NCT06605053

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Oct 2024Dec 2027

First Submitted

Initial submission to the registry

September 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

September 17, 2024

Last Update Submit

June 27, 2025

Conditions

HIV Antiretroviral Therapy (ART) AdherencePMTCTPregnancyRetention in CareHIV ViremiaEarly Infant HIV Diagnosis

Keywords

Adolescent girls and young womenHIVVertical transmissionPMTCTCo-productionCo-designInterventionTanzaniaSub-Saharan AfricaRetention in care

Outcome Measures

Primary Outcomes (3)

  • Time to ART attrition

    The hazard rate of discontinuing ART for any reason including death, stopping ART or loss to follow-up for 90 consecutive days from scheduled appointment

    24 months

  • Detectable viral load

    The proportion of participants with detectable viral load, defined as ≥50 viral copies/mL of blood after at least three months of ART use (for those who started ART at enrolment) or detectable VL after enrolment (for those already on ART at enrolment).

    24 months

  • HIV-free infant survival

    Defined as the proportion of infant who are alive and tested negative at final HIV test by 18+ months postpartum, or last available data point

    24 months

Secondary Outcomes (3)

  • Repeat pregnancy

    24 months

  • Uptake of PMTCT services

    24 months

  • Maternal/pregnancy loss

    24 months

Other Outcomes (2)

  • Acceptability

    24 months

  • Intervention feasibility

    24 months

Study Arms (2)

Intervention arm (co-produced intervention package to optimize PMTCT care)

EXPERIMENTAL

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.

Behavioral: Co-produced intervention to optimize PMTCT care engagement

Control: standard care

NO INTERVENTION

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.

Interventions

Co-produced intervention to optimize PMTCT care engagementBEHAVIORAL

While the specific interventions package will developed earlier in the project, it may include evidence-based approaches such as peer mentor mothers, male partner involvement, flexible hours for girls/young women and mobile phone reminders. Overall, the interventions should be brief and easy to integrate into standard care, aiming to 'nudge' or motivate participants (towards improved engagement, retention, and outcomes) as well as health care providers or community stakeholders to better understand and support girls/young women\'s specific needs. 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.

Intervention arm (co-produced intervention package to optimize PMTCT care)

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • AGYW whose ART (Antiretroviral Therapy) status was not recorded.
  • Women who had not started ART.
  • Sub-study 2 (qualitative):
  • 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.
  • \- Mentally or severely ill individuals unable to participate in the study activities.
  • Sub-study 3 (co-production)
  • AGYW, HCPs, spouses/partners, parents, and community stakeholders who participated in the qualitative study II.
  • Research team members.
  • \- Mentally or severely ill individuals unable to participate in the study activities.
  • Sub-study 4 (cluster-randomized implementation trial)
  • \- 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.
  • AGYW whose ART (Antiretroviral Therapy) status was not recorded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Management and Development for Health

Dar es Salaam, Tanzania

RECRUITING

Management and Development for Health

Kagera, Tanzania

RECRUITING

Related Publications (1)

  • Lyatuu GW, Urrio R, Naburi H, Lyaruu P, Simba B, Siril H, Philipo E, Machumi L, Kibao A, Kajoka D, Nyamhagatta M, Sando D, Biberfeld G, Orsini N, Kilewo C, Ekstrom AM. Vertical HIV transmission within 18 months post partum among women on lifelong antiretroviral therapy for HIV in Dar es Salaam, Tanzania: a prospective cohort study. Lancet HIV. 2023 Jan;10(1):e33-e41. doi: 10.1016/S2352-3018(22)00289-2. Epub 2022 Dec 7.

    PMID: 36495896BACKGROUND

Central Study Contacts

Anna E Kågesten, PhD

CONTACT

0046707302287anna.kagesten@ki.se

Goodluck Lyatuu, PhD

CONTACT

255022 2771615glyatuu@mdh.or.tz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A two-arm, cluster randomized implementation trial in routine healthcare settings providing day-to-day vertical HIV prevention services in Dar es Salaam (urban) and Kagera (rural) regions of Tanzania to pilot test a co-produced intervention package for feasibility, acceptability, and preliminary effect.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 20, 2024

Study Start

October 7, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

TA(2)