscious of safe injecting practices, which were described as not using needles twice, keeping the product refrigerated, disinfecting and rotating injecting sites, and using sterilised water to dissolve the product. She was aware of synthetic tanning products being unlicensed, unregulated and possibly contaminated. She appeared assured in the self-administration of double dosage and self-management of nausea with benzodiazepines and by injecting before sleep. Experiences of synthetic tanning were positive, with reported feelings of enhanced self-confidence and perceived attractiveness grounded in her confidence in the product's effectiveness to achieve a desired darkened skin tone. No long term or chronic negative outcomes were reported. Development of tolerance and awareness of dependence on synthetic tanning agents was described. CONCLUSION: We discuss her expert account as it relates to the synthetic tanning product outcomes, risk heuristics, sourcing routes and make recommendations for policy.

The Irish Traveller community: social capital and drug use.

The Irish Traveller community experiences severe marginalization, poverty, discrimination, and compromised health. Research indicates a distinct lack of structural understanding of Traveller negotiation of conflict within dominant sedentarist societal norms and values. Gender-based focus groups (n = 12) of Travellers (n = 57) were conducted as part of a large scale regional needs analysis for Travellers and substance use in Ireland and analyzed thematically using the social capital framework in terms of Traveller experiences within settled communities, exposure to drugs, and drug using contexts. Discriminatory experiences, low levels of institutional trust, and an influx of drug activity in Traveller communities are contributing to the neutralization of drug taking risk and the development of normative and reciprocal relationships in drug activities. A holistic, inter-governmental approach is needed to address social exclusion factors by reducing marginalization, preserving the Traveller ethnic identity, minimizing racist and discriminatory instances, understanding the Traveller risk environment, and fostering inclusive relationships with settled communities.