scholarly journals Connecting Youth and Young Adults to Optimize ART Adherence (YouTHrive): Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
K J Horvath Horvath ◽  
R MacLehose ◽  
A Martinka ◽  
J Dewitt ◽  
L Hightow-Weidman ◽  
...  
Keyword(s):  
New York ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Phase 1 ◽  
Art Adherence ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Beta Testing ◽  
Us Cities

BACKGROUND Youth account for a disproportionately high rates of new HIV infections in the United States (US). Despite intensive efforts to engage people living with HIV (PLWH) in the US, less than half of 13-24 years old achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. OBJECTIVE There are three phases of this project. Phase 1 involves conducting focus groups in three cities (New York City, Chicago, and Houston) to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YouTHrive intervention among youth living with HIV (YLWH) in 6 US cities (Atlanta, New York City, Chicago, Houston, Philadelphia, and Tampa). METHODS In Phase 1, we will conduct six focus groups with approximately 8 youths (15-19 years old) and young adults (20-24 years old) each in three US cities to obtain: 1) feedback from YLWH about the “look and feel” and content of an existing adult-focused web-based ART adherence intervention; and 2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve collaboration with our technology development partner to update the existing intervention to include features and functionality recommended by YLWH in Phase 1. Phase 2 will conclude with beta testing with 12 participants to ensure that all features are working properly and function in a way that users can easily navigate. For Phase 3, we will enroll 300 YLWH in 6 US cities into a two-arm prospective randomized controlled trial (RCT). Participants randomized to the control condition will view a weekly newsletter for 20 weeks. The newsletter will be delivered via e-mail and will contain information on topics related to HIV, with the exception of ART adherence. Participants randomized to the YT intervention condition will be given access to the YT site for 20 weeks. Study assessments will occur at enrollment and 5, 8, and 11 months postenrollment. RESULTS Participant recruitment began in May 2017 for Phase 1 of the study. The data collection for Aim 3 is anticipated to end in April 2020. CONCLUSIONS The efficacy trial of the YT intervention will help to fill gaps in understanding about the efficacy of mobile interventions to improve ART adherence among at-risk populations. Other important questions remain to be addressed, including how best to incorporate virtual ART interventions into clinical care and when they are most effectively delivered. CLINICALTRIAL ClinicalTrials.gov (NCT03149757); University of North Carolina at Chapel Hill Institutional Review Board (16-3136).

scholarly journals Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial

10.2196/11502 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e11502 ◽  
Author(s):  
K J Horvath ◽  
R F MacLehose ◽  
A Martinka ◽  
J DeWitt ◽  
L Hightow-Weidman ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Phase 1 ◽  
Art Adherence ◽  
Phase 2 ◽  
Phase 3 ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Living With Hiv ◽  
Beta Testing ◽  
Us Cities

Background Despite intensive efforts to engage people living with HIV in the United States, less than half of the youth aged 13 to 24 years achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. Objective There are 3 phases of this project. Phase 1 involves conducting focus groups to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YT intervention among youth living with HIV (YLWH). Methods In phase 1, we will conduct 6 focus groups with approximately 8 youths (aged 15-19 years) and young adults (aged 20-24 years), each in 3 US cities to obtain (1) feedback from YLWH about the look and feel and content of an existing adult-focused Web-based ART adherence intervention and (2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve updating the existing intervention to include features and functionality recommended by YLWH in phase 1; it will conclude with beta testing with 12 participants to gain feedback on the overall design and ensure proper functionality and ease of navigation. For phase 3, we will enroll 300 YLWH in 6 US cities (Atlanta, Chicago, Houston, New York City, Philadelphia, and Tampa) into a 2-arm prospective RCT. Participants will be randomized 1:1 to YT intervention or control group. The randomization sequence will be stratified by city and use random permuted blocks of sizes 2 and 4. Participants randomized to the control condition will view a weekly email newsletter on topics related to HIV, with the exception of ART adherence, for 5 months. Participants randomized to the YT intervention condition will be given access to the YT site for 5 months. Study assessments will occur at enrollment and 5, 8, and 11 months post enrollment. The primary outcome that will be assessed is sustained viral load (VL), defined as the proportion of participants in each study arm who have suppressed VL at both the 5- and 11-month assessment; the secondary outcome that will be assessed is suppressed VL at both the 5- and 11-month assessment between drug-using and nondrug-using participants assigned to the YT intervention arm. Results Participant recruitment began in May 2017 for phase 1 of the study. The data collection for aim 3 is anticipated to end in April 2020. Conclusions The efficacy trial of the YT intervention will help to fill gaps in understanding the efficacy of mobile interventions to improve ART adherence among at-risk populations. Trial Registration ClinicalTrials.gov NCT03149757; https://clinicaltrials.gov/ct2/show/NCT03149757 (Archived by WebCite at http://www.webcitation.org/73pw57Cf1) International Registered Report Identifier (IRRID) DERR1-10.2196/11502

scholarly journals A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Susan Ramsey ◽  
Evan Ames ◽  
Julia Uber ◽  
Samia Habib ◽  
Seth Clark
Keyword(s):  
Controlled Trial ◽  
Phase 1 ◽  
Effect Sizes ◽  
Art Adherence ◽  
Phase 2 ◽  
Face To Face ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

BACKGROUND Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. OBJECTIVE The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. METHODS This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. RESULTS Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. CONCLUSIONS This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15356

scholarly journals A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial

10.2196/15356 ◽  
2019 ◽  
Vol 8 (11) ◽  
pp. e15356
Author(s):  
Susan Ramsey ◽  
Evan Ames ◽  
Julia Uber ◽  
Samia Habib ◽  
Seth Clark
Keyword(s):  
Controlled Trial ◽  
Phase 1 ◽  
Effect Sizes ◽  
Art Adherence ◽  
Phase 2 ◽  
Face To Face ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

Background Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. Objective The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. Methods This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. Results Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. Conclusions This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus. Trial Registration ClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128 International Registered Report Identifier (IRRID) DERR1-10.2196/15356

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Socio-Ecological Natural Experiment with Randomized Controlled Trial to Promote Active Commuting to Work: Process Evaluation, Behavioral Impacts, and Changes in the Use and Quality of Walking and Cycling Paths

2019 ◽  
Vol 16 (9) ◽  
pp. 1661 ◽  
Author(s):  
Minna Aittasalo ◽  
Johanna Tiilikainen ◽  
Kari Tokola ◽  
Jaana Suni ◽  
Harri Sievänen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Natural Experiment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Active Commuting ◽  
Phase 2 ◽  
Behavioral Strategies ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Journey To Work

Active commuting to work (ACW) has beneficial effects on health, traffic, and climate. However, more robust evidence is needed on how to promote ACW. This paper reports the findings of a multilevel natural experiment with a randomized controlled trial in 16 Finnish workplaces. In Phase 1, 11 workplaces (1823 employees) from Area 1 were exposed to environmental improvements in walking and cycling paths. In Phase 2, five more workplaces (826 employees) were recruited from Area 2 and all workplaces were randomized into experimental group (EXP) promoting ACW with social and behavioral strategies and comparison group (COM) participating only in data collection. Process and impact evaluation with questionnaires, travel diaries, accelerometers, traffic calculations, and auditing were conducted. Statistics included Wilcoxon Signed Ranks Test, Mann-Whitney U-test, and after-before differences with 95% confidence intervals (95% CI). After Phase 1, positive change was seen in the self-reported number of days, which the employees intended to cycle part of their journey to work in the following week (p = 0.001). After Phase 2, intervention effect was observed in the proportion of employees, who reported willingness to increase walking (8.7%; 95% CI 1.8 to 15.6) and cycling (5.5%; 2.2 to 8.8) and opportunity to cycle part of their journey to work (5.9%; 2.1 to 9.7). To conclude, the intervention facilitated employees’ motivation for ACW, which is the first step towards behavior change.

scholarly journals Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men (Preprint)

2018 ◽  
Author(s):  
Keith J Horvath ◽  
K Rivet Amico ◽  
Darin Erickson ◽  
Alexandra M Ecklund ◽  
Aldona Martinka ◽  
...  
Keyword(s):  
New York ◽  
New York City ◽  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Hiv Positive ◽  
Art Adherence ◽  
Randomized Controlled ◽  
Sex With Men

BACKGROUND The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented. OBJECTIVE The aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City. METHODS A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence. RESULTS Participant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019. CONCLUSIONS The efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features. CLINICALTRIAL ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6) REGISTERED REPORT IDENTIFIER RR1-10.2196/10182

scholarly journals Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
John A Joska ◽  
Lena S Andersen ◽  
Rosana Smith-Alvarez ◽  
Jessica Magidson ◽  
Jasper S Lee ◽  
...  
Keyword(s):  
South Africa ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Art Adherence ◽  
First Line ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

BACKGROUND There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). OBJECTIVE This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. METHODS This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). RESULTS The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. CONCLUSIONS Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals. CLINICALTRIAL ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14200

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2018 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial

10.2196/14200 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e14200 ◽  
Author(s):  
John A Joska ◽  
Lena S Andersen ◽  
Rosana Smith-Alvarez ◽  
Jessica Magidson ◽  
Jasper S Lee ◽  
...  
Keyword(s):  
South Africa ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Art Adherence ◽  
First Line ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

Background There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). Objective This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. Methods This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). Results The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. Conclusions Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals. Trial Registration ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824 International Registered Report Identifier (IRRID) DERR1-10.2196/14200

scholarly journals Correction: Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
John A Joska ◽  
Lena S Andersen ◽  
Rosana Smith-Alvarez ◽  
Jessica Magidson ◽  
Jasper S Lee ◽  
...  
Keyword(s):  
South Africa ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Art Adherence ◽  
First Line ◽  
Randomized Controlled ◽  
Persons Living With Hiv ◽  
Living With Hiv

UNSTRUCTURED There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals. ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824

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