Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa
Introduction Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e065848.full |
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| author | Lawrence C Long Matthew Fox Donald M Thea Sophie Pascoe Jeremy Kane Sithabile Mngadi Pertunia Manganye Kristina Metz Taylor Allen Srishti Sardana Ross Greener Amy Zheng Laura K Murray |
| author_facet | Lawrence C Long Matthew Fox Donald M Thea Sophie Pascoe Jeremy Kane Sithabile Mngadi Pertunia Manganye Kristina Metz Taylor Allen Srishti Sardana Ross Greener Amy Zheng Laura K Murray |
| author_sort | Lawrence C Long |
| collection | DOAJ |
| description | Introduction Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa.Methods and analysis We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs.Ethics and dissemination Ethics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals.Trial registration number NCT04242992. |
| format | Article |
| id | doaj-art-7b84e2670bc7495eaaf36f9aa3a49037 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-7b84e2670bc7495eaaf36f9aa3a490372025-08-20T03:53:17ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-065848Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South AfricaLawrence C Long0Matthew Fox1Donald M Thea2Sophie Pascoe3Jeremy Kane4Sithabile Mngadi5Pertunia Manganye6Kristina Metz7Taylor Allen8Srishti Sardana9Ross Greener10Amy Zheng11Laura K Murray12Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USABoston University, Boston, Massachusetts, USAHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USADepartment of Internal Medicine, Faculty of Health Sciences University of the Witwatersrand, Johannesburg, South AfricaDepartment of Internal Medicine, Faculty of Health Sciences University of the Witwatersrand, Johannesburg, South AfricaDepartment of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USADepartment of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USADepartment of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USADepartment of Internal Medicine, Faculty of Health Sciences University of the Witwatersrand, Johannesburg, South AfricaDepartment of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USADepartment of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USAIntroduction Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa.Methods and analysis We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs.Ethics and dissemination Ethics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals.Trial registration number NCT04242992.https://bmjopen.bmj.com/content/12/12/e065848.full |
| spellingShingle | Lawrence C Long Matthew Fox Donald M Thea Sophie Pascoe Jeremy Kane Sithabile Mngadi Pertunia Manganye Kristina Metz Taylor Allen Srishti Sardana Ross Greener Amy Zheng Laura K Murray Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa BMJ Open |
| title | Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa |
| title_full | Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa |
| title_fullStr | Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa |
| title_full_unstemmed | Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa |
| title_short | Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa |
| title_sort | study protocol a randomised trial of the effectiveness of the common elements treatment approach ceta for improving hiv treatment outcomes among women experiencing intimate partner violence in south africa |
| url | https://bmjopen.bmj.com/content/12/12/e065848.full |
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