NCT06647797

Brief Summary

Our novel communication strategy aims to promote HIV testing in Uganda with reassuring messages about the ability to have stable relationships and healthy families with the increased availability of pre-exposure prophylaxis (PrEP). We will evaluate the feasibility and acceptability of this communication strategy among clients and partners within assisted partner notification and antenatal care programs in two hospitals and evaluate preliminary effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,666

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

October 16, 2024

Last Update Submit

January 15, 2026

Conditions

Keywords

Antiretroviral medication

Outcome Measures

Primary Outcomes (2)

  • Change in rate of partner HIV testing (antenatal care)

    7 month baseline period and 7 month intervention period

  • Change in rate of partner HIV testing (assisted partner notification)

    7 month baseline period and 7 month intervention period

Secondary Outcomes (3)

  • Change overall facility-level HIV testing

    7 month baseline period and 7 month intervention period

  • Change in PrEP uptake among eligible HIV negative partners

    7 month baseline period and 7 month intervention period

  • Change in ART uptake among eligible HIV positive partners

    7 month baseline period and 7 month intervention period

Study Arms (2)

Communication intervention "HOPE"

EXPERIMENTAL

* Patient-facing education materials * Provider counseling job aid and training

Behavioral: HOPE Clinical Communication Campaign

Usual care

NO INTERVENTION

Usual care

Interventions

* Patient-facing educational materials * Provider counseling training and job aid

Communication intervention "HOPE"

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Client or partner of client receiving antenatal or assisted partner notification services at one of two study hospitals (Gombe Hospital or Mityana Hospital)

You may not qualify if:

  • Individuals under the age of 18 years (for interviews and surveys only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gombe Hospital

Gombe, Uganda

Location

Mityana Hospital

Mityana, Uganda

Location

Study Officials

  • Emily Hurley, PhD

    Children's Mercy Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two hospital sites. One randomized to implement the communication intervention, the other continuing with usual care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Research Faculty

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

September 15, 2024

Primary Completion

July 4, 2025

Study Completion

October 1, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified dataset and other materials will be made available to individual researchers upon reasonable request.

Locations