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