Actively Recruiting

Phase Not Applicable
Age: 15Years +
FEMALE
NCT06605053

Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania

Led by Karolinska Institutet · Updated on 2025-06-29

222

Participants Needed

2

Research Sites

164 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

M

Management and Development for Health, Tanzania

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania

Who Can Participate

Age: 15Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adolescent girls and young women (AGYW) aged 15-24 years living with HIV who started prevention of mother-to-child transmission (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, or never pregnant for qualitative studies
  • Health care providers at clinics offering PMTCT services
  • Spouses, partners, parents of AGYW, and community stakeholders within the study area
  • AGYW, health care providers, spouses/partners, parents, community stakeholders, and research team members involved in intervention co-production
  • Pregnant AGYW living with HIV receiving vertical HIV prevention services between January 1, 2026, and June 30, 2026, for trial participation, with follow-up until June 30, 2027
Not Eligible

You will not qualify if you...

  • AGYW without recorded antiretroviral therapy (ART) status
  • Women who have not started ART
  • Mentally or severely ill individuals unable to participate in study activities

AI-Screening

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Trial Site Locations

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

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Research Team

A

Anna E Kågesten, PhD

CONTACT

G

Goodluck Lyatuu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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