NCT06605053Recruiting
Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania
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)
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- First submitted
- 17 Sept 2024
- Start date
- 7 Oct 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- HIV
- NCT number
- NCT06605053
What you commit to
- Study type: Interventional
- Planned participants: 222
- From 7 Oct 2024 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- AGYW whose ART (Antiretroviral Therapy) status was not recorded.
- AGYW whose ART (Antiretroviral Therapy) status was not recorded.
Other
- Women who had not started ART.
- Sub-study 2 (qualitative):
- \- Mentally or severely ill individuals unable to participate in the study activities.
- Sub-study 3 (co-production)
- \- Mentally or severely ill individuals unable to participate in the study activities.
- Sub-study 4 (cluster-randomized implementation trial)
Who the study is looking for
- 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, 2020.
- Infants born to the included AGYW during this period.
- 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.
- AGYW, HCPs, spouses/partners, parents, and community stakeholders who participated in the qualitative study II.
- Research team members.
- \- 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, 2027.
Criteria the registry did not label
- Sub-study 1 (registry-based cohort analysis):
Age in the registry: 15 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Management and Development for Health Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Recruiting |
| Management and Development for Health Coordinator of this site? Confirm its status | Kagera | Tanzania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.