Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605053
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women with HIV in Tanzania
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENding HIV Transmission to Infants by Generating Evidence to Optimize Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women with HIV in Tanzania ENGAGE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENGAGE
Brief Summary:
The goal of this clinical trial is to find better ways to care for pregnant and postpartum adolescent girls and young women AGYW aged 15-24 years with HIV in Tanzania and to prevent them from passing HIV to their babies The main questions it aims to answer are
How often do young pregnant women with HIV go to their health appointments and stay on their treatment up to two years after giving birth
How many babies born to young women with HIV stay HIV-free for two years
How soon do young women with HIV get pregnant again after giving birth and what factors affect this
What are the best ways to help young women with HIV stay in care and stay healthy during and after pregnancy
What social and structural factors affect whether young pregnant women with HIV go to their health appointments and stay on their treatment
How can we work with young women with HIV to create and test a package of interventions to improve their healthcare during and after pregnancy
Can this package of interventions help young women with HIV stay in care and remain healthy during and after pregnancy
Participants will
Have their health data analyzed via health service records of all women who received HIV prevention services between 2018 and 2020 and were followed until 2023 across 559 health facilities in Tanzania
Participate in qualitative interviews to share their experiences and challenges with staying in care
Help to co-create a package of interventions to improve care
Take part in a cluster-randomized trial to test these interventions Researchers will compare the outcomes of the intervention package to see if they improve care engagement retention and health outcomes for AGYW with HIV during and after pregnancy
How often do young pregnant women with HIV go to their health appointments and stay on their treatment up to two years after giving birth
How many babies born to young women with HIV stay HIV-free for two years
How soon do young women with HIV get pregnant again after giving birth and what factors affect this
What are the best ways to help young women with HIV stay in care and stay healthy during and after pregnancy
What social and structural factors affect whether young pregnant women with HIV go to their health appointments and stay on their treatment
How can we work with young women with HIV to create and test a package of interventions to improve their healthcare during and after pregnancy
Can this package of interventions help young women with HIV stay in care and remain healthy during and after pregnancy
Participants will
Have their health data analyzed via health service records of all women who received HIV prevention services between 2018 and 2020 and were followed until 2023 across 559 health facilities in Tanzania
Participate in qualitative interviews to share their experiences and challenges with staying in care
Help to co-create a package of interventions to improve care
Take part in a cluster-randomized trial to test these interventions Researchers will compare the outcomes of the intervention package to see if they improve care engagement retention and health outcomes for AGYW with HIV during and after pregnancy
Detailed Description:
Background Sub-Saharan Africa SSA remains the most affected region by the global HIV pandemic accounting for half of all new HIV infections and 66 of the worlds 39 million people living with HIV PLHIV In SSA two-thirds of new HIV infections occur among women of reproductive age with adolescent girls and young women AGYW aged 15-24 years being 35 times more likely to acquire HIV compared to young men Pregnant AGYW with HIV face poorer outcomes on antiretroviral treatment ART and have elevated risks of vertical HIV transmission to their infants
In 2022 SSA had 84 of the 130000 estimated new HIV infections in children aged 0-14 years globally with vertical transmission accounting for over 90 of these cases Effective use of ART among pregnant and breastfeeding women with HIV can reduce the risk of vertical HIV transmission to less than 2 However significant gaps remain with Tanzania being one of the countries with the highest numbers of new HIV infections in children and women of reproductive age Despite progress in reducing vertical transmission rates pregnant AGYW continue to lag in efforts to end HIV infections in children having poorer HIV treatment outcomes higher vertical transmission rates and higher reproductive health risks While good quality evidence on AGYW is missing available data shows that AGYWs specific needs are not sufficiently addressed by standard care There is therefore an urgent need to expand knowledge on and explore effective approaches to improve HIV and reproductive healthcare experience and outcomes for pregnant AGYW with HIV
Study Objectives The purpose of the ENGAGE project is to optimize care for prevention of vertical HIV transmission and HIV treatment among pregnant and postpartum AGYW with HIV and their infants and to improve the prevention of unintended pregnancies among AGYW in Tanzania - a setting where HIV is endemic and maternal mortality remains a leading cause of death among young women
This is done via four sub-studies with the following specific objectives
Sub-study 1
To investigate patterns and trends of health service uptake retention and health outcomes among pregnant postpartum AGYW living with HIV up to two years after delivery
To determine 2-years HIV-free survival rate among infants born to AGYW living with HIV
To assess the timing and spacing of subsequent pregnancies and factors influencing them among AGYW living with HIV enrolled in prevention of vertical HIV transmission services
Sub-study 2
To synthesize available evidence on potential interventions to improve health service uptake retention and health outcomes among pregnant postpartum AGYW living with HIV enrolled in prevention of vertical HIV transmission services
To understand social-structural factors influencing health service uptake retention and health outcomes among pregnant postpartum AGYW living with HIV
Sub-study 3
To co-create and prototype a tailored package of micro-interventions to optimize healthcare for prevention of vertical HIV transmission services for AGYW
Sub-study 4
To assess the feasibility and preliminary effect of a micro-intervention package tailored to improve service uptake retention and health outcomes among pregnant AGYW living with HIV
Study Design and setting This is a mixed-methods implementation research project embedded within routine healthcare settings It employs a sequential explanatory design starting with an analysis of quantitative cohort data on adolescent girls and young women AGYW enrolled in PMTCT Option B sub-study 1 This is followed by a stepwise qualitative inquiry aimed at co-producing and prototyping a package of interventions that can be seamlessly integrated to enhance existing care approaches sub-studies 2-3 The intervention package will then be pilot-tested for feasibility and preliminary effectiveness using a cluster-randomized clinical trial design sub-study 4
The project will be conducted in the regions of Dar es Salaam Kagera and Tabora in Tanzania Dar es Salaam the most populous and main commercial hub of Tanzania is predominantly urban with a population of 54 million out of the countrys 62 million In contrast Kagera and Tabora are primarily rural with populations of 30 million and 34 million respectively The prevalence of HIV among adults aged 15 and older is 42 in Dar es Salaam 57 in Kagera and 56 in Tabora Annually these regions see approximately 200000 new pregnant women attending antenatal care ANC clinics in Dar es Salaam 140000 in Kagera and 200000 in Tabora with 3-4 of these women being HIV positive Among these HIV-positive pregnant women those aged 15 to 24 years constitute about 20 in Dar es Salaam 27 in Kagera and 24 in Tabora
Sub-study I Registry-based Retrospective Cohort Design and Participants This observational cohort study utilizes data from routine healthcare records of 559 MDH-supported health facilities which account for over 90 of HIV care in the three regions of Dar es Salaam Kagera and Tabora The study includes all pregnantpostpartum AGYW with HIV who started vertical HIV prevention services between January 1 2018 and December 31 2020 and their infants born from this pregnancybreastfeeding episode
Data Collection and Analysis Data will be sourced from the Tanzania national electronic CTC2 database which stores information on HIV care and vertical HIV prevention services The primary outcomes measured include time to ART attrition detectable viral load and HIV-free infant survival Secondary outcomes include repeat pregnancy uptake of vertical HIV prevention services and maternalpregnancy loss Data will be analyzed using statistical methods such as the Kaplan Meier method Cox regression generalized estimating equations GEE and Poisson regression
Limitations and Mitigation The study acknowledges challenges related to the quality and completeness of routinely collected data To address these issues physical verification will be performed by obtaining patient charts and updating the CTC2 database Multiple methods including multiple imputation and propensity scores will be employed to handle incomplete or missing data
Sub-study II Evidence Review and Consultations Part 1 Evidence Review Design and Scope A systematic review based on the PRISMA guidelines will be conducted to identify potential interventions to improve engagement retention and health outcomes of vertical HIV prevention services among AGYW in SSA The review will include experimental designs with a control group and will focus on studies conducted between 2014 and 2023
Search Strategy and Data Extraction Peer-reviewed articles and grey literature will be searched using databases such as PubMed and Medline The search strategy will consider the four PICO elements PatientPopulationProblem Intervention Comparison and Outcomes to develop the search syntax Data extraction will be done using a standardized excel sheet to capture key study aspects
Synthesis and Risk of Bias Assessment For experimental studies meta-analysis will be conducted if feasible Otherwise findings will be synthesized using a comprehensive narrative approach Risk of bias will be assessed using appropriate tools for each study type and the overall certainty of evidence will be rated using the Cochrane GRADE approach
Part 2 Qualitative consultations will be conducted through in-depth interviews IDIs and focus group discussions FGDs with AGYW ages 15-24 years healthcare providers spousespartners parents and community stakeholders The study will be conducted in Dar es Salaam urban and Kagera rural regions
Data Collection and Analysis Participants will be recruited using purposive sampling Data will be collected using semi-structured interview guides and analyzed using content analysis Themes and subthemes will be identified and discussed by the research team
Sub-study III Co-design and Prototyping of an Intervention package Design and Participants This stage involves co-creating a package of interventions with AGYW healthcare providers and community stakeholders The participants will be organized into an intervention development group consisting of about 24 members including pregnant and postpartum AGYW spousespartners parentsguardians healthcare providers community stakeholders and research team members
Co-production Process The co-production process will be conducted through a series of workshops over six months The workshops will be held in neutral accessible and safe communitypublic venues to enhance active interactions Participants will use various methods of participation including flash cards role play and writing on whiteboardsflip chartssticky notes The outcome will be a package of interventions designed to improve engagement retention and outcomes of AGYW in vertical HIV prevention services
Prototyping Stage During the prototyping stage the intervention development group research team and other reproductive healthAGYW experts will draft intervention materials and training manuals These will be tested at 1-2 purposefully selected intervention facilities The process will involve training healthcare providers or other stakeholders to deliver the interventions and gaining input from AGYW and providers on the acceptability of the content and methods
Sub-study IV Pilot-test the Intervention Package Design and Participants two-arm cluster randomized trial to evaluate the feasibility acceptability and preliminary effectiveness of the interventions in Dar es Salaam and Kagera regions of Tanzania Participants will include pregnant AGYW living with HIV new previously diagnosed and transfers who are receiving vertical HIV prevention services between January 1 2026 and June 30 2026 with follow-up extending for at least one year until June 30 2027
Sampling Method and Sample Size The sample size for the study was estimated using a formula for cluster randomized studies which inflates the sample size for a two-arm simple randomized study using the design effect The design effect accounts for the clustering effect with an intra-cluster correlation coefficient ICC of 002 and an average cluster size of 12 The final sample size is determined to be 222 participants 111 per arm providing 80 power to detect a 15 difference in retention rate between the intervention and control arms with a standard error of 005
Facility Sampling and Randomization Between 2018 and 2020 376 MDH-supported facilities provided vertical HIV prevention services to at least one AGYW in Dar es Salaam and Kagera regions From these 225 facilities that enrolled at least 10 AGYW per year were identified 116 in Dar es Salaam and 139 in Kagera The facilities include hospitals health centers and dispensaries Using block randomization 12 facilities per region will be randomized into six intervention and six control arms ensuring a balanced distribution of facility levels
Intervention and Control At each intervention facility a focal team of 2-3 persons comprising both AGYW and healthcare providers will be trained and engaged to drive the implementation of the intervention package This team will orient and engage other staff and stakeholders to deliver the interventions identify and address gaps and monitor implementation fidelity and quality using standard operating procedures and job aids The interventions will be integrated into routine care with hands-on supportive supervision and mentorship provided by local researchers through weekly follow-ups in the first month and monthly thereafter The intervention package may include components such as SMSphone call reminders peer mother support and flexible clinic hours tailored to the needs of AGYW The control arm will received standard PMTCT care as per national Tanzania guidelines
Data Collection and Analysis Data for assessing the preliminary effect on primary outcomes will be extracted from the existing Tanzania national electronic CTC2 database Data will be analyzed using statistical methods such as Kaplan Meier and Cox regression for time to ART attrition and HIV-free infant survival generalized estimating equations GEE for detectable viral load and Poisson regression for the composite outcome of optimal vertical HIV prevention Additional qualitative data will be collected from AGYW and healthcare providers through face-to-face interviews using a semi-structured questionnaire
Fidelity Assessment and Feasibility To ensure comprehensive fidelity measurement the study will use a combination of methods at various levels of implementation These methods will include checklists adherence reports structured audits and fidelity assessment protocols Fidelity assessments will be conducted at baseline before implementation begins periodically at weeklymonthly intervals during the interventions implementation and at the end of the intervention to evaluate overall fidelity
Study Limitations and Mitigation To address potential data quality issues in the CTC2 database the study will implement rigorous validation and cleaning processes cross-referencing with other sources conducting data quality assessments and addressing missing data through appropriate imputation methods This approach aims to enhance the reliability and integrity of the study findings
Ethical considerations The project has received ethical approval from the National Health Research Ethics Committee NaTHREC in Tanzania Approval will also be sought from the Swedish Ethical Review Authority EPM for analysis of de-identified data in Sweden
Key ethical aspects include
Informed Consent Informed consent will be obtained from all participants involved in new data collection For minors aged 15-17 years who are considered emancipated consent will be sought directly from them without the need for parental consent
Privacy and Confidentiality The study involves the collection of sensitive personal information To protect participants privacy personal identifiers such as names and addresses will not be extracted from the registry Interviews will be conducted in pre-arranged private spaces and all study data will be stored securely in password-protected computers with access limited to the research team
Minimizing Risks The study is designed to use routine healthcare data supplemented by qualitative data from focus group discussions and interviews The risks to participants are considered minimal but potential risks and ethical considerations have been identified and addressed
Implications The ENGAGE study represents a significant effort to address the unique needs of young women living with HIV in Tanzania aiming to improve their health outcomes and reduce the risk of HIV transmission to their infants Through a collaborative and evidence-based approach the study seeks to contribute to the global goal of eliminating HIVAIDS
In 2022 SSA had 84 of the 130000 estimated new HIV infections in children aged 0-14 years globally with vertical transmission accounting for over 90 of these cases Effective use of ART among pregnant and breastfeeding women with HIV can reduce the risk of vertical HIV transmission to less than 2 However significant gaps remain with Tanzania being one of the countries with the highest numbers of new HIV infections in children and women of reproductive age Despite progress in reducing vertical transmission rates pregnant AGYW continue to lag in efforts to end HIV infections in children having poorer HIV treatment outcomes higher vertical transmission rates and higher reproductive health risks While good quality evidence on AGYW is missing available data shows that AGYWs specific needs are not sufficiently addressed by standard care There is therefore an urgent need to expand knowledge on and explore effective approaches to improve HIV and reproductive healthcare experience and outcomes for pregnant AGYW with HIV
Study Objectives The purpose of the ENGAGE project is to optimize care for prevention of vertical HIV transmission and HIV treatment among pregnant and postpartum AGYW with HIV and their infants and to improve the prevention of unintended pregnancies among AGYW in Tanzania - a setting where HIV is endemic and maternal mortality remains a leading cause of death among young women
This is done via four sub-studies with the following specific objectives
Sub-study 1
To investigate patterns and trends of health service uptake retention and health outcomes among pregnant postpartum AGYW living with HIV up to two years after delivery
To determine 2-years HIV-free survival rate among infants born to AGYW living with HIV
To assess the timing and spacing of subsequent pregnancies and factors influencing them among AGYW living with HIV enrolled in prevention of vertical HIV transmission services
Sub-study 2
To synthesize available evidence on potential interventions to improve health service uptake retention and health outcomes among pregnant postpartum AGYW living with HIV enrolled in prevention of vertical HIV transmission services
To understand social-structural factors influencing health service uptake retention and health outcomes among pregnant postpartum AGYW living with HIV
Sub-study 3
To co-create and prototype a tailored package of micro-interventions to optimize healthcare for prevention of vertical HIV transmission services for AGYW
Sub-study 4
To assess the feasibility and preliminary effect of a micro-intervention package tailored to improve service uptake retention and health outcomes among pregnant AGYW living with HIV
Study Design and setting This is a mixed-methods implementation research project embedded within routine healthcare settings It employs a sequential explanatory design starting with an analysis of quantitative cohort data on adolescent girls and young women AGYW enrolled in PMTCT Option B sub-study 1 This is followed by a stepwise qualitative inquiry aimed at co-producing and prototyping a package of interventions that can be seamlessly integrated to enhance existing care approaches sub-studies 2-3 The intervention package will then be pilot-tested for feasibility and preliminary effectiveness using a cluster-randomized clinical trial design sub-study 4
The project will be conducted in the regions of Dar es Salaam Kagera and Tabora in Tanzania Dar es Salaam the most populous and main commercial hub of Tanzania is predominantly urban with a population of 54 million out of the countrys 62 million In contrast Kagera and Tabora are primarily rural with populations of 30 million and 34 million respectively The prevalence of HIV among adults aged 15 and older is 42 in Dar es Salaam 57 in Kagera and 56 in Tabora Annually these regions see approximately 200000 new pregnant women attending antenatal care ANC clinics in Dar es Salaam 140000 in Kagera and 200000 in Tabora with 3-4 of these women being HIV positive Among these HIV-positive pregnant women those aged 15 to 24 years constitute about 20 in Dar es Salaam 27 in Kagera and 24 in Tabora
Sub-study I Registry-based Retrospective Cohort Design and Participants This observational cohort study utilizes data from routine healthcare records of 559 MDH-supported health facilities which account for over 90 of HIV care in the three regions of Dar es Salaam Kagera and Tabora The study includes all pregnantpostpartum AGYW with HIV who started vertical HIV prevention services between January 1 2018 and December 31 2020 and their infants born from this pregnancybreastfeeding episode
Data Collection and Analysis Data will be sourced from the Tanzania national electronic CTC2 database which stores information on HIV care and vertical HIV prevention services The primary outcomes measured include time to ART attrition detectable viral load and HIV-free infant survival Secondary outcomes include repeat pregnancy uptake of vertical HIV prevention services and maternalpregnancy loss Data will be analyzed using statistical methods such as the Kaplan Meier method Cox regression generalized estimating equations GEE and Poisson regression
Limitations and Mitigation The study acknowledges challenges related to the quality and completeness of routinely collected data To address these issues physical verification will be performed by obtaining patient charts and updating the CTC2 database Multiple methods including multiple imputation and propensity scores will be employed to handle incomplete or missing data
Sub-study II Evidence Review and Consultations Part 1 Evidence Review Design and Scope A systematic review based on the PRISMA guidelines will be conducted to identify potential interventions to improve engagement retention and health outcomes of vertical HIV prevention services among AGYW in SSA The review will include experimental designs with a control group and will focus on studies conducted between 2014 and 2023
Search Strategy and Data Extraction Peer-reviewed articles and grey literature will be searched using databases such as PubMed and Medline The search strategy will consider the four PICO elements PatientPopulationProblem Intervention Comparison and Outcomes to develop the search syntax Data extraction will be done using a standardized excel sheet to capture key study aspects
Synthesis and Risk of Bias Assessment For experimental studies meta-analysis will be conducted if feasible Otherwise findings will be synthesized using a comprehensive narrative approach Risk of bias will be assessed using appropriate tools for each study type and the overall certainty of evidence will be rated using the Cochrane GRADE approach
Part 2 Qualitative consultations will be conducted through in-depth interviews IDIs and focus group discussions FGDs with AGYW ages 15-24 years healthcare providers spousespartners parents and community stakeholders The study will be conducted in Dar es Salaam urban and Kagera rural regions
Data Collection and Analysis Participants will be recruited using purposive sampling Data will be collected using semi-structured interview guides and analyzed using content analysis Themes and subthemes will be identified and discussed by the research team
Sub-study III Co-design and Prototyping of an Intervention package Design and Participants This stage involves co-creating a package of interventions with AGYW healthcare providers and community stakeholders The participants will be organized into an intervention development group consisting of about 24 members including pregnant and postpartum AGYW spousespartners parentsguardians healthcare providers community stakeholders and research team members
Co-production Process The co-production process will be conducted through a series of workshops over six months The workshops will be held in neutral accessible and safe communitypublic venues to enhance active interactions Participants will use various methods of participation including flash cards role play and writing on whiteboardsflip chartssticky notes The outcome will be a package of interventions designed to improve engagement retention and outcomes of AGYW in vertical HIV prevention services
Prototyping Stage During the prototyping stage the intervention development group research team and other reproductive healthAGYW experts will draft intervention materials and training manuals These will be tested at 1-2 purposefully selected intervention facilities The process will involve training healthcare providers or other stakeholders to deliver the interventions and gaining input from AGYW and providers on the acceptability of the content and methods
Sub-study IV Pilot-test the Intervention Package Design and Participants two-arm cluster randomized trial to evaluate the feasibility acceptability and preliminary effectiveness of the interventions in Dar es Salaam and Kagera regions of Tanzania Participants will include pregnant AGYW living with HIV new previously diagnosed and transfers who are receiving vertical HIV prevention services between January 1 2026 and June 30 2026 with follow-up extending for at least one year until June 30 2027
Sampling Method and Sample Size The sample size for the study was estimated using a formula for cluster randomized studies which inflates the sample size for a two-arm simple randomized study using the design effect The design effect accounts for the clustering effect with an intra-cluster correlation coefficient ICC of 002 and an average cluster size of 12 The final sample size is determined to be 222 participants 111 per arm providing 80 power to detect a 15 difference in retention rate between the intervention and control arms with a standard error of 005
Facility Sampling and Randomization Between 2018 and 2020 376 MDH-supported facilities provided vertical HIV prevention services to at least one AGYW in Dar es Salaam and Kagera regions From these 225 facilities that enrolled at least 10 AGYW per year were identified 116 in Dar es Salaam and 139 in Kagera The facilities include hospitals health centers and dispensaries Using block randomization 12 facilities per region will be randomized into six intervention and six control arms ensuring a balanced distribution of facility levels
Intervention and Control At each intervention facility a focal team of 2-3 persons comprising both AGYW and healthcare providers will be trained and engaged to drive the implementation of the intervention package This team will orient and engage other staff and stakeholders to deliver the interventions identify and address gaps and monitor implementation fidelity and quality using standard operating procedures and job aids The interventions will be integrated into routine care with hands-on supportive supervision and mentorship provided by local researchers through weekly follow-ups in the first month and monthly thereafter The intervention package may include components such as SMSphone call reminders peer mother support and flexible clinic hours tailored to the needs of AGYW The control arm will received standard PMTCT care as per national Tanzania guidelines
Data Collection and Analysis Data for assessing the preliminary effect on primary outcomes will be extracted from the existing Tanzania national electronic CTC2 database Data will be analyzed using statistical methods such as Kaplan Meier and Cox regression for time to ART attrition and HIV-free infant survival generalized estimating equations GEE for detectable viral load and Poisson regression for the composite outcome of optimal vertical HIV prevention Additional qualitative data will be collected from AGYW and healthcare providers through face-to-face interviews using a semi-structured questionnaire
Fidelity Assessment and Feasibility To ensure comprehensive fidelity measurement the study will use a combination of methods at various levels of implementation These methods will include checklists adherence reports structured audits and fidelity assessment protocols Fidelity assessments will be conducted at baseline before implementation begins periodically at weeklymonthly intervals during the interventions implementation and at the end of the intervention to evaluate overall fidelity
Study Limitations and Mitigation To address potential data quality issues in the CTC2 database the study will implement rigorous validation and cleaning processes cross-referencing with other sources conducting data quality assessments and addressing missing data through appropriate imputation methods This approach aims to enhance the reliability and integrity of the study findings
Ethical considerations The project has received ethical approval from the National Health Research Ethics Committee NaTHREC in Tanzania Approval will also be sought from the Swedish Ethical Review Authority EPM for analysis of de-identified data in Sweden
Key ethical aspects include
Informed Consent Informed consent will be obtained from all participants involved in new data collection For minors aged 15-17 years who are considered emancipated consent will be sought directly from them without the need for parental consent
Privacy and Confidentiality The study involves the collection of sensitive personal information To protect participants privacy personal identifiers such as names and addresses will not be extracted from the registry Interviews will be conducted in pre-arranged private spaces and all study data will be stored securely in password-protected computers with access limited to the research team
Minimizing Risks The study is designed to use routine healthcare data supplemented by qualitative data from focus group discussions and interviews The risks to participants are considered minimal but potential risks and ethical considerations have been identified and addressed
Implications The ENGAGE study represents a significant effort to address the unique needs of young women living with HIV in Tanzania aiming to improve their health outcomes and reduce the risk of HIV transmission to their infants Through a collaborative and evidence-based approach the study seeks to contribute to the global goal of eliminating HIVAIDS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None