Browsing by Author "Zani, Babalwa"

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    Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial
    (BioMed Central, 2018-03-22) Fairall, Lara; Petersen, Inge; Zani, Babalwa; Folb, Naomi; Georgeu-Pepper, Daniella; Selohilwe, One; Petrus, Ruwayda; Mntambo, Ntokozo; Bhana, Arvin; Lombard, Carl; Bachmann, Max; Lund, Crick; Hanass-Hancock, Jill; Chisholm, Daniel; McCrone, Paul; Carmona, Sergio; Gaziano, Thomas; Levitt, Naomi; Kathree, Tasneem; Thornicroft, Graham
    Background The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.
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    Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial
    (BioMed Central, 2018-03-22) Petersen, Inge; Bhana, Arvin; Folb, Naomi; Thornicroft, Graham; Zani, Babalwa; Selohilwe, One; Petrus, Ruwayda; Mntambo, Ntokozo; Georgeu-Pepper, Daniella; Kathree, Tasneem; Lund, Crick; Lombard, Carl; Bachmann, Max; Gaziano, Thomas; Levitt, Naomi; Fairall, Lara
    Background The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA). Methods/design The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months. Discussion This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa. Trial registration South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015.
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    Nurse led home-based care for people with HIV/AIDS
    (BioMed Central, 2018-03-27) Wood, Elizabeth M; Zani, Babalwa; Esterhuizen, Tonya M; Young, Taryn
    Background Home-based care is used in many countries to increase quality of life and limit hospital stay, particularly where public health services are overburdened. Home-based care objectives for HIV/AIDS can include medical care, delivery of antiretroviral treatment and psychosocial support. This review assesses the effects of home-based nursing on morbidity in people infected with HIV/AIDS. Methods The trials studied are in HIV positive adults and children, regardless of sex or setting and all randomised controlled. Home-based care provided by qualified nurses was compared with hospital or health-facility based treatment. The following electronic databases were searched from January 1980 to March 2015: AIDSearch, CINAHL, Cochrane Register of Controlled Trials, EMBASE, MEDLINE and PsycINFO/LIT, with an updated search in November 2016. Two authors independently screened titles and abstracts from the electronic search based on the study design, interventions and types of participant. For all selected abstracts, full text articles were obtained. The final study selection was determined with use of an eligibility form. Data extraction was performed independently from assessment of risk of bias. The results were analysed by narrative synthesis, in order to be able to obtain relevant effect measures plus 95% confidence intervals. Results Seven studies met the inclusion criteria. The trial size varied from 37 to 238 participants. Only one trial was conducted in children. Five studies were conducted in the USA and two in China. Four studies looked at home-based adherence support and the rest at providing home-based psychosocial support. Reported adherence to antiretroviral drugs improved with nurse-led home-based care but did not affect viral load. Psychiatric nurse support in those with existing mental health conditions improved mental health and depressive symptoms. Home-based psychological support impacted on HIV stigma, worry and physical functioning and in certain cases depressive symptoms. Conclusions Nurse-led home-based interventions could help adherence to antiretroviral therapy and improve mental health. Further larger scale studies are needed, looking in more detail at improving medical care for HIV, especially related to screening and management of opportunistic infections and co-morbidities.
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    Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register
    (Public Library of Science, 2011) Zani, Babalwa; Pienaar, Elizabeth D; Oliver, Joy; Siegfried, Nandi
    Introduction To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs). Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. Objectives To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20), Zambia (12) and Zimbabwe (9). The median sample size was 628 (range 33-9645). Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA) and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial landscape in Africa. Of note, few principal investigators and funders are from Africa. These findings mirror our previous work and continue to indicate a need for strengthening trial research capacity in Africa.