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CHWs, mHealth, and Combination HIV Prevention (mLAKE)

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ClinicalTrials.gov Identifier: NCT02556957
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 20, 2015
First Posted Date  ICMJE September 22, 2015
Last Update Posted Date August 31, 2020
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • Population Prevalence of Detectable Viremia [ Time Frame: 4 Years ]
    Proportion of the entire population who have detectable HIV viremia
  • ART Coverage (self-report) [ Time Frame: 4 Years ]
    Proportion of HIV+ persons who are on ART
  • HIV Care Coverage (self-report) [ Time Frame: 4 years ]
    Proportion of HIV+ persons who are in HIV care
  • Medical Male Circumcision Coverage (self-report) [ Time Frame: 4 years. ]
    Proportion of men who are circumcised
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • HIV Incidence [ Time Frame: 4 years. ]
  • Sexual Behaviors (self-report) [ Time Frame: 4 years ]
    Proportion of the population which has multiple partners and/or inconsistent or no condom use
  • Population HIV Viral Load [ Time Frame: 4 years ]
    The mean viral load of HIV+ persons
  • HIV Counseling and Testing Coverage (self-report) [ Time Frame: 4 years ]
    Proportion of the entire population who have received HIV Counseling and Testing
  • HIV Prevalence [ Time Frame: 4 years ]
    The prevalence of HIV in the entire population
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHWs, mHealth, and Combination HIV Prevention
Official Title  ICMJE CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
Brief Summary

Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field.

The investigators propose an implementation science, cluster-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support and counseling tools to promote CHP along this entire continuum of HIV service utilization. The hypotheses for this implementation science research are that residents in clusters receiving the implementation intervention will have improved CHP service uptake and decreased Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.

The intervention will be evaluated through a pragmatic, cluster-randomized trial nested within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort Study (RCCS). Intervention arm participants will be visited in their place of residence by CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP health counseling, linkage, and adherence support, all supported by a mHealth decision support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will be HIV incidence, population viral load, implementation measures, retention, virologic suppression, and sexual behaviors.

Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will be prospectively measured to provide information on program affordability.

Through this study, a novel, low-cost, and scalable implementation intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE HIV
Intervention  ICMJE
  • Behavioral: HealthScouts
  • Other: Standard of Care
Study Arms  ICMJE
  • Experimental: HealthScouts Intervention
    HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
    Interventions:
    • Behavioral: HealthScouts
    • Other: Standard of Care
  • Active Comparator: Standard of Care
    Referral by RCCS to HIV services. Free HIV clinic available in the community.
    Intervention: Other: Standard of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2020)
3773
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
2500
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Resident of Kasensero

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02556957
Other Study ID Numbers  ICMJE IRB00062089
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Larry W Chang Johns Hopkins School of Medicine
PRS Account Johns Hopkins University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP