Status:
RECRUITING
Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Management and Development for Health, Tanzania
Conditions:
HIV Antiretroviral Therapy (ART) Adherence
PMTCT
Eligibility:
FEMALE
15+ years
Phase:
NA
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 passi...
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 world's 39 million people living with HIV ...
Eligibility Criteria
Inclusion
- Sub-study 1 (registry-based cohort analysis):
- 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.
Exclusion
- 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, 2027.
- Exclusion criteria:
- AGYW whose ART (Antiretroviral Therapy) status was not recorded.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT06605053
Start Date
October 7 2024
End Date
December 1 2027
Last Update
June 29 2025
Active Locations (2)
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1
Management and Development for Health
Dar es Salaam, Tanzania
2
Management and Development for Health
Kagera, Tanzania