Improving Access to HIV Testing for Children in Uganda

NCT07236905 | Recruiting DMC

• 1 other identifier: R21MH135815-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if HIV screening testing can be done for children ages 18 months to 5 years by traditional healers in Southwestern Uganda. The main questions the investigators aim to answer are:

• Will caretakers of children coming to a traditional healer for their care accept an HIV test from them?
• What views of HIV such as stigma and knowledge might affect the caretaker's choice to accept HIV testing or not for their child? Researchers will compare how many caretakers accept HIV testing for their child by a traditional healer compared to how many accept and go for testing at a nearby health center after being referred by a healer. Participants will:
• Complete a form with the child's health history and past medical history
• Complete surveys on knowledge and understanding of HIV and stigma
• Decide to to have a rapid, oral swab test the child-participant for HIV
• Complete a follow up call once per month for 3 months to see if the child-participant went for follow up care for those in the referral group or for those who tested positive by the traditional healer

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

pediatric; child; HIV; traditional healer; Uganda; sub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

• Number of participants who complete HIV testing

  Total number of participants who complete HIV testing

  from enrollment up to 3 months post

Secondary Outcomes (2)

• Number of children with a positive HIV test

  enrollment to 3 months post

• Number of HIV-positive children who initiate antiretroviral treatment (ART)

  enrollment to 3 months post

Study Arms (2)

Intervention

EXPERIMENTAL

Healer-facilitated Test

Diagnostic Test: HIV saliva swab screening test

Referral for testing

ACTIVE COMPARATOR

Traditional healers will refer children to a nearby health center for HIV testing, which is the current standard of care.

Other: Referral for HIV testing

Interventions

HIV saliva swab screening test DIAGNOSTIC_TEST

A screening swab test that can be self-administered and is commercially availble for HIV

Intervention

Referral for HIV testing OTHER

Referral by a traditonal healer to a health center for HIV testing

Referral for testing

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 18 months to 5 years old
• Have a parent or caregiver present who can provide informed consent
• Not previously tested for HIV in the past three months
• Npt previously known to be HIV-infected.

You may not qualify if:

• unwilling or unable to participate in study procedures or provide written informed consent.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator
• Mbarara University of Science and Technology: collaborator
• Cornell University/Weill Cornell Medical Center: collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Referral and Consultation; HIV Testing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Anneka Hooft, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Radhika Sundararajan, MD, PhD

  Weill Cornell School of Medicine

  PRINCIPAL INVESTIGATOR

• Denis Nansera, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anneka Hooft, MD, MPH

CONTACT

775-813-6254; anneka.hooft@ucsf.edu

Elizabeth Butrick, MS

CONTACT

415-601-6399; elizabeth.butrick@ucsf.edu

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: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 19, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months after publication of results with no end date (or as determined by NDA)
• Access Criteria: Access will be moderated by NDA with those fulfilling requirements having access to data

Locations

UG (1)