CHWs, mHealth, and Combination HIV Prevention (mLAKE)
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|ClinicalTrials.gov Identifier: NCT02556957|
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : December 7, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: HealthScouts Intervention
HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
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
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02556957
|Rakai Health Sciences Program||Recruiting|
|Principal Investigator:||Larry W Chang||Johns Hopkins School of Medicine|