Actively Recruiting
Led by Karolinska Institutet · Updated on 2025-06-29
222
Participants Needed
2
Research Sites
N/A
Total Duration
K
Karolinska Institutet
Lead Sponsor
M
Management and Development for Health, Tanzania
Collaborating Sponsor
Researchers are investigating better ways to care for pregnant and postpartum adolescent girls and young women (AGYW) aged 15-24 years with HIV in Tanzania. The study aims to understand how often these young women attend health appointments and stay on treatment up to two years after giving birth, how many babies remain HIV-free for two years, factors influencing repeat pregnancies, and the best ways to support health care engagement. The project focuses on improving prevention of HIV transmission to infants and optimizing HIV treatment outcomes for this vulnerable group. The study involves analyzing health service records from 559 facilities in Tanzania for all AGYW who started prevention of mother-to-child transmission (PMTCT) services between 2018 and 2020. It includes qualitative interviews to gather experiences, co-creation of an intervention package with participants and healthcare providers, and a cluster-randomized trial to test this intervention. The intervention package may include peer mentor support, male partner involvement, flexible clinic hours, and phone reminders, aiming to improve care engagement and retention. Participants will provide health data through existing records and take part in interviews and workshops. The trial will follow pregnant AGYW receiving PMTCT services between January and June 2026, with outcomes measured up to two years after delivery. Researchers will assess time to treatment dropout, viral load detectability, infant HIV-free survival, repeat pregnancies, and use of prevention services. The study includes ongoing monitoring of intervention quality and ethics oversight, with participation lasting until June 2027.
CONDITIONS
Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months (January 1, 2026 to June 30, 2026)
Participants receive a co-produced package of interventions integrated into routine PMTCT care to improve engagement, retention, and health outcomes. The intervention includes approaches such as peer mentor mothers, male partner involvement, flexible clinic hours, and mobile phone reminders. A focal team at each facility supports delivery and monitors intervention quality.
Weekly visits in the first month and monthly visits thereafter
Duration - 12 months (July 1, 2026 to June 30, 2027)
Participants are followed for at least one year after the intervention period to monitor ART retention, viral load, HIV-free survival of infants, and other health outcomes using routine healthcare data and additional interviews.
Periodic follow-up visits as part of routine care
Total: 2 locations
1
Management and Development for Health
Dar es Salaam, Tanzania
Actively Recruiting
2
Management and Development for Health
Kagera, Tanzania
Actively Recruiting
A
Anna E Kågesten, PhD
G
Goodluck Lyatuu, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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Goodluck Willey Lyatuu, Roseline Urrio, Helga Naburi...
https://pubmed.ncbi.nlm.nih.gov/36495896