Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adolescent Behavior
  • Alcohol Drinking
  • Cost Effectiveness
  • HIV
  • Hypertension
  • Maternal Child Health
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase A includes conducting parallel randomized trials to assess effectiveness, fidelity and cost and improve context-specific "fit" of prevention and treatment interventions.Masking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 15 years and 125 years
Gender
Both males and females

Description

In the "optimization" Phase A, the study will conduct randomized trials to assess effectiveness, fidelity and cost and improve context-specific "fit" of prevention and treatment interventions. Phase A will evaluate dynamic treatment packages tailored to the needs of heavy alcohol users and mobile po...

In the "optimization" Phase A, the study will conduct randomized trials to assess effectiveness, fidelity and cost and improve context-specific "fit" of prevention and treatment interventions. Phase A will evaluate dynamic treatment packages tailored to the needs of heavy alcohol users and mobile populations. Phase A will evaluate dynamic choice prevention delivered in the context of antenatal/family planning clinics, the outpatient department, in youth hubs, and in the community delivered by village health teams. Phase A will evaluate a linkage intervention for patients with hypertension. Combining effectiveness with implementation, costing and modelling outcomes, the study will optimize intervention packages with context-specific adaptations in structured consultation with stakeholders. In the "evaluation" Phase B, the study will evaluate the effects of Dynamic Prevention and Dynamic Treatment intervention packages based on data from Phase A and new advances from outside the study, alone and in combination, on prevention coverage, population-level viral suppression, and HIV incidence, as well as other health outcomes, in a 2x2 balanced, community randomized factorial design. Phase B will measure outcomes within longitudinal cohorts of residents living within study communities. Phase B will evaluate population-level intervention implementation outcomes, elucidate mechanisms of action and component intervention effects, and estimate incremental costs and gains. Finally, the study will use the HIV Synthesis Model to model outcomes and costs of Phase B results over a period of decades to inform policy and stakeholder decisions to adopt successful strategies to achieve and sustain HIV epidemic control. Structured stakeholder consultations are formally incorporated in the study design and leverage regular and ongoing collaborations the study team has with the HIV, non-communicable disease and general health leads in Kenya and Uganda Ministries of Health and PEPFAR implementing partners at the national and the regional level.

Tracking Information

NCT #
NCT04810650
Collaborators
  • University College, London
  • Infectious Diseases Research Collaboration, Uganda
  • Makerere University
  • Kenya Medical Research Institute
  • University of California, Berkeley
  • University of Massachusetts, Amherst
  • University of Pennsylvania
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute of Mental Health (NIMH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Diane Havlir, MD University of California, San Francisco Principal Investigator: Moses Kamya, MBChB, PhD Makerere University Principal Investigator: Maya Petersen, PhD University of California, Berkeley