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The arrival of coronavirus disease 2019 (COVID-19) on the African continent resulted in a range of lockdown measures that curtailed the spread of the infection but caused economic hardship. African countries now face difficult choices regarding easing of lockdowns and sustaining effective public health control measures and surveillance. Pandemic control will require efficient community screening, testing, and contact tracing; behavioral change interventions; adequate resources; and well-supported, community-based teams of trained, protected personnel. We discuss COVID-19 control approaches in selected African countries and the need for shared, affordable, innovative methods to overcome challenges and minimize mortality. This crisis presents a unique opportunity to align COVID-19 services with those already in place for human immunodeficiency virus, tuberculosis, malaria, and non communicable diseases through mobilization of Africa's interprofessional healthcare workforce. By addressing the challenges, the detrimental effect of the COVID-19 pandemic on African citizens can be minimized.
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COVID-19 , Pandemias , África/epidemiologia , Controle de Doenças Transmissíveis , Busca de Comunicante , Humanos , Morbidade , SARS-CoV-2RESUMO
Southern Africa remains the epicentre of the human immunodeficiency virus (HIV) epidemic with AIDS the leading cause of death amongst adolescents. Poor policy translation, inadequate programme implementation and fragmentation of services contribute to adolescents' poor access to sexual and reproductive health and rights (SRHR) services. This study assessed an integrated, school-based SRHR and HIV programme, modelled on the South African Integrated School Health Policy in a rural, high HIV-prevalence district. A retrospective cohort study of 1260 high-school learners was undertaken to assess programme uptake, change in HIV knowledge and behaviour and the determinants of barrier-methods use at last sexual intercourse. Programme uptake increased (2%-89%; P�<�0.001) over a 16-month period, teenage-pregnancy rates declined (14%-3%; P�<�0.050) and accurate knowledge about HIV transmission through infected blood improved (78.3%-93.8%; P�<�0.050), a year later. Post-intervention, attending a clinic perceived as adolescent-friendly increased the odds of barrier-methods use during the last sexual encounter (aOR=1.85; 95% CI: 1.31-2.60), whilst being female (aOR=0.69; 95% CI: 0.48-0.99), <15 years (aOR=0.44; 95% CI: 0.24-0.80), or having >5 sexual partners in the last year (aOR=0.59; 95% CI: 0.38-0.91) reduced the odds. This study shows that the unmet SRHR needs of under-served adolescents can be addressed through integrated, school-based SRHR programmes.
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Infecções por HIV , Saúde Reprodutiva , Adolescente , Feminino , Humanos , Gravidez , Estudos Retrospectivos , Instituições Acadêmicas , Comportamento SexualRESUMO
The HIV epidemic is strongly gendered. Women and girls are more likely to contract HIV for biological and social reasons in Sub-Saharan Africa and men living with HIV are more likely to be lost to follow-up and die on antiretroviral therapy (ART) than women. Care work is also gendered, with women shouldering the burden of HIV care-related work. This paper considers the potential of male delivered community health work to improve men's HIV-related health outcomes and shift gendered norms related to care work. It describes the experiences and perspectives of eight HIV community health workers and their clients from the Cape Town area, and reviews current evidence on male-focused HIV and sexual and reproductive health services, gender transformation and men and care. Findings suggest that meaningfully involving more men in HIV care work may be a way to shift damaging hegemonic masculine norms related to care and health, and that South Africa's roll-out of National Health Insurance could be an opportunity to do so. Barriers to engaging men in this feminised profession are also explored.
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Agentes Comunitários de Saúde , Infecções por HIV , Feminino , Humanos , Masculino , Masculinidade , Pesquisa Qualitativa , África do SulRESUMO
BACKGROUND: There have been concerns about reduced adherence and human immunodeficiency virus (HIV) virological suppression (VS) among clinically well people initiating antiretroviral therapy (ART) with high pre-ART CD4 cell counts. We compared virological outcomes by pre-ART CD4 count, where universal ART initiation was provided in the HIV Prevention Trials Network 071 (PopART) trial in South Africa prior to routine national and international implementation. METHODS: This prospective cohort study included adults initiating ART at facilities providing universal ART since January 2014. VS (<400 copies/mL), confirmed virological failure (VF) (2 consecutive viral loads >1000 copies/mL), and viral rebound were compared between participants in strata of baseline CD4 cell count. RESULTS: The sample included 1901 participants. VS was ≥94% among participants with baseline CD4 count ≥500 cells/µL at all 6-month intervals to 30 months. The risk of an elevated viral load (≥400 copies/mL) was independently lower among participants with baseline CD4 count ≥500 cells/µL (3.3%) compared to those with CD4 count 200-499 cells/µL (9.2%) between months 18 and 30 (adjusted relative risk, 0.30 [95% confidence interval, .12-.74]; P = .010). The incidence rate of VF was 7.0, 2.0, and 0.5 per 100 person-years among participants with baseline CD4 count <200, 200-499, and ≥500 cells/µL, respectively (P < .0001). VF was independently lower among participants with baseline CD4 count ≥500 cells/µL (adjusted hazard ratio [aHR], 0.23; P = .045) and 3-fold higher among those with baseline CD4 count <200 cells/µL (aHR, 3.49; P < .0001). CONCLUSIONS: Despite previous concerns, participants initiating ART with CD4 counts ≥500 cells/µL had very good virological outcomes, being better than those with CD4 counts 200-499 cells/µL. CLINICAL TRIALS REGISTRATION: NCT01900977.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Adulto , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Contagem de Linfócito CD4 , HIV , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Humanos , Estudos Prospectivos , África do Sul/epidemiologia , Carga ViralRESUMO
Antiretroviral treatment (ART) initiation in HIV-infected pregnant women in sub-Saharan Africa (SSA) remains inadequate, and there is a severe shortage of professional healthcare workers in the region. The effectiveness of community support programmes for HIV-infected pregnant women and their infants in SSA is unclear. This study compared initiation of maternal antiretrovirals and infant outcomes amongst HIV-infected pregnant women and their infants who received and did not receive community-based support (CBS) in a high HIV-prevalence setting in South Africa. A cohort study, including HIV-infected pregnant women and their infants, was conducted at three sentinel surveillance facilities between January 2009 and June 2012, utilising enhanced routine clinical data. Through home visits, CBS workers encouraged uptake of interventions in the ART cascade, provided HIV-related education, ART initiation counselling and psychosocial support. Outcomes were compared using Kaplan-Meier analyses and multivariable Cox and log-binomial regression. Amongst 1105 mother-infant pairs included, 264 (23.9%) received CBS. Amongst women eligible to start ART antenatally, women who received CBS had a reduced risk of not initiating antenatal ART, 5.4% vs. 30.3%; adjusted risk ratio (aRR) = 0.18 (95% CI: 0.08-0.44; P < .0001). Women who received CBS initiated antenatal ART with less delay after the first antenatal visit, median 26 days vs. 39 days; adjusted hazard ratio (aHR) = 1.57 (95% CI: 1.15-2.14; P = .004). Amongst women who initiated antenatal zidovudine (ZDV) to prevent vertical transmission, women who received CBS initiated ZDV with less delay, aHR = 1.52 (95% CI: 1.18-2.01; P = .001). Women who received CBS had a lower risk of stillbirth, 1.5% vs. 5.4%; aRR = 0.24 (95% CI: 0.07-1.00; P = .050). Pregnant women living with HIV who received CBS had improved antenatal triple ART initiation in eligible women, women initiated ART and ZDV with shorter delays, and had a lower risk of stillbirth. CBS is an intervention that shows promise in improving maternal and infant health in high HIV-prevalence settings.
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Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Transmissão Vertical de Doenças Infecciosas/prevenção & controle , Complicações Infecciosas na Gravidez/tratamento farmacológico , Gestantes/psicologia , Adulto , Estudos de Coortes , Serviços de Saúde Comunitária , Pesquisa Participativa Baseada na Comunidade , Aconselhamento , Feminino , Humanos , Lactente , Gravidez , Resultado da Gravidez , Cuidado Pré-Natal , Prevalência , África do Sul/epidemiologia , Resultado do Tratamento , População Urbana , Adulto JovemRESUMO
Retaining high levels of patients in care who are virally suppressed over long treatment periods has been an important challenge for antiretroviral treatment (ART) programmes in sub-Saharan Africa, the region having the highest HIV burden globally. Clinic-linked community-based adherence support (CBAS) programmes provide home-based adherence and psychosocial support for ART patients. However, there is little evidence of their longer-term impact. This study assessed the effectiveness of CBAS after eight years of ART. CBAS workers are lay healthcare personnel providing regular adherence and psychosocial support for ART patients and their households through home visits addressing household challenges affecting adherence. A multicentre cohort study using routinely collected data was undertaken at six public ART sites in a high HIV-prevalence South African district. Patient retention, loss to follow-up (LTFU), viral suppression and CD4 cell restoration were compared between patients with and without CBAS, using competing-risks regression, linear mixed models and log-binomial regression. 3861 patients were included, of whom 1616 (41.9%) received CBAS. Over 14,792 patient-years of observation, the cumulative incidence of LTFU was 37.3% and 46.2% amongst patients with and without CBAS, respectively, following 8 years of ART; adjusted subhazard ratio (CBAS vs. no CBAS) = 0.74 (95% CI: 0.66-0.84; P < .0001). Amongst patients on ART for 6.5-8 years, proportions not achieving viral suppression were 11.4% and 19.4% in patients with and without CBAS, respectively; adjusted risk ratio = 0.47 (95% CI: 0.26-0.86; P = .015). Annual CD4 cell increases from baseline were 62.8 cells/µL/year and 51.5 cells/µL/year amongst patients with and without CBAS, respectively, after 6.5 years or more (P = .034). After adjustment, annual CD4 cell recovery was 15.1 cells/µL/year (95% CI: 2.7-27.6) greater in CBAS patients (P = .017). ART patients who received CBAS had improved long-term patient retention, viral suppression and immunological restoration. CBAS is an intervention that can improve longer-term ART programme outcomes in resource-limited settings.
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Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Adesão à Medicação , Apoio Social , Adulto , Instituições de Assistência Ambulatorial , Contagem de Linfócito CD4 , Estudos de Coortes , Feminino , Seguimentos , Infecções por HIV/imunologia , Recursos em Saúde , Visita Domiciliar , Humanos , Perda de Seguimento , Masculino , Avaliação de Programas e Projetos de Saúde , África do Sul , Resposta Viral Sustentada , Fatores de Tempo , Resultado do Tratamento , Carga Viral/efeitos dos fármacosRESUMO
There is concern that the expansion of ART (antiretroviral treatment) programmes to incorporate the use of treatment as prevention (TasP) may be associated with low levels of adherence and retention in care, resulting in the increased spread of drug-resistant HIV. We review research published over the past year that reports on interventions to improve adherence and retention in care in Southern Africa, and discuss these in terms of their potential to support the expansion of ART programmes for TasP. We found eight articles published since January 2012, seven of which were from South Africa. The papers describe innovative models for ART care and adherence support, some of which have the potential to facilitate the ongoing scale- up of treatment programmes for increased coverage and TasP. The extent to which interventions from South Africa can be effectively implemented in other, lower-resource Southern African countries is unclear.
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Fármacos Anti-HIV/administração & dosagem , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/prevenção & controle , Adesão à Medicação , Humanos , África do SulRESUMO
Adherence to antiretroviral treatment (ART) is a challenge in childhood, and children on ART have reduced virological suppression compared to adults. This study evaluated the effect of community-based adherence support (CBAS) on virological outcomes amongst children receiving ART in four South African provinces. Patient Advocates are lay CBAS workers who provide adherence and psychosocial support for patients, undertaking home visits to address household challenges affecting adherence. Patient Advocates provide counselling for children's carers regarding adherence and psychosocial problems. A multicentre cohort study using routinely collected data was conducted at 57 public ART sites including ART-naive children (<16 years) starting ART. Virological suppression until four years of ART was compared between children who received and did not receive CBAS. Analyses were by intention-to-treat, controlling for confounding using multivariable generalised estimating equations. A total of 4853 children were included, of whom 982 (20.2%) received CBAS. The median baseline age was 6.3 years and the baseline CD4 cell percentage was 12.0%; both were equivalent between the two groups. CBAS children had more advanced baseline clinical disease (62.1% vs. 52.6% World Health Organisation stages III or IV; P < 0.0001). A total of 5908 viral load results were analysed. Virological suppression was 65.6% (95% confidence interval [CI]: 62.7-68.4%) vs. 55.5% (95% CI: 54.1-57.0%) in CBAS and non-CBAS children, respectively, at any time-point on treatment (P < 0.0001). In analyses controlling for baseline clinical, demographic, site-related variables and time on ART, children receiving CBAS were more likely to achieve virological suppression, adjusted odds ratio (aOR) 1.60 (95% CI: 1.35-1.89; P < 0.0001). The effect of CBAS increased in magnitude with increasing durations of ART, and CBAS particularly improved virological suppression in a higher-risk subgroup (children younger than two years, aOR 2.47 [95% CI: 1.59-3.84]). CBAS was associated with improved virological suppression in children receiving ART. Expanded implementation of this low-cost intervention should be considered in resource-poor settings.
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Fármacos Anti-HIV/uso terapêutico , Redes Comunitárias/estatística & dados numéricos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Adesão à Medicação/psicologia , Carga Viral/efeitos dos fármacos , Adolescente , Contagem de Linfócito CD4 , Criança , Pré-Escolar , Pesquisa Participativa Baseada na Comunidade , Feminino , Seguimentos , Infecções por HIV/imunologia , Infecções por HIV/virologia , Humanos , Lactente , Modelos Logísticos , Masculino , Defesa do Paciente , Apoio Social , África do Sul , Resultado do TratamentoRESUMO
About 85% of Zimbabwe's >1.4 million people living with HIV are on antiretroviral treatment (ART). Further expansion of its treatment program will require more efficient use of existing resources. Two promising strategies for reducing resource utilization per patient are multi-month medication dispensing and community-based service delivery. We evaluated the costs to providers and patients of community-based, multi-month ART delivery models in Zimbabwe. We used resource and outcome data from a cluster-randomized non-inferiority trial of three differentiated service delivery (DSD) models targeted to patients stable on ART: 3-month facility-based care (3MF), community ART refill groups (CAGs) with 3-month dispensing (3MC), and CAGs with 6-month dispensing (6MC). Using local unit costs, we estimated the annual cost in 2020 USD of providing HIV treatment per patient from the provider and patient perspectives. In the trial, retention at 12 months was 93.0% in the 3MF, 94.8% in the 3MC, and 95.5% in the 6MC arms. The total average annual cost of HIV treatment per patient was $187 (standard deviation $39), $178 ($30), and $167 ($39) in each of the three arms, respectively. The annual cost/patient was dominated by ART medications (79% in 3MF, 87% in 3MC; 92% in 6MC), followed by facility visits (12%, 5%, 5%, respectively) and viral load (8%, 8%, 2%, respectively). When costs were stratified by district, DSD models cost slightly less, with 6MC the least expensive in all districts. Savings were driven by differences in the number of facility visits made/year, as expected, and low uptake of annual viral load tests in the 6-month arm. The total annual cost to patients to obtain HIV care was $10.03 ($2) in the 3MF arm, $5.12 ($0.41) in the 3MC arm, and $4.40 ($0.39) in the 6MF arm. For stable ART patients in Zimbabwe, 3- and 6-month community-based multi-month dispensing models cost less for both providers and patients than 3-month facility-based care and had non-inferior outcomes.
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Sub-Saharan Africa carries the highest burden of HIV, with approximately 70% of all people living with HIV (PLWH) globally living in this region. The provision of antiretroviral treatment (ART) significantly affects already overburdened health systems, which need to accommodate large volumes of ART patients while facing a shortage of professional health workers, infrastructure challenges and medical resources. Finding alternative ways to provide routine services to PLWH has become significantly more urgent. Multi-month dispensing (MMD) of ART aims to improve access to treatment for PLWH, while also improving the efficiency of the health system. This study explores the experienced benefits and challenges of community-based MMD in order to make recommendations for future implementation efforts. Twenty focus group discussions were conducted with members of community ART refill groups (CARGs) who received 3-monthly or 6-monthy MMD. Individual interviews were also conducted with health providers. All interviews and focus group discussions took place between April and June 2019 conducted by research nurses in English, Shona or Ndebele. Multiple benefits of community-based MMD were reported, including decreased congestion in health facilities, improved service delivery, decline in staff burnout and increased time availability for CARG members due to less time spent at clinics, improved ART adherence and social support experienced amongst members of CARGs. Identified challenges included the possibility of being exposed to HIV-related stigma when belonging to a CARG, and low levels of medical supplies and ART stock at clinics. Recommendations were made by CARG members and health care workers on how CARGs could be improved and sustained in the future. Results from this study show that the implementation of community-based MMD holds multiple benefits at an individual and health facility level. Future recommendations include evaluating the feasibility of MMD among other vulnerable populations.
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Fármacos Anti-HIV , Infecções por HIV , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Humanos , Pesquisa Qualitativa , ZimbábueRESUMO
INTRODUCTION: Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility-based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster-randomized trials investigating community-based DSD in Zimbabwe and Lesotho. METHODS: Individual-level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard-of-care three-monthly ART provision at healthcare facilities (SoC, control); ART provided three-monthly in community ART groups (CAGs) (3MC) and ART provided six-monthly in either CAGs or at community-distribution points (6MC). Clinical visits were three-monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual-level regression analyses were conducted by intention-to-treat specifying for clustering and adjusted for country. RESULTS AND DISCUSSION: A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%-8.5%). Retention in 6MC was non-inferior versus SoC, aRD = 1.7% (95% CI: -2.5%-5.9%) (prespecified non-inferiority aRD margin -3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92-1.03) for 3MC versus SoC, and 0.98 (CI: 0.95-1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16-1.80) for 3MC versus SoC; and 0.82 (CI: 0.25-2.79) for 6MC versus SoC. CONCLUSIONS: Community-based DSD incorporating three- and six-monthly ART refills and single annual clinical visits were at least non-inferior to standard facility-based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370.
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Fármacos Anti-HIV , COVID-19 , Infecções por HIV , Adulto , África Austral , Fármacos Anti-HIV/uso terapêutico , Serviços de Saúde Comunitária , Infecções por HIV/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Fatores de Tempo , Carga ViralRESUMO
BACKGROUND: Out-of-facility multi-month dispensing (MMD) is a differentiated service delivery model which provides antiretroviral treatment (ART) at intervals of up to 6 monthly in the community. Limited randomized evidence investigating out-of-facility MMD is available. We evaluated participant outcomes and compared out-of-facility MMD models using data from cluster-randomized trials in Southern Africa. SETTING: Eight districts in Zimbabwe and Lesotho. METHODS: Individual-level participant data from 2 cluster-randomized trials that included stable adults receiving ART at 60 facilities were pooled. Both trials had 3 arms: ART collected 3-monthly at healthcare facilities (3MF, control); ART provided three-monthly in community ART groups (CAGs) (3MC); and ART provided 6-monthly in either CAGs or on an individual provider-patient basis (6MC). Participant retention, viral suppression and incidence of unscheduled facility visits were compared. RESULTS: Ten thousand one hundred thirty-six participants were included, 3817 (37.7%), 2893 (28.5%) and 3426 (33.8%) in arms 3MF, 3MC and 6MC, respectively. After 12 months, retention was non-inferior for 3MC (95.7%) vs. 3MF (95.0%) {adjusted risk difference (aRD) = 0.3 [95% confidence interval (CI): -0.8 to 1.4]}; and 6MC (95.1%) vs. 3MF [aRD = -0.2 (95% CI: -1.4 to 1.0)]. Retention was greater amongst intervention arm participants in CAGs versus 6MC participants not in CAGs, aRD = 1.5% (95% CI: 0.2% to 2.9%). Viral suppression was excellent (≥98%) and unscheduled facility visits were not increased in the intervention arms. CONCLUSIONS: Three and 6-monthly out-of-facility MMD was non-inferior versus facility-based care for stable ART patients. Out-of-facility 6-monthly MMD should incorporate small group peer support whenever possible. CLINICALTRIAL REGISTRATION: ClinicalTrials.gov NCT03238846 and NCT03438370.
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Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Adolescente , Adulto , África Austral , Fármacos Anti-HIV/uso terapêutico , COVID-19 , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Retenção nos Cuidados , Fatores de Tempo , Adulto JovemRESUMO
INTRODUCTION: Multimonth dispensing (MMD) of antiretroviral treatment (ART) aims to reduce patient-related barriers to access long-term treatment and improve health system efficiency. However, randomized evidence of its clinical effectiveness is lacking. We compared MMD within community ART refill groups (CARGs) vs. standard-of-care facility-based ART delivery in Zimbabwe. METHODS: A three-arm, cluster-randomized, pragmatic noninferiority trial was performed. Thirty health care facilities and associated CARGs were allocated to either ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC). Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were eligible. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrollment were compared, using regression models specified for clustering (ClinicalTrials.gov: NCT03238846). RESULTS: 4800 participants were recruited, 1919, 1335, and 1546 in arms 3MF, 3MC, and 6MC, respectively. For retention, the prespecified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms, 3MC (94.8%) vs. 3MF (93.0%), adjusted RD = 1.1% (95% CI: -0.5% to 2.8%); 6MC (95.5%) vs. 3MF: aRD = 1.2% (95% CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD = 0.1% (95% CI: -2.4% to 2.6%). VL completion at 12 months was 49%, 45%, and 8% in 3MF, 3MC, and 6MC, respectively. VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk = 1.0 (95% CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk = 0.9 (95% CI: 0.9-1.0). CONCLUSION: Retention in CARGs receiving three- and six-monthly MMD was noninferior versus standard-of-care facility-based ART delivery. VS in 3MC was high. VS in six-monthly CARGs requires further evaluation.
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Antirretrovirais/uso terapêutico , Prescrições de Medicamentos , Infecções por HIV/tratamento farmacológico , HIV-1 , Assistência Ambulatorial , Análise por Conglomerados , Serviços de Saúde Comunitária/organização & administração , Redes Comunitárias , Feminino , Humanos , Masculino , Adesão à Medicação , Fatores de Tempo , Resultado do Tratamento , Carga ViralRESUMO
BACKGROUND: South Africa has the highest HIV prevalence globally, which disproportionately affects women. Hazardous alcohol use reduces antiretroviral adherence which can lead to adverse health. Few evidence-based interventions addressing hazardous alcohol use and HIV have been implemented in real-world settings. This study aimed to evaluate implementation outcomes from the Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town. METHODS: We conducted this implementation science trial using a modified stepped-wedge design. Four health clinics were paired with four substance use rehabilitation programs and randomized into four cycles. Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle). We assessed adoption, acceptability, appropriateness, cost, and fidelity using a mixed methods approach. RESULTS: Adoption: 100 % of staff trained in the WHC and designated as interventionists delivered one or more workshops. Acceptability: Interventionists found the WHC content beneficial to their patients and the WHC improved connections between clinical units in facilities. Appropriateness: The WHC aligned with facility goals to improve antiretroviral adherence and reduce alcohol use; however, there were implementation challenges, including staff shortages, stigma, and few places to refer women for supportive services. Cost: The cost of implementing the WHC was 20.59 ZAR (1.40 USD) per attendee. Fidelity: Interventionists implemented the WHC with high fidelity and quality. CONCLUSIONS: The findings suggest it is feasible to integrate the WHC into usual-care settings. Future efforts to scale up the intervention will need to address social and structural implementation challenges. TRIAL REGISTRATION: NCT02733003 approved 1/21/2016.
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Ciência da Implementação , Adulto , Consumo de Bebidas Alcoólicas , Etanol , Feminino , Infecções por HIV/epidemiologia , Humanos , Masculino , Comportamento de Redução do Risco , Estigma Social , África do Sul/epidemiologia , Saúde da MulherRESUMO
INTRODUCTION: Adolescents and youth receiving antiretroviral treatment (ART) in sub-Saharan Africa have high attrition and inadequate ART outcomes, and evaluations of interventions improving ART outcomes amongst adolescents are very limited. Sustainable Development Goal (SDG) target 3c is to substantially increase the health workforce in developing countries. We measured the effectiveness and cost-effectiveness of community-based support (CBS) provided by lay health workers for adolescents and youth receiving ART in South Africa. METHODS: A retrospective cohort study including adolescents and youth who initiated ART at 47 facilities. Previously unemployed CBS-workers provided home-based ART-related education, psychosocial support, symptom screening for opportunistic infections and support to access government grants. Outcomes were compared between participants who received CBS plus standard clinic-based care versus participants who received standard care only. Cumulative incidences of all-cause mortality and loss to follow-up (LTFU), adherence measured using medication possession ratios (MPRs), CD4 count slope, and virological suppression were analysed using multivariable Cox, competing-risks regression, generalized estimating equations and mixed-effects models over five years of ART. An expenditure approach was used to determine the incremental cost of CBS to usual care from a provider perspective. Incremental cost-effectiveness ratios were calculated as annual cost per patient-loss (through death or LTFU) averted. RESULTS: Amongst 6706 participants included, 2100 (31.3%) received CBS. Participants who received CBS had reduced mortality, adjusted hazard ratio (aHR) = 0.52 (95% CI: 0.37 to 0.73; p < 0.0001). Cumulative LTFU was 40% lower amongst participants receiving CBS (29.9%) compared to participants without CBS (38.9%), aHR = 0.60 (95% CI: 0.51 to 0.71); p < 0.0001). The effectiveness of CBS in reducing attrition ranged from 42.2% after one year to 35.9% after five years. Virological suppression was similar after three years, but after five years 18.8% CBS participants versus 37.2% non-CBS participants failed to achieve viral suppression, adjusted odds ratio = 0.24 (95% CI: 0.06 to 1.03). There were no significant differences in MPR or CD4 slope. The cost of CBS was US$49.5/patient/year. The incremental cost per patient-loss averted was US$600 and US$776 after one and two years, respectively. CONCLUSIONS: CBS for adolescents and youth receiving ART was associated with substantially reduced patient attrition, and is a low-cost intervention with reasonable cost-effectiveness that can aid progress towards several health, economic and equality-related SDG targets.
Assuntos
Saúde do Adolescente/economia , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Adolescente , Adulto , Instituições de Assistência Ambulatorial/economia , Fármacos Anti-HIV/economia , Criança , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pesquisa Operacional , Modelos de Riscos Proporcionais , Características de Residência , Estudos Retrospectivos , África do Sul/epidemiologia , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: WHO recommends antiretroviral treatment (ART) for all HIV-positive individuals. This study evaluated the association between baseline CD4 count and attrition in a cohort of HIV positive adults initiating ART at three department of health (DOH) clinics routinely providing ART at baseline CD4 counts >500cells/µL for the HPTN 071 (PopART) trial. METHODS: All clients attending the DOH clinics were managed according to standard care guidelines with the exception that those starting ART outside of pertinent local guidelines signed research informed consent. DOH data on all HIV-positive adult clients recorded as having initiated ART between January 2014 and November 2015 at the three study clinics was analysed. Attrition, included clients lost to follow up or died, and was defined as 'being three or more months late for an antiretroviral pharmacy pick-up appointment'. All clients were followed until attrition, transfer out or end May 2016. RESULTS: A total of 2423 clients with a median baseline CD4 count of 328 cells/µL (IQR 195-468) were included of whom 631 (26.0%) experienced attrition and 140 (5.8%) were TFO. Attrition was highest during the first six months of ART (IR 38.3/100 PY; 95% CI 34.8-42.1). Higher attrition was found amongst those with baseline CD4 counts > 500 cells/µL compared to those with baseline CD4 counts of 0-500 cells/µL (aHR 1.26, 95%CI 1.05 to 1.52) This finding was confirmed on subset analyses when restricted to individuals non-pregnant at baseline and when restricted to individuals with follow up of > 12months. CONCLUSIONS: Attrition in this study was high, particularly during the first six months of treatment. Attrition was highest amongst clients starting ART at baseline CD4 counts > 500 cells/µL. Strategies to improve retention amongst ART clients, particularly those starting ART at baseline CD4 counts >500cells/µL, need strengthening. Improved monitoring of clients moving in and out of ART care and between clinics will assist in better understanding attrition and ART coverage in high burden countries.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Contagem de Linfócito CD4 , Infecções por HIV/tratamento farmacológico , Infecções por HIV/imunologia , Adolescente , Adulto , Terapia Antirretroviral de Alta Atividade , Ensaios Clínicos como Assunto , Feminino , Programas Governamentais , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , África do Sul , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Sub-Saharan Africa is the world region with the greatest number of people eligible to receive antiretroviral treatment (ART). Less frequent dispensing of ART and community-based ART-delivery models are potential strategies to reduce the load on overburdened healthcare facilities and reduce the barriers for patients to access treatment. However, no large-scale trials have been conducted investigating patient outcomes or evaluating the cost-effectiveness of extended ART-dispensing intervals within community ART-delivery models. This trial will assess the clinical effectiveness, cost-effectiveness and acceptability of providing ART refills on a 3 vs. a 6-monthly basis within community ART-refill groups (CARGs) for stable patients in Zimbabwe. METHODS: In this pragmatic, three-arm, parallel, unblinded, cluster-randomized non-inferiority trial, 30 clusters (healthcare facilities and associated CARGs) are allocated using stratified randomization in a 1:1:1 ratio to either (1) ART refills supplied 3-monthly from the health facility (control arm), (2) ART refills supplied 3-monthly within CARGs, or (3) ART refills supplied 6-monthly within CARGs. A CARG consists of 6-12 stable patients who meet in the community to receive ART refills and who provide support to one another. Stable adult ART patients with a baseline viral load < 1000 copies/ml will be invited to participate (1920 participants per arm). The primary outcome is the proportion of participants alive and retained in care 12 months after enrollment. Secondary outcomes (measured at 12 and 24 months) are the proportions achieving virological suppression, average provider cost per participant, provider cost per participant retained, cost per participant retained with virological suppression, and average patient-level costs to access treatment. Qualitative research will assess the acceptability of extended ART-dispensing intervals within CARGs to both providers and patients, and indicators of potential facility-level decongestion due to the interventions will be assessed. DISCUSSION: Cost-effective health system models that sustain high levels of patient retention are urgently needed to accommodate the large numbers of stable ART patients in sub-Saharan Africa. This will be the first trial to evaluate extended ART-dispensing intervals within a community-based ART distribution model, and results are intended to inform national and regional policy regarding their potential benefits to both the healthcare system and patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03238846 . Registered on 27 July 2017.
Assuntos
Fármacos Anti-HIV/economia , Fármacos Anti-HIV/provisão & distribuição , Serviços Comunitários de Farmácia/economia , Custos de Medicamentos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Fármacos Anti-HIV/administração & dosagem , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Prescrições de Medicamentos/economia , Estudos de Equivalência como Asunto , Infecções por HIV/diagnóstico , Infecções por HIV/virologia , Humanos , Ensaios Clínicos Pragmáticos como Assunto , Fatores de Tempo , Resultado do Tratamento , Carga Viral , ZimbábueRESUMO
INTRODUCTION: Antiretroviral treatment (ART) guidelines recommend life-long ART for all HIV-positive individuals. This study evaluated tuberculosis (TB) incidence on ART in a cohort of HIV-positive individuals starting ART regardless of CD4 count in a programmatic setting at 3 clinics included in the HPTN 071 (PopART) trial in South Africa. METHODS: A retrospective cohort analysis of HIV-positive individuals aged ≥18 years starting ART, between January 2014 and November 2015, was conducted. Follow-up was continued until 30 May 2016 or censored on the date of (1) incident TB, (2) loss to follow-up from HIV care or death, or (3) elective transfer out; whichever occurred first. RESULTS: The study included 2423 individuals. Median baseline CD4 count was 328 cells/µL (interquartile range 195-468); TB incidence rate was 4.41/100 person-years (95% confidence interval [CI]: 3.62 to 5.39). The adjusted hazard ratio of incident TB was 0.27 (95% CI: 0.12 to 0.62) when comparing individuals with baseline CD4 >500 and ≤500 cells/µL. Among individuals with baseline CD4 count >500 cells/µL, there were no incident TB cases in the first 3 months of follow-up. Adjusted hazard of incident TB was also higher among men (adjusted hazard ratio 2.16; 95% CI: 1.41 to 3.30). CONCLUSIONS: TB incidence after ART initiation was significantly lower among individuals starting ART at CD4 counts above 500 cells/µL. Scale-up of ART, regardless of CD4 count, has the potential to significantly reduce TB incidence among HIV-positive individuals. However, this needs to be combined with strengthening of other TB prevention strategies that target both HIV-positive and HIV-negative individuals.