Trial results for an integrated care delivery study for HIV in adolescent girls and young women were posted on ClinicalTrials.gov on 2025-09-15, with 2150 participants enrolled.
Background
Human Immunodeficiency Virus (HIV) continues to be a significant public health challenge, particularly among adolescent girls and young women (AGYW) in regions like Zambia. Connecting AGYW with consistent, accessible care is crucial for effective HIV prevention and treatment. This includes regular HIV testing, ensuring linkage to care for those who test positive, promoting retention in care, and supporting adherence to antiviral treatment. The study aimed to evaluate a multilevel package of interventions designed to establish a sustainable platform for these essential services, focusing on integrated wellness care clinics and a specific intervention called SHIELD (Support for HIV Integrated Education, Linkages to care, and Destigmatization).
Trial design
This completed study, designated as Phase NA, enrolled 2150 participants to investigate interventions for HIV. The trial tested a multilevel package of interventions, including integrated wellness care (IWC) clinics and the SHIELD intervention, which aimed to educate and empower AGYW and their families and create community-based support. Participants were assigned to one of three groups: Control, SHIELD Only, or SHIELD + IWC Clinic.
Key results
The trial reported several key measurements across the intervention groups:
- HIV Testing (Count of Participants):
- Control group: 33 participants.
- SHIELD Only group: 52 participants.
- SHIELD + IWC Clinic group: 139 participants.
- HIV-/u Proportion Tested for HIV in the Past 6 Months (Count of Participants):
- Control group: 40 participants.
- SHIELD Only group: 95 participants.
- SHIELD + IWC Clinic group: 125 participants.
- HIV+ Proportion With Undetectable Viral Load at 12 Months (Count of Participants):
- Control group: 99 participants.
- SHIELD Only group: 74 participants.
- SHIELD + IWC group: 76 participants.
- HIV Risk Behavior - Delay in First Intercourse (Mean age in years):
- Control group: 16.48 years (Standard Deviation 2.36).
- SHIELD Only group: 16.85 years (Standard Deviation 1.70).
- SHIELD + IWC Clinic group: 16.88 years (Standard Deviation 1.63).
What this means
The results suggest that integrated care models, particularly the combination of SHIELD and IWC clinics, can significantly increase HIV testing rates and the proportion of HIV-negative/unknown status individuals tested within a six-month period among adolescent girls and young women. Furthermore, both SHIELD interventions demonstrated a slight delay in the mean age of first intercourse compared to the control group, indicating a positive impact on HIV risk behavior. However, the proportion of HIV-positive participants with an undetectable viral load at 12 months was higher in the control group compared to the intervention groups, suggesting that the tested interventions may require further refinement to improve viral suppression outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03995953, titled "Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia", were posted on 2025-09-15 on clinicaltrials.gov.