Kasensero, Uganda, a fishing community on Lake Victoria, 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. We propose a household-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). Combination HIV Prevention (CHP) is the implementation of multiple 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, counseling, and text messaging tools to promote CHP along this entire continuum of service utilization. Intervention feasibility has been supported by pilot work, and we now propose a randomized evaluation. The hypotheses are that household residents receiving the intervention will have improved CHP service uptake and decreased HIV incidence compared to controls.
In Aim 1, the intervention will be evaluated through a pragmatic, household-randomized trial (n~1200 households, n~1800 participants). Intervention arm participants will be visited by CHWs trained to evaluate and triage household into risk categories, provide tailored CHP health counseling, linkage, and adherence support, and send targeted text messages, all supported by a mHealth decision support tool. The conceptual framework is based on a situated Information, Motivation, and Behavioral Skills (sIMB) model. The primary outcomes will be CHP service coverage and HIV incidence at 36 months. Other outcomes will be community viral load, sIMB and implementation measures, retention, virologic suppression, and sexual behaviors.
In Aim 2, mixed methods 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 also be prospectively measured to provide information on program affordability. Through these Aims, a novel, low-cost, and scalable 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.

Public Health Relevance

This study will examine whether low-cost community health workers using mobile phone-based tools can successfully triage clients and promote uptake of HIV treatment and prevention services among household residents in a Ugandan fishing community with an extremely high burden of HIV. Evidence supporting this intervention would significantly influence HIV programs working with similar populations and help bring the HIV epidemic under control.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH107275-04
Application #
9481690
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Gordon, Christopher M
Project Start
2015-05-07
Project End
2020-04-30
Budget Start
2018-05-01
Budget End
2019-04-30
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
Grabowski, Mary K; Reynolds, Steven J; Kagaayi, Joseph et al. (2018) The validity of self-reported antiretroviral use in persons living with HIV: a population-based study. AIDS 32:363-369
Olawore, Oluwasolape; Tobian, Aaron A R; Kagaayi, Joseph et al. (2018) Migration and risk of HIV acquisition in Rakai, Uganda: a population-based cohort study. Lancet HIV 5:e181-e189
Billioux, Veena G; Grabowski, Mary K; Ssekasanvu, Joseph et al. (2018) HIV viral suppression and geospatial patterns of HIV antiretroviral therapy treatment facility use in Rakai, Uganda. AIDS 32:819-824
Mwinnyaa, George; Gray, Ronald H; Grabowski, Mary K et al. (2018) Brief Report: Age-Disparate Relationships and HIV Prevalence Among Never Married Women in Rakai, Uganda. J Acquir Immune Defic Syndr 79:430-434
Grabowski, M Kate; Serwadda, David M; Gray, Ronald H et al. (2017) HIV Prevention Efforts and Incidence of HIV in Uganda. N Engl J Med 377:2154-2166
Long, Amanda; Mbabali, Ismail; Hutton, Heidi E et al. (2017) Design and Implementation of a Community Health Worker HIV Treatment and Prevention Intervention in an HIV Hot Spot Fishing Community in Rakai, Uganda. J Int Assoc Provid AIDS Care 16:499-505
Chang, Larry W; Mbabali, Ismail; Kong, Xiangrong et al. (2017) Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. Trials 18:494
Billioux, Veena G; Chang, Larry W; Reynolds, Steven J et al. (2017) Human immunodeficiency virus care cascade among sub-populations in Rakai, Uganda: an observational study. J Int AIDS Soc 20:21590
Chang, Larry W; Grabowski, Mary K; Ssekubugu, Robert et al. (2016) Heterogeneity of the HIV epidemic in agrarian, trading, and fishing communities in Rakai, Uganda: an observational epidemiological study. Lancet HIV 3:e388-e396