Clinical trial Recruiting at 2 sites Interventional Ages 15 and up Women only

Improving prevention and care for pregnant and postpartum adolescent girls and young women with HIV in Tanzania

Official title: 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)

Run by Karolinska Institutet · NCT06605053 · Data updated 2026-11-12

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.

More Pregnancy trials

Quick facts

Study typeInterventional
Ages15 Years and up
SexWomen only
Enrollment222 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations2 sites (Dar es Salaam and 1 other locations)
StatusRecruiting
StartedOctober 7, 2024
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedJune 29, 2025
Trial IDNCT06605053 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.