CHWs, mHealth, and Combination HIV Prevention

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: HealthScouts; Other: Standard of Care

• Registration Number: NCT02556957
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-09
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3773

Inclusion Criteria

• Resident of Kasensero

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HealthScouts Intervention	HealthScouts	HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
HealthScouts Intervention	Standard of Care	HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
Standard of Care	Standard of Care	Referral by RCCS to HIV services. Free HIV clinic available in the community.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rakai Health Sciences Program; 🇺🇬 Entebee, Uganda