NCT06004011

Brief Summary

Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort. In this study, the investigators will test peer-to-peer education and support strategies to increase use of early diagnosis services in HIV treatment facilities and improve compliance with cancer treatment in the cancer center.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,100

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress62%
May 2024Jul 2027

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

August 15, 2023

Last Update Submit

January 13, 2026

Conditions

Keywords

cancer screeningImplementation trial

Outcome Measures

Primary Outcomes (2)

  • Proportion who complete screening/physical examination

    Number who complete screening/physician exams

    12 months after study enrollment

  • Proportion who complete recommended cancer treatment modalities

    Number who complete treatment

    12 months after diagnosis

Secondary Outcomes (3)

  • Proportion who complete recommended follow-up supplemental diagnostic procedures

    3 months from receipt of follow-up referral

  • Proportion who initiate cancer treatment

    3 months from diagnosis

  • Proportion alive at 12 months

    12 months after diagnosis

Study Arms (2)

ARROW strategies

EXPERIMENTAL

The ARROW strategies which use peer-peer support at the patient level (through peer counselors), at the provider level (through peer lead education sessions) and at the health system level (through a health collaborative forum) to deliver high quality screenings and ensure cancer treatment completion.

Other: ARROW strategies

One-time education

ACTIVE COMPARATOR

The comparator arm participants will receive one-time education and usual care services.

Other: One-time education

Interventions

ARROW strategies are peer-to-peer support at the patient, provider and health system levels

ARROW strategies

The comparison group will receive a one-time education campaign that will provide informational brochures to adolescents and young adults living with HIV and HIV providers

One-time education

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration

You may not qualify if:

  • pregnant at study enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Facilities

Lusaka, Zambia

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsSarcoma, KaposiLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

May 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations