HIVPhase 4HIPCYNCT06474364
HIV Prevention and Care Interventions for Youth in Uganda
A Phase 4 study testing Long-acting Cabotegravir injection and SEARCH-YOUTH in people with HIV, run by MU-JHU CARE at 1 site in Uganda.
Trial summary
Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Long-acting Cabotegravir injection and SEARCH-YOUTH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUganda
- Study dates
- 5 Aug 2024to 31 Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Adolescents and young adults with increased likelihood of HIV acquisition
- One or more reactive HIV test results at Screening or Enrollment, even if HIV infection is not confirmed.
- Has a cognitive impairment that prevents understanding of study procedures and precludes informed consent.
- Plan to move out of the greater study catchment area during study period.
- Enrolled in another intervention study.
- Already on PrEP.
Show all 16Show fewer
- Unwilling or unable to commit to using CAB LA
- Ineligible to initiate CAB-LA as per the Uganda national PrEP guidelines
- Hepatotoxicity and or Hepatitis B infection
- Potential exposure to HIV in past 72 hours
- Signs/symptoms of acute HIV infection
- Current or chronic history of liver disease or known hepatic/biliary abnormalities, history of seizure disorder, clinically significant cardiovascular disease, coagulopathy, and inflammatory skin conditions, as defined in Human Subjects Protection document. (Cabotegravir IB or package insert)
- Hypersensitivity to any active substances or other substances in CAB-LA
- Allergic or hypersensitivity reaction(s) with previous use of CAB or other integrase inhibitor medications Adolescents and young adults living with HIV
- Not able to give written informed consent.
- Not receiving care in selected facilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
MU-JHU Care Ltd
Kampala
Philippa Musoke, +256200404100, pmusoke@mujhu.org
Philippa Musoke
About this study
Official title: Using Implementation Science to Understand and Design Stakeholder Informed Innovative Interventions to Improve Youth HIV Prevention and Care Continuums in Rural and Urban Uganda.
Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. The investigators propose to evaluate novel evidence-based HIV prevention and care interventions (including Cabotegravir LongActing (CABLA) to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda. The results will provide important evidence to inform Uganda and other regional countries' policy on integrated HIV prevention, care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections (STIs) in order to reach the UNAIDS 95-95-95 targets and HIV epidemic control.
Read the detailed description
Adolescents and Young Adults (AYA) have a high HIV incidence and poor outcomes along the entire HIV prevention and care cascades compared to adults. Despite the high HIV burden, both uptake of oral Pre-Exposure Prophylaxis (PrEP) (HIV negatives) and achieving viral suppression (HIV positives) are sub-optimal among youth in Sub-Saharan Africa. Among youth in Uganda, uptake and persistence on oral PrEP is low, with reasons for discontinuation including: pill burden, low perceived severity of HIV, need for partner or parental approval, HIV-related stigma, fear of side-effects and health facility barriers. Cabotegravir, a is new long-acting antiretroviral (CABLA) and highly efficacious PrEP choice that can mitigate barriers to use of daily oral PrEP. The Investigators propose to evaluate evidence-based HIV prevention and care interventions to improve implementation outcomes among high-risk AYA (15-24 years) in Uganda. The study covers the continuum of care, will use novel screening methods for HIV risk, will involve teams that are highly experienced in youth-focused clinical trials and Implementation Science (ImS), will implement Ministry of Health (MOH) approved community differentiated service delivery models for delivery CABLA, will evaluate the implementation of the Sustainable East Africa Research in Community Health (SEARCH) -Youth (SY), a multi-component intervention comprising of life-stage based assessment and support to increase viral suppression in high-risk AYA with HIV, and will use hybrid effectiveness implementation designs to assess these evidence-based interventions. The aims include: Aim 1: Using the Consolidated Framework for Implementation Research (CFIR), the investigators will identify determinants of potential implementation success of two innovations: CABLA and SY implementation at the community, clinic, provider, and patient levels in 5 geographically distinct sites in Uganda. Aim 2a: Using a hybrid effectiveness implementation type II design, the investigators will assess the uptake and persistence of CAB-LA. The investigators will conduct a randomized prospective study to assess effectiveness for the provision of CABLA among high risk AYA. Effectiveness outcome will be proportion of study subjects who have initiated CABLA and persisted at 18 months of follow-up comparing facility and community delivery options. Implementation outcomes will be feasibility, acceptability, adoption and maintenance using Reach Effectiveness Adoption Implementation Maintenance (REAIM). Aim 2b: Using a hybrid effectiveness implementation type III design the investigators will assess implementation (feasibility, adoption, fidelity, and sustainment) and effectiveness of the SY intervention in increasing long-term virologic suppression (<200 c/mL) at 18 months of follow-up in 5 Clinical Research Performance Sites (CRPS) using REAIM. Aim 3: The investigators will use platforms in aims 1 and 2 to strengthen capacity of ImS and to translate findings into policy and guidelines. The study involves solid community and institutional partnerships and builds on a strong multi-disciplinary team highly experienced in innovative methods and implementation science in sub-Saharan Africa. The project, building on Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H) and Adolescent HIV prevention and treatment implementation Science Alliance (AHISA), is responsive to World Health Organization's, Uganda's MoH priorities regarding the gap in HIV services for highly vulnerable AYA. It will test a novel, scalable and integrated approach to initiate and sustain support for high-risk AYA in Low and Middle Income Countries (LMICs).
- Conditions
- HIV
- Being tested
- Long-acting Cabotegravir injection, SEARCH-YOUTH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting Cabotegravir injectionDrug
Cabotegravir is a potent integrase inhibitor that has been approved for use as PrEP.
SEARCH-YOUTHOther
It is a life stage informed HIV care model that dynamically supports adolescents and young adults living with HIV to achieve viral suppression and reduce depression through life event tailored solutions.
| Study group | Role | What they receive |
|---|---|---|
| Health facilty delivery model | Experimental | AYA will be randomized to access CABLA at the health facility. Receives: Drug: Long-acting Cabotegravir injection |
| Community venue delivery model | Experimental | AYA will be randomized to receive Cabotegravir from a community pharmacy/drop-in center. Receives: Drug: Long-acting Cabotegravir injection |
| SEARCH-YOUTH | Other | Virally unsuppressed or likely to be unsuppressed AYA, Youth living with HIV will receive the SEARCH-YOUTH intervention in addition to the standard MoH HIV care package. Receives: Other: SEARCH-YOUTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding the implementation science outcomes
Understanding of implementation outcomes:
- adoption,
- preference for delivery models and reasons for preference,
- scale-up feasibility (different from trial feasibility),
- experiences implementing the intervention components,
- mechanisms of action of the intervention that result in success or failure (suppressed or unsuppressed, and uptake and persistence of CAB-LA),
- sustainability,
- key factors that impact the effectiveness of individual components of each intervention, and
- implementation barriers and facilitators from the delivery side.
Measured: 18 months
Effectiveness of 2 delivery models of increasing uptake and persistence of CABLA
Using a hybrid implementation-effectiveness type II design, we will assess the effectiveness of the intervention in increasing uptake and persistence of CABLA in five CRPS and their catchment areas as well as the Implementation Science indicators of feasibility, acceptability, adoption and maintenance using RE-AIM framework.
Measured: 24 months
To evaluate scale up of the real-world implementation of the SEARCH-YOUTH multi-level intervention in routine HIV clinics in Uganda.
This aim will use a hybrid effectiveness implementation type III design to assess co-primary aims of the implementation science indicators of adoption, fidelity, and sustainment as well as effectiveness of the intervention on virologic suppression.
Measured: 24 months
Cost and cost-effectiveness of the implementation of two evidence-based interventions for HIV prevention and HIV care among Adolescents and Young Adults (AYAs) in Uganda.
We will use standard micro-costing techniques and time-and-motion studies to measure the cost of the implementation strategies.
Measured: 24 months
Research and non-research team members trained in implementation science.
The formation of the project ImS interest group, the number of the research consortium members and other key stakeholders trained in ImS, and the number of ImS trainings/meetings conducted. The long-term outcomes for the capacity building are; the number of research consortium members that enroll in the longitudinal ImS training at the Mak-ImS training program and the number of ImS projects developed by the regional ImS interest groups.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start5 Aug 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Youth with high likelihood of HIV acquisition shall be randomized to receive injectable PrEP (CABLA) services in either the facility model (at CRPS) or in the community model via drop-in centers or alternative community, drug distribution points. Participants shall receive PrEP (CAB-LA) at baseline or enrolment, 4 weeks after 1st dose and every 8 weeks until end of the study. Participants shall undergo blood tests for safety monitoring prior to and after initiation (6 monthly) of CAB-LA. Youth living with HIV will be identified from existing CRPS cohorts or from newly diagnosed patients seeking care. These participants shall either be non-suppressed in spite of ART experience (existing cohorts) or have a high risk for non-suppression (e.g. those newly identified, those who use alcohol, those who interrupt care or those that have not disclosed their status). Participants will receive the standard MOH plus the SY HIV care package.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MU-JHU CARE
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University Joint AIDS Program, Infectious Diseases Research Collaboration, Uganda, Baylor College of Medicine, University of California, San Francisco
- Responsible party
- Principal investigator, Philippa Musoke, MBChB, PhD, MU-JHU CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474364
- Sponsor's protocol ID
- UG1HD113241
- Acronym
- HIPCY
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Implementation Science to Understand and Design Stakeholder Informed Innovative Interventions to Improve Youth HIV Prevention and Care Continuums in Rural and Urban Uganda.
- ClinicalTrials.gov ID
- NCT06474364
- Acronym / sponsor ID
- HIPCY / UG1HD113241
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- MU-JHU CAREUniversity, hospital or other
- Collaborators
- Makerere University Joint AIDS Program, Infectious Diseases Research Collaboration, Uganda, Baylor College of Medicine, University of California, San Francisco
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. The investigators propose to evaluate novel evidence-based HIV prevention and care interventions (including Cabotegravir LongActing (CABLA) to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda. The results will provide important evidence to inform Uganda and other regional countries' policy on integrated HIV prevention, care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections (STIs) in order to reach the UNAIDS 95-95-95 targets and HIV epidemic control.
Detailed description
Adolescents and Young Adults (AYA) have a high HIV incidence and poor outcomes along the entire HIV prevention and care cascades compared to adults. Despite the high HIV burden, both uptake of oral Pre-Exposure Prophylaxis (PrEP) (HIV negatives) and achieving viral suppression (HIV positives) are sub-optimal among youth in Sub-Saharan Africa. Among youth in Uganda, uptake and persistence on oral PrEP is low, with reasons for discontinuation including: pill burden, low perceived severity of HIV, need for partner or parental approval, HIV-related stigma, fear of side-effects and health facility barriers. Cabotegravir, a is new long-acting antiretroviral (CABLA) and highly efficacious PrEP choice that can mitigate barriers to use of daily oral PrEP. The Investigators propose to evaluate evidence-based HIV prevention and care interventions to improve implementation outcomes among high-risk AYA (15-24 years) in Uganda. The study covers the continuum of care, will use novel screening methods for HIV risk, will involve teams that are highly experienced in youth-focused clinical trials and Implementation Science (ImS), will implement Ministry of Health (MOH) approved community differentiated service delivery models for delivery CABLA, will evaluate the implementation of the Sustainable East Africa Research in Community Health (SEARCH) -Youth (SY), a multi-component intervention comprising of life-stage based assessment and support to increase viral suppression in high-risk AYA with HIV, and will use hybrid effectiveness implementation designs to assess these evidence-based interventions. The aims include: Aim 1: Using the Consolidated Framework for Implementation Research (CFIR), the investigators will identify determinants of potential implementation success of two innovations: CABLA and SY implementation at the community, clinic, provider, and patient levels in 5 geographically distinct sites in Uganda. Aim 2a: Using a hybrid effectiveness implementation type II design, the investigators will assess the uptake and persistence of CAB-LA. The investigators will conduct a randomized prospective study to assess effectiveness for the provision of CABLA among high risk AYA. Effectiveness outcome will be proportion of study subjects who have initiated CABLA and persisted at 18 months of follow-up comparing facility and community delivery options. Implementation outcomes will be feasibility, acceptability, adoption and maintenance using Reach Effectiveness Adoption Implementation Maintenance (REAIM). Aim 2b: Using a hybrid effectiveness implementation type III design the investigators will assess implementation (feasibility, adoption, fidelity, and sustainment) and effectiveness of the SY intervention in increasing long-term virologic suppression (<200 c/mL) at 18 months of follow-up in 5 Clinical Research Performance Sites (CRPS) using REAIM. Aim 3: The investigators will use platforms in aims 1 and 2 to strengthen capacity of ImS and to translate findings into policy and guidelines. The study involves solid community and institutional partnerships and builds on a strong multi-disciplinary team highly experienced in innovative methods and implementation science in sub-Saharan Africa. The project, building on Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H) and Adolescent HIV prevention and treatment implementation Science Alliance (AHISA), is responsive to World Health Organization's, Uganda's MoH priorities regarding the gap in HIV services for highly vulnerable AYA. It will test a novel, scalable and integrated approach to initiate and sustain support for high-risk AYA in Low and Middle Income Countries (LMICs).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Youth with high likelihood of HIV acquisition shall be randomized to receive injectable PrEP (CABLA) services in either the facility model (at CRPS) or in the community model via drop-in centers or alternative community, drug distribution points. Participants shall receive PrEP (CAB-LA) at baseline or enrolment, 4 weeks after 1st dose and every 8 weeks until end of the study. Participants shall undergo blood tests for safety monitoring prior to and after initiation (6 monthly) of CAB-LA. Youth living with HIV will be identified from existing CRPS cohorts or from newly diagnosed patients seeking care. These participants shall either be non-suppressed in spite of ART experience (existing cohorts) or have a high risk for non-suppression (e.g. those newly identified, those who use alcohol, those who interrupt care or those that have not disclosed their status). Participants will receive the standard MOH plus the SY HIV care package.
| Arm | Type | Receives |
|---|---|---|
| Health facilty delivery model | Experimental | Drug: Long-acting Cabotegravir injectionAYA will be randomized to access CABLA at the health facility. |
| Community venue delivery model | Experimental | Drug: Long-acting Cabotegravir injectionAYA will be randomized to receive Cabotegravir from a community pharmacy/drop-in center. |
| SEARCH-YOUTH | Other | Other: SEARCH-YOUTHVirally unsuppressed or likely to be unsuppressed AYA, Youth living with HIV will receive the SEARCH-YOUTH intervention in addition to the standard MoH HIV care package. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Adolescents and young adults with increased likelihood of HIV acquisition
- One or more reactive HIV test results at Screening or Enrollment, even if HIV infection is not confirmed.
- Has a cognitive impairment that prevents understanding of study procedures and precludes informed consent.
- Plan to move out of the greater study catchment area during study period.
- Enrolled in another intervention study.
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 |
|---|---|---|
| Long-acting Cabotegravir injectionCabotegravir is a potent integrase inhibitor that has been approved for use as PrEP. | Drug | Community venue delivery model, Health facilty delivery model |
| SEARCH-YOUTHIt is a life stage informed HIV care model that dynamically supports adolescents and young adults living with HIV to achieve viral suppression and reduce depression through life event tailored solutions. | Other | SEARCH-YOUTH |
Primary outcome
Understanding the implementation science outcomes
Time frame: 18 months
Understanding of implementation outcomes: 1. adoption, 2. preference for delivery models and reasons for preference, 3. scale-up feasibility (different from trial feasibility), 4. experiences implementing the intervention components, 5. mechanisms of action of the intervention that result in success or failure (suppressed or unsuppressed, and uptake and persistence of CAB-LA), 6. sustainability, 7. key factors that impact the effectiveness of individual components of each intervention, and 8. implementation barriers and facilitators from the delivery side.
Effectiveness of 2 delivery models of increasing uptake and persistence of CABLA
Time frame: 24 months
Using a hybrid implementation-effectiveness type II design, we will assess the effectiveness of the intervention in increasing uptake and persistence of CABLA in five CRPS and their catchment areas as well as the Implementation Science indicators of feasibility, acceptability, adoption and maintenance using RE-AIM framework.
To evaluate scale up of the real-world implementation of the SEARCH-YOUTH multi-level intervention in routine HIV clinics in Uganda.
Time frame: 24 months
This aim will use a hybrid effectiveness implementation type III design to assess co-primary aims of the implementation science indicators of adoption, fidelity, and sustainment as well as effectiveness of the intervention on virologic suppression.
Cost and cost-effectiveness of the implementation of two evidence-based interventions for HIV prevention and HIV care among Adolescents and Young Adults (AYAs) in Uganda.
Time frame: 24 months
We will use standard micro-costing techniques and time-and-motion studies to measure the cost of the implementation strategies.
Research and non-research team members trained in implementation science.
Time frame: 60 months
The formation of the project ImS interest group, the number of the research consortium members and other key stakeholders trained in ImS, and the number of ImS trainings/meetings conducted. The long-term outcomes for the capacity building are; the number of research consortium members that enroll in the longitudinal ImS training at the Mak-ImS training program and the number of ImS projects developed by the regional ImS interest groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long-acting Cabotegravir injection and SEARCH-YOUTH in people with HIV, run by MU-JHU CARE at 1 site 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 0 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippa Musoke, MBChB, PhD (+256200404100, pmusoke@mujhu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding the implementation science outcomes (time frame: 18 months). The study lists 5 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 29 Jul 2025.