Stigma-directed services (Stig2Health) to improve ‘linkage to care’ for people living with HIV in rural Tanzania: study protocol for a nested pre-post implementation study within the Kilombero and Ulanga Antiretroviral Cohort

Background: HIV-related stigma is a major barrier to the timely linkage and retention of patients in HIV care in sub-Saharan Africa, where most people living with HIV/AIDS reside. In this implementation study we aim to evaluate the effect of stigma-directed services on linkage to care and other health outcomes in newly diagnosed HIV-positive patients. Methods: In a nested project of the Kilombero and Ulanga Antiretroviral Cohort in rural Tanzania, we conduct a prospective observational pre-post study to assess the impact of a bundle of stigma-directed services for newly diagnosed HIV positive patients. Stigma-directed services, delivered by a lay person living with HIV, are i) post-test counseling, ii) post-test video-assisted teaching, iii) group support therapy and group health education, and iv) mobile health. Patients receiving stigma services (enrolled from 1 st February 2020 to 31 st August 2021) are compared to a historical control receiving the standard of care (enrolled from 1 st July 2017 to 1 st February 2019). The primary outcome is 'linkage to care'. Secondary endpoints are retention in care, viral suppression, death and clinical failure at 6-12 months (up to 31 st August 2022). Self-reported stigma and depression are assessed using the Berger Stigma scale and the PHQ-9 questionnaire, respectively. The sample size calculation was based on cohort data from 2018. Assuming a pre-intervention cohort of 511 newly diagnosed adults of whom 346 (68%) were in care and on antiretroviral treatment (ART) at 2 months, a 10% increase in linkage (from 70 to 80%), a two-sided type I error rate of 5%, and 90% power, 321 adults are required for the post-implementation group. Discussion: We expect that integration of stigma-directed services leads to an increase of proportions of patients in care and on ART. The findings will provide guidance on how to integrate stigma-directed services into routine care in rural sub-Saharan Africa.

sub-Saharan Africa is home to almost three-quarters of all individuals living with HIV/AIDS in the world. Yet, sub-Saharan Africa also has one of the most severe shortages of trained medical and behavioral health care workers in the world to tackle the needs of the huge epidemic. This gap between HIV-related treatment needs and staff resources has presented the need for “task shifting” or “task sharing,” defined as delegating tasks to less specialized health care workers, and/or considering ways of sharing tasks across a clinical team. Task shifting has been a key implementation strategy for increasing access to antiretroviral therapy (ART) to treat HIV/AIDS across sub-Saharan Africa. For behavioral medicine, task shifting can be used for the delivery of behavioral health interventions for HIV medication adherence and co-occurring mental health problems. In this chapter, we aim to demonstrate how the efforts to use task shifting for rolling out ART programs in sub-Saharan Africa can inform behavioral medicine task shifting efforts to expand access to evidence-based ART adherence counseling and mental health interventions in HIV care in sub-Saharan Africa. We focus specifically on examples of task shifting cognitive behavioral therapy (CBT) for ART adherence, depression, and substance use among individuals living with HIV/AIDS in sub-Saharan Africa. Although there have been few examples to date of task shifting CBT in the context of HIV care in sub-Saharan Africa, we use these promising early examples to inform future considerations for adapting and implementing CBT using a task shifting model in this population.

IntroductionThe provision of HIV treatment and care in sub-Saharan Africa faces multiple challenges, including weak health systems and attrition of trained health workers. One potential response to overcome these challenges has been to engage community health workers (CHWs).MethodologyA systematic literature search for quantitative and qualitative studies describing the role and outcomes of CHWs in HIV care between inception and December 2012 in sub-Saharan Africa was performed in the following databases: PubMed, PsychINFO, Embase, Web of Science, JSTOR, WHOLIS, Google Scholar and SAGE journals online. Bibliographies of included articles were also searched. A narrative synthesis approach was used to analyze common emerging themes on the role and outcomes of CHWs in HIV care in sub-Saharan Africa.ResultsIn total, 21 studies met the inclusion criteria, documenting a range of tasks performed by CHWs. These included patient support (counselling, home-based care, education, adherence support and livelihood support) and health service support (screening, referral and health service organization and surveillance). CHWs were reported to enhance the reach, uptake and quality of HIV services, as well as the dignity, quality of life and retention in care of people living with HIV. The presence of CHWs in clinics was reported to reduce waiting times, streamline patient flow and reduce the workload of health workers. Clinical outcomes appeared not to be compromised, with no differences in virologic failure and mortality comparing patients under community-based and those under facility-based care. Despite these benefits, CHWs faced challenges related to lack of recognition, remuneration and involvement in decision making.ConclusionsCHWs can clearly contribute to HIV services delivery and strengthen human resource capacity in sub-Saharan Africa. For their contribution to be sustained, CHWs need to be recognized, remunerated and integrated in wider health systems. Further research focusing on comparative costs of CHW interventions and successful models for mainstreaming CHWs into wider health systems is needed.

Whilst the discourse of palliative care in HIV management is largely documented and regarded as being an essential component, various authors have further argued that within the context of HIV care in sub-Saharan Africa, palliative care and exploration of the dimensions thereof is largely lacking. This article presents the lived experiences of nurses involved in palliative care, thus providing the perspective of nurses and the multi-faceted dimensions of the nature of caring inherent. This study explored the respondents' understanding of the concepts 'caring' and 'terminal patient' and described the experiences of nurses caring for terminally-ill patients with HIV and how these experiences influence the nature of care rendered. Qualitative research using Husserl's approach of phenomenology design underpinned the study and Giorgi's steps of analysis were used to make meaning of the data. The concept 'caring' was experienced by the nurses as transforming the patients' quality of life through supportive care and hope for life. Palliative care made the nurses conscious of their own mortality, enabling them to be more sensitive, compassionate and dedicated to caring for their patients. The findings described the social networking that enabled nurses to collaborate with colleagues in the interdisciplinary teams and shared knowledge, skills and support within the palliative care team in order to optimise patient outcomes. Nurses with prolonged involvement in caring for terminally-ill patients with HIV experienced helplessness and emotional stress. Recommendations based on the results are that training in psychological and holistic care of the patient, professional counselling and stress management services are needed to support the nurse in this context.

BackgroundSeveral interventions to improve long term retention (12 months and above) on treatment have been rigorously evaluated in Sub-Saharan Africa (SSA). However, research on interventions to improve retention of patients in the early stages of treatment (6 months) during this era of Universal Test and Treat has only recently emerged. The aim of this study is to systematically map evidence of interventions used to improve early retention of patients in antiretroviral therapy (ART) programmes in SSA.MethodsWe searched PubMed, EMBASE and Cochrane electronic databases to identify studies describing interventions aimed at improving early retention in ART treatment. We applied the methodological frameworks by Arksey and O’Malley (2005) and Levac et al. (2010). We also followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Interventions were categorized according to key broad areas in the existing literature.ResultsA total of 2,241 articles were identified of which 19 met the inclusion criteria and were eligible for this review, with the majority either being randomized control trials 32% (n = 6) or cohort studies 32% (n = 6). The studies reviewed were conducted in 11 SSA countries. The most common interventions described under key broad areas included: Health system interventions such as Universal Test-and-Treat, integration of ART initiation, HIV Testing and Counselling and Antenatal Care services and reduction of ART drug costs; Patient centered approaches such as fast track ART initiation, Differentiated Drug Delivery models and point of care HIV birth testing; Behavioral interventions and support through lay counselors, mentor mothers, nurse counselors and application of quality improvement interventions and financial incentives. Majority of the studies targeted the HIV positive adults and pregnant women.ConclusionWith the introduction of Universal Test-and-Treat and same-day initiation of ART, findings suggest that adoption of policies that expand ART uptake with the goal of reducing HIV transmission at the population level, promoting patient centered approaches such as fast track ART initiation, Differentiated Service Delivery models and providing adequate support through Mentor Mothers, lay and nurse counselors may improve early retention in HIV care in SSA. However, these interventions have only been tested in few countries in the region which points to how hard evidence based HIV programming is. Further research investigating the impact of individual and a combination of interventions to improve early retention in HIV care, including for various groups at high risk of attrition, is warranted across SSA countries to fast track the achievement of 95-95-95 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets by 2030.

BackgroundOrganization of HIV care and treatment services, including clinic staffing and services, may shape clinical and financial outcomes, yet there has been little attempt to describe different models of HIV care in sub-Saharan Africa (SSA). Information about the relative benefits and drawbacks of different models could inform the scale-up of antiretroviral therapy (ART) and associated services in resource-limited settings (RLS), especially in light of expanded client populations with country adoption of WHO’s test and treat recommendation.MethodsWe characterized task-shifting/task-sharing practices in 19 diverse ART clinics in Tanzania, Uganda, and Zambia and used cluster analysis to identify unique models of service provision. We ran descriptive statistics to explore how the clusters varied by environmental factors and programmatic characteristics. Finally, we employed the Delphi Method to make systematic use of expert opinions to ensure that the cluster variables were meaningful in the context of actual task-shifting of ART services in SSA.ResultsThe cluster analysis identified three task-shifting/task-sharing models. The main differences across models were the availability of medical doctors, the scope of clinical responsibility assigned to nurses, and the use of lay health care workers. Patterns of healthcare staffing in HIV service delivery were associated with different environmental factors (e.g., health facility levels, urban vs. rural settings) and programme characteristics (e.g., community ART distribution or integrated tuberculosis treatment on-site).ConclusionsUnderstanding the relative advantages and disadvantages of different models of care can help national programmes adapt to increased client load, select optimal adherence strategies within decentralized models of care, and identify differentiated models of care for clients to meet the growing needs of long-term ART patients who require more complicated treatment management.

ABSTRACTMany gaps in care exist for provision of antiretroviral therapy (ART) in sub-Saharan Africa. Differentiated HIV care tailors provision of ART for patients based on their level of acuity, providing alternatives for where, by whom, and how often care occurs. We conducted a scoping review to assess novel differentiated care models for ART provision for stable HIV-infected adults in sub-Saharan Africa, and how these models can be used to guide differentiated care implementation in Kenya. A systematic search was conducted using PubMed, Embase, Web of Science, Popline, Cochrane Library, and African Index Medicus between January 2006 and January 2017. Grey literature searches and handsearching were also used. We included articles that quantitatively assessed the health, acceptability, and cost-effectiveness of differentiated HIV care. Two reviewers independently performed article screening, data extraction and determination of inclusion for analysis. We included 40 publications involving over 240,000 participants spanning nine countries in sub-Saharan Africa – 54.4% evaluated clinical outcomes, 23.5% evaluated acceptability outcomes, and 22.1% evaluated cost outcomes. Differentiated care models included: facility fast-track drug refills and appointment spacing, facility or community-based ART groups, community ART distribution points or home-based care, and task-shifting or decentralization of care. Studies suggest that these approaches had similar outcomes in viral load suppression and retention in care and were acceptable alternatives to standard HIV care. No clear results could be inferred for studies investigating task shifting and those reporting cost-effectiveness outcomes. Kenya has started to scale up differentiated care models, but further evaluation, quality improvement and research studies should be performed as different models are rolled out.

BackgroundLimited information exists on adults ≥50 years receiving HIV care in sub-Saharan Africa.MethodologyUsing routinely-collected longitudinal patient-level data among 391,111 adults ≥15 years enrolling in HIV care from January 2005–December 2010 and 184,689 initiating ART, we compared characteristics and outcomes between older (≥50 years) and younger adults at 199 clinics in Kenya, Mozambique, Rwanda, and Tanzania. We calculated proportions over time of newly enrolled and active adults receiving HIV care and initiating ART who were ≥50 years; cumulative incidence of loss to follow-up (LTF) and recorded death one year after enrollment and ART initiation, and CD4+ response following ART initiation.FindingsFrom 2005–2010, the percentage of adults ≥50 years newly enrolled in HIV care remained stable at 10%, while the percentage of adults ≥50 years newly initiating ART (10% [2005]-12% [2010]), active in follow-up (10% [2005]-14% (2010]), and active on ART (10% [2005]-16% [2010]) significantly increased. One year after enrollment, older patients had significantly lower incidence of LTF (33.1% vs. 32.6%[40–49 years], 40.5%[25–39 years], and 56.3%[15–24 years]; p-value<0.0001), but significantly higher incidence of recorded death (6.0% vs. 5.0% [40–49 years], 4.1% [25–39 years], and 2.8% [15–24 years]; p-valve<0.0001). LTF was lower after vs. before ART initiation for all ages, with older adults experiencing less LTF than younger adults. Among 85,763 ART patients with baseline and follow-up CD4+ counts, adjusted average 12-month CD4+ response for older adults was 20.6 cells/mm3 lower than for adults 25–39 years of age (95% CI: 17.1–24.1).ConclusionsThe proportion of patients who are ≥50 years has increased over time and been driven by aging of the existing patient population. Older patients experienced less LTF, higher recorded mortality and less robust CD4+ response after ART initiation. Increased programmatic attention on older adults receiving HIV care in sub-Saharan Africa is warranted.

Background Diabetes is a common comorbidity among people living with HIV. As the prevalence of diabetes rises across sub-Saharan Africa (SSA), there is an urgent need for effective interventions to address diabetes and pre-diabetic conditions in HIV patients. The META (Metformin Treatment in Africa) trial aims to assess the effectiveness of metformin in preventing diabetes among people living with HIV (PLHIV) on antiretroviral therapy (ART) who have pre-diabetes. This paper presents the process evaluation, which explores the feasibility, acceptability, and perceived effectiveness of the META trial and its intervention in real-world clinical settings in Dar es Salaam, Tanzania. Methods A mixed methods approach will be employed using a pragmatic realist theoretical framework. Qualitative data will be gathered through in-depth semi-structured interviews using stratified purposive sampling of trial participants (n=20), policymakers (n=10) and focus group discussions with associated health care providers and clinicians working in HIV and non-communicable disease care (n=20). Short cross-sectional surveys will be administered prior to interviews. Data collection will take place across five health facilities in Dar es Salaam, Tanzania. Qualitative data analysis will be complemented by Braun and Clarke’s ‘Reflexive Thematic Analysis’ technique, and survey data will be analysed using SPSS. Discussion The study’s pragmatic realist framework is expected to produce findings with greater depth, scope, and practical relevance. The study findings will contribute to existing knowledge regarding the experiential components of trials involving persons on ART and/or with pre-diabetes, as well as metformin-based interventions. Findings will support interpretation of trial outcomes, highlight facilitators and barriers to implementation, and provide evidence to guide future policy, scale-up, and integration of diabetes prevention strategies into HIV care in SSA. Process evaluation registration: Clinicaltrials.gov, NCT06743698 Trial registration: ISRCTN77382043

HIV/AIDS is associated with significant mental health morbidity in high-income countries, and depression associated with HIV/AIDS has been linked with faster disease progression and reduced drug adherence. However, research on mental health is scarce in sub-Saharan Africa where infection levels are highest. This cross-sectional study of 220 HIV-positive outpatients at a dedicated Tanzanian HIV/AIDS care centre assessed sociodemographics, clinical variables and prevalence of ICD-10 common mental health diagnoses via a standardised psychiatric questionnaire (the Clinical Interview Schedule – Revised). Depression or mixed anxiety and depression was identified in 15.5% of subjects, with 4.5% suffering from other anxiety disorders. This suggests routine HIV care in sub-Saharan Africa should include assessment and treatment of mental health issues.

BackgroundNutritional care is not optimally integrated into pediatric HIV care in sub-Saharan Africa. We assessed the 6-month effect of a nutritional support provided to children living with HIV, followed in a multicentric cohort in West Africa.MethodsIn 2014-2016, a nutritional intervention was carried out for children living with HIV, aged under 10 years, receiving antiretroviral therapy (ART) or not, in five HIV pediatric cohorts, in Benin, Togo and Côte d’Ivoire. Weight deficiency was assessed using two definitions: wasting (Weight for Height Z-score [WHZ] for children<5 years old or Body-Mass-Index for Age [BAZ] for ≥5 years) and underweight (Weight for Age Z-score [WAZ]) (WHO child growth standards). Combining these indicators, three categories of nutritional support were defined: 1/ children with severe malnutrition (WAZ and/or WHZ/BAZ <-3 Standard Deviations [SD]) were supported with Ready-To-Use Therapeutic Food (RUTF), 2/ those with moderate malnutrition (WAZ and/or WHZ/BAZ = [-3;-2[ SD) were supported with fortified blended flours produced locally in each country, 3/ those non malnourished (WAZ and WHZ/BAZ ≥-2 SD) received nutritional counselling only. Children were followed monthly over 6 months. Dietary Diversity Score (DDS) using a 24h recall was measured at the first and last visit of the intervention.ResultsOverall, 326 children were included, 48% were girls. At baseline, 66% were aged 5-10 years, 91% were on ART, and 17% were severely immunodeficient (CD4 <250 cells/mL or CD4%<15). Twenty-nine (9%) were severely malnourished, 63 (19%) moderately malnourished and 234 (72%) non-malnourished. After 6 months, 9/29 (31%) and 31/63 (48%) recovered from severe and moderate malnutrition respectively. The median DDS was 8 (IQR 7-9) in Côte d’Ivoire and Togo, 6 (IQR 6-7) in Benin. Mean DDS was 4.3/9 (sd 1.2) at first visit, with a lower score in Benin, but with no difference between first and last visit (p=0.907), nor by intervention groups (p-value=0.767).ConclusionsThis intervention had a limited effect on nutritional recovery and dietary diversity improvement. Questions remain on determining appropriate nutritional products, in terms of adherence, proper use for families and adequate energy needs coverage for children living with HIV.Trial registrationPACTR202001816232398, June 01, 2020, retrospectively registered.

Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid-rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization's (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness-implementation randomized trial comparing 3 optimized strategies for delivering 3HP-facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid-to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (≥11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion. ClinicalTrials.gov NCT03934931.

The absolute CD4+ T cell count in adults and CD4+ T cell percentage of lymphocytes (CD4%) in pediatrics compliment clinical history and physical examination to inform decisions about initiating antiretroviral therapy (ART). In addition, these immunologic markers predict host susceptibility to specific opportunistic infections, selected drug toxicities, and mortality. These benefits argue strongly for the availability of CD4+ T cell testing capacity in all settings where HIV infection is treated. Several currently available flow cytometry-based devices, and novel CD4+ T cell enumeration techniques such as the panleucogating CD4 are especially suitable for resource-constrained settings. At this time, unfortunately, the landscape of HIV care in sub-Saharan Africa is a mosaic characterized by large areas where CD4+ T cell testing capacity is limited or unavailable, and small, but growing, pockets where the capacity exists. Routine HIV quantification is currently unaffordable and unsustainable in the great majority of the region; therefore, a reliance on CD4+ T cell testing is inevitable for now. To this end, correcting the disparities in CD4+ T cell testing capacity and defining the minimum laboratory requirements for the safe use of antiretroviral drugs through well-designed clinical studies are some of the most urgent priorities of the ongoing global scale-up of ART.

Objective:We examine the efficacy of short message service (SMS) and SMS with peer navigation (SMS + PN) in improving linkage to HIV care and initiation of antiretroviral therapy (ART).Design:I-Care was a cluster randomized trial conducted in primary care facilities in North West Province, South Africa. The primary study outcome was retention in HIV care; this analysis includes secondary outcomes: linkage to care and ART initiation.Methods:Eighteen primary care clinics were randomized to automated SMS (n = 7), automated and tailored SMS + PN (n = 7), or standard of care (SOC; n = 4). Recently HIV diagnosed adults (n = 752) were recruited from October 2014 to April 2015. Those not previously linked to care (n = 352) contributed data to this analysis. Data extracted from clinical records were used to assess the days that elapsed between diagnosis and linkage to care and ART initiation. Cox proportional hazards models and generalized estimating equations were employed to compare outcomes between trial arms, overall and stratified by sex and pregnancy status.Results:Overall, SMS (n = 132) and SMS + PN (n = 133) participants linked at 1.28 [95% confidence interval (CI): 1.01–1.61] and 1.60 (95% CI: 1.29–1.99) times the rate of SOC participants (n = 87), respectively. SMS + PN significantly improved time to ART initiation among non-pregnant women (hazards ratio: 1.68; 95% CI: 1.25–2.25) and men (hazards ratio: 1.83; 95% CI: 1.03–3.26) as compared with SOC.Conclusion:Results suggest SMS and peer navigation services significantly reduce time to linkage to HIV care in sub-Saharan Africa and that SMS + PN reduced time to ART initiation among men and non-pregnant women. Both should be considered candidates for integration into national programs.Trial registration:NCT02417233, registered 12 December 2014; closed to accrual 17 April 2015.

The postnatal period remains the most at-risk period for the mother-infant dyad. Most maternal and neonatal deaths occur in the immediate postnatal period, contributing to the greatest burden of child mortality. Appropriate care for mothers and newborns during this critical period is essential to improve their survival. However, access to quality care during this period remains a challenge, especially in resource-limited settings. This chapter examines challenges to postnatal care (PNC) in sub-Saharan Africa (SSA), drawing on existing evidence. A comprehensive review of critically appraised literature was undertaken. The findings indicate suboptimal uptake of PNC, resulting in high maternal and neonatal morbidity and mortality in the postnatal period. Challenges to the delivery of quality PNC include poor healthcare infrastructure and access to basic health services, and underlying structural determinants such as widespread poverty, illiteracy, harmful cultural practices, marginalization of women, and inadequate political will by governments. These challenges underscore the need for intensified efforts to improve PNC in the region. Innovative approaches to increasing demand and reaching mothers with PNC services within communities are critically needed to improve access and utilization of PNC in SSA, improve maternal and child health outcomes, and contribute to achieving the sustainable development goals in 2030.