HIVNCT06647797
Enhancing Communication on Relationship Preservation, Safer Conception and PrEP to Promote HIV Testing in Uganda
A study testing HOPE Clinical Communication Campaign in people with HIV and Antenatal Care, run by Children's Mercy Hospital Kansas City at 2 sites in Uganda.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV, Antenatal Care, Antiretroviral Therapy
- What is being tested?
- HOPE Clinical Communication Campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,359 participants
- Where
- 2 sitesUganda
- Study dates
- 15 Sep 2023to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Client or partner of client receiving antenatal or assisted partner notification services at one of two study hospitals (Gombe Hospital or Mityana Hospital)
Who cannot join
- Individuals under the age of 18 years (for interviews and surveys only)
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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
- Being tested
- HOPE Clinical Communication Campaign
- Keywords
- Antiretroviral medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE Clinical Communication CampaignBehavioural
- Patient-facing educational materials
- Provider counseling training and job aid
| Study group | Role | What they receive |
|---|---|---|
| Communication intervention "HOPE" | Experimental | * Patient-facing education materials
* Provider counseling job aid and training Receives: Behavioral: HOPE Clinical Communication Campaign |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 7 month baseline period and 7 month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start15 Sep 2023
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two hospital sites. One randomized to implement the communication intervention, the other continuing with usual care
- Masking
- None (open label)
- Enrolment
- 22,359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Emily Hurley, Children's Mercy Hospital Kansas City
- Investigators
- Emily Hurley, PhD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647797
- Sponsor's protocol ID
- STUDY00002400
- Other IDs
- 5R34MH132473
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2024
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified dataset and other materials will be made available to individual researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Communication on Relationship Preservation, Safer Conception and PrEP to Promote HIV Testing in Uganda
- ClinicalTrials.gov ID
- NCT06647797
- Acronym / sponsor ID
- STUDY00002400
- Conditions
- HIV, Antenatal Care, Antiretroviral Therapy, Pre-Exposure Prophylaxis
- Keywords
- Antiretroviral medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,359 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Makerere University, National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two hospital sites. One randomized to implement the communication intervention, the other continuing with usual care
| Arm | Type | Receives |
|---|---|---|
| Communication intervention "HOPE" | Experimental | Behavioral: HOPE Clinical Communication Campaign* Patient-facing education materials * Provider counseling job aid and training |
| Usual care | No intervention | –Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Client or partner of client receiving antenatal or assisted partner notification services at one of two study hospitals (Gombe Hospital or Mityana Hospital)
Key exclusion criteria (1 listed)
- Individuals under the age of 18 years (for interviews and surveys only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOPE Clinical Communication Campaign* Patient-facing educational materials * Provider counseling training and job aid | Behavioural | Communication intervention "HOPE" |
Primary outcome
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified dataset and other materials will be made available to individual researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Hurley, PhD principal investigator
Children's Mercy Kansas City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE Clinical Communication Campaign in people with HIV and Antenatal Care, run by Children's Mercy Hospital Kansas City at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.