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Completed

NCT Number: NCT06647797

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gombe Hospital, Gombe, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HOPE Clinical Communication Campaign

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

Primary outcomes

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

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

    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).

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

    Time frame: 7 month baseline period and 7 month intervention period

    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.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • Makerere University
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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