Improving 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)

This project will test a co-designed package of services to help pregnant and postpartum adolescent girls and young women (15–24) with HIV in Tanzania stay on treatment, keep their babies HIV-free, and remain in care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 222 (estimated)
• Ages: 15 Years and up
• Sex: Female
• Sponsor: Karolinska Institutet (Academic / other)
• Locations: 2 sites (Dar es Salaam and 1 other locations)
• Trial ID: NCT06605053 on ClinicalTrials.gov

What this trial studies

This mixed-methods project combines a registry-based cohort analysis, qualitative interviews, and co-production workshops to optimize PMTCT care for adolescent girls and young women (AGYW) aged 15–24 with HIV. The cohort component follows AGYW who started PMTCT between 2018 and 2020 to measure appointment attendance, ART retention, viral suppression, infant HIV-free survival, and repeat pregnancy up to two years postpartum. Qualitative interviews with AGYW, healthcare providers, partners, parents, and community stakeholders will identify social and structural barriers to care. Findings will be used to co-design and pilot a package of interventions tailored to the needs and preferences of AGYW in the study regions.

Who should consider this trial

Good fit: Adolescent girls and young women aged 15–24 living with HIV who are pregnant or up to two years postpartum in the participating regions of Tanzania, and infants born to them for registry analyses, are ideal candidates.

Not a fit: People who have not started ART, whose ART status is not recorded, or those who are mentally or severely ill and unable to participate are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the co-produced approach could increase ART retention and viral suppression among pregnant and postpartum AGYW and reduce vertical HIV transmission to their infants.

How similar studies have performed: Related PMTCT programs combining ART support and community engagement have reduced vertical transmission in other settings, but co-produced packages specifically tailored to pregnant AGYW are relatively novel and have limited direct evidence.

Eligibility criteria

Sub-study 1 (registry-based cohort analysis):

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Dar es Salaam and 1 other locations

• Management and Development for Health — Dar es Salaam, Tanzania (Recruiting)
• Management and Development for Health — Kagera, Tanzania (Recruiting)

Study contacts

• Study coordinator: Anna E Kågesten, PhD

Conditions HIV Antiretroviral Therapy Adherence; PMTCT; Pregnancy; Retention in Care; HIV Viremia; Early Infant HIV Diagnosis; Adolescent girls and young women; HIV