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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Republic of Tanzania
Management and Development for Health
RECRUITING
Dar Es Salaam
Management and Development for Health
RECRUITING
Kagera
Contact Information
Primary
Anna E Kågesten, PhD
anna.kagesten@ki.se
0046707302287
Backup
Goodluck Lyatuu, PhD
glyatuu@mdh.or.tz
255022 2771615
Time Frame
Start Date: 2024-10-07
Estimated Completion Date: 2027-12
Participants
Target number of participants: 222
Treatments
Experimental: Intervention arm (co-produced intervention package to optimize PMTCT care)
Pregnant girls/young women 15-24 years living with HIV (new, previously diagnosed, and transfers) receiving PMTCT services in routine healthcare randomized to the intervention between 01st January and 30th June 2026 and followed up for at least one year to 30th June 2027. While the specific intervention will developed earlier in the project, it may include a package of evidence-based approaches such as peer mentor mothers, male partner involvement, flexible hours for girls/young women and mobile phone reminders. A focal team of 2-3 persons will be trained and engaged to drive the implementation of the interventions at randomized faciltiies. The focal team will orient and engage other staff and stakeholders to deliver the interventions, identify and address gaps, and monitor implementation fidelity and quality using standard operating procedures.
No_intervention: Control: standard care
Pregnant AGYW living with HIV (new, previously diagnosed, and transfers) receiving vertical HIV prevention services in routine healthcare centres acting as control facilities, between 01st January and 30th June 2026 and followed up for at least one year to 30th June 2027. No intervention is administered to this arm; participants will receive a standard of care for PMTCT services per Tanzania national guidelines.
Related Therapeutic Areas
Sponsors
Collaborators: Management and Development for Health, Tanzania
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov