Virologic outcomes after early referral of stable HIV-positive adults initiating ART to community-based adherence clubs in Cape Town, South Africa: A randomised controlled trial.

BACKGROUND: Differentiated service delivery (DSD) models are recommended for stable people living with HIV on antiretroviral therapy (ART) but there are few rigorous evaluations of patient outcomes. METHODS: Adherence clubs (ACs) are a form of DSD run by community health workers at community venues with 2-4 monthly ART refills and annual nurse assessments). Clinic-based care involves 2-monthly ART refills and 4-monthly nurse/doctor assessments. We compared virologic outcomes in stable adults randomised to ACs at four months post-ART initiation to those randomised to primary health care (PHC) ART clinics through 12 months on ART in Cape Town, South Africa (NCT03199027). We hypothesised that adults randomised to ACs would be more likely to be virally suppressed at 12 months post-ART initiation, versus adults randomised to continued PHC care. We enrolled consecutive adults on ART for 3-5 months who met local DSD ['adherence clubs' (AC)] eligibility (clinically stable, VL<400 copies/mL). The primary outcome was VL<400 copies/mL at 12 months on ART. RESULTS: Between January 2017 and April 2018, 220 adults were randomised (mean age 35 years; 67% female; median ART duration 18 weeks); 85% and 94% of participants randomised to ACs and PHCs attended their first service visit on schedule respectively. By 12 months on ART, 91% and 93% randomised to ACs and PHCs had a VL<400 copies/mL, respectively. In a binomial model adjusted for age, gender, previous ART use and nadir CD4 cell count, there was no evidence of superiority of ACs compared to clinic-based care (RD, -2.42%; 95% CI, -11.23 to 6.38). Findings were consistent when examining the outcome at a threshold of VL <1000 copies/mL. CONCLUSION: Stable adults referred to DSDs at 4 months post-ART initiation had comparable virologic outcomes at 12 months on ART versus PHC clinics, with no evidence of superiority. Further research on long-term outcomes is required.

Improved virologic outcomes in postpartum women living with HIV referred to differentiated models of care.

OBJECTIVES: Differentiated service delivery (DSD) models are used to deliver antiretroviral therapy (ART) but data are limited in postpartum women, who are at high risk of non-adherence and elevated viral load (VL) over the extended postpartum period. DESIGN: Randomized controlled trial. METHODS: We enrolled consecutive postpartum women who initiated ART during pregnancy and met local DSD eligibility (clinically stable, VL less than 400 copies/ml) at a large primary healthcare (PHC) clinic. Women were randomized to a community-based 'adherence club' (AC, the local DSD model: community health worker-led groups of 20-30 patients with ART dispensing at a community venue) or routine PHC clinics (local standard of care with nurse/doctor-led services). Follow-up visits with VL separate from routine care took place at 3, 6, 12, 18 and 24 months postpartum. Endpoints were time to VL of at least 1000 copies/ml (primary) and VL of at least 50 copies/ml (secondary) by intention-to-treat. RESULTS: At enrolment ( n  = 409), the median duration postpartum was 10 days, all women had a VL less than 1000 copies/ml and 88% had a VL less than 50 copies/ml; baseline characteristics did not differ by arm. Twenty-four-month retention was 89%. Sixteen and 29% of women in AC experienced a VL of at least 1000 copies/ml by 12 and 24 months, compared to 23 and 37% in PHC, respectively (hazard ratio [HR] = 0.71; 95% confidence interval [CI] = 0.50-1.01). Thirty-two and 44% of women in ACs had a VL of at least 50 copies/ml by 12 and 24 months, compared to 42 and 56% in PHC, respectively (HR = 0.68; 95% CI = 0.51-0.91). CONCLUSIONS: Early DSD referral was associated with reduced viraemia through 24 months postpartum and may be an important strategy to improve maternal virologic outcomes.

Care and management of a double burden of chronic diseases: Experiences of patients and perceptions of their healthcare providers.

AIM: The increasing burden of comorbid HIV infection and hypertension necessitates a focus on healthcare services providing care for chronic multi-morbidities. The aim of this study was to evaluate the perceptions and experiences of 1) people living with HIV infection and comorbid hypertension, and 2) their healthcare providers, related to their diagnoses and interactions with chronic healthcare services in South Africa. METHODS: This study comprised quantitative and qualitative arms with a multi-layered approach. We randomly selected 17 public healthcare facilities providing HIV care across Cape Town and surrounding rural municipalities. RESULTS: Interviews were conducted with clinicians (n = 11), specialised nursing professionals (n = 10), lay counsellors (n = 12), six patients focus groups (n = 35) and 20 in-depth individual patient interviews. There were mixed views on being treated at integrated vs. separate chronic care facilities regarding quality of care and privacy/anonymity. Specialised clinics offered better care for HIV infection while hypertension and other non-communicable diseases were neglected. Privacy about HIV status maybe better maintained in integrated clinics but not if status was disclosed by having the green-coloured HIV treatment card. A single appointment date was considered advantageous as it saved time and money leading to greater compliance; however, waiting times at clinics were longer with perhaps fewer patients seen. CONCLUSIONS: The mixed reactions elicited to the integration of healthcare services for HIV, hypertension and other non-communicable diseases highlights the complexities involved in implementing such services. Greater human resources with retraining and reskilling of healthcare staff is required for the optimal management of chronic multi-morbidities.

Community-based adherence clubs for postpartum women on antiretroviral therapy (ART) in Cape Town, South Africa: a pilot study.

BACKGROUND: With an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care. METHODS: Newly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses. RESULTS: Between February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001). CONCLUSION: This study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services. TRIAL REGISTRATION: ClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

Differentiated models of care for postpartum women on antiretroviral therapy in Cape Town, South Africa: a cohort study.

BACKGROUND: The numbers of women initiating lifelong antiretroviral therapy (ART) during pregnancy and postpartum is increasing rapidly, presenting a burden on health systems and an urgent need for scalable models of care for this population. In a pilot project, we referred postpartum women who initiated ART during pregnancy to a community-based model of differentiated ART services. METHODS: Eligible women (on ART for at least 3 months with viral load (VL)<1000 copies/mL) were offered a choice of two ART models of care: (i) referral to an existing system of community-based 'adherence clubs', operated by lay counsellors with medication collection every 2-4 months; or (ii) referral to local primary healthcare clinics (PHC) with services provided by clinicians and medication collection every 1-2 months (local standard of care for postpartum ART). For evaluation, women were followed through 6-months postpartum with VL testing separate from either ART service. RESULTS: Through September 2015, n = 129 women were enrolled (median age, 28 years; median time postpartum, 10 days). Overall, 65% (n = 84) chose adherence clubs and 35% (n = 45) chose PHCs; there were no demographic or clinical predictors of this choice. Location of service delivery was commonly cited as a reason for choice by women selecting either model of care; shorter waiting times, ability to receive ART from lay counsellors and less frequent appointments were motivations for choosing adherence clubs. Among women choosing adherence clubs, 15% never attended the service and another 11% attended the service but were not retained through six months postpartum. Overall, 86% of women (n = 111) remained in the evaluation through 6 months postpartum; in this group, there were no differences in VL<1000 copies/mL at six months postpartum between women choosing PHCs (88%) vs. adherence clubs (92%; p = 0.483), but women who were not retained in adherence clubs were more likely to have VL≥1000 copies/mL compared to those who remained (p = 0.002). DISCUSSION: Adherence clubs may be a valuable model for postpartum women initiating ART in pregnancy, with good short-term outcomes observed during this critical period. To support optimal implementation, further research is needed into patient preferences for models of care, with consideration of integration of maternal and child health services, while ART adherence and retention require ongoing consideration in this population.

South African healthcare provider perspectives on transitioning adolescents into adult HIV care.

BACKGROUND: The first generation of South African (SA) children perinatally infected with HIV is entering adulthood, and there is now a pressing need for systematised transfer of these patients from paediatric to adult care. OBJECTIVES: Previous research has investigated the HIV healthcare transition in North America and Europe, yet none has been conducted in SA. Our study is the first to describe the perspectives of healthcare providers overseeing the transition in resource-limited settings. METHODS: We approached healthcare providers working in government paediatric HIV clinics and hospitals in the Western Cape Province, SA. Seven physicians and counsellors in adolescent/paediatric care, representing five clinics, were interviewed, and 43 completed a written survey. Interviews addressed the current state of the transition, barriers and facilitators, and model components. Interviews were assessed for major themes using framework analysis, while logistic regression was applied to survey responses to identify associations with measured covariates. RESULTS: Analysis of interview transcripts revealed several overarching perspectives that were corroborated by survey responses. One barrier identified was the healthcare providers' difficulty in letting go of their relationships with the adolescent patients. Since healthcare providers regarded their patients as particularly vulnerable, they felt a strong and protective attachment towards them. A second barrier identified was a lack of structure and effective communication between adult and paediatric providers; accordingly, healthcare providers feared that they were transferring their adolescents unprepared, to a judgemental, depersonalised and overburdened environment. All interviewees and a majority of survey respondents (>80%) agreed that the formation of adolescent support groups in adult care clinics as well as a later transition age would improve the transition process. CONCLUSION: This study highlights the need for a systematic healthcare transition for HIV-positive adolescents cared for in the Western Cape, while acknowledging the limitations of the current healthcare infrastructure. Several feasible recommendations have been identified, including forming support groups and greater involvement of adolescent healthcare providers to facilitate the transition.

Implementation and Operational Research: Community-Based Adherence Clubs for the Management of Stable Antiretroviral Therapy Patients in Cape Town, South Africa: A Cohort Study.

BACKGROUND: Community-based models of antiretroviral therapy (ART) delivery are widely discussed as a priority in the expansion of HIV treatment services, but data on their effectiveness are limited. We examined outcomes of ART patients decentralized to community-based adherence clubs (CACs) in Cape Town, South Africa and compared these to patients managed in the community health center. METHODS: The analysis included 8150 adults initiating ART from 2002 to 2012 in a public sector service followed until the end of 2013. From June 2012, stable patients (on ART >12 months, suppressed viral load) were referred to CACs. Loss to follow-up (LTFU) was compared between services using proportional hazards models with time-varying covariates and inverse probability weights of CAC participation. FINDINGS: Of the 2113 CAC patients (71% female, 7% youth ages ≤ 24 years), 94% were retained on ART after 12 months. Among CAC patients, LTFU [adjusted hazard ratio (aHR): 2.17, 95% confidence interval (CI): 1.26 to 3.73 ] and viral rebound (aHR 2.24, 95% CI: 1.00 to 5.04) were twice as likely in youth (16-24 years old) compared with older patients, but no difference in the risk of LTFU or viral rebound was observed by sex (P-values 0.613 and 0.278, respectively). CAC participation was associated with a 67% reduction in the risk of LTFU (aHR: 0.33, 95% CI: 0.27 to 0.40) compared with community health centre, and this association persisted when stratified by patient demographic and clinic characteristics. INTERPRETATION: CACs are associated with reduced risk of LTFU compared with facility-based care. Community-based models represent an important development to facilitate ART delivery and possibly improve patient outcomes.

South African Healthcare Provider Perspectives on Transitioning Adolescents into Adult HIV Care

Background. The first generation of South African (SA) children perinatally infected with HIV is entering adulthood; and there is now a pressing need for systematised transfer of these patients from paediatric to adult care.Objectives. Previous research has investigated the HIV healthcare transition in North America and Europe; yet none has been conducted in SA. Our study is the first to describe the perspectives of healthcare providers overseeing the transition in resource-limited settings.Methods. We approached healthcare providers working in government paediatric HIV clinics and hospitals in the Western Cape Province; SA. Seven physicians and counsellors in adolescent/paediatric care; representing five clinics; were interviewed; and 43 completed a written survey. Interviews addressed the current state of the transition; barriers and facilitators; and model components. Interviews were assessed for major themes using framework analysis; while logistic regression was applied to survey responses to identify associations with measured covariates.Results. Analysis of interview transcripts revealed several overarching perspectives that were corroborated by survey responses. One barrier identified was the healthcare providers' difficulty in letting go of their relationships with the adolescent patients. Since healthcare providers regarded their patients as particularly vulnerable; they felt a strong and protective attachment towards them. A second barrier identified was a lack of structure and effective communication between adult and paediatric providers; accordingly; healthcare providers feared that they were transferring their adolescents unprepared; to a judgemental; depersonalised and overburdened environment. All interviewees and a majority of survey respondents (80%) agreed that the formation of adolescent support groups in adult care clinics as well as a later transition age would improve the transition process.Conclusion. This study highlights the need for a systematic healthcare transition for HIV-positive adolescents cared for in the Western Cape; while acknowledging the limitations of the current healthcare infrastructure. Several feasible recommendations have been identified; including forming support groups and greater involvement of adolescent healthcare providers to facilitate the transition

Implementation of community-based adherence clubs for stable antiretroviral therapy patients in Cape Town, South Africa.

INTRODUCTION: Community-based models of antiretroviral therapy (ART) delivery have been recommended to support ART expansion and retention in resource-limited settings. However, the evidence base for community-based models of care is limited. We describe the implementation of community-based adherence clubs (CACs) at a large, public-sector facility in peri-urban Cape Town, South Africa. METHODS: Starting in May 2012, stable ART patients were down-referred from the primary care community health centre (CHC) to CACs. Eligibility was based on self-reported adherence, >12 months on ART and viral suppression. CACs were facilitated by four community health workers and met every eight weeks for group counselling, a brief symptom screen and distribution of pre-packed ART. The CACs met in community venues for all visits including annual blood collection and clinical consultations. CAC patients could send a patient-nominated treatment supporter ("buddy") to collect their ART at alternate CAC visits. Patient outcomes [mortality, loss to follow-up and viral rebound (>1000 copies/ml)] during the first 18 months of the programme are described using Kaplan-Meier methods. RESULTS AND DISCUSSION: From June 2012 to December 2013, 74 CACs were established, each with 25-30 patients, providing ART to 2133 patients. CAC patients were predominantly female (71%) and lived within 3 km of the facility (70%). During the analysis period, 9 patients in a CAC died (<0.1%), 53 were up-referred for clinical complications (0.3%) and 573 CAC patients sent a buddy to at least one CAC visit (27%). After 12 months in a CAC, 6% of patients were lost to follow-up and fewer than 2% of patients retained experienced viral rebound. CONCLUSIONS: Over a period of 18 months, a community-based model of care was rapidly implemented decentralizing more than 2000 patients in a high-prevalence, resource-limited setting. The fundamental challenge for this out of facility model was ensuring that patients receiving ART within a CAC were viewed as an extension of the facility and part of the responsibility of CHC staff. Further research is needed to support down-referral sooner after ART initiation and to describe patient experiences of community-based ART delivery.