Working… Menu

CHWs, mHealth, and Combination HIV Prevention (mLAKE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02556957
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : August 31, 2020
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: HealthScouts Other: Standard of Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3773 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HealthScouts Intervention
HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
Behavioral: HealthScouts
Other: Standard of Care
Active Comparator: Standard of Care
Referral by RCCS to HIV services. Free HIV clinic available in the community.
Other: Standard of Care

Primary Outcome Measures :
  1. Population Prevalence of Detectable Viremia [ Time Frame: 4 Years ]
    Proportion of the entire population who have detectable HIV viremia

  2. ART Coverage (self-report) [ Time Frame: 4 Years ]
    Proportion of HIV+ persons who are on ART

  3. HIV Care Coverage (self-report) [ Time Frame: 4 years ]
    Proportion of HIV+ persons who are in HIV care

  4. Medical Male Circumcision Coverage (self-report) [ Time Frame: 4 years. ]
    Proportion of men who are circumcised

Secondary Outcome Measures :
  1. HIV Incidence [ Time Frame: 4 years. ]
  2. Sexual Behaviors (self-report) [ Time Frame: 4 years ]
    Proportion of the population which has multiple partners and/or inconsistent or no condom use

  3. Population HIV Viral Load [ Time Frame: 4 years ]
    The mean viral load of HIV+ persons

  4. HIV Counseling and Testing Coverage (self-report) [ Time Frame: 4 years ]
    Proportion of the entire population who have received HIV Counseling and Testing

  5. HIV Prevalence [ Time Frame: 4 years ]
    The prevalence of HIV in the entire population

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Resident of Kasensero

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02556957

Layout table for location information
Rakai Health Sciences Program
Entebee, Uganda
Sponsors and Collaborators
Johns Hopkins University
Layout table for investigator information
Principal Investigator: Larry W Chang Johns Hopkins School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Johns Hopkins University Identifier: NCT02556957    
Other Study ID Numbers: IRB00062089
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: September 2019