Enhancing Communication on Relationship Preservation, Safer Conception and PrEP to Promote HIV Testing in Uganda

NCT06647797 | Completed Results

• 2 other identifiers: STUDY000024005R34MH132473
• Study Type: interventional
• Target: 22,359
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Antenatal Care; Pre-Exposure Prophylaxis; Antiretroviral Therapy

Keywords

Antiretroviral medication

Outcome Measures

Primary Outcomes (2)

• Change in Rate of HIV Testing (Male Partners of Antenatal Care Patients)

  We used register extraction of standard ANC clinic registers to determine testing status of male partners of each patient who had an ANC visit during the baseline and intervention periods. We excluded those indicating the male partner was not recommended for HIV testing (known HIV negative from previous test during this pregnancy; known HIV positive from previous test during this pregnancy; known HIV positive determined prior to first ANC visit; known HIV negative according to test conducted within 4 weeks prior to first ANC visit). Successful testing as a composite outcome included partners who tested for the first time (positive or negative) or completed a re-test following a negative test earlier in the pregnancy (recommended after 3 months).

  7 month baseline period (Sept 2023- March 2024) and 7 month intervention period (Sept 2024- March 2025)

• Change in Rate of HIV Testing Among Partners of Assisted Partner Notification (APN) Program

  APN partner testing was extracted from standard clinic registers. We excluded partners who were known to be HIV positive or deceased. Our analysis examined the portion of APN partners recommended for testing who presented at the hospital for testing.

  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

HOPE Clinical Communication Campaign BEHAVIORAL

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

Communication intervention "HOPE"

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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)

Sponsors & Collaborators

• Makerere University: collaborator
• Children's Mercy Hospital Kansas City: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Gombe Hospital

Gombe, Uganda

Location

Mityana Hospital

Mityana, Uganda

Location

Limitations and Caveats

Findings are limited to one intervention site and may not reflect how other hospitals or lower-level health centers may experience the intervention. Effectiveness analyses were exploratory in this R34 study, which was not designed to detect main effects.

Results Point of Contact

• Title: Emily Hurley
• Organization: Children's Mercy

eahurley@cmh.edu

8167014481

Study Officials

• Emily Hurley, PhD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Research Faculty

Model Details: Two hospital sites. One randomized to implement the communication intervention, the other continuing with usual care

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: September 15, 2023
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: September 22, 2026
• Results First Posted: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

UG (2)