HIV Prevention and Care Interventions for Youth in Uganda (HIPCY)

July 25, 2025 updated by: Philippa Musoke, MBChB, PhD, MU-JHU CARE

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Philippa Musoke, MBChB, PhD
  • Phone Number: +256200404100
  • Email: pmusoke@mujhu.org

Study Contact Backup

  • Name: Judith Mbanza, M.A. MSc.
  • Phone Number: +256200404100
  • Email: jmbanza@mujhu.org

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • MU-JHU Care Ltd
        • Contact:
        • Principal Investigator:
          • Philippa Musoke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Adolescents and young adults with increased likelihood of HIV acquisition

  • AYA 15 to 24 years of age
  • Classified as high risk using our screening tool.
  • Documented HIV un-infected as per the national HIV testing algorithm.
  • Willing to use PrEP
  • Willing to provide written informed consent.
  • No plans to relocate permanently in the next 6 months
  • No suspicion of acute HIV infection:
  • Hepatitis B virus surface antigen (HBsAg)-negative and accepts HB vaccination
  • Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results.
  • HIV-uninfected, based on HIV test results obtained at screening and enrolment visit and just prior to randomization. All HIV test results must be obtained and must all be negative/non-reactive according to national HIV testing algorithm. Adolescents and young adults living with HIV
  • AYA 15-24 years' old
  • Willing to receive ART at participating health facilities
  • Have high-risk characteristics for viral load non-suppression, such as missed visits, disengagement from care, new to care, and non-suppressed viral load (VL) on the last VL testing.
  • Willing to provide written informed consent.
  • No plans to relocate permanently in the next 6 months
  • Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results

Exclusion Criteria:

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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health facilty delivery model
AYA will be randomized to access CABLA at the health facility.
Drug: Long-acting Cabotegravir injection
Cabotegravir is a potent integrase inhibitor that has been approved for use as PrEP.
Experimental: Community venue delivery model
AYA will be randomized to receive Cabotegravir from a community pharmacy/drop-in center.
Drug: Long-acting Cabotegravir injection
Cabotegravir is a potent integrase inhibitor that has been approved for use as PrEP.
Other: SEARCH-YOUTH
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.
Other: SEARCH-YOUTH
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
18 months
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.
24 months
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.
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.
Time Frame: 24 months
We will use standard micro-costing techniques and time-and-motion studies to measure the cost of the implementation strategies.
24 months
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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MU-JHU CARE

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baylor College of Medicine
University of California, San Francisco
Infectious Diseases Research Collaboration, Uganda
Makerere University Joint AIDS Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UG1HD113241 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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