CHWs, mHealth, and Combination HIV Prevention

Study Overview
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Brief Summary
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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.

Official Title
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CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)

Conditions
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HIV

Intervention / Treatment
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* Behavioral: HealthScouts
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resident of Kasensero Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population Prevalence of Detectable Viremia | Proportion of the entire population who have detectable HIV viremia | 4 Years | 
| ART Coverage (self-report) | Proportion of HIV+ persons who are on ART | 4 Years | 
| HIV Care Coverage (self-report) | Proportion of HIV+ persons who are in HIV care | 4 years | 
| Medical Male Circumcision Coverage (self-report) | Proportion of men who are circumcised | 4 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Incidence |  | 4 years. | 
| Sexual Behaviors (self-report) | Proportion of the population which has multiple partners and/or inconsistent or no condom use | 4 years | 
| Population HIV Viral Load | The mean viral load of HIV+ persons | 4 years | 
| HIV Counseling and Testing Coverage (self-report) | Proportion of the entire population who have received HIV Counseling and Testing | 4 years | 
| HIV Prevalence | The prevalence of HIV in the entire population | 4 years |