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

NCT ID: NCT06647797

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-10-01

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.

Detailed Description

Optimizing uptake of HIV testing is critical to meeting 95-95-95 goals in sub-Saharan Africa. As 30% of new infections in occur within married or cohabitating couples, maximizing testing among individuals who are or may someday be in serious heterosexual relationships has been identified as one of the most cost-effective strategies to curb the epidemic. Childbearing is highly valued throughout Sub-Saharan Africa, and fears of relationship dissolution and loss of the ability to have children remain significant barriers to HIV testing. The expanding availability of pre-exposure prophylaxis (PrEP) presents an opportunity to counter these fears with strategic communication (NOT-MH-21-105) that reassure couples of their ability to have a healthy family even if one or both members are HIV positive. Our long-term objective is to leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment (antiretroviral therapy) or prevention (PrEP) among partnered individuals in Uganda. We recently successfully piloted this communication strategy within Uganda's assisted partner notification program (APN). In this R34, we will: (1) conduct formative research to expand the communication strategy into a multi-component intervention with broader reach; and (2) conduct a pilot trial of the intervention, PrEPing Healthy Families. To achieve Aim 1, we will work with a community advisory board (CAB) of providers to a) create communication materials (brochures, scripts) and counseling protocols tailored to clients and partners across the array of couples' testing pathways in APN and antenatal care (ANC). As CAB providers pilot materials and tracking systems with clients and partners during this development phase, study staff will conduct field observations and qualitative interviews focused on feasibility and acceptability, informing revised intervention materials. To achieve Aim 2, we will collect baseline data at APN and ANC clinics within two large public healthcare facilities over nine months. Sites will then be randomized to implement PrEPing Healthy Families or their existing communication approach (usual care) over the next nine months. We will collect mixed-methods data on feasibility and acceptability through intervention tracking in APN/ANC registers, client exit surveys, and qualitative interviews with clients, partners and providers. Through register extraction, we will examine limited efficacy on outcomes that would be relevant to a larger trial (partner HIV testing, client service uptake initiation of PrEP/ART), and explore potential moderators. Overall, results will yield important insights in a promising new communication strategy (NOT-MH-21-105) that may connect more individuals to the HIV cascades of care for treatment or prevention and prepare us for a large-scale, cluster randomized controlled trial to determine impact on testing and initiation of PrEP/ART.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Communication intervention "HOPE"

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

Group Type: EXPERIMENTAL

HOPE Clinical Communication Campaign

Intervention Type: BEHAVIORAL

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

Usual care

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HOPE Clinical Communication Campaign

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Emily Hurley

Doctoral Research Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Hurley, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Kansas City

Locations

Gombe Hospital

Gombe, , Uganda

Mityana Hospital

Mityana, , Uganda

Countries

Uganda

Other Identifiers

5R34MH132473

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002400

Identifier Type: -

Identifier Source: org_study_id