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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Time to ART attrition
研究概览
简要总结
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.
详细描述
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 world's 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 3.5 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 130,000 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant/postpartum adolescent girls and young women (AGYW) with HIV aged 15-24 years, who started PMTCT services between January 1, 2018, and December 31,
- •Infants born to the included AGYW during this period.
排除标准
- •AGYW whose ART (Antiretroviral Therapy) status was not recorded.
- •Women who had not started ART.
- •Sub-study 2 (qualitative):
- •Inclusion Criteria:
- •AGYW living with HIV who are currently pregnant, previously pregnant/postpartum, and never pregnant).
- •HCPs (Health Care Providers) at clinics providing PMTCT services.
- •Spouses/partners/parents of AGYW and community stakeholders within the study setting.
- •Exclusion criteria
- •Mentally or severely ill individuals unable to participate in the study activities.
- •Sub-study 3 (co-production)
- •Inclusion criteria:
- •AGYW, HCPs, spouses/partners, parents, and community stakeholders who participated in the qualitative study II.
- •Research team members.
- •Exclusion criteria:
- •Mentally or severely ill individuals unable to participate in the study activities.
- •Sub-study 4 (cluster-randomized implementation trial)
- •Inclusion criteria:
- •Pregnant AGYW living with HIV (new, previously diagnosed, and transfers) receiving vertical HIV prevention services in routine healthcare between January 1, 2026, and June 30, 2026, and followed up for at least one year until June 30,
- •Exclusion criteria:
- •AGYW whose ART (Antiretroviral Therapy) status was not recorded.
结局指标
主要结局
Time to ART attrition
时间窗: 24 months
The hazard rate of discontinuing ART for any reason including death, stopping ART or loss to follow-up for 90 consecutive days from scheduled appointment
Detectable viral load
时间窗: 24 months
The proportion of participants with detectable viral load, defined as ≥50 viral copies/mL of blood after at least three months of ART use (for those who started ART at enrolment) or detectable VL after enrolment (for those already on ART at enrolment).
HIV-free infant survival
时间窗: 24 months
Defined as the proportion of infant who are alive and tested negative at final HIV test by 18+ months postpartum, or last available data point
次要结局
- Repeat pregnancy(24 months)
- Uptake of PMTCT services(24 months)
- Maternal/pregnancy loss(24 months)
研究者
Anna Kågesten
Associate Professor
Karolinska Institutet