The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
Abstract Background Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal ad...
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| Format: | Article |
| Language: | English |
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BMC
2020-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-020-4131-8 |
| _version_ | 1819050771081068544 |
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| author | Maria H. Kim Tapiwa A. Tembo Alick Mazenga Xiaoying Yu Landon Myer Rachael Sabelli Robert Flick Miriam Hartig Elizabeth Wetzel Katie Simon Saeed Ahmed Rose Nyirenda Peter N. Kazembe Mtisunge Mphande Angella Mkandawire Mike J. Chitani Christine Markham Andrea Ciaranello Elaine J. Abrams |
| author_facet | Maria H. Kim Tapiwa A. Tembo Alick Mazenga Xiaoying Yu Landon Myer Rachael Sabelli Robert Flick Miriam Hartig Elizabeth Wetzel Katie Simon Saeed Ahmed Rose Nyirenda Peter N. Kazembe Mtisunge Mphande Angella Mkandawire Mike J. Chitani Christine Markham Andrea Ciaranello Elaine J. Abrams |
| author_sort | Maria H. Kim |
| collection | DOAJ |
| description | Abstract Background Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. Methods This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses. Discussion This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes. Trial registration ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018. |
| first_indexed | 2024-12-21T11:53:20Z |
| format | Article |
| id | doaj.art-6800a20360c240228363fd1f0964385e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T11:53:20Z |
| publishDate | 2020-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6800a20360c240228363fd1f0964385e2022-12-21T19:05:00ZengBMCTrials1745-62152020-02-0121111310.1186/s13063-020-4131-8The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in MalawiMaria H. Kim0Tapiwa A. Tembo1Alick Mazenga2Xiaoying Yu3Landon Myer4Rachael Sabelli5Robert Flick6Miriam Hartig7Elizabeth Wetzel8Katie Simon9Saeed Ahmed10Rose Nyirenda11Peter N. Kazembe12Mtisunge Mphande13Angella Mkandawire14Mike J. Chitani15Christine Markham16Andrea Ciaranello17Elaine J. Abrams18Baylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalBaylor College of Medicine Children’s Foundation MalawiBaylor College of Medicine Children’s Foundation MalawiUniversity of Texas Medical Branch at GalvestonDivision of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape TownBaylor College of Medicine Children’s Foundation MalawiBaylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalBaylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalBaylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalBaylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalBaylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalHIV Unit, Malawi Ministry of HealthBaylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s HospitalBaylor College of Medicine Children’s Foundation MalawiBaylor College of Medicine Children’s Foundation MalawiBaylor College of Medicine Children’s Foundation MalawiHealth Promotion & Behavioral Sciences, The University of Texas School of Public HealthDivision of Infectious Diseases, Department of Medicine; Medical Practice Evaluation Center; both at Massachusetts General HospitalICAP at Columbia, Mailman School of Public Health and Vagelos College of Physicians and Surgeons, Columbia UniversityAbstract Background Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. Methods This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses. Discussion This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes. Trial registration ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.http://link.springer.com/article/10.1186/s13063-020-4131-8HIVART (antiretroviral therapy)RetentionAdherencePMTCT (prevention of mother-to-children transmission)Video |
| spellingShingle | Maria H. Kim Tapiwa A. Tembo Alick Mazenga Xiaoying Yu Landon Myer Rachael Sabelli Robert Flick Miriam Hartig Elizabeth Wetzel Katie Simon Saeed Ahmed Rose Nyirenda Peter N. Kazembe Mtisunge Mphande Angella Mkandawire Mike J. Chitani Christine Markham Andrea Ciaranello Elaine J. Abrams The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi Trials HIV ART (antiretroviral therapy) Retention Adherence PMTCT (prevention of mother-to-children transmission) Video |
| title | The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi |
| title_full | The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi |
| title_fullStr | The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi |
| title_full_unstemmed | The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi |
| title_short | The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi |
| title_sort | video intervention to inspire treatment adherence for life vital start protocol for a multisite randomized controlled trial of a brief video based intervention to improve antiretroviral adherence and retention among hiv infected pregnant women in malawi |
| topic | HIV ART (antiretroviral therapy) Retention Adherence PMTCT (prevention of mother-to-children transmission) Video |
| url | http://link.springer.com/article/10.1186/s13063-020-4131-8 |
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