ClinicalTrials.Veeva

Menu

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

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status

Completed

Conditions

Pre-Exposure Prophylaxis
Antiretroviral Therapy
HIV
Antenatal Care

Treatments

Behavioral: HOPE Clinical Communication Campaign

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06647797
5R34MH132473 (U.S. NIH Grant/Contract)
STUDY00002400

Details and patient eligibility

About

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.

Full 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.

Enrollment

7,666 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7,666 participants in 2 patient groups

Communication intervention "HOPE"
Experimental group
Description:
* Patient-facing education materials * Provider counseling job aid and training
Treatment:
Behavioral: HOPE Clinical Communication Campaign
Usual care
No Intervention group
Description:
Usual care

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems